CN105078426A

CN105078426A - System, method and device for diagnosing sleep apnea

Info

Publication number: CN105078426A
Application number: CN201410193275.1A
Authority: CN
Inventors: 邱春元
Original assignee: 邱春元
Current assignee: Zhengzhou Fangxin Biotechnology Co.,Ltd.
Priority date: 2014-05-08
Filing date: 2014-05-08
Publication date: 2015-11-25
Anticipated expiration: 2034-05-08
Also published as: CN105078426B

Abstract

The invention provides a system, a method and a device for diagnosing sleep apnea. In one example, the device for diagnosing respiratory tract obstruction is provided, and the device comprises a wearable hollow nasal tube positioned in the upper respiratory tract and above the stenosis point, and an end imaging sensor connected to the nasal tube for collecting the image data of the respiratory tract. The device further can comprise a controller and a communication interface which are in communication connection with a selected remote device and used for forwarding the image data of the respiratory tract to the remote device for determining the respiratory tract obstruction. In some examples, a method can be provided. The method comprises the following steps: receiving the image data of the respiratory tract from the remote end imaging sensor connected to the nasal tube above the stenosis point and in the upper respiratory tract, analyzing the image data of the respiratory tract, and displaying the image data of the respiratory tract in a sleep research report for recognizing the respiratory tract block relevant to obstructive sleep apnea.

Description

For diagnosing system, the method and apparatus of sleep apnea

Technical field

The present invention relates generally to for diagnosing system, method and apparatus with monitoring sleep, parahypnosis, sleep apnea and correlation behavior, relates more particularly to the system for observing respiratory passage unblocked in sleep, method and apparatus.

Background technology

Obstructive sleep apnea (OSA) is that a kind of because tongue periodically makes that upper respiratory tract subsides (collapse), the inflow of block air causes people in sleep cycle frequently breathless disease.Although estimate be 3-7% in male in the prevalence of U.S. OSA and be 2-5% in women, in some crowd obese patient of 28% (the such as body-mass index higher than), this prevalence sharply increases.In addition, due to the diagnosis limitation of current known method, moderate may not make a definite diagnosis for many years up to the women of 93% and the male of 82% to severe OSA is suffered from.

The sleep study being designed for diagnosis and detection OSA is using the sleep study center of polysomnogram (PSG) to carry out usually.But PSG comprises patient is connected to multiple cable between sleep period, and this can disturb sleep cycle, thus increase the difficulty of diagnosis.Portable PSG unit is known and is designed for minimizing PSG complexity further, but still depends on the physiological reaction of closing the delay after occurring at respiratory tract.Known being aimed at of endoscopic technique is breathed and snoring in sleep cycle monitoring.But this technology may still require heavy equipment with the air-flow of monitoring in upper respiratory tract but also the means lacked for detecting sleeping posture, is especially absent from the scene well-trained professional and observes in the remote environment of sleep cycle.

Summary of the invention

Inventor has recognized that the shortcoming of said method, and discloses the wearable hollow nasal tube be positioned in upper respiratory tract above narrow point in the present invention, and it comprises and is connected to described nasal tube to collect the end imaging sensor of respiratory tract view data; This remote-control device is forwarded to determine controller and the communication interface of respiratory tract obstruction with the remote-control device for being communicatively connected to selection and by described respiratory tract view data.In an embodiment, this device can comprise for nasal tube described in anchoring further with the inflatable bladders making the described end imaging sensor being positioned at this nasal tube top end be positioned at respiratory tract image data collection position.Thus this device is positioned the top of narrow point described in nasopharynx, and end imaging sensor relative to nose Open Side Down angularly, it allows the viewing of enhancing of respiratory tract.As mentioned above, this device can comprise one or more biophysics sensor further, for the detection of the enhancing of the respiratory passage unblocked between OSA screening and diagnostic period, also can comprise and be configured for the monitoring air-flow when collecting the visual pattern of upper respiratory tract and the air sampling mouth performing air analysis (such as, carbon dioxide monitoring).This device advantageously can comprise the head pose sensor for detecting the device orientation relative to head pose further, and respiratory passage unblocked is associated to sleeping posture by its permission in sleep study.Thus, by arranging nasal tube and end imaging sensor above upper airway stricture point, breathing pattern can be monitored in sleep and not disturb sleep cycle, simultaneously this device record and be connected with by network be connected remote computing device communicate.In this way, described apparatus and method can be advantageously used in by making respiratory tract direct imaging and diagnose OSA, particularly in response to sleeping posture, especially when the long-range generation of sleep activity.

As described herein, in some examples, use the sleep study of device of the present invention and system can perform in the first place, and synchronously or subsequently remotely analyze one or more breathing pattern in the second place, it allows to carry out the real-time or early stage diagnosis of parahypnosis for patient and medical professional in mode more easily.Such as, patient cosily can carry out sleep study evening in the U.S. in its family, simultaneously carries out observing daytime in China (or other places) and analyzes the result of sleep study, or on the contrary.In addition, in some embodiment, this device can comprise timer or timing means, and recorded measured value is carried out time mark by its permission, thus synchronously for the further data analysis of sleep pattern.

According to a further aspect in the invention, a kind ofly comprise wearable hollow nasal tube for detecting respiratory tract obstruction in sleep to diagnose the device of OSA, described hollow nasal tube is positioned the top of narrow point in upper respiratory tract; End imaging sensor, described end imaging sensor is connected to described nasal tube to collect respiratory tract view data; Controller and communication interface, described controller and communication interface for being communicatively connected to the remote-control device of selection and described respiratory tract view data being forwarded to this remote-control device to determine respiratory tract obstruction in sleep.

In one embodiment, described device also comprises for nasal tube described in anchoring with the inflatable bladders making described end imaging sensor be positioned at respiratory tract image data collection position.

In one embodiment, described nasal tube is relative to longitudinal flexion.

In one embodiment, described end imaging sensor is positioned at the top end of described nasal tube with the top making the image data collection position of described end imaging sensor be positioned at narrow point described in nasopharynx, and relative to nose, Open Side Down angularly to watch respiratory tract further for wherein said end imaging sensor.

In one embodiment, described end imaging sensor is in video camera and thermal imaging device.

In one embodiment, described device also comprises and throwing light on for the light source of respiratory tract image data collection to described respiratory tract.

In one embodiment, described device also comprises sound detection sensor, and wherein said sound detection sensor is at least one in mike, stethoscope or Doppler sounds device.

In one embodiment, described device also comprises the oxygen saturation sensor for collecting respiratory tract data, and wherein said respiratory tract data are forwarded to the remote-control device of selection together with described respiratory tract view data.

In one embodiment, described device also comprises head pose sensor, and for collecting the head pose data relative to device orientation, wherein said head pose data are forwarded to the remote-control device of selection together with described respiratory tract view data.

In one embodiment, described device also comprises head pose sensor, and for collecting the head pose data relative to device orientation, wherein said head pose data are forwarded to the remote-control device of selection together with described respiratory tract view data; Described head pose sensor comprises accelerometer, gyroscope and for detecting in the sensor of motion.

In one embodiment, described device also comprises sound detection sensor, and wherein said sound detection sensor is at least one in mike, stethoscope or Doppler sounds device; Described device also comprises head movement enumerator, for the head pose data of the number of times and frequency of collecting the head movement comprised in sleep.

In one embodiment, described device also comprises one or more biophysics sensor, and it comprises EEG sensor, EKG sensor and can one or more based in the carbon dioxide monitoring sensor of the gas level in the data determination respiratory tract collected or exchange rate.

According to a further aspect in the invention, a kind of system for remote diagnosis obstructive sleep apnea comprises: the tubulose respiratory tract assessment apparatus being arranged in upper respiratory tract, described tubulose assessment apparatus comprises: the wearable hollow nasal tube with end imaging sensor, and described end imaging sensor is used for direct viewing respiratory tract to generate respiratory tract view data; For determining that respiratory tract air flow is to generate the gas flow indicator of airstream data; For to collect and by the processor of forwarded respiratory tract view data and airstream data, communication interface and memorizer; With the remote computing device for analyzing the breathing pattern data relevant to obstructive sleep apnea; And the communication connection between described tubulose respiratory tract assessment apparatus and remote computing device, described communication connection is used for described respiratory tract view data to be forwarded to described remote computing device to determine respiratory tract obstruction.

In one embodiment, described gas flow indicator is sound detection sensor.

In one embodiment, described system also comprises oxygen tissus sensor.

In one embodiment, described system also comprises head pose sensor and head movement enumerator, for determining head pose data in sleep cycle.

In one embodiment, described system also comprises one or more biophysics sensor, and it comprises EEG sensor, EKG sensor and can based on the carbon dioxide monitoring sensor of the gas level in the data determination respiratory tract collected or exchange rate.

In one embodiment, to programme the data received from described tubulose respiratory tract assessment apparatus with automatic analysis to described remote computing device, wherein said respiratory tract view data is by time mark.

In one embodiment, described system also comprises for wear position that nasal tube is anchored at selection one or more with what collect in the inflatable bladders of respiratory tract view data and nose retainer by described.

According to a further aspect in the invention, a kind of for monitoring the narrow method of the upper respiratory tract relevant to obstructive sleep apnea, comprise and receive respiratory tract view data, described respiratory tract view data record in sleep cycle from the long-range end imaging sensor of the nasal tube of the top being connected to narrow point in upper respiratory tract; And analyze described respiratory tract view data and in sleep study report, show described respiratory tract view data to identify that the respiratory tract relevant to obstructive sleep apnea is closed.

In one embodiment, described method also comprises from oxygen saturation sensor, for determining the one or more reception bio-physical datas the carbon dioxide monitoring sensor of gas level in respiratory tract or exchange rate and sound detection device between sleep period, and analyzes described bio-physical data and show described bio-physical data in described sleep study report.

In one embodiment, the sensor that described method also comprises from indicating relative to the head pose of described nasal tube receives head gesture data, and analyzes described head pose data and show described head pose data in described sleep study report.

In one embodiment, described method also comprises reception airstream data, and analyzes described airstream data and show described airstream data in the described sleep study report of described airstream data.

Separately or by reference to the accompanying drawings according to following detailed description of the invention, above-mentioned advantage of the present invention, other advantages and feature will be clearer.Should be understood that and provide foregoing for introducing the selection of the concept further described in a specific embodiment in simplified form.This is not meant to be key or the essential characteristics of theme required for protection, and its scope is only defined by the claims.In addition, theme required for protection is not limited to the embodiment of any shortcoming solved described in above-mentioned or of the present invention any part.

Accompanying drawing explanation

Read by independent or reference accompanying drawing the example being referred to herein as the embodiment of detailed description of the invention, advantage of the present invention can be understood more fully, wherein:

Figure 1A shows the illustrative diagram according to system of the present invention;

Figure 1B-Fig. 1 D shows example respiratory tract with the normal suction illustrated in sleep and represent completely and the respiratory tract of obstruction that blocks of part respiratory tract;

Fig. 2 A and Fig. 2 B shows the exemplary embodiment of the system of the Figure 1A with the respiratory tract assessment apparatus be inserted in nasal cavity;

Fig. 3 A and Fig. 3 B shows according to exemplary hollow nose imaging device of the present invention;

How Fig. 4 can based on the data determination head pose collected if diagrammatically illustrating head pose sensor;

Fig. 5 shows the enlarged drawing with the hollow nose image forming tube being changed the example tunable sensor of posture by airbag deployment;

Fig. 6 A-Fig. 6 D shows the example schematic diagram that respiratory tract is closed and measured (measurement);

Fig. 7 shows and how collects various data together with the visual pattern of Fig. 6 and illustrate to diagnose the example of sleep apnea;

Fig. 8 shows the example flow diagram of the operation according to respiratory tract assessment apparatus of the present invention; And

Fig. 9 is the example flow diagram based on the data diagnosis OSA received from respiratory tract assessment apparatus.

Detailed description of the invention

This document describes the wearable tubulose respiratory tract assessment apparatus for determining upper airway stricture (airwayconstriction) and method, the vision figure of described equipment and method permission upper airway stricture combines the respiratory tract sensed and collects together with head pose data.In one example, this device is configurable for the signal that transmits and receive data, thus the three unities carry out sleep study and analyze in second remote site data time can carry out real-time Data Transmission and the Long-distance Control of this device.Comprise head pose sensor to allow further in sleep study, respiratory passage unblocked to be associated with sleeping posture and to diagnose for the OSA strengthened.Although describe the device comprising the one or more sensors (such as air-flow and/or carbon dioxide monitoring sensor) operated in conjunction with described end view image-position sensor in some embodiment, it should be understood that in some embodiment, this device can comprise there is end imaging sensor wearable hollow nasal tube to collect respiratory tract view data, and other sensors one or more can be its operations can work in coordination with and/or synchronous peripheral unit (such as commercially available pulse blood oxygen instrument) with respiratory tract assessment apparatus herein.Therefore, respiratory tract assessment apparatus of the present invention allows the imaging being collected in the upper respiratory tract in sleep in conjunction with other sleep physiology data, for diagnosis obstructive sleep apnea (OSA).As described herein, in some embodiment, respiratory tract assessment apparatus can comprise nasopharynx imaging sensor and light source, head pose sensor, information processing centre and control system, and various sensor, such as pneumatic sensor, oxygen and/or carbon dioxide sensor (such as carbon dioxide monitoring sensor), electroencephalogram (EEG) sensor, electrocardiography transducer (EKG), and one or more sound detection devices etc.Especially, the nose imaging sensor of respiratory tract assessment apparatus can be positioned on the nasal cavity above oropharynx, with the visual confirmation of the obstruction allowing respiratory passage unblocked or caused by the tongue subsided and uvula in OSA.

Described device is further configured to and is placed in nasal cavity at long-time internal fixtion.Such as, in sleep study, user can wear this tubular equipment and reach 12 hours, and data are collected in the following manner.Therefore, also can design wireless device for ease of activity, carry out with the interruption allowing sleep study patient to happen occasionally less in sleep cycle (such as, use toilet, drink water) time.Therefore, this device wearable device can be easily inserted in cavity and in whole sleep study, to keep the view of the substantial constant in respiratory tract region as one.

As further example, this device can be positioned in nasal cavity in the state waken, with the baseline measurements of recording respiration road diameter with other physiological parameters.Then, same a little parameters can trailer record in the sleep state in later stage, thus allows the determination of one or more factor, includes but not limited to, the generation of respiratory tract obstruction or OSA, frequency and degree.In addition, comprise head pose sensor, in some embodiment, can realize directed relative to the device of the head pose determined in sleep cycle.In this way, this device can record the visual pattern that the respiratory tract diameter relevant to body gesture or head pose changes or block.For clarity sake, use identical Reference numeral to indicate similar element in the accompanying drawings.

Fig. 1 shows the illustrative diagram according to OSA diagnostic system 100 of the present invention.As detailed below, respiratory tract assessment apparatus 102 can comprise for the various sensors manifested with detect the ventilatory pattern relevant to respiratory tract obstruction.Such as, in embodiment as herein described, end imaging sensor 104 can be hotness video camera or the conventional DRAM at the top end place of pipe in respiratory tract assessment apparatus 102, for absorbing the image of upper respiratory tract above upper airway stricture point.The end that end imaging sensor can be positioned this pipe in some embodiment should be understood, near the end that roughly can be positioned at this pipe in other embodiments, any other position that the pickup image or carry out that maybe can realize the upper respiratory tract above upper airway stricture point is observed.Nose imaging sensor 104 allows further the collection of the video (such as, 1 frame/second) of continuous print or interval, thus breathing in upper respiratory tract in record sleep cycle dynamically, respiratory passage unblocked and change anatomically.Especially, this can use image to determine the degree of upper respiratory tract obstruction relative to baseline profile (the profile)/data of collecting when being regained consciousness by diagnosis person/patient and persistent period.Such as, imaging data can be used to determine from the image collected or the respiratory tract that calculates narrows (such as to identify, if partial blockage, more than 10 seconds, is diagnosed as hypopnea) or the frequency of subside (such as, if total blockage, more than 10 seconds, is diagnosed as asphyxia in fact) and persistent period.In this way, the one of asphyxia-hypopnea index (AHI) as the diagnosis index of OSA can be generated further.AHI refers within the time period, the number of times of the asphyxia such as, occurred in sleep per hour and hypopnea outbreak.Although the secondary substance instruction using the diagnosis of traditional OSA of AHI to depend on complete or incomplete respiratory tract obstruction routinely obtains indirectly, but by contrast, device as herein described and system use the direct imaging of respiratory tract to obtain AHI.In addition, also as described herein, in order to light source (such as LED bulb) can also be comprised, to strengthen the viewing environment in internal cavity to upper respiratory tract illumination.But, be in the embodiment of thermal imaging sensor at end imaging sensor, optionally can comprise light source.

In some examples, respiratory tract assessment apparatus 102 can comprise insertion tube.Such as, in the embodiment in diagram but not as restriction, two pipes be inserted in nasal cavity and/or oral cavity can be provided.In some examples, this pipe can communicate to connect with one or more air velocity also referred to as pneumatic sensor and carbon dioxide monitoring sensor 106.These sensors can be comprised in a device, for measure in instruction sleep cycle or some other time interim air-flow, gas level and/or exchange rate (exchangerate).Comprise the dependency that one or more pneumatic sensor allows to distinguish from normal reflex response (such as, unconsciously to swallow, sneeze and/or cough) visual pattern of OSA further in sleep.As described herein, can allow to comprise one or more pneumatic sensor in the device carrying out individually or simultaneously being measured by air-flow or the CO2 of nose, mouth and/or trachea.

In some example, the generation of upper airway stricture may depend on the specific sleep posture adopted in sleep cycle.Therefore, in an exemplary device, can built-in head pose sensor 108, be used to indicate the orientation of the device relative to patients head's posture.Such as, head pose sensor 108 can be the accelerometer measuring the Local inertial reference frame relative to gravitational field.Therefore, respiratory tract assessment apparatus can allow the location of the device determined relative to gravitational field in one or more cavity relative to the placement of head pose.Head pose data can be used to determine or to be extracted in the patient sleeps's posture (such as, lying down with supine back floating position) in whole sleep cycle.Patient sleeps's gesture data can block data syn-chronization further and be associated with other sensors and respiratory tract.Consequently, can for various sleeping posture, such as back floating position, posture of lying on the left side or right lateral position, set up AHI.In addition, the head movement enumerator collected in sleep and comprise the head pose data of head movement number of times or frequency can also be built up in, to determine sleep quality.

In some embodiment, also can communicate to connect with this device for the various extra biophysics sensor 110 detecting EEG (electroencephalogram), EKG (electrocardiogram), EOG (electro-oculogram), EMG (electromyogram) and/or tissue oxygenation saturation.Therefore, in one example, this device can comprise oxygen saturation sensor to collect respiratory tract data, and these respiratory tract data are forwarded to by the remote-control device selected together with respiratory tract view data.About sensor placement, biophysics sensor can be positioned on the surface of device (and/or being positioned at device) or to be positioned on relevant adnexa or assembly.Comprise biophysics sensor can collect the autonomic reflex data of selection and it is associated with visual pattern, for the confirmation of OSA diagnosis.In another exemplary embodiment, respiratory tract assessment apparatus 102 also can comprise the one or more trachea transducer 112 for synchronously monitoring various state above and below narrow point.Such as, trachea transducer 112 can be the sound detection device of such as mike, stethoscope or Doppler sounds device.

In another exemplary embodiment, trachea transducer 112 can be oxygen sensor for monitoring in trachea oxygen level and/or the nitrogen level naturally existed or nitrogen sensor.In another example, this trachea transducer can be such as be configured for produce the permanent magnet in magnetic field or the magnetic sensor of electric magnet in trachea.As nonrestrictive example, trachea transducer 112 and the air sampling tube 220 (as shown in Figures 2 and 3) of any position be located on device can be comprised, with air in nasal cavity and/or oral cavity and the air-flow of sampling.The use of trachea transducer and air sampling tube can provide extra gas analysis, such as, by carbon dioxide monitoring or mass spectral analysis etc.

Return Fig. 1, controller 120 can comprise processor 122, memory element 124 and communication interface 126.Processor 122 and communication interface 126 can be connected to memorizer 124 by bus.Controller 120 also can be configured to and communicates with remote computing device 130 with by communication interface 126.In some embodiment, memorizer 124 can comprise nonvolatile memory and volatile memory, and program or algorithm can be stored by nonvolatile memory and be performed, to complete operation as herein described by the processor of the part using volatile memory.Controller 120 also can comprise 24 hours able to programme timers and timer arrangement, and it allows the synchronous of data collection process, and in some embodiment, the data that also can realize further collecting carry out time mark for further analysis.

Respiratory tract assessment apparatus 102 can be configured to and communicates with remote computing device 130.Therefore, controller 120 can comprise the transmitter for sending and receive wireless signal further.Such as, in device, the local data stored connect (such as by one or more network, the Internet by WiFi connects) be uploaded to remote computing device 130, for the well-trained professional's analyzing and diagnosing by supplier or doctor's office and/or sleep study center.Thus, real time remote can be realized according to device of the present invention in some embodiment or upload data at the end of research.Alternatively, or extraly, the port of such as data input/output port can be comprised, in order to directly this device is connected to remote computing device (such as, computer in doctor's office or other user's sets), it can allow, at the end of research, the data of storage are directly downloaded to accountant.

In some examples, the data of remote logging stored in memory element 124 manually can be watched by one or more well-trained professional and/or by data processor automatic analysis.Such as, OSA analytical tool case 132 can be located on remote computing device 130, for analyzing one or more data pattern sensed, to diagnose the degree of obstructive sleep apnea or upper airway stricture in sleep cycle.For the sake of simplicity, analytical tool case 132 comprises the ventilatory pattern analyzer 134 for the analysis and comparison one or more data patterns relevant to obstructive sleep apnea as shown in the figure; From other reflex actions occurred in upper respiratory tract, distinguish the image model analyzer 136 of closedown for assessment of obstruction or degree of congestion simultaneously; For analyzing the biophysics pattern analyzer 138 of one or more bio-physical data pattern; Export with the formatted print for generating diagnostic result with the OSA Report Builder 140 contributing to diagnosis.

Although OSA analytical tool case 132 comprises pattern analyzer 134, image model analyzer 136, biophysics pattern analyzer 138 and Report Builder 140 as shown in the figure, these instruments are that example illustrates and unrestricted.Other analysis programmes are also possible.As diagram, analytical tool case 132 can comprise for the instrument based on the data diagnosis OSA collected.Such as, can one or more to calculate AHI, the i.e. asphyxia of generation per hour and the asphyxia-hypopnea index of hypopneic attack times in use instrument at this.As mentioned above, when partial blockage continues 10 seconds or more of a specified duration, hypopnea occurs, and asphyxia occurs when total blockage in fact continues 10 seconds or more of a specified duration.In addition, AHI scale can be used to diagnose OSA based on the attack times detected.As an example, when 5-15 outbreak per hour being detected, be diagnosed as slight OSA; Moderate OSA is diagnosed as when 15-30 outbreak per hour being detected; And detect per hour more than 30 times outbreak time be diagnosed as severe OSA.Extraly or alternatively, this data can combine to realize OSA and diagnose with the information from other sensors.Such as, the head movement collected by head pose sensor 108 or gesture data can be used for combining to determine sleep quality further with the image of respiratory tract.As another example, measure (such as, passing through pulse blood oxygen instrument) together with the periphery oxygen saturation (SPO2) declined or oxygen saturation also can change with EEG or EKG and be associated with one or more in data pattern or sleeping posture.In this way, described device is used in when determining sleep quality and diagnoses OSA.

Figure 1B and Fig. 1 C shows the example respiratory tract illustrating and how the passage blocked occurs because tongue subsides in sleep cycle.As shown in the figure, to suck pattern for reference for the accompanying drawing example shown together with the unobstructed respiratory tract of various anatomical features and the respiratory tract of obstruction.Such as, Figure 1B shows the nose air-flow 150 and the implication stream 152 that enter nasal cavity and oral cavity when normal suction respectively.Then, because respiratory tract is unobstructed and do not blocked by the tongue subsided, therefore two air-flows can accumulate and be directed into trachea further and the single air-flow arriving individual lung (not shown).On the contrary, Fig. 1 C shows and subsides when tongue and become obstruction to respiratory tract when respiratory tract back promotion soft palate (comprising uvula) and epiglottis.In response to obstructing event, as the X respectively shown in 160 and 162 places binds indicated by line, nose air-flow and implication fail to be convened for lack of a quorum and are blocked.

For clarity sake, Fig. 1 D shows the respiratory tract of partial blockage, and wherein turbulent air flow occurs on narrow point.As shown in the figure, in one example, nose air-flow 170 can produce and implication stream 172 is blocked simultaneously.But other examples of relative wind configuration are also possible.Therefore, two air-flows also can part unobstructed, or alternatively, in some example, air can flow through oral cavity and the air-flow flowing through nasal cavity is blocked simultaneously.Because respiratory tract partial blockage, the air-flow 174 of turbulent flow can produce, and is wherein chaotic and irregular by the air-flow of narrow point.In some example, when owing to breathing in sleep by the air movement of the respiratory tract of partial blockage cause in respiratory system mechanism occur vibration time, turbulent flow air-flow 174 can cause undesirable snoring sound.Consequently, in some example, air-flow 176 can shown in dotted linely reduce relative to nose air-flow 170.In this way, one or more respiratory tract can become blocking, and its use can detect according to method of the present invention.

Fig. 2 A and Fig. 2 B shows the exemplary embodiment according to OSA diagnostic system 100 of the present invention.Such as, Fig. 2 A shows the respiratory tract assessment apparatus 102A with the nasal tube 202A be inserted in nasal cavity 204.Nasal tube 202A can be the flexible, hollow tube being applicable to be inserted in nasal cavity.In some examples, nasal tube 202A can comprise allow above narrow point 206 by device downward bias to and be easy to insert and be placed in soft, the flexible beak most advanced and sophisticated 203 in cavity or other configurations.In illustrated first embodiment, respiratory tract assessment apparatus 102A comprises the nose retainer 210 of the mesh 212 being entered respiratory tract with permission air by hollow devices.This device also can comprise the guide gasbag 250 having and can be used for the air injection ports 232 (or valve) of being inflated by fill opening 252 pairs of air bags 250.In diagram embodiment, inflatable bladders 250 can be comprised device is anchored at original position during sleep study together with nose retainer.In this way, airbag aeration is allowed to the contact of the increase between air bag and nasal cavity, thus to play device anchoring in sleep study and prevent this device inwardly or the effect of outwards motion.Therefore, make the arrangement stabilisation of device, it allows according to the more lasting imaging circumstances of method herein and the clinical practice of enhancing.In addition, may be the tunnel that sealing between the air bag 250 of one or more air bag and nasal cavity can create further by hollow devices in some embodiment, it plays the effect of the air-flow be guided through.Therefore, be optimized to realize the sensitiveer diagnostic measures in sleep study by the air-flow of device.

In the example shown in the series of figures, nasal tube 202A has 70 degree to the 90 degree pipes bent at top end, watches respiratory tract for when being positioned over above narrow point 206.Therefore, illustrated unrestriced tube shape can form the view of the enhancing of uvula, soft palate and upper airway stricture by end imaging sensor 104.At this, end imaging sensor 104 is video camera for the sake of simplicity.But in other embodiments, end imaging sensor can be thermal imaging device.Therefore, end imaging sensor 104 is the video cameras of the top end being positioned at nasal tube 202A.Although describe in embodiment herein for the enhancing view of upper airway stricture bending device or there is the device of turn of bilge, it is conceivable that end imaging sensor 104 may further include the assembly for regulating the location relative to nasal tube.But for the sake of simplicity, end imaging sensor 104 is described as having the orientation knowing view that can provide narrow point 206 when inserting in nasopharynx as shown in the figure at this.Such as, when the top end of nasal tube 202A is positioned in nasopharynx as shown in Figure 2 A, tube end is formed as relative to nose retainer 210 in 70 degree of angles to 90 degree of scopes.Therefore, Open Side Down angularly to watch respiratory tract relative to nose for end imaging sensor, and the angle of settling for the sake of simplicity usually close to but be less than 90 degree, its any narrow optimization viewing allowing respiratory tract and Qi Nei to occur.

Fig. 2 B shows second embodiment of respiratory tract assessment apparatus 102B, its also comprise have for be easy to insert and downward bias to soft, flexible end and the nasal tube 202B at flexible beak tip 203, to be increased in the easiness of the arrangement in the nasal cavity 204 above narrow point 206.In an embodiment, beak tip 203 to be integrated in flexible nasal tube and to comprise the working of plastics with beak profile.Thus the most advanced and sophisticated and nasal tube of this beak can form single, continuous print structure.But, this is unrestricted and in other embodiments, this softness and the beak of flexibility tip also can comprise the tip of the separation be configured to except the end of nasal tube and/or can be made up of other materials (such as, rubber), as long as this material can be inserted in health for a long time.As mentioned above, most advanced and sophisticated allow tubulose respiratory tract assessment apparatus more easily and atraumatic ground is inserted in nasal cavity, because traumatic insertion (with hemorrhage) can operate by disturb sensor, and in some example, also damage the definition of imageing sensor.Such as, when being inserted in nasal cavity, most advanced and sophisticated meeting is only at nasopharynx overlying contact cavity back.In response to this, beak most advanced and sophisticated flexible and slide nasal cavity with produce be conducive to settling above upper airway stricture 206 downward bias of end imaging sensor 104 to.In addition, nasal tube 202B has the diameter that is less than nose cut outs and certain length (such as, be less than the distance between nose and ear) hollow pipe, this hollow pipe can be placed in nasal cavity (such as, before oropharynx in nasopharynx) above narrow point.As this example provide, device can allow spontaneous respiratory nasal and the non-disrupted sleep cycle.As further shown, nasal tube 202B is connected to nose retainer 210, and nasal tube 202B is divided into Part I and Part II by it, and it is too far to prevent this device from inserting in nasal cavity, and it can make pipe walk around narrow point and damage diagnostic procedure, and then becomes therapy equipment.Therefore, nose retainer 210 makes this device relative to the position stabilization of nasal cavity, thus provides the constant environment for watching respiratory tract passage, particularly viewing in long-time (such as, 4-10 hour) relevant to the length of one's sleep.In some embodiment, the air sampling tube 220 that can be positioned mouth 222 front can be connected to nasal tube 202B and nose retainer 210.But this is unrestricted, and this pipe can be connected in other positions along nasal tube 202B.

Air sampling tube 220 is used to indicate mouth and breathes.In an exemplary embodiment, air sampling tube 220 can comprise mike or other audio devices.In some examples, mike can be positioned the front of neck to indicate air-flow.Therefore, in some example, the length of air sampling tube 220 quite can grow to reach neck region in sleep study.But, the length of air sampling tube 220 is nonrestrictive, and in other examples, air sampling tube can be the air sampling mouth for gas analysis, wherein air-flow with constant polydispersity index for carbon dioxide monitoring analysis (such as, from the sealed tube that air sampling tube 220 stretches out).Do not have air-flow by nasal cavity because some people is complete mouth breather, comprise air sampling tube 220 and substantially can eliminate false positive results.For these people, the air-flow from mouth or mike indicates breathing, and the image collected illustrates airway collapse, these information instruction false positive results, and is not considered to apnea episodes.In addition, when the air-flow by mouth, nose and trachea mike not detected, but when image illustrates unobstructed respiratory tract, false negative can be there is, such as occur in central sleep apnea, this is the brain state (braincondition) occurred due to the instability generation neurological breathing signal of Human feed back's mechanism.

In Fig. 2 A and Fig. 2 B, each respiratory tract assessment apparatus is connected to network 240.Therefore, mancarried device can be configured to and is connected to network 240, and can realize the communication with multiple remote computing device 242, it can be configured to the data that automatic analysis receives simultaneously.Accountant 242 can be positioned at away from the place of carrying out sleep study.Therefore connection between respiratory tract assessment apparatus and accountant 242 allows remotely this device of monitor and forecast.Such as, the information (such as, visual pattern) from end imaging sensor 104 can be sent to accountant 242 in sleep study.And then user also can receive the instruction of automatic network 240.In this way, remotely can monitor, control and/or supervise sleep study.Between respiratory tract assessment apparatus and network be connected to device in sleep study center or home environment time or be useful when being studied by not well-trained professional.Therefore, sleep study can be carried out at the three unities, and in identical place by using the personnel of accountant 242 to supervise.Or user can use accountant 242 remotely to operate and respiratory tract assessment apparatus disclosed in controlling.Such as, by doctor's data collection the three unities, can study in another place simultaneously.In addition, respiratory tract assessment apparatus can by being connected through the network of wireless connections or wired connection with accountant.

Fig. 3 A and Fig. 3 B schematically illustrates according to hollow nose imaging device of the present invention.In figure 3 a, illustrate in greater detail relative to the respiratory tract assessment apparatus 102A described in Fig. 2 A.As mentioned above, respiratory tract assessment apparatus 102A is first embodiment of hollow nasopharynx imaging device 300A.As mentioned above, respiratory tract assessment apparatus 102A comprises that to have at the top end of flexible pipe be as shown in the figure 70 degree to 90 degree bending hollow nasal tube 202A.Therefore, the view of the enhancing of respiratory tract when the shape of device allows to insert in nasal cavity.Also comprise beak most advanced and sophisticated 203 and allow device easy arrangement in the above described manner in nasopharynx further.End imaging sensor 104 is positioned at top end, can collect the image of respiratory tract in sleep study.Nasal tube 202A is connected to nose retainer 210 further, in case locking apparatus inserts too far in nasal cavity.Therefore, nose retainer 210 makes device relative to the position stabilization of nasal cavity, thus provides the constant environment for watching respiratory tract passage, particularly relevant between sleep period long-time in (such as, 4-10 hour).In diagram embodiment, nose retainer 210 comprises the mesh 212 allowing air-flow to flow through.

As mentioned above, respiratory tract assessment apparatus 102A also comprises the guide gasbag 230 had for the air injection ports 232 (such as, valve) of being inflated by fill opening 252 pairs of air bags 250.In diagram embodiment, during sleep study, respiratory tract assessment apparatus 102A can comprise air bag 250, device to be anchored at the position of expectation together with nose retainer.Such as, balloon inflatable to allow the contact of the increase between air bag and nasal cavity, thus plays anchor in sleep study and prevents the effect that this device inwardly or outwards moves.In this way, comprise inflatable air bag with anchoring nasal tube, so that end imaging sensor is positioned at respiratory tract image data collection position.Therefore, make the arrangement stabilisation of device, it allows according to the more lasting imaging circumstances of method of the present invention and the clinical practice of enhancing.In addition, can be the tunnel that sealing between the air bag 250 of one or more air bag and nasal cavity can also produce by hollow devices in some embodiment, it plays the effect of the air-flow be guided through.Therefore, optimize by the air-flow of this device to realize the sensitiveer diagnostic measures in sleep study.In addition, air bag 250 can be used for the location being regulated one or more sensor by airbag deployment.Thus, described in more detail as follows, sensor localization can be regulated in response to the output lower than threshold value by inflating the air bag be positioned at below sensor, to regulate the relative altitude of one or more sensor, thus increasing the contact surface area between sensor and nasal wall.Comprise dotted line with instruction from the air of injection port 232 by with the surface in the hollow pipe reaching the one or more air bags in device.

About the structure of respiratory tract assessment apparatus 102B, Fig. 3 B shows the exemplary hollow nasopharynx imaging device 300B according to the second embodiment of the present invention.Hollow nasopharynx imaging device 300 comprises and is connected to nose retainer 210 and the nasal tube 202B being connected to the second air sampling tube 220 further.When device is inserted in cavity, two-way airflow can be produced.Such as, in expiration when respiratory tract not occurring and closing, air can flow into nasal cavity from trachea 226 and by nasal tube 202B.Extraly or alternatively, air can flow into oral cavity from trachea 226 and by mouth 222.In an identical manner, when air-breathing, extraneous air is by entering the near-end of nasal tube 202B and being branched into conduct further and guiding in health by two air-flows of nasal tube 202B and the second air sampling tube 220, second air sampling tube 220 can be that being communicated to as shown in the air sampling tube 220 of the dotted line in Fig. 2 B is remained silent through the pass of the air-flow of respiratory tract assessment apparatus 102B in some example, and wherein with constant polydispersity index air-flow for carbon dioxide monitoring analysis.Alternatively, when upper airway stricture, can be reduced or substantially eliminate by one or more in the air-flow of device.Although nasal tube is put into nasal cavity in this description, and the second air sampling tube is put in the front in oral cavity, but in some embodiment, a pipe in two pipes or another pipe can be settled to use other data pick-up record data one or more alternatively.Such as, air sampling tube 220 can comprise the microphone sensor that is placed on trachea front alternatively to monitor the air-flow flow through wherein.In addition, also in other examples, device can comprise the single pipe of the respiratory tract for visually monitoring narrow top.

Again get back to Fig. 3 B, in the example shown in the series of figures, nasal tube 202B is the pipe of the longitudinal flexion relative to device, and bending energy realizes the placement of this device relative to narrow point 206.Therefore, pipe curvature is formed except the upper airway stricture view of enhancing except allowing via end imaging sensor 104, also forms the view of the enhancing of uvula and soft palate.This end imaging sensor 104 is the video camera of the top end being positioned at nasal tube 202B in an embodiment.Although this device is described as relative to longitudinal flexion, curvature measure can change in operation.Such as, when the top end of nasal tube 202B is positioned in nasopharynx as shown in Figure 2 B, tube end is formed as relative to nose retainer 210 in 70 degree of angles to 90 degree of scopes.Therefore, for the sake of simplicity, the angle of arrangement usually close to but be less than 90 degree, its any narrow optimization viewing allowing respiratory tract and wherein occur.

As mentioned above, in some embodiment, this device can comprise close to end imaging sensor 104 further to allow throw light on to upper respiratory tract and to obtain the nasopharynx light source 310 of the viewing ability of increase.As an example, nasopharynx light source 310 can be intermittent flash lamp or have low energy consumption and the persistent characteristic studied to adapt to extended sleep with the constant LED of zonule (such as, being less than 1mm2) of height.But in other embodiments, nasopharynx light source 310 can be thermograph or thermal camera for using the hot profile in respiratory tract to form image.

End imaging sensor 104 can be configured to video (such as, the 1 frame/second) record carrying out continuous print or interval in sleep cycle.Therefore, the dynamic image of the anatomical change of upper respiratory tract can be watched to compare the baseline profile/data assessment obstruction collected when being regained consciousness by diagnosis person or the degree of blocking.Because each image record is by time mark, the frequency that also can narrow from the image calculating respiratory tract collected or subside and period.Such as, imaging data can be used for determining that respiratory tract opening narrows with the frequency of 20 times per hour 50% to reach 10 seconds or more of a specified duration, and it is further used for calculating the AHI consistent with moderate OSA.Alternatively, as another example, imaging data can be used for determining that respiratory tract blocks with the frequency 100% of 30 times per hour to reach 10 seconds or more for a long time, which create the AHI consistent with severe OSA.Therefore, according to the present invention, described respiratory tract assessment apparatus can allow to carry out AHI calculating from the direct imaging of respiratory tract.

Also can be included in device in 106 air velocities schematically shown and composition sensor.Comprise the air-flow that pneumatic sensor allows to monitor separately or synchronously in some example by nose, mouth and/or trachea.Gas flow indicator can determine that air-flow from mouth is to generate airstream data.Thus the confirmation of the visual pattern a collected step of going forward side by side can be provided to allow to distinguish OSA from the normal physiological reflex occurred (swallowing such as, in sleep, sneeze and cough) from the data of one or more pneumatic sensor.Such as, when respiratory tract obstruction, can be stopped by nasal cavity and oral cavity (or trachea) both air-flows, and when reflex response, air can continue to flow through oral cavity and trachea.Alternatively or extraly, in some example, pneumatic sensor 106 can be one or more in O2 sensor for determining gas level in respiratory tract or exchange rate based on the data collected or CO2 sensor (such as carbon dioxide monitoring sensor).

Biophysics sensor schematically shows 110 and comprises various sensor to detect EEG, EKG, EOG, EMG and tissue oxygenation saturation.Biophysics sensor 110 can be positioned at the surface of nasal tube to allow to confirm OSA further in a manner described below.Contact for signal detection because biophysics sensor 110 can depend in some example with chamber wall, by being deployed in the location (such as by increase or reduce sensor height) of the air bag below sensor relative to the one or more sensor of the surface modulation of device, to regulate sensor localization, thus increase sensor surface contact area.In this way, owing to the ventilatory pattern of increase being detected based on obtained signal, also signal sensitivity can be increased.Although air bag can be comprised to strengthen sensor surface contact in some example, in other examples, one or more air bag can be comprised together with nose retainer device is anchored at original position during sleep study.Therefore, air pump is sent in air bag the contact allowing to increase between air bag and nasal cavity, thus while playing anchor under study for action anti-locking apparatus is inwardly or the effect of outwards motion.Therefore, make the arrangement stabilisation of device, it advantageously allows more constant imaging circumstances and the clinical practice of enhancing.In addition, the sealing between one or more air bag and nasal cavity produces plays by the tunnel of device the effect guiding air-flow by tunnel.Therefore, can optimize the air-flow by device, it can realize the sensitiveer diagnostic measures in sleep study.

As mentioned above, trachea transducer 112 can being comprised in the second air sampling tube 220, comprising the one or more sensors for monitoring each state near the trachea of narrow below.Such as, trachea transducer can be the sound detection device of at least one comprised in mike, stethoscope or doppler equipment, to be designed for the monitoring one or more breathing pattern relevant to OSA and anatomical variations.In optional embodiment, trachea transducer 112 can be comprised extraly or alternatively in nasal tube, thus the breathing pattern detected in nasal cavity 204 and anatomical variations.Although trachea transducer 112 is positioned at the end of air sampling tube 220 as shown in the figure, the unrestricted and sensor of this arrangement can be positioned at any position along device to realize diagnostic measures.

About the device shown in Fig. 3 A and Fig. 3 B, the sensing data of collection can be forwarded by controller 120 and be processed.Controller 120 can be comprise microprocessor unit 122, input/output end port 330, be illustrated as in this concrete example read only memory (ROM) chip 124 for performing a programme and the electronic storage medium of calibration value and the pico computer of data/address bus.Storage medium read only memory 124 can be programmed with the mechanized data presentation directives that can be performed by processor 122, for execution said method and expection but its dependent variable specifically do not listed.Except those signals discussed above, controller 120 can receive the various signals from the sensor being connected to respiratory tract assessment apparatus.

Except the sensor, head pose sensor 108 can embed in nose retainer 210, determines head pose in sleep cycle.Nose retainer 210 can be positioned at the near-end of respiratory tract assessment apparatus, thus during sleep study, anti-locking apparatus inwardly or outwards slides.Therefore, nose retainer 210 can have larger diameter and larger size compared to the nostril be connected with nasal cavity 204, and they are usually different according to age, sex and ethnic group.The arrangement of device can by being adhered on the skin of the patient by the belt through device in external stability.Alternatively, in some examples, such as Fig. 2 A, respiratory tract assessment apparatus may further include and deployablely prevents from also preventing relative to the inwardly or outwards motion of cavity the top end air bag of the accidental movement caused due to sneeze or cough with anchor simultaneously.Although the shape of nose retainer 210 as shown is cylindrical for the sake of simplicity, other shapes also can be considered and also be possible.In an exemplary embodiment, head pose sensor 108 is three axis accelerometers, but this and unrestricted, and head pose sensor also can be gyroscope (gyroscope) for detecting wherein each kind of action or sensor.Because head pose/position sensor 108 provides the instruction of the device orientation relative to patients head's posture, the head pose therefore in sleep cycle can extract from the data of being collected by end imaging sensor 104 based on the relative orientation of the respiratory tract assessment apparatus 102 about patient.In addition, because the head pose in sleep is by time mark, record be associated to respiratory tract and narrow or subside, therefore these data can be used for the sleeping posture determined during sleep cycle.Such as, when patient is to sleep with the back floating position posture of lying on the left side (such as on the left of it) that is 90 degree, described patient can experience to narrow with the frequency of 3 times per hour and 50% reach 10 seconds.Alternatively, in back floating position (such as, upper flat dorsad sleep), the frequency that identical patient can experience 20 times per hour that increase narrows and 50% reaches 10 seconds.Therefore, head pose sensor 108 is used in sleep determines head pose, thus from the data diagnosis OSA collected.In some embodiment, nose retainer 210 can comprise for when sleep study starts by alignment mark 320 that respiratory tract assessment apparatus 102 aligns relative to head pose.Therefore, method according to the present invention allows to determine the AHI that position is relevant.Such as, the OSA attack times that is more or experience increase because some people may snore in specific sleeping posture, so the AHI of the frequency based on various sleeping posture (such as, left AHI, right AHI or the AHI that lies on the back) and/or head movement can be determined, with directly treatment further.The frequency of sleeping posture and head movement is the factor of sleep quality, directly to treat further.

Detect about head pose, how Fig. 4 schematically shows head pose sensor 108 based on relative sensors alignment differentiation two head poses compared to fixed reference frame.At this, roughly illustrate together with the unit vector relative to fixed coordinate system orientation cartesian coordinate system 402 (such as, comprising x-axis, y-axis and z-axis).Such as, in an embodiment, the y-axis of cartesian coordinate system 402 can represent gravitational field, and represent the vector relevant to accelerometer reference axis.

In order to be described, Fig. 4 shows the schematic diagram of the sleeping posture above health axle, namely sees the longitudinal axis of health from the top down.Such as, at 404 places, head pose is positioned at the supine Back to Sleep posture of health.Alternatively, at 406 places, head is in posture of lying on the left side (such as, in left side sleep).According to these gesture data, the angle between two different sleeping postures can be the predetermined angle of 90 degree or other, and it also corresponds to the angular displacement can measured by head pose sensor 108.These two different sleeping postures can produce different physiologic sleep reactions in the above described manner, and it can also be detected by method of the present invention and for from the data diagnosis OSA collected.Although back floating position 404 and the angular displacement of lying on the left side between posture 406 as shown are 90 degree for the sake of simplicity, usually head pose sensor 108 can detect any angular displacement and relative orientation (such as, from three-dimensional but not two dimensional motion).

Now forward Fig. 5 to, how the enlarged drawing showing nasal tube 202A regulates sensor localization by airbag deployment to further describe.In order to be described, two exemplary contact sensitive sensor illustrate in 502 and 504.As mentioned above, these sensors can represent EEG or the EKG sensor on the outer surface being positioned at nasal tube 202A.For the sake of simplicity, reference sensor 502 is concordant with tube-surface as shown in the figure, and air bag 506 launches and changes with the location of the motor adjustment sensor by being orthogonal to tube-surface by being located through of tunable sensors 504.Connection between each sensor to controller 120 schematically shows.About the inflation of air bag, in an embodiment, the guide gasbag comprising air injection ports and valve can be comprised in device, for one or more airbag aeration.Sensor localization thus can in response to the output lower than threshold value by regulating, to regulate the relative altitude 508 as shown in Δ H, to increase sensor and the contact surface area such as between nasal wall the airbag aeration be positioned at below sensor.Although Fig. 5 shows the air bag for changing sensor localization, can comprise extraly or alternatively for making device at other air bags one or more of the position stabilization of nasal cavity.Thus respiratory tract assessment apparatus anchoring can put the observation of the enhancing allowed in sleep study in place.As mentioned above, one or more air bag is also salable or block respiratory tract, is guided through this device with this air-flow all in fact.Therefore, one or more air bag can stop pipe ambient air to leak and produce the tunnel-effect increasing diagnosis degree of accuracy and measurement sensistivity further.Airbag aeration therefore can when patient awoke initial calibration phase such as by well-trained medical professional or in some example by patient by rotate and/or further by insertion and extract and adjusting device locate manually carry out.Although be described herein manual gasbag inflation to regulate, in some embodiments, automatically can regulate gasbag pressure based on the sensor detection level lower than the threshold value preset or specify.

Because apparatus and method are herein by realizing the vision-based detection of OSA from narrow some top view respiratory tract obstruction, Fig. 6 A-Fig. 6 D shows the example diagram of the respiratory tract obstruction of the various closedown degree in sleep.There is provided these examples as examples shown, and be not intended to limit by any way.In fig. 6, the unobstructed respiratory tract surrounded by pharynx and soft palate/uvula is shown.Epiglottis also illustrates and correspondingly carries out labelling.As above-mentioned detailed description, because tongue subsides, it moves relative to respiratory tract, thus plays the effect of narrow air stream wherein.Such as, at Fig. 6 B, along with tongue (not visible) pushes soft palate and uvula (and epiglottis) in the above described manner as illustrated in figures ib and 1 c to, respiratory tract partial blockage.Then, in figure 6 c, tongue subsides in fact completely thus is blocked in the air stream in narrow respiratory tract.Finally, in figure 6d, along with tongue loosens and pressure lentamente in delivering oral, the mode that the respiratory tract blocked in fact starts to allow air again to start to flow is recovered (subside).Along with blockage recovery, in sleep cycle and then rebuild respiratory tract, and eupnea pattern occurs again.In this way, the visual pattern that respiratory tract closes outbreak can be collected and automatic analysis together with other auxiliary datas, to determine obstruction in the whole sleep study cycle or degree of congestion.

Because respiratory tract assessment apparatus 102 comprises the various extra sensor for monitoring and detecting, the visual pattern collected associates by other physiological changies along with respiratory tract obstruction and/or confirms in some example.For this reason, Fig. 7 shows the example diagram of other data various can collected together with the visual pattern shown in Fig. 6 A-Fig. 6 D.Wherein, each exemplary sensors is also as shown in the figure in response to the time function that the time increases from left to right.Indicated by empty vertical line further from the obstruction of Fig. 6 A-Fig. 6 D or the degree of closedown.Such as, the first vertical line being labeled as t0 represents the beginning of research.Then, along with the carrying out of research, the starting of upper airway stricture occurs in the t1 (such as, timer periods 23:30:20 or intervalometer setting 2:20:10, and data collection starts from 21:10:10) representing respiratory tract partial blockage because tongue subsides.T2 (such as, 23:30:30 or 2:20:20), respiratory tract narrow in fact and due to can oxygen consuming amount minimizing and physiological reaction starts to manifest.This is narrow continues to time point t3 (23:30:45 or 2:20:35), and at this time point, the tongue subsided removes from respiratory tract, thus no longer barrier air passage.Remove in response to narrow, along with health recovers from respiratory tract obstruction, physiological status starts to get back to its normal level in fact.In response to the data collected, medical professional or analysis programme can analytical data, to be identified in the apnea episodes (closedown such as continuing 15 seconds) occurred when patient sleeps with back floating position.In the example shown in the series of figures, apnea episodes is attended by the stopping of air-flow, serious oxygen saturation decline, bradycardia and brain waves different compared with the reference curve collected before sleep study (not shown) further.In addition, although be not clearly shown that in the figure 7, the data of the head movement counting of representative accumulation also can be collected and for identifying overall sleep quality.

As shown in the sample data of Fig. 7, provide the advantage compared to the physiology caused by upper airway stricture and system change from narrow top visual indication respiratory tract.Such as, visual imaging data can be closed by Real time identification respiratory tract, and relative to this closedown in fact without lag time.On the contrary, the data of Fig. 7 show various extra data pick-up and can record profile (test feature) change after relative to completely narrow time lag when narrow beginning during t1 and t2.Therefore, the confirmation that these sensors provide the OSA diagnosis of view-based access control model image is comprised.In addition, because the data pattern sensed before t1 is conventional, execution analysis instrument is to detect trickle change (minimizing of such as amplitude or mean variation) and its result automatically can be carried out with being associated of visual pattern in some example.In addition, according to device of the present invention, this analytical behavior remotely can occur to carry out sleep study in another place at the three unities simultaneously.

For the sensing data of Fig. 7, in top graph, show the respiratory tract image of Fig. 6 A-Fig. 6 D.Then, in the second figure, provide the example schematic diagram of head pose.Such as can collect this pattern by head pose sensor 108.For the sake of simplicity, shown angular data representative is relative to the head pose of the posture of lying on the left side of Fig. 4.Therefore, when patient with lie on the left side posturizing sleep time produce 0 degree of 702 places, but when patient sleeps on its backside with back floating position the angle of 90 degree of generation shown in 704.As can be seen here, when patient is with right lateral position sleep, the angle of 180 degree can therefore be produced.For the sake of simplicity, in the example shown, the change of sleeping posture occurs together with the apnea episodes recorded.But respiratory tract obstruction can occur for multiple reason and shown head pose is only to provide as example.

Flow pattern is there is shown at the 3rd of Fig. 7.Such as can collect this pattern by the pneumatic sensor 106 being positioned at nasal tube 202B.Wherein, before t1, airstream data in response to the suction in the breathing cycle and exhalation event to fluctuate by a relatively large margin.Then, between t1 and t2, when patient sleeping posture is changed to from lying on the left side lie on the back time, upper airway stricture occurs, and it produces the minimizing of air-flow.Narrow in response to this, the amplitude of the data of fluctuation starts to reduce, and it represents air-flow less in upper respiratory tract.At t2, due to the respiratory tract of blocking, amplitude is essentially zero.Assessment AHI can be used as and thus the basis of diagnosis OSA during between t2 and t3.

In response to the respiratory tract of blocking, the measurement that the oxygen saturation as the relative measurement of the oxygen amount of dissolving in such as systemic medium also can provide respiratory tract to close.Such as, in an embodiment, sensor 110 can measure oxygen saturation.But this physiological reaction can have the time lag blocking beginning completely compared to t2 place.Such as, can still reduce in the response of 710, O2 sensor, air-flow response (and visual imaging) instruction is simultaneously closed in fact completely.Then, oxygen saturation can be reduced to the lower plateau (plateau) of the instruction closedown at 712 places with time lag.The time lag produced can cause the susceptiveness of the minimizing about OSA diagnosis.For this reason, system and a method according to the invention comprises for data pattern being associated to obtained this kind of sensor also confirming the visual pattern of diagnosis further.At t3, once remove blocking, oxygen level is rebuild along with air-flow and starts to increase in upper respiratory tract.

In an embodiment, the sensor 110 on the surface of device can detect EEG or ECG extraly or alternatively in cavity.But in some example, patterns of change (such as, at 720 places) can postpone relative to the generation of respiratory tract closedown, and it is alternately for diagnosing according to method support herein or foundation.In other embodiment, trachea transducer 112 can be the auscultation sensor of such as mike, stethoscope or Doppler sounds device, for sound relevant to heart or lung in recording respiration road, thus provides the measurement of arterial pressure.Blood pressure thus in response to respiratory tract close and increase and be provided for OSA diagnose extra support.In this way, sound detection device can be used for indicating the air-flow in sleep cycle.

In view of above-mentioned, in an exemplary embodiment, device can collect visual pattern and the air flow information of the respiratory tract obstruction relevant to the head pose in sleep cycle.The data collected can wireless transmission or manually download (such as, by being inserted into the cable of port) to remote computing device and analyze to set up OSA diagnosis further.In addition, because this device comprises control system, remotely can control sensor activation and the one or more data patterns as respiratory tract data of collection wireless transmission for real-time analysis, it allows urgent OSA to diagnose.

Fig. 8 shows the exemplary method that remotely can operate respiratory tract assessment apparatus 102.Particularly, Fig. 8 shows the example flow diagram illustrated for the method 800 of control device in sleep cycle.As mentioned above, device can generate data the three unities (such as, in home environment or sleep study center), and analyzes in the second place (the second such as, intracardiac in doctor's office or sleep study place).

As mentioned above, the method is included in upper respiratory tract and places respiratory tract assessment apparatus, and this respiratory tract assessment apparatus comprises and is positioned at narrow top and the complete end imaging sensor 104 watching narrow point.Such as, nasal tube 202B can be inserted in nasal cavity 204 until the further insertion of device is stopped by nose retainer 210.Then, because nasal tube 202B is relative to the longitudinal flexion of pipe, end imaging sensor 104 can have the clear view in oral cavity, comprises nasopharynx, uvula and soft palate.Extraly, the second air sampling tube 220 can be positioned the front in oral cavity, thus measures the air-flow from mouth.

At 804 places, method 800 comprises the one or more sensing station of adjustment, to increase contact surface area.Such as, in an embodiment, air bag can manually be inflated with based on produce from low contact surface area low but detectable signal regulates the location of sensor (such as, EEG sensor) in the direction being orthogonal to tube-surface.Adjustment one or more sensor after, can be recorded as under waking state at 806 places picture and biophysics sensor baseline measurements and with 24 hours timer synchronization.Then, at 808 places, the data collection undertaken by one or more sensor bedtime is together with intervalometer, can start sleep study.Such as, in an embodiment, the intervalometer comprising initial time and end time can be arranged in device, during controlling this research.In addition, at 810 places, one or more sensor can be opened and collect data continuously or off and on during studying, under many circumstances normally 4-10 hour.As an example, may 11:00PM be started from during research and proceed until morning 6:00AM.Therefore, at 11:00PM, nasopharynx light source 310 can be unlocked, and end imaging sensor 104 starts to collect data with predetermined speed simultaneously.Extra sensor, such as, pneumatic sensor 106, also can activate when the beginning of sleep study, and therefore in research process, collect various data.This research may occur in family or at sleep study center, and well-trained professional monitors patient and/or data in whole research process.Alternatively, for beginning one's study, patient can press the start button on lower device at h.d., and it activates and records one or more device sensors that data reach 4-10 hour continuously or off and on when patient is in sleep state.In another possibility, well-trained professional can one or more sensors after patient opens respiratory tract assessment apparatus in remote activation device.

At 812 places, recorded data can locally on device store, until request is used for the transmission analyzed further.Therefore, 814 illustrate that the data collected transfer in remote computing device.As mentioned above, these data can be transferred to the place being away from sleep study.If transmission occurs in research process, then these data wirelessly can be sent via network 240 or manually manually downloaded by cable, for the automatic mode analysis on remote computing device at 816 places.As an example, remote computing device can comprise the artificial intelligence being configured to analyze one or more transmitted data set for pattern match and pattern recognition analysis.Therefore, data set (such as, the image from end imaging sensor 104) can compare with reference database, to identify each pattern relevant to sleep apnea (such as, the cross-sectional area of the respiratory tract of imaging).Thus, accountant 130 can comprise for analysis chart picture (such as, by searching for via binary image coded data and processing the area of respiratory tract) and the pattern comparing this digital information and known storage is further (such as, represent the image of AHI) or in some example, the programmable instructions that the benchmark data of collecting during by regaining consciousness with main body compares.In addition, because data are by time mark, accountant can also temporally analytical data thus realize carrying out in this way the confirmation of sleep apnea.In some embodiments, data can be sent out in research process, but manually can analyze, such as, after the contingent well-trained expert human review unobstructed by identification of breathing road at the end of research.Alternatively, if transmission does not occur during studying, then these data can locally on device store, and download in another time.At 818 places, collected data can manually be checked by well-trained professional or automatically be checked by the data processor be positioned on remote computing device.Data processor can comprise the pattern matching algorithm with mode identificating ability, the relation that the pattern of blocking with identification of breathing road and the air-flow, oxygen saturation and EEG or EKG that record change.According to the conclusion of this research, at 820 places, sleep study report can be generated, to contribute to the diagnosis of the OSA based on recorded data by remote computing device.

In fig .9, an example flow of method 900 illustrates for the process based on the data diagnosis OSA received from respiratory tract assessment apparatus.As mentioned above, wearable device can comprise inflatable air bag with anchoring nasal tube, end imaging sensor is arranged on respiratory tract image data collection position.Therefore, this is used for monitoring the narrow method of the upper respiratory tract relevant to OSA and comprises end imaging sensor reception respiratory tract view data from afar, end imaging sensor be connected to be placed in upper respiratory tract and be positioned at narrow above nasal tube, wherein in this respiratory tract view data of sleep period interocclusal record, analyze the data received, and in sleep study report, show these data and other relevant informations relevant with obstructive sleep apnea further.In this way, respiratory tract view data can be used to identify that the respiratory tract relevant to obstructive sleep apnea is closed.

At 902 places, method 900 comprises end imaging sensor from afar and receives by the respiratory tract view data of time mark, end imaging sensor be connected to be placed in upper respiratory tract and be positioned at narrow above nasal tube, wherein in this respiratory tract view data of sleep period interocclusal record as above.In an embodiment, method 900 comprises together with the data receiver respiratory tract view data from one or more extra sensor.Such as, by the signal relevant with the amount of oxygen dissolved in bodily tissue, bio-physical data from oxygen saturation sensor collection, thus can represent that respiratory tract is closed.As another example, bio-physical data can one or more carbon dioxide monitoring sensor collection extraly or alternatively from the gas level can determined respiratory tract or exchange rate between sleep period.As another example, can collect the data from sound detection device (such as, mike), its instruction respiratory tract is closed, thus instruction air-flow.In another embodiment, the sensor that method 900 can additionally or alternatively comprise from indicating relative to the head pose of nasal tube receives head gesture data (as described in Figure 4).Although provide various example, be understandable that, the data set comprising the various combinations combined with the visual pattern collected by end imaging sensor by the data of one or more sensor collection can be received.Such as, the data set received can comprise the visual pattern together with head pose data, and this allows the OSA determining that position is relevant in the above described manner.Alternatively, in another example, visual pattern can be received, to determine the degree of the OSA in sleep cycle together with head pose and/or oxygen saturation levels.Therefore, the data from all the sensors on device can also be received and analyze in a manner described herein.

At 904 places, method 900 also comprises analysing respiratory tract view data to determine frequency and the number of times of the respiratory tract obstruction occurred in sleep study.For the sake of simplicity, the frequency of the closedown just occurred and number of times are to describe this method.But one or more remote-control device can also be configured to analysing respiratory tract and closes the degree of outbreak and determine AHI thus.As mentioned above, AHI refers in the time period, such as, the number of times of the asphyxia occurred in sleep per hour and hypopnea outbreak, and described system obtains AHI by the direct imaging of respiratory tract.Alternatively, OSA analytical tool case 132 can comprise the instruction of the number of times for the head movement occurred in count sleep research, therefore comprises the instruction number of times of head movement or the enumerator of frequency, to determine sleep quality.Therefore, various analytical activity and their combination can be performed to determine OSA, AHI, sleep quality etc.

At 906 places, method 900 is included in sleep study report and shows respiratory tract view data, to identify that the respiratory tract relevant to OSA is closed.It is by printing equipment (such as that sleep study report can comprise, printer) printout that generates, it relates to sleep pattern data and OSA, but this is nonrestrictive and sleep study report is watched on a display screen and/or transmits (such as, passing through Email) digital document to medical professional, patient etc. safely.In this way, apparatus and method described herein, can be advantageously used in the direct imaging diagnosis obstructive sleep apnea by respiratory tract, particularly in response to sleeping posture, especially when the long-range generation of sleep activity.

Those skilled in the art can associate many changes and amendment to the reading of description, and do not depart from the spirit and scope of description.But should be understood that, configuration described herein and/or method are exemplary in essence, and these concrete embodiments or example do not think to have limited significance, because many changes are possible.It is one or more that described concrete routine or method can represent in the data collection strategy of any amount.Therefore, shown various actions can shown in order, with other orders, parallel or elliptically carry out in some cases.Equally, the order of said process can be changed.

It should be understood that configuration disclosed herein and routine are exemplary in essence, and these concrete forms of implementation do not think to have limited significance, because many changes are possible.Theme of the present invention comprises various system disclosed herein and configuration, and other features, function, and/or all novelties of character with non-obvious combination and sub-portfolio.

Claim particularly point out be regarded as novel in non-obvious some combination and sub-portfolio.These claim can relate to finger " one " element or " first " element or its equivalent.These claim should be understood to include the combination of one or more such element, both two or more such elements neither requiring nor excluding.Other combinations of disclosed feature, function, element and/or character and sub-portfolio can by this claim of amendment or by the new claim request protection in the application or related application.Such claim, be no matter wider than the scope of original claim, narrower, to equal or different, be also deemed to be included in theme of the present invention.

Claims

1., for detecting respiratory tract obstruction to diagnose a device of OSA in sleep, comprising:

Wearable hollow nasal tube, described hollow nasal tube is positioned the top of narrow point in upper respiratory tract;

End imaging sensor, described end imaging sensor is connected to described nasal tube to collect respiratory tract view data;

Controller and communication interface, described controller and communication interface can be used for being communicatively connected to the remote-control device of selection and described respiratory tract view data are forwarded to this remote-control device to determine respiratory tract obstruction.

2. device according to claim 1, also comprising can be one or more with what collect in the inflatable bladders of respiratory tract view data and nose fixed stop by wearing position that nasal tube is anchored at selection.

3. device according to claim 1, it is characterized in that, described end imaging sensor is positioned at the top end of described nasal tube with the top making the image data collection position of described end imaging sensor be positioned at narrow point described in nasopharynx, and wherein said end imaging sensor is downward relative to nose opening surface angularly to watch respiratory tract further.

4. device according to claim 1, is characterized in that, described end imaging sensor is one and associated illumination source in video camera and thermal imaging device.

5. device according to claim 1, is characterized in that, also comprises sound detection sensor, and wherein said sound detection sensor is at least one in mike, stethoscope or Doppler sounds device.

6. device according to claim 1, also comprise one or more biophysics sensor, it comprises oxygen saturation sensor, EEG sensor, EKG sensor and can based on the carbon dioxide monitoring sensor of the gas level in the data determination respiratory tract collected or exchange rate, wherein said breath data can be forwarded to the remote-control device of selection together with described respiratory tract view data.

7. device according to claim 1, it is characterized in that, also comprise head pose sensor, for collecting the head pose data relative to device orientation, wherein said head pose data are forwarded to the remote-control device of selection together with described respiratory tract view data, and described head pose sensor comprises accelerometer, gyroscope and for detecting in the sensor of motion; Also comprise head movement enumerator, for the head pose data of the number of times and frequency of collecting the head movement comprised in sleep.

8., for a system for remote diagnosis obstructive sleep apnea, comprising:

Be arranged in the tubulose respiratory tract assessment apparatus of upper respiratory tract, described tubulose assessment apparatus comprises:

Have the wearable hollow nasal tube of end imaging sensor, described end imaging sensor is used for direct viewing respiratory tract to generate respiratory tract view data;

For determining that respiratory tract air flow is to generate the gas flow indicator of airstream data;

For to collect and by the processor of forwarded respiratory tract view data and airstream data, communication interface and memorizer; With

For analyzing the remote computing device of the breathing pattern data relevant to obstructive sleep apnea; And

Communication connection between described tubulose respiratory tract assessment apparatus and remote computing device, described communication connection is used for described respiratory tract view data to be forwarded to described remote computing device to determine respiratory tract obstruction.

9., for monitoring the narrow method of the upper respiratory tract relevant to obstructive sleep apnea, comprising:

Respiratory tract view data is received, described respiratory tract view data record in sleep cycle from the long-range end imaging sensor of nasal tube of the top being connected to narrow point in upper respiratory tract; And

Analyze described respiratory tract view data and in sleep study report, show described respiratory tract view data to identify that the respiratory tract relevant to obstructive sleep apnea is closed.

10. method according to claim 9, it is characterized in that, also comprise and receive head gesture data from instruction relative to the sensor of the head pose of described nasal tube, and analyze described head pose data and show described head pose data in described sleep study report.