The application is that international filing date is that JIUYUE in 2006 20 days, international application no are PCT/US2006/036594, the application number that enters the China national stage is 200680035642.9, denomination of invention is divided an application for the patent application of " for the diagnosis and treatment of the system and method for patient's breathing patterns ".
Background technology
Sun plug property sleep apnea syndrome (OSAS) is a kind of generally acknowledged sleep disorder that may affect about 1-5% Adult Groups.OSAS causes one of excessive daytime the most general drowsiness reason.OSAS occurs in it obese males the most continually, and is to arrange one for the treatment of common cause to the sleep disorder clinic.
OSAS is relevant to many situations, wherein has on the anatomy that the upper air flue of patient exists or dynamic stricturization, and is characterized in the intermittent sun plug of air flue is occuring between sleep period.Anaphora continuously howsoever, this sun plug all can cause lacking (asphyxia) to the disordered breathing degree of the obvious obstruction (hypopnea and snoring) that is with or without the air-flow minimizing from whole air-flows.The condition of illness of this syndrome is low and to asphyxia and the relevant interruptions of sleep of waking up from sleep subsequently to be caused by hypoxemia, hypercapnia, heart arteries and veins.
At present not yet can fully work out the pathology of OSAS.Yet, be recognized that: be to press on the glottis that causes air flue (collapsible) behavior of withering partly to cause owing to breathing the negative inner chamber of attempting producing on the obstruction of air flue part between sleep period.Thus, in suffering from the patient of OSAS, between sleep period, (startlingresistor) (namely no matter how start (air-breathing) presses, air-flow is limited to fixed value) stopped up in the performance of upper air flue basically as being taken aback.Partially or completely airway collapse can cause the loss of air flue situation (airway tone), and this is the symptom of showing effect in bed and might expands as OSAS.
From 1981, developed into the most effective therapeutic modality to OSAS by wear Positive Airway Pressure (PAP) therapy that the tight fit nose cup implements between sleep period, and be nursing standard now.The availability of this non-intruding form therapy has caused extensively disclose and a large amount of former bronchotomus for fear having occurred and avoid the patient of medical institutions OSAS.The increase of the comfort level of PAP system has become for the main research purpose that improves patient compliance PAP therapy.
The PAP therapy has become the primary treatment method in sun plug property sleep disorder breathing (OSDB), and sun plug property sleep disorder is breathed increase and upper air flue improper all condition of illness that wither and cause obvious non-physiology airflow obstruction partly that comprise obstructive sleep apnea, upper airway obstruction syndrome, snoring, the excessive upper airway collapse of bringing out of sleep.When the pressure decreased in the withered part in air flue to as around under " critical tissue pressure " defined level of inwall the time, this withering can occur usually.This PAP therapy is intended to the pressure of the part that can wither in air flue is maintained critical tissue pressure or at any time on critical tissue pressure.In the past, when the patient puts on this device, pass to the pressure of patient airway to realizing this target higher than this critical tissue pressure by always increasing.
In general, the needs of PAP therapy occurred over just between sleep period.Yet conventional P AP therapy is not considered the state of sleeping/wake up, and conventional P AP system applies unnecessary pressure when the patient wakes up.Institute's applied pressure or normal pressure or the pressure of breathing judgement that needs based on treatment.Because needing the judgement of feedback of a plurality of signals of PAP therapy, airway collapse finds that pathological events (for example high sign that stops up of asphyxia, hypopnea and other air flue) is used for determining that the multiple strategy of minimum pressure has had differentiation based on expression.
Although it has obtained success, the use limitation of conventional P AP system still exists, and for example eliminates the required pressure of asphyxia from not accommodating of face shield.Especially, the patient often reports when waking up because high pressure does not feel well.For fear of this discomfort, should only when falling asleep, the patient provide institute's applied pressure.For example, " slope (ramp) " system utilizes the activation of patient in startup is exerted pressure to postpone, however this ramp system do not wake up at night from the dynamic response patient, unless pressed the button and premeditated the activation by the patient.
The patient during having a sleepless night uncomfortable often with from normal breathing pattern for example, near constant breath size and frequency) relevant to the change that comprises abnormal breathing pattern.These abnormal patterns for example comprise deep breathing, the minibreak of separation and the change of the breath stream shape that do not change in any normal mode) inspection only followed the tracks of by air-flow is found, and when often occurring in the patient and agonizing because of the PAP system.
The continuous algorithm of exerting pressure with automatically titration of some conventional P AP system's utilization.These algorithms depend on the detection sign from the airway collapse of breath signal.Yet the algorithm of these conventional P AP system has some limitation.For example, the undesired pattern that also can show breathing and more common when anxiety although the experimenter revives, this can disturb calculating the processing of the breath signal of exerting pressure.
The specific embodiment
Fig. 1 illustrates the exemplary embodiment according to system 1 of the present invention.System 1 can comprise via conduit 21 connections to receive the face shield 20 with specified pressure air-flow from flow generator 22.The amount of pressure that offers particular patient changes according to patient's specified conditions.Can use any traditional PAP therapy and determine this amount of pressure.
Face shield 20 covers patient's nose and/or face.Traditional pneumatic sensor 23 is coupled to conduit 2l.Sensor 23 detects and goes to/from patient's airflow rate and/or offered patient's pressure by generator 22.Sensor 23 can be at generator 22 inside and outside.The signal corresponding with air-flow and/or pressure is provided for blood processor 24 in order to process.This blood processor 24 outputs to traditional volume control device 25 to control the pressure that is applied to fluid conduit systems 21 by flow generator 22 with signal.Those skilled in that art are appreciated that, flow generator for some type that can be used as flow generator 22, blood processor 24 can directly be controlled flow generator 22, rather than controls air-flow from flow generator by handling volume control device 25 independently.
System 1 also can comprise continuous release mouth or other breather 28.Breather 28 can make the gas that is included in patient's exhaled air flow shunt to prevent that breath from being sucked again from the input air-flow.
Fig. 2 illustrates an exemplary embodiment of the method according to this invention.In step 202, the patient is by being placed in face shield 20 oneself on the face and giving generator 22, air flow controller 25 and blood processor 24 energisings and startup system 1.
In step 204, system 1 starts the Real-Time Monitoring process of patient's breathing patterns.Monitoring process is carried out by blood processor 24, and blood processor 24 is provided by the patient data of pre-stored and relevant the going to that is provided by sensor 23/from the current data of patient and/or institute's applied pressure.
In monitoring process, 24 couples of patients' of blood processor current state decision making (for example, whether the patient is in sleep, revives and normally breathes or revive but breathe abnormally due to misery or anxiety).This judgement can be made based on multiple different measurement.For example, blood processor 24 can be analyzed patient's heart rate, blood pressure, EEG data, breathing pattern etc. when determining patient's states.
The multifrequency nature of patient's breathing patterns can be taken to make into account this class judges.Fig. 3 and Fig. 4 illustrate the breathing pattern that the expression patient is quiet during the PAP therapy, loosen normally breathing.Fig. 3 represents the insomnia (patient is anxiety or misery not) under relaxation state.Fig. 4 is illustrated in loosening respiratory period between the sleep period that the patient correctly is treated by the PAP therapy.In either case, transmit institute's applied pressure with can not damaging comfort level.In addition, there is the sleep disorder respiratory period of the essential PAP of employing therapy therebetween.The sleep disorder spiro-index comprise asphyxia (as with deeply breathe alternately occur greater than the 8-10 zero air-flow phase of second), hypopnea (as obvious minimizing, continued 10 seconds or the longer time and by the circulation of air flow cycle of more deeply breathing and finishing) or cycle of intermittence of signal shape or varying cyclically (as it is characterized by waveform flatten, by the breathing end of normal shape).
On the contrary, the exemplary character representation patient of back revives and is in anxiety and agonizing state: pure mouth is breathed (sensor 23 that for example is configured to detect from patient's nose air-flow does not have signal); The unstable deep breathing that air-breathing number of times changes; Irregular spacing between breathing (but do not mean sleep and need the cyclicity asphyxia etc. of high pressure more).Fig. 7 illustrates the dry random insomnia phase of this kind, and the irregular variation of the depth that is characterized as breathing of breathing pattern and/or frequency and/or expression patient are in the irregular variation of reviving and being in patient's air-flow tracking shape of anxiety or uncomfortable state during this period.Yet, do not have cyclicity to change (for example periodically irregular) in breath size, this cyclicity variation for example can be found under asphyxia and hypopnea sleep quality.To reduce institute's applied pressure when not required in order to a kind of in the method that increases patient's comfort level.The patient of obstructive sleep apnea when reviving at all without any need for pressure.Therefore reduce the pressure that is applied to face shield and will improve user's comfort level in this irregular respiratory period, until the patient for example falls asleep, this can recover or be identified as simply the circulation of asphyxia and hypopnea but the sun plug phase of rule or the upper airway obstruction of increase characterize by systematicness).
Can distinguish above-mentioned breathing pattern, the obstructive apnea of for example Cheyne-Stokes respiration (cheynestoke) and other form from the slow conversion of breath size and air-breathing sequential.Fig. 5 represents the patient's breathing patterns in the PAP therapy, and it comprises upper airway obstruction and the hypopnea situation that increases between sleep period, and Fig. 6 represents the breathing pattern corresponding with repeatedly blocking asphyxia.In both cases, the change of breath size and frequency regulated lentamente and be repeatedly with the circulation (for example irregular regularly).During these, institute's applied pressure is maybe must being raised of needing, but does not represent to help like this to reduce patient's misery.Therefore, institute's applied pressure should not be lowered.
Fig. 8 illustrates the REM sleep period.This Sleep stages, for example every 90 minutes ortho sleep occur 10-30 minute, and breathing pattern often is characterized as irregular breathing.The potential exception of this modal representation to the insomnia of use scrambling indicating anxiety.Yet between respiratory period, the patient is in sleep state and must keeps institute's applied pressure (namely not reducing) during having a sleepless night at this type.During REM visible such irregular with the insomnia show irregular distinct in a plurality of key parameters.The breathing pattern that this kind is relevant to REM can comprise for example deep breathing shortage, particularly the trend of the breathing rate of the deep breathing shortage after pause, total height, low flow rate and shallow breathing gathering.During the pattern of respiratory air flow signal and dry random insomnia, the difference of visible pattern makes and these states can be separated, and can be used to change institute's applied pressure.
Every patient's data are also collected and recorded to blood processor 24.These data can manually be collected and input or itself automatically collected and input by blood processor 24 by the technical staff.For example, the technical staff can monitor patient respiratory and determine simultaneously whether the patient revives.Then, when the patient fell asleep, patient's the breathing pattern but technical staff's labelling is fallen asleep was in order to use these data in the judgement whether blood processor 24 revives to the patient afterwards.When the data base of built vertical patient inhalation characteristics, will be more accurate significantly to patient's making of judging of having a sleepless night.
In step 206, blood processor 24 judges whether patient's states changes.For example, blood processor 24 can judge that the patient is in sleep state and still is waken up; Or the patient revive or fallen asleep.If do not change, processing configuration 24 continues monitoring process.
If patient's states changes, blood processor 24 will be adjusted pressure to adapt to patient's current state (step 208).For example, if the patient has revived and patient's breathing pattern represents to be in as shown in Figure 7 dry random insomnia phase, blood processor 24 can reduce the institute's applied pressure that offers the patient within this period.This minimizing can be that removing fully of the pressure of exerting pressure is that flow generator 22 reduces to flow velocity the level that any fine pressure is not provided to patient's face shield, simultaneously the instrument minimum necessary flow that is maintained to breather 28 by loop gathers to prevent C02), or local minimizing the (the minimizing air-flow partly of the air pressure that produces when namely flow generator 22 only produces and is enough to maintain the patient and sleeps).
On the other hand, if the patient falls asleep, but blood processor 24 instruction stream amount control device 25 rising pressure are to patient's institute's applied pressure of sleeping time.For example, this may represent to become the situation of pattern shown in Figure 4 from pattern shown in Figure 7 when patient's breathing pattern.In this case, blood processor 24 should increase pressure.From that time, the pressure of this increase should not reduce, unless a plurality of of presetting in breathing pattern detected.For example, if patient's breathing pattern shows upper airway obstruction and the hypopnea that increase has as shown in Figure 5 occured, blood processor 24 should keep at least uniform pressure or, preferably, increase pressure.In addition, block asphyxia if patient's breathing pattern shows repeatability shown in Figure 6, pressure should be kept identical value at least, perhaps preferably increases; If perhaps the patient shows and represents that he is in the dormant irregular breathing of REM, because patient during this type of respiration falls asleep, institute's applied pressure should keep at least with other sleep period in identical level (that is, not being reduced to as during having a sleepless night).
In step 210, blood processor 24 judges whether oneself is presented for the instruction of parting systems 1, if provided this instruction as, if the patient presses designated button or through the preset time time limit), system 1 closes and finishes all monitoring and air-flow generation activities.Otherwise system 1 continues the monitoring process of step 204.
According to the advantage of system l of the present invention be: he is in and revives and during the irregular breathing pattern of anxiety state when the patient has expression, adjust the pressure that is applied to the patient (for example reduce to zero or preset low-level).When breathing is regular (for example expression sleep) or show the sleep disorder breath state, can keep or increase this pressure.
In another embodiment of the present invention, system 1 can be used in one or more diagnostic application.Namely, blood processor 24 can obtain the state of the data of relevant patient's breathing patterns and record patient and not apply pressure to the patient from sensor 23.For example, the present invention can comprise when the patient that be used for to determine as shown in Figure 9 is in the dormant method 100 of REM.In step 102, system 1 is activated and face shield 20 is covered and is coupled to the patient.In step 104, sensor 23 obtains the data of indication patient's breathing patterns.
In step 106, blood processor 24 determines whether breathing pattern is identified as the REM sleep state.For example, when breathing pattern comprises the trend of deep breathing shortage (for example, after respiratory standstill), high breathing rate, low flow rate and shallow breathing gathering, but blood processor 24 identification of breathing patterns are the REM sleep state.When breathing pattern was not identified as the REM sleep state, blood processor 24 can continue to collect the data of relevant patient's breathing patterns.
In step 108, blood processor 24 identification of breathing pattern is the REM sleep state and it is reported to the user (for example, doctor) of system 1.In addition or interchangeable, but blood processor 24 labellings part internal records to remind the patient to be in the REM sleep state scheduled time.Namely, after the REM sleep state was identified, blood processor 24 can continue to identify patient's breathing pattern to determine the dormant termination of REM.
In another embodiment of the present invention, system 1 can be used for detecting the patient regulates pressure when falling asleep/reviving and based on it.Method 250 according to this embodiment shown in Figure 10.In step 252, system 1 initializes and face shield 20 is covered in the patient.In step 254, blood processor 24 is determined the first state of patient based on the data of the relevant patient's breathing patterns that obtains from sensor 23.In this embodiment, blood processor 24 can determine whether the patient is in sleep state or wake states based on breathing pattern.Namely, above-mentioned data can be indicated the breathing state of rule, and it is identified as sleep state or wake states usually.
In another embodiment, but whether blood processor 24 test example such as patient are in sleep state.Namely, when the patient is in wake states, can use this system 1.After system 1 initialized, blood processor 24 can be given tacit consent to the patient and be in wake states.Like this, blood processor 24 can only detect the patient and whether be in sleep state, and when not detecting sleep state, the acquiescence patient is in wake states.
In step 256, blood processor applies air pressure according to state.In one embodiment, CPAP can apply with the first level and apply with the second level in wake states at sleep state.In another embodiment, can apply the CPAP(" automatically-CPAP " of automatic adjusting).In this embodiment, when determining sleep state, blood processor 24 can be towards the first horizontal adjustment pressure, and when definite wake states, can be towards the second horizontal adjustment pressure.One skilled in the art will appreciate that and utilize this embodiment, can be determined based on identifying sleep and wake states by blood processor 24 whole lengths of one's sleep of patient.
In another embodiment of the present invention, system 1 can comprise the neutral net that is coupled in blood processor 24 and the sensor 23 that is used for the identification patient's states.Neutral net (neural network) can obtain data and determine patient's states based on above-mentioned data from sensor 23.Before the neutral net operation and/or in its running, it can be trained to identification corresponding to the feature of the breathing pattern of above-mentioned one or more states.
Figure 11 illustrates for the method 300 of carrying out the neutral net according to the present invention.In step 302, neutral net is built into the breathing state for time identification patient.In one embodiment, neutral net comprises a plurality of nodes, and it comprises input, hides and output node.The predetermined number of output node can equal the number of the state that is identified.For example, when identification during following state: (i) breathing state of rule, (ii) sleep disorder breathing state, (iii) REM sleep state and (iv) dry random wakefulness state, neutral net can comprise four output nodes.
In step 304, use the sample breath data neural network training that is obtained by the input node.Sample breath data can be known as one of corresponding states by the operator of system 1.For example, sample breath data can manually be evaluated as corresponding state.In step 306, with the breath data of test, neutral net is tested.The breath data of test can be different from the breath data of sampling, but can be known as one of corresponding states by the operator of system 1.In step 308, determine whether neutral net is carried out satisfactorily.If do not carry out satisfactorily, continue training.
In step 310, neural network training by training and execution satisfactorily, therefore detects patient's states with it.Blood processor 24 obtains breath data and measures the parameter of the predetermined number of breath data from sensor 23.Breath data can obtain by the breathing (for example, five breathings) of predetermined number.Above-mentioned parameter can include but not limited to peak flow, respiratory time, exhalation time, frequency and total breathing time.Although will present invention is described with respect to the measurement of independent respiration parameter, those skilled in the art will be understood that or to have betwixt the respiration measurement parameter of the scheduled time/its respiratory intervals to the continuous breathing of arbitrary number.
Can produce to measure and gather, it can comprise intermediate value, meansigma methods, scope and the standard deviation of each parameter.In addition, can identify difference in each parameter that is between continuous breathing.During above-mentioned difference can be included in and gather.In gathering, breathing can be categorized as predetermined order (for example, ascending order, descending) based on one or more parameters.
Then can will gather in the input node of input neural network.Then neutral net can gather and/or each breathing with the output node identification of corresponding patient's states.For example, in one case, gather and to indicate the patient to be in the breathing state of rule.In another case, a breathing can be indicated the breathing state of rule, and predetermined number is breathed the interior dry random wakefulness state of another breathing indication.
After status recognition or in the status recognition process, blood processor 24 can obtain predetermined number and breathe more breath data that last breathes more predetermined numbers breathings afterwards.In case state is identified, blood processor 24 can be fed to based on above-mentioned status adjustment patient's pressure.
In other one exemplary embodiment of the present invention, after patient's states was identified, blood processor 24 can utilize predetermined algorithm to regulate pressure.Shown in Figure 12 according to the method 400 of this embodiment.In step 402, system 1 initializes, and blood processor 24 is fed to the patient with default level with pressure.
In step 404, blood processor 24 determines whether patient's breathing pattern indicates the sleep disorder breathing state.In step 406, when the sleep disorder breathing state being detected, blood processor 24 increases pressure towards the first predetermined pressure (for example treating pressure) with predetermined increment.According to this embodiment, the arbitrarily more detection of sleep disorder breathing state can increase the speed (for example, the time between the minimizing increment) that pressure increases.
In step 408, blood processor 24 determines whether patient's breathing pattern indicates dry random wakefulness state.In step 410, when dry random wakefulness state being detected, blood processor 24 reduces pressure towards the second predetermined pressure (for example under wake states more comfortable pressure) with predetermined increment.According to this embodiment, the arbitrarily more detection of dry random wakefulness state can increase the speed that pressure increases.
In the implementation of method 400, when blood processor 24 determines that patient's breathing pattern is indicated regular breathing state and/or REM sleep state, can be as aforementioned supply pressure.For example, when owing to the sleep disorder breathing state being detected and increase pressure, and blood processor 24 can continue to increase pressure towards the first predeterminated level when the breathing state of rule being detected.Namely, any part in method 400, blood processor 24 can detect patient's breathing pattern and whether indicate regular breathing state and/or REM sleep state.
According to above-described embodiment, blood processor 24 can be used in automatically-CPAP pattern in addition.In this mode, blood processor 24 keeps and/or adjusting pressure automatically.But when dry random wakefulness state being detected, blood processor 24 can reduce pressure with predetermined decrease towards the second predetermined pressure.When any other state being detected, blood processor 24 automatically replies automatically-CPAP pattern.
In an embodiment more of the present invention, system 1 can be used for detecting predetermined flow situation, all as if indicate destructive breathing pattern of short duration or that continue to revive, for example, be in deep breathing in regular respiration phase express of short duration 3-5 second revive or continue revive, as being measured by EEG.
What should understand is for those skilled in that art, in the situation that do not break away from the spirit or scope of the present invention, can make multiple correction and change to structure of the present invention and method.Therefore, purport of the present invention contains all corrections of the present invention and the change that falls in claims and equivalent scope thereof.