CN101137977A - Apparatus for acoustic diagnosis of abnormalities in coronary arteries - Google Patents

Abstract

The apparatus and methods disclosed herein relate to diagnosis of disease through the detection of signals from portions of a body. The signals may be acoustic signals, which can be used to diagnose the presence, severity and/or location of occlusions in arteries, such as the coronary arteries. The signals may be detected through noninvasive methods such as, for example, passive reception. Such methods can avoid many of the problems associated with invasive angiogram and angioplasty procedures. The apparatus and methods described herein are not limited to use for diagnosing occlusions in the coronary arteries, but can be used for a wide variety of biomedical diagnosis in human and nonhuman animals.

Description

The acoustic diagnostic instrument of abnormalities in coronary arteries

The cross reference of related application

[0001] the application requires the right of priority of following patented claim, and intactly incorporate each of these applications into this paper as a reference, make each become the part of instructions herein: the U.S. Provisional Patent Application the 60/645th that on January 20th, 2005 submitted to, No. 284, exercise question is " APPARATUS AND METHOD FORNON-INVASIVE DIAGNOSING OF CORONARY ARTERY DISEASE "; No. the 60/654.840th, the U.S. Provisional Patent Application of submitting on February 17th, 2005, exercise question is " APPARATUS ANDMETHOD FOR NON-INVASIVE DIAGNOSING OF CORONARY ARTERYDISEASE "; No. the 60/671st, 954, the U.S. Provisional Patent Application of submitting on April 15th, 2005, exercise question is " APPARATUS AND METHOD FOR NON-INVASIVE DIAGNOSING OFCORONARY ARTERY DISEASE "; And the U.S. Provisional Patent Application the 60/699th of submission on July 14th, 2005, No. 812, exercise question is " NON-INVASIVE TOOL FOR CORONARY ARTERY DIAGNOSIS USING SIGNAL CHARACTERISTIC ANALYSIS (CADSCAN) ANDISO-SURFACE OPTIMAL MEMBRANE-ADHERENT COMPLIANT (ISOMAC) SENSORS ".The application also intactly incorporates following application into this paper as a reference and make it to become the part of instructions herein: the U.S. Patent application the 10/830th that on April 23rd, 2004 submitted to, No. 719, exercise question is " APPARATUS AND METHOD FOR NON-INVASIVE DIAGNOSING OFCORONARY ARTERY DISEASE ".

Background

Invention field

[0002] the invention disclosed herein relate generally to detects and handles the apparatus and method of body signal, relates to the apparatus and method that detect and handle the health acoustical signal particularly.

General introduction

[0003] signal that relates to by detecting from body part of apparatus and method disclosed herein diagnoses the illness.Described signal can be an acoustical signal, and it can be used for diagnosing for example inaccessible existence, the order of severity and/or position in the coronary artery of artery.Described signal can be detected by noninvasive method, for example by passive acceptance (passive reception).These class methods can be avoided the many problems relevant with invasive angiogram and angioplasty.Apparatus and method described herein are not limited to be used to diagnose coronary occlusion, but can be used for various widely biomedical diagnostics among the mankind or the non-human animal.

The accompanying drawing summary

[0004] aforementioned and other target of the present invention and advantage will further be explained in together with accompanying drawing in the detailed description of embodiment, and wherein in whole accompanying drawings, identical reference numerals is described components identical.

[00051 Fig. 1 shows the diagram of human heart coronarius.

[0006] Fig. 2 is because the profile illustration coronarius that crack patch (fissuring plaque) part narrows down.Illustration is represented the thrombosis that part is inaccessible and entirely shut.

[0007] Fig. 3 schematically for example understands on the patient and to insert the pipe guide that is used for angioplasty or angiography.

[0008] fluid schematically described in having the pipe of narrow of Fig. 4 A and 4B flows.Fig. 4 A has schematically described Laminar Flow, and Fig. 4 B has schematically described the turbulent flow in this narrow downstream.

[0009] Fig. 5 for example understands the female small echo (Morlet mother wavelet) of Morlet.

[0010] Fig. 6 A-6D for example understands the sub-small echo (daughter wavelet) of the female small echo of Morlet shown in Figure 5.

[0011] Fig. 7 schematically illustrates the sampling grid of wavelet transform and shows example corresponding to the sub-small echo of four kinds of time-frequency resolution unit (time-frequency resolution cells).

[0012] Fig. 8 schematically illustrates the Di Kaer coordinate system, and it can be advantageously used in expression and be positioned at (x_s, y_s, z_s) narrow, by this narrow sound wave that sends, and receive described sound wave, be positioned at (x_l, y_l, z_l) a plurality of sonic transducers.

[0013] Fig. 9 is the process flow diagram of the general step of the expression method that is used for diagnosing coronary occlusion.

[0014] the general corresponding relation between dissect on Figure 10 A basis of schematically illustrating sonic transducer and health is placed with described sensor on described health.

[0015] Figure 10 B schematically illustrates the embodiment of placing sonic transducer on patient body.

[0016] Figure 10 C schematically illustrates the embodiment that is used for placing the model of sonic transducer on patient body.

[0017] Figure 11 A-11C has illustrated various heart signals and the feature that exists in heart signal.

[0018] Figure 12 A is the schematic block diagrams that has illustrated from the method for the existence of acoustic data diagnosis coronary occlusion.

[0019] Figure 12 B is for six different scale parameters (scale parameter) value, from the figure of the heartbeat diastole of wavelet coefficient absolute value partly.

[0020] Figure 13 is a process flow diagram, and it has described the method for related small echo Diagnostic parameters and comparative diagnoses parameter on the statistics.

[0021] Figure 14 A has schematically described the embodiment of the device of diagnosis coronary artery disease.

[0022] Figure 14 B has schematically described the planimetric map of the embodiment of the device of diagnosing coronary artery disease.

[0023] Figure 14 C has schematically described the outboard profile of the embodiment shown in Figure 14 B.

[0024] Figure 14 D is the photo of embodiment of the device of diagnosis coronary artery disease.

[0025] Figure 14 E has schematically described the front perspective view of the embodiment of the diagnostic device that comprises portable unit and base station.

[0026] Figure 14 F has schematically described the rear perspective of the diagnostic device shown in Figure 14 E.

[0027] Figure 15 A schematically described the embodiment that can be used for diagnostic device general electronic structure.

[0028] Figure 15 B and Figure 15 C have schematically described the functional block diagram of the embodiment of the device of diagnosing coronary artery disease.

[0029] Figure 16 A-16N has schematically described the electron device in the device that is suitable for use in the diagnosis coronary artery disease.

Detailed description of the preferred embodiment

[0030] organ and tissue can produce acoustic energy, and it is by the part transmission of described health.This acoustic energy can comprise sound wave, and it is the vibration in medium, and described acoustic energy is propagated by described medium.Usually, described medium is compressed in the direction identical with the sonic propagation direction, forms wave of compression.Described sound wave is propagated with the velocity of sound, and this velocity of sound depends in part on the medium that described sonic propagation passes through.For example, the velocity of sound can be about 1540m/s in soft bodily tissue, and the velocity of sound can be about 4000m/s in bone tissue.The sound wave that produces by health can with suck at the moving of the various organs of health or regional inner cell or body fluid, muscular movement, air in the lung or the like relevant.Each of these sound can comprise the information that can be used for diagnostic purpose by the doctor.For example, open by the heart of beating, heart valve and closed and/or blood can provide information about the patient health state relevant with heart and vascular system by the flow sound that produces of vascular system.

[0031] many patients suffer from dangerous medical symptom, and wherein cholesterol or plaque deposition thing accumulate on the inwall of body vessel or artery.Coronary artery disease is meant this class accumulation when it occurs on the inwall of heart arter.Fig. 1 has describedheart 100 and main coronary artery.The accumulation of patch or cholesterol may promote obstruction of artery, and when serious the obstruction took place in coronary artery, fatal heart attack may take place.When sonorific biophysics process was understood, it was possible utilizing the acoustical signal that produces in the health to carry out medical diagnosis.

[0032] Fig. 2 has describedartery 210, and it transportsblood plasma 211a andred blood cell 211b (red blood cell) passes through whole patient body.In suffering from the patient of coronary artery disease, cholesterol orpatch layer 212 form on the inwall of artery 210.Thispatch layer 212 has reduced the hemophoric capacity of affected artery, and () blood flow volume for example, musculature causes arriving the nutrient and the oxygen lack of tissue thereby reduce the blood flow by artery and be transported to the tissue supplied with by artery.Thispatch layer 212 also may weaken the wall of being attacked artery.What as shown in Figure 2,patch accumulation 213 may causeartery 210 narrows 215.Artery narrow 215 can be called as in this article narrow or inaccessible.As used herein, term " narrow (stenosis) " and " inaccessible (occlusion) " are wide in range terms, and be used with their common implications, and, except offering some clarification on, comprise that without limitation any xsect that narrows, blocks (partly or entirely) or blood vessel or pipe unusually reduces.Term " narrow " and " obturation " include but not limited to coronariusly be narrowed or block by what coronary artery disease caused.Term " narrow " and " obturation " can be exchanged use, except specifying.

[0033]crack 214 may be developed inpatch 212, and causes blood clot (thrombus) to form in artery 210.Illustration above among Fig. 2 has schematically been described thetube wall thrombus 216 that causes part obturation 217 (for example the xsect ofartery 210 is reduced).Part inaccessible 217 may cause unsettled angina in some patients, and embolism can take place easily, and this may cause the other obturation in initial inaccessible 217 downstreams.Illustration below among Fig. 2 has schematically been described thethrombus 218 of caused entirely shutting 219 (for example, the xsect ofartery 210 is basically by total blockages).Entirely shut and 219 may in some patients, cause miocardial infarction.Blood clot (forexample example grumeleuse 216 and 218 shown in Fig. 2) may increase the weight of the problem by patch accumulation generation.Not onlypatch 212 is to small part occlude vessel or artery, and blood clot can rest on the part of described vessel occlusion and further increase the weight of obstructing problem.Certainly, even be not the same position that patch accumulation has taken place in vascular system, blood clot itself also can form embolism and other vascular or the artery of inaccessible health wholly or in part.Blood clot in coronary artery is the reason of many heart attacks.

[0034] present, many invasive techniques are used to diagnose coronary artery disease.For example, " angiogram " is highly invasive method, and it requires conduit to be inserted into (for example by femoral artery or other main artery) in the health.Then, this conduit is admitted to by vascular system, arrives vascular or artery to be detected, for example coronary artery up to it.This method has and the relevant many inferior positions of its height invasive, and may produce the risk of very harmful spinoff.Fig. 3 has described the catheter length that angiogram may need.Conduit 316 is as follows by schematically showing: extend its insertion point frompatient 318 femoral artery, through blood vessel 320, and enters patient's heart 322.Such cathterization may be essential for angiogram and angiopoiesis step subsequently.Angiopoiesis comprises by compression, removes or the shape that otherwise changes the plaque deposition on the vascular sidewall is handled obturation in the vascular.Because there is the great demand for the non-invasive diagnostic installation method in the height invasive of the method for these diagnosis coronary artery diseases, diagnostic device method for example described herein.

[0035] as mentioned above, coronary artery disease may cause the passage of blood flow warp to narrow.Although many biosystems are complicated more, the model of simplifying can be used for helping to describe the physical state that fluid flows through passage, and this passage has narrow relatively part.Fig. 4 A and 4B have schematically describedpassage 410, and it has thexsect 420 along its length variations.Describedxsect 420 drops to minimum value at 430 places, constriction district, is increased to initial value then.Pump (for example, shown in Figure 1 heart) provides the stabilize fluid flow through passage 410.Fig. 4 A has schematically described the situation of laminar flow, wherein fluid velocity be stable, stably with orderly.Fluid line offlow 440---the route that the expression segment fluid flow is taked converges reposefully when arrivingconstriction district 430, and separates reposefully after by constriction district 430.Flow velocity increases reposefully from initial value (450a represents with arrow), reaches maximal value in the position inconstriction district 430, and falls back initial value reposefully (450b represents with arrow).Laminar flow usually only takes place under lower flow velocity, and is minimum by any sound that laminar flow produced generally.Fig. 4 B has schematically described the situation of turbulent flow, and it takes place when fluid velocity is higher than the flow velocity of finding under the laminar flow situation usually.Flow velocity increases from the initial value (450c represents with arrow) similar to the initial value 450a Fig. 4 A reposefully, and flow velocity increases when arriving constriction district 430.Yet, the laminar flow in Fig. 4 A, the turbulent flow in thezone 460 behindconstriction district 430 is characterized byflow velocity 450d, and it is unsettled, unordered and confusion.Hydrodynamic pressure in theturbulent area 460 ofpassage 410 is increased, and this makes described pump keep this flow velocity difficulty more.Described turbulent flow produces the pressure to the tube wall ofpassage 410, and it may cause infringement.Described turbulent flow resolves into the turbulent flow whirlpool of scramble pattern inturbulent area 460, it can form contrast with the line of laminar flow stably 440 shown in Fig. 4 A.Described turbulent flow produces unique sound wave, and it is fromturbulent area 460 spread outs.The sound that sound bigger usually (for example having higher sonic wave amplitude) that turbulent flow produces and frequency ratio laminar flow produce is higher.For example, turbulent flow and/or other physiological phenomenon relevant with heart murmur can be heard by stethoscope.

[0036] with the simplified model of Fig. 4 A and 4B relatively, inaccessible in the coronary artery usually than the narrow 430 more unsmooth and more not gradual changes ofmodel passage 410, this can cause the turbulent flow described in the model than Fig. 4 B turbulent flow of complexity more.For example, Fig. 2 schematically describes because patch cracking, crack and the some kinds of vascular occlusions of breaking and causing.Inaccessible 217,219 structurally can be highly irregular, and can have the porosity of degree varies.In addition, inaccessible 217,219 can comprise erose thrombus 216,218.Further, in health, blood flow needn't take place with constant speed, even also is so in the part of the blood vessel with constant cross-section, and reason is that heart beats with the periodicity pulse, rather than on flow direction stable, continuous power.And vascular and artery not only expand outwardly under pressure, and they can be by the contraction of muscle around it.These biodynes have reduced coronary artery will have the possibility of constant xsect.Yet as mentioned above, the patch accumulation can reduce elasticity coronarius, reduces this effect in suffering from the patient of coronary artery disease.

[0037] by the fluid passage narrow or the inaccessible turbulent flow that causes produces acoustic energy, described narrow or inaccessible because patch in coronary artery accumulates takes place.This turbulent flow does not exist in no arterial occlusive healthy patients generally speaking, perhaps do not exist at least with identical degree, therefore, the existence of this type of turbulent flow whether and its further feature can be used for diagnosing coronary artery disease.Through after the described obturation, for example should downstream one side (for example, thezone 460 among Fig. 4 B) of obturation in flow channel on, turbulent flow may be strong especially.This fluid turbulent can produce the voice signal or the acoustical signal of high frequency.In that part of heartbeat cycle period that is called as diastole, these signals can be detected.This part cardiac cycle is quiet relatively, because the muscle of heart is in strong contraction, and with respect to heartbeat round-robin other parts, heart valve is quiet relatively.

[0038] by the organ acoustic energy that produces of heart for example, can by one or more sonic transducers that place the health outside in addition Noninvasive detect and monitoring.When incident acoustic wave arrived sonic transducer, described sensor can produce the simulating signal with certain amplitude, and described amplitude is corresponding to described incident sound wave amplitude.Square being directly proportional of the acoustic energy or the sound intensity and sonic wave amplitude.Detected simulating signal like this can be the continuous variation function of time, and it can be transferred to hardware or software module, is handled.Generally speaking, by under one group of discrete time to analog signal sampling, this simulating signal is converted into digital signal.(analog-to-digital converter ADC) can be used for this type of conversion to analog to digital converter.One group of acoustical signal value of inscribing when this digital signal is included in a plurality of the sampling.Usually, with fixing sampling rate for example 22,000Hz is to analog signal sampling.This sampling rate can be conditioned or be tuning, depends on the frequency of pending signal and/or the frequency or the further feature of any noise.Sampling rate can depend on the processing speed of other element in device.

The analysis of acoustical signal

[0039] in some embodiments, provide apparatus and method, it is used for detecting the obturation in patient's coronary artery.This device can have one or more sonic transducers, and it is attached to (for example, the known location on patient's chest) on the patient's body.This sensor can receive the acoustical signal that is produced by health, and the another part that this acoustical signal can be transferred to described device analyzed, and is for example undertaken by producing with the proportional electric signal of described acoustical signal.Threshold amplitude scope or frequency range or time range can be established, to discern signal to be evaluated.Described signal can be handled, to determine existing and/or the order of severity of in coronary artery obturation or many places obturation.In some embodiments, this method further comprise determine inaccessible with respect to one or more sonic transducers the position or with respect to the position of anatomical cardiac structure.

[0040] signal processing method can comprise amplification, filtration, digitizing, synchronous and/or demultiplexing (multiplexing) signal.Described processing may further include the identification division signal, and described part signal is corresponding to heartbeat or corresponding to diastole of heartbeat.In some embodiments, described disposal route can be discerned incident, the systole phase of this incident indication heartbeat and/or the beginning of diastole.In some embodiments, this incident can comprise a part of acoustical signal, and it is in scheduled frequency range and/or above threshold amplitude.Have certain frequency and can indicate existence inaccessible in one or more coronary artery above the acoustical signal of threshold amplitude.

[0041] described signal processing method may further include the various combinations of conversion from the signal of sonic transducer reception.This conversion can comprise Fourier transform, wavelet transformation or other signal analysis conversion.In some embodiments, more than one conversion can be applicable to signal.Wavelet transformation analysis can provide the time delay analysis of described signal and scale (scale) (frequency) to analyze.Time delay parameter and scale parameter can be used for estimating that the hear sounds sound of IC turbulent flow (or originate from) propagates by health and by sonic transducer and detect institute's time spent.In some embodiments, relative time postpones and can be estimated, to determine the occlusion locations in one of coronary artery.The value of time delay and scale parameter---wherein Wavelet Transform Parameters has local maximum---can be determined and can be used for to determine the inaccessible order of severity.In other embodiments, the centre of moment of the part of wavelet coefficient (centroid) can be used for determining time delay.In other embodiments, the variance of wavelet coefficient (variance) can be used for indicating the existence or the seriousness of coronary artery disease.

[0042] some embodiments of method disclosed herein can comprise the following steps some or all: the chest that a plurality of sonic transducers is attached to the patient; By each received signal of a plurality of sonic transducers, described signal indication patient's repeatedly heartbeat; Set up threshold amplitude and frequency range, to discern the signal that to be estimated; And handle described signal, be used for determining in the inaccessible existence of coronary artery or seriousness and described obturation position with respect to described a plurality of sonic transducers.

[0043] in some embodiments, the method for the obturation in detection patient's the coronary artery can comprise one or more following parts as signal Processing: amplification, digitizing, filtration, synchronous and/or demultiplexing signal.In some embodiments, the method for the obturation in detection patient's the coronary artery can comprise that identification surpasses the existence of the signal amplitude of the threshold amplitude of being set up, and described amplitude is in the frequency range of setting up, and this is as the part of treatment step.In some embodiments, the treatment step of described method may further include at least a signal that receives from described a plurality of sonic transducers is carried out wavelet transformation analysis.Described wavelet transformation analysis can provide time domain (time domain) analysis or frequency analysis or both.In some embodiments, the method of the obturation in detection patient's the coronary artery may further include and shows the position of blocking with respect at least one of described a plurality of sonic transducers, perhaps with respect to visual at least one position of patient's heart, or the position by textual description.And described method may further include and shows the information relevant with the order of severity of described obturation.

[0044] in some embodiments, the method for the obturation in described detection patient's the coronary artery may further include sonic transducer is connected on the known location with respect to determined reference point on patient's chest.Then, Bi Sai position can be determined with respect to the position and/or the reference point of described sonic transducer.

Carry out signal Processing with wavelet transformation

[0045] as mentioned above, sonic transducer receives acoustical signal, its sound wave of launching corresponding to heart (or the sound wave that produces corresponding to the artery turbulent flow).This acoustical signal represents to arrive the sonic wave amplitude at sensing station place.In some embodiments, by producing analog receiving signal, sonic transducer responds to described sound wave.In some such embodiments, this analog receiving signal can be exaggerated, filters, sampling and digitizing, for example, is undertaken by analog to digital converter, to produce digital signal.This digital signal representation is by the heart emission and at the amplitude of sampling instant by the sound wave of sensor reception.Use many known signal processing technologies, this digital signal can be processed.For example, in some embodiments, digital signal can be further filtered, and to remove unwanted or external component of signal, for example ambient sound is made an uproar.In addition, various conversion can be applied to this digital signal before or after filtering.For example, Fourier transform can be applied to this digital signal, with the amount of the acoustic energy in the sound wave of determining to vibrate under different frequency.

[0046] in using the method for Fourier analysis, this digital signal is broken down into the weighted sum of sinusoidal curve basis function (sine and cosine), its each with different constant frequency vibrations.The amplitude of sinusoidal curve basis function is decay in time not, this means that this basis function has unlimited propagation distance in time domain.Fourier analysis can be used for calculating how much acoustic energy (or power) under each different frequency to be comprised in the described signal.

[0047] has been found that coronary occlusion can produce frequency range at the acoustic energy of about 500Hz to about 1000Hz.Referring to, J.L. Semmlow for example, et al., " Noninvasive Detection of Coronary ArteryDisease Using Parametric Spectral Analysis Methods; " pp.33-35, IEEE Engineering inMedicine and Biology Magazine, March 1990, and Y.M.Akay, et al., " NoninvasiveAcoustical Detection of Coronary Artery Disease:A Comparative Study of SignalProcessing Methods, " pp.571-578, IEEE Transactions on Biomedical Engineering, vol.40, no.6, June 1993, and both are all incorporated into this paper in view of the above as a reference and as the part of this instructions.In different patients, can be different corresponding to the amplitude and the frequency range of turbulent flow acoustic energy, and the about 500Hz-1000Hz intention of aforesaid scope is only as the example that can be used for the audio range of diagnostic purpose.For example, in some patients, described frequency range can be from about 300Hz to 2000Hz.Other frequency---higher and/or lower, can produce by coronary occlusion, and these frequencies can be different in inhuman animal.In addition, the acoustic energy by the ill part emission of the unusual or health of other type can comprise different frequency ranges.

[0048] signal can be characterized by centre frequency and frequency range.Centre frequency is represented the average frequency of signal, and frequency range represents to comprise the frequency range of most of acoustic energy.Centre frequency and frequency range can use the Fourier analysis technology to be determined.Signal can be divided into narrow frequency or wideband, and this depends on duty-cycle, and it is the ratio of frequency range and centre frequency.Narrow frequency signal has the duty-cycle less than 1, and this represents that the major part of their energy is present near the arrowband of centre frequency.By contrast, broadband signal has the duty-cycle greater than 1, and this represents that the major part of their energy is present on the frequency away from centre frequency.

[0049] in addition, signal can be characterized as being stable state or unstable state.Steady-state signal has the statistics attribute of constant or slow variation, make the signal snapshot under particular moment may show with another the time inscribe the similar statistics attribute of the snapshot of obtaining.As if non-static signals may have random component, makes that the snapshot under particular moment may have minimum consistance with the snapshot of inscribing this same signal of obtaining when different.

[0050] because the sinusoidal basis function that uses in Fourier analysis vibrates with constant frequency, and not decay in time, so the Fourier method can be suitable for narrow frequency, stationary singnal.Yet, may comprise wideband, non-static signals by the acoustic energy of heart emission.For example, be found from the duty-cycle of measuring from a patient's heart signal and equal about 2.2, it is greater than 1 (this point is divided the transformation from narrow frequency to wideband).In addition, the blood flow in the known occluded artery is characterized by turbulent flow, and described turbulent flow is at random nonstatic process normally.Therefore, the signal analysis technology of suitable wideband, non-static acoustical signal can be used for the analysis of cardiac signal.This type of technology can also be used in combination with Fourier method or other signal analysis technology.

[0051] wavelet analysis is developed, and partly is used to provide the analytical approach that is used for wideband, non-static signals.In wavelet transformation, according to the basis function that is called as small echo, signal is decomposed.Form contrast with sinusoidal fourier basis functions with unlimited propagation distance, small echo at the center near the time by localization, and their amplitude early than or to be later than in time of this center time be little.Similar with fourier basis functions, small echo vibrates, but small echo is not usually with fixing hunting of frequency.Fig. 5 shows the representative example ofsmall echo 500, and it is called as " Morlet small echo ".Fig. 5 is the amplitude image of Morletsmall echo 500, and it is as the function of time t.This Morletsmall echo 500 vibrates, near center time (central time) t=0, assembles (centered), and along with away from t=0, amplitude fading.

[0052] each of the wavelet function that uses in wavelet transformation derives from single " female small echo (motherwavelet) " (being also referred to as " analysis wavelet (analyzing wavelet) ").The small echo that derives from female small echo is called as " sub-small echo (daughter wavelet) ".By female small echo of (i) translation in time (moving) and the (ii) female small echo of convergent-divergent (enlarge or compression) on amplitude, sub-small echo derives out from female small echo.Therefore, sub-small echo is the duplicate of the Pan and Zoom of female small echo.The wavelet transformation of signal is school microscop (mathematicalmicroscope), and how well related its measurement described signal under each Pan and Zoom value with sub-small echo.In fact, by regulating the Pan and Zoom parameter, wavelet transformation allows people to change the focus of school microscop, and the details of differentiating signal under the difference moment and different frequency.Other details about wavelet transformation can find in many common available textbooks, for example " Wavelet Theory and Its Applications ", Randy K.Young writes, Kluwer Academic Publishers publishes, its disclosed full content intactly is incorporated herein by reference thus, and as the part of this instructions.

[0053] advantage of wavelet analysis is as follows: compare common requirement change still less, the highly periodic function Fourier analysis of sine and cosine for example, have the potential mother wavelet function of a large amount of kinds.By selecting suitable female small echo, different mathematics aspect that can analytic signal.For example, can be suitable for determining at the Morletsmall echo 500 shown in Fig. 5 whether signal contains the short-term " pulse (burst) " of wave energy.Because female small echo be localization in time function and can be by suitably convergent-divergent and translation, so wavelet transformation is suitable for analyzing wideband, non-static signals, for example from those signals of heart.

[0054] will represent by function g (t) as the value of female small echo of the function of time t.For example, the femalesmall echo 500 of Morlet shown in Figure 5 can be represented by mathematical function:

e^-t2/2[cos(σt)-e^-σ2/2]， (1)

Wherein σ is customized parameter (being set equal to five in Fig. 5).Sub-small echo is the convergent-divergent and the translation duplicate of female small echo.The time displacement parameter will be represented by τ, and zooming parameter will be represented by s.Bigger τ value is corresponding to the bigger in time translation of female small echo.Bigger s value is corresponding to longer time scale and lower frequency.Littler s value is corresponding to shorter time scale and the frequency of Geng Gao.Therefore, the vibration frequency of sub-small echo and its scale parameter are inversely proportional to.The sub-small echo of convergent-divergent and translation is by g_{S, τ}(t) represent, and define by following relational expression:

$g_{s,\mathrm{\τ}}\left(t\right)=\frac{1}{\sqrt{\left|s\right|}}g\left(\frac{t-\mathrm{\τ}}{s}\right).---\left(2\right)$

The choice criteria factor

To keep the energy in the sub-small echo to equate with energy in female small echo.In other embodiment of wavelet method, normalization factor can differently be selected.

[0055] under big scale parameter value (low frequency), sub-small echo is that the duplicate of (decay) is put and weakened in the expansion of female small echo.Under little scale parameter value (high-frequency), sub-small echo is the duplicate of the compression and the enhancing (amplification) of female small echo.Fig. 6 A-6D has described four sub-small echo example 610-640 that derive from the female small echo 500 of Morlet.In Fig. 6 A, sub-small echo 610 is not scaled (for example, s=1), but with τ=5 translations (moving right).In Fig. 6 B, sub-small echo 620 is not by translation (for example, τ=0), but with the s=5 convergent-divergent, this produces the diffusion (expansion) of female small echo 500 and the duplicate that weakens.In Fig. 6 C, sub-small echo 630 is not by translation, but with the s=1/2 convergent-divergent, this produces the duplicate of the compression and the enhancing of female small echo 500.At last, in Fig. 6 D, sub-small echo 640 is not only by translation (τ=3) but also scaled (s=1/3).Although Fig. 6 A-6D for example understands four kinds of example small echos, there is infinite a plurality of sub-small echo, it is corresponding to all probable values of scale and translation parameters.For example understand the mathematical ability of small echo at the example small echo shown in Fig. 6 A-6D, it can be moved arbitrarily and convergent-divergent, the oscillation characteristics that may exist in signal with coupling.

[0056] advantage of wavelet analysis is as follows: many mathematical functions can be selected to as female small echo.Require as the mathematics of female small echo for function g (t) " tolerable " (for example, tolerable on the mathematics) to be: this function vibration have limited energy, and mean value is zero.For function g (t) tolerable be: following " allowing constant (admissibilityconstant) " c as the adequate condition of female small echo_gBe finite (less than infinity):

$c_g\&equiv;{\&Integral;}_{-\&infin;}^{+\&infin;}\frac{{\left|G\left(\mathrm{\&omega;}\right)\right|}^2}{\left|\mathrm{\&omega;}\right|}\mathrm{d\&omega;}<\&infin;---\left(3\right)$

In formula (3), G (ω) is the Fourier transform of g (t), and ω is the frequency variable with the t conjugation.For being finite big integration in the formula (3), must equal zero in ω=0 o'clock function G (ω), from wherein as can be seen the mean value of female small echo must be zero:

${\&Integral;}_{-\&infin;}^{+\&infin;}g\left(t\right)\mathrm{dt}=0---\left(4\right)$

Many natural signs satisfy admissible condition and can be used as female small echo.

[0057] continuous wavelet transform of the signal r (t) relevant with female small echo g (t) (continuous wavelet transform, CWT) determined by all time values are carried out integration:

$\mathrm{WT}[r,g](s,\mathrm{\&tau;})=\frac{1}{\sqrt{\left|s\right|}}\underset{-\&infin;}{\overset{+\&infin;}{\&Integral;}}r\left(t\right)g^{*}\left(\frac{t-\mathrm{\&tau;}}{s}\right)\mathrm{dt}---\left(5\right)$

Complex conjugate represented in asterisk on g.Symbolic representation in the formula (5): wavelet transformation WT is by two in the square bracket amount definition, i.e. input signal r and female small echo g.For any given signal and female small echo, wavelet transformation is in bracket two the independently functions of scale and translation variable s and τ.

[0058] from the definition of formula (2) neutron small echo as can be seen, the wavelet transformation under any value of scale and translation is the complex conjugate integration of signal times with sub-small echo:

$\mathrm{WT}[r,g](s,\mathrm{\&tau;})=\underset{-\&infin;}{\overset{+\&infin;}{\&Integral;}}r\left(t\right)g_{s,\mathrm{\&tau;}}^{*}\left(t\right)\mathrm{dt}---\left(6\right)$

Therefore, the value of continuous wavelet transform is coupling or the measuring of " overlapping (overlap) " between signal and the sub-small echo.Coupling is big more between signal and the sub-small echo, and the value of wavelet transformation is big more.An advantage of continuous wavelet transform comes from female small echo by Pan and Zoom arbitrarily, then with the ability of signal correction connection.Another advantage is from the ability of selecting female small echo in advance, and described female small echo mates the expection or the known form of feature of interest in the described signal usually.In fact, wavelet transformation will carry out as better school microscop, reach this degree so that female small echo and mate described signal characteristic better.

[0059] continuous wavelet transform of signal comprises a large amount of information, and may be difficult calculating estimating under all possible scale and the translation.Usually (s τ) samples to continuous wavelet transform at limited point in the plane in two dimension.The conversion of this sampling is called as wavelet transform, and (discrete wavelet transform, DWT), and the value of the wavelet transform under described limited any one that put is called as wavelet coefficient (waveletcoefficient).

[0060] in some embodiments, select limited sampled point, with in that (s τ) forms grid (or grid) in the plane.In some embodiments, the grid of sampled point is selected as diadic (is the end with 2) grid (dyadicgrid), and this produces the logarithm sampling of scale and translation parameters.In an embodiment of diadic grid, sampled point can be selected according to following formula:

s＝2^-jj＝0，1，2，...，J

τ＝2^-jk_τ0k＝0，1，2，...，2^j (7)

[0061] a pair of integral indices j and k mark sampled point on grid.Index j is corresponding to the discrete steps on scale, and index k is corresponding to the discrete steps in translation.Scaling exponent j proceeds to maximal value J from null value.Recall the littler bigger frequency of scale correspondence, formula (7) shows that bigger index j value is corresponding to higher frequency.For example, the minimum value of j (j=0) in signal corresponding to the scale (s=1) and the slowest target frequency of maximum.Bigger value is corresponding to littler scale and bigger frequency.As an example, equal 10 j value time corresponding division ratio maximum scale little 1/2¹⁰=1/1024 multiple, and corresponding frequency correspondingly than minimumtarget frequency height 2¹⁰=1024 times.Therefore, greatest exponential value J can be selected, so that scale parameter is crossed over whole range of target frequencies in the grid.In some embodiments of the apparatus and method of being discussed, greatest exponential value J equals 16 in this article.

[0062] Li San translation stepping and time parameter τ_oBe directly proportional, described time parameter can be conditioned, to be fit to this problem.For example, in some embodiments, time parameter can be set, and equals the duration of patient's heartbeat or the duration of the signal that equals to be accepted by sensor.Should discrete translation stepping also depend on scale parameter, reason is thefactor 2 in formula (7)^-jExistence.Therefore, this discrete translation stepping is littler under higher frequency (higher j).Because the size of described discrete translation stepping changes themaximum number 2 of translation stepping with j^jAlso depend on index j.The size of discrete time displacement stepping is littler under higher frequency, so that small echo can be differentiated the signal characteristic under those frequencies fully.

[0063] Fig. 7 is a synoptic diagram, and it has described Figure 70 0 of the time frequency resolution of the diadic grid embodiment that is provided by formula (7), and it is the function of scale and translation parameters.Transverse axis 710 express time translation parameterss, wherein τ (and k) increases to the right.The longitudinal axis 712 expression scale parameter and frequencies, it is inverse correlation each other.In Fig. 7, along the longitudinal axis 712 upwards, frequency increases, and is therefore downward along the longitudinal axis 712, and scale increases.Index j value is littler in the bottom of axle 712, and bigger in top j value.

[0064] Fig. 7 has described whole (s, τ) the time frequency resolution unit 720 in the plane (rectangle frame 720 in Fig. 7).Resolution is meant the amount of the clarity of signal that can distinguish by small echo under any specific sampled point.In Figure 70 0, unit 720 any one regional 718 is corresponding to the small echo resolution in this position.The horizontal width 722 express time resolutions of unit 720, and the vertical height 724 of unit 720 is corresponding to scale (or frequency) resolution.The area of unit 720 is the long-pending of horizontal width 722 and vertical height 724.

[0065] Fig. 7 shows, frequency is sampled by logarithm on this diadic grid.Low-limit frequency is represented in the bottom of Figure 70 0.Next higher frequency is the twice of previous frequency, so analogizes.Therefore, the vertical height 724 of resolution elements 720 upwards increases.The selection of diadic grid causes sample frequency to be arranged to octave in formula (7).Fig. 7 shows that also the horizontal width 722 of translation stepping depends on scale.For example, under higher frequency, the horizontal width 722 of translation stepping is littler, so that wavelet transformation can be differentiated the higher frequency feature in the described signal.Do not need this type of little translation stepping owing to differentiate the signal characteristic of slower variation, the horizontal width 722 of translation stepping increases on the bottom direction of Figure 70 0.Therefore, the diadic grid [for example, formula (7)] advantage is as follows: regulate with the order of magnitude automatically, to differentiate the signal characteristic under each frequency by the translation stepping.

[0066] as shown in Figure 7, the area 718 of time frequency resolution unit 720 depends in (s, τ) position of this unit in the plane.The area 718 of unit 720 is proportional with " size (size) " of the sub-small echo that is used to analyze this signal.By expressing the example of employed sub-small echo under each scale, Fig. 7 has schematically described this proportionate relationship.Under lower frequency, sub-small echo 730a is put by expansion and is weakened, with have low-frequency signal characteristic and be associated.Under higher frequency, sub-small echo 730b, 730c and 730d are compressed and strengthen, to be associated with the signal characteristic with higher frequency.The mathematical relation of sub-small echo and female small echo [formula (2)] is selected, so that sub-small echo can be in that (s τ) in the plane, differentiates the signal characteristic under all scales effectively.In addition, according to diadic grid [for example, formula (7)] to (s, τ) to sample be favourable on the plane, because the duty-cycle of each time frequency unit 720 (ratio of frequency range and centre frequency) is independent of scale.

[0067] in other embodiments, different sampling grids can be used.For example, some embodiments can all utilize linear grid on scale and translation parameters, rather than the logarithm grid.Other embodiment can utilize logarithm-linearity or linearity-logarithm sampling grid.Many selections all are possible.For example, in some embodiments, the sampling grid that is similar to formula (7) is used, and wherein scaling exponent comprises value j=1,2,4,8,12 and 16, and it is corresponding to frequency 62.5Hz, 125Hz, 250Hz, 500Hz, 750Hz and 1000Hz.

[0068] as discussed, the continuous wavelet transform of definition can [for example, formula (7)] sampled point be estimated, to form wavelet transform at grid in formula (5).The value of formula (5) under sampled point is called as wavelet coefficient.Wavelet coefficient is a columns, and it can be by corresponding to the sampling index j of grid and k mark in addition.In some embodiments, signal is represented by sequence of real numbers.In some these type of embodiments, small echo is also by real number representation [for example, formula (1) is the real number value function].Therefore, in these embodiments, wavelet coefficient also is a real number.Yet in other real number mode, signal, small echo or both can be represented with plural number (for example, having the number of real part and imaginary part), and wavelet coefficient can be a plural number.

[0069] wavelet coefficient can use any of various numerical methods to be estimated.In one embodiment, the integration in formula (5) can be calculated by the numerical quadrature technology, for example, and such as Simpson's rule.In another embodiment, signal r (t) and female small echo g (t) can be sampled and digitizing.Maximum scale (s=1, j=0) under, wavelet coefficient equals the cross correlation between signal and the female small echo.By digitized signal and female small echo long-pending being carried out suitable summation, the integration in can calculating formula (5).In some embodiments, the instruction of machine language multiply-accumulate can be used, to increase processing speed.Because on the diadic grid, each the back scale little 2 multiple, be extraction (for example, by 2 samplings (subsampled by2) again) duplicate of female small echo at each sub-small echo under the scale of back.Therefore, for each value of scaling exponent j, wavelet coefficient can calculate by extracting summation method (decimation-and-summation process), as knowing in digital field.In another embodiment, wavelet transform can be calculated according to the sub-band coding algorithm, and described algorithm relates to the low pass of signal and considers ripple and high-pass filtering.

[0070] advantage of Wavelet Transform is the wide region selection of female small echo.As discussed above, the tolerable small echo can be vibration, to have limited energy and mean value be any function of zero.Many functions have these character, and can be used as female small echo.Normally used small echo is named with their founder, for example such as Morlet small echo or Daubechies small echo.The various embodiments of system and method disclosed herein have utilized Haar small echo, Morlet small echo or Daubechies small echo.Other embodiment can utilize the continuous or discrete wavelet of other any kind.For example, some embodiments can adopt any member of Hermitian small echo, Mexican hat small echo, coiflet small echo, symlet small echo or quadrature or biorthogonal wavelet class.

[0071] in some embodiments of diagnosis coronary artery disease, the Morlet small echo has been found the result that can provide suitable.In some such embodiments, the value of adjustable parameter σ [referring to formula (I)] can be configured to corresponding with frequency, for example, and 10Hz, 62.5Hz, 750Hz, 1000Hz or 2000Hz.In other embodiments, adjustable parameter σ can be set and equal and one of the scale of sampling on the grid corresponding frequency, for example, and such as minimum (or the highest) scale parameter.In other embodiments, other the female small echo except the Morlet small echo can be used.

[0072] some embodiments of system and method disclosed by the invention can be used to make up female small echo from a part of signal of diseased heart.This part can comprise signal or signal characteristic, and described feature is that coronary artery disease is distinctive or representational.Specific heart signal can be selected as female small echo, and reason is the effect that it has the most clearly reflected coronary artery disease.By guaranteeing that this part satisfies the small echo admissible condition, this part of described signal can be used as the template that makes up female small echo.In one embodiment, representative heart signal can be sampled and digitizing before being used as female small echo.

[0073] some embodiments of system and method disclosed by the invention can use each patient's oneself the part of heart signal as female small echo.In other embodiment of described system and method, wavelet analysis can carry out with more than one female small echo, to realize diagnosis more accurately.In one embodiment, the type of female small echo can be revised by the health care professional of using described method.

[0074] although some preferred embodiment can be applied to small wave converting method discussed in this article the diagnosis of coronary artery disease, but should be appreciated that these methods can be applied to the diagnosis or the sign of other disease, illness, symptom, disorder, syndrome or pathology.Described method and system can be applied to other organ or tissue.Although system and method disclosed herein is described with regard to human diseases, this is not to be a kind of restriction, and described method and system also can be applied to the disease of inhuman animal.

[0075] in addition, some embodiments can use wavelet method in conjunction with Fourier or other signal processing method, so that extra diagnostic message to be provided.For example, in one embodiment, fourier method can be advantageously used in the frequency range of the turbulent flow acoustic energy of determining that coronary occlusion is produced, and wavelet method can be advantageously used in seriousness and/or the position of determining described obturation.

Detect acoustic energy by sonic transducer

[0076] Fig. 8 has schematically described the others relevant with the location with narrow 820 detection, and described narrow 820 may reside in the patient's body.With reference to three-dimensional system of coordinate 810, determine in health, on the health or the position of any point around the health is easily.At the coordinate system shown in Fig. 8 810 are Di Kaer coordinate systems, and wherein every bit is by (x, y, z) coordinate setting.In other embodiments, different coordinate systems can be used, for example, and such as spherical coordinate.Fig. 8 has shown and has been positioned at coordinate position (x_s, y_s, z_s) narrow 820.These narrow 820 generation acoustic energy 830, it is transmitted in the patient body.One or more sonic transducer 840a-840d are positioned at (x_i, y_i, z_i), wherein integer i is the index number of each sensor of mark.If the sum of sensor represents that with N then the scope of index number i is that i=0 (for first sensor) is to i=N-1 (for N sensor).For example, Fig. 8 shows and is positioned at (x₀, y₀, z₀) first sensor 840a, be positioned at (x₁, y₁, z₁) second sensor 840b, be positioned at (x₂, y₂, z₂) the 3rd sensor 840c and be positioned at (x₃, y₃, z₃) the 4th sensor 840d.The sum of sensor can be one, two, three, four, five or more a plurality of.In embodiment shown in Figure 8, four sensors are illustrated, although still less or more sensor can be used in other embodiment.

[0077]acoustic energy 830 propagates into each sensor 840a-840d along path 842a-842d from narrow 820.From at (x_s, y_s, z_s) locate narrow at (x_i, y_i, z_i) the path d of i sensor locating_i(Pythagoras ' s equation) determined by the Pythagoras equation:

$d_i^2={(x_i-x_s)}^2+{(y_i-y_s)}^2+{(z_i-z_s)}^2.---\left(8\right)$

[0078] in some Noninvasive embodiment, sensor 840a-840d is positioned at the surface of patient body.Yet in other embodiments, one or more sensor 840a-840d can be positioned at patient's body cavity.Although nonessential, preferably, sensor 840a-840d is positioned at and centers on narrow 820 position basically, and not with collinear structure or coplanar structure arrangement basically basically.For example, sensor 840a-840d can be arranged, so that they provide the heart 3-D view from the visual angle of wide region.In some embodiments, sensor 840a-840d is placed on the cardiac auscultation point.In some embodiments, although nonessential, preferably, sensor 840a-840d is placed on such position, the feasible bodily tissue of propagating through substantially the same type from narrow 820 to each sensor 840a-840d acoustic energy 830.In these embodiments, along each bar of path 842a-842d, the value of the velocity of sound is substantially the same.For example, selecting one, to avoid the path of the substantial portion of lung tissue be useful, because the aerial speed of sound (about 340m/s) is different substantially with speed (about 1540m/s) in the health soft tissue.Similarly, in some useful embodiments, the path of containing bony process matter part (velocity of sound equals about 4000m/s) is avoided.

Be applied to the Wavelet Transform of acoustical signal

[0079] Xia Mian example model is for example understood an embodiment of Wavelet Transform, and described Wavelet Transform is used for existence and/or the position at acoustical signal diagnosis coronary artery stenosis.This example model is not intended to limit the scope of disclosed system and method, but the illustrative examples of Wavelet Transform.In other embodiment of apparatus and method, can adopt to be used for acoustical signal and its different models of propagating through bodily tissue.

[0080] in this example model, supposes narrow emission acoustical signal A (t).Described acoustical signal comprises that turbulent blood flow is through the described narrow sound wave that produces.This turbulent flow can produce frequency range at the sound wave of about 500Hz between about 1000Hz.As shown in Figure 8,acoustic energy 830 is propagated in whole health and is propagated into each of sensor 840a-840d along path 842a-842d, and signal is received there.In this example model, velocity of propagation is assumed that steady state value c, and it is chosen as 1540m/s, and this is the acoustic propagation velocity in the health soft tissue.Yet, in other model, can use non-constant value.

[0081] when acoustical signal along described propagated to i sensor, described signal is because systemic absorption and scattering and weakened and spread (convergent-divergent).In addition, the limited travel-time τ of described signal demand_i, to arrive i sensor, reason is the finite speed of sound.Travel-time is learned equation τ by constant motion_i=d_iThe velocity correlation connection of/c and path and sound.At last, signal may be by the noise degradation.The combination of these physical influences shows that the acoustical signal that is received by i sensor can be as follows by modelling:

$R_i\left(t\right)=\frac{{\mathrm{\&alpha;}}_i}{\sqrt{s_i}}A\left(\frac{t-{\mathrm{\&tau;}}_i}{s_i}\right)+n_i\left(t\right).---\left(9\right)$

In formula (9), α_iThe representative decay, s_iRepresentative diffusion (convergent-divergent), and τ_iThe representative voice signal is from narrow 820 emissions with in the travel-time between the sensor 840a-840d reception.Noise n in this signal_i(t), be assumed to be statistic processes at random, its signal A (t) with emission is irrelevant.

[0082] wavelet transformation of the signal that receives at i sensor place can pass through R_i(t) substitution formula (5) and obtaining.Noise items n_i(t) wavelet transformation average out to zero is because noise and female small echo g (t) are irrelevant.Can be write at the resulting wavelet transformation of signal that i sensor place receives

$\mathrm{WT}[R_i,g](s,\mathrm{\&tau;})={\mathrm{\&alpha;}}_i\mathrm{WT}[A,g](\frac{s}{s_i},\frac{\mathrm{\&tau;}-{\mathrm{\&tau;}}_i}{s_i}).---\left(10\right)$

Formula (10) shows the wavelet transformation of the signal that is received---it is the amount that can easily measure, equals attenuation parameter α_iMultiply by the wavelet transformation of the narrow 820 acoustical signal A that launched (t).Therefore, even the signal of being launched is by physical influence: the degradation that weaken, diffusion, time displacement and noise causes changes, and still, the potential character of the signal of being launched still can be released from the wavelet transformation the formula (10).Yet formula (10) shows that the wavelet transformation that these physical influences require to be transmitted is estimated at convergent-divergent shown in the dexter bracket and mobile independent variable place.

[0083] in some embodiments of system and method disclosed herein, female small echo g (t) is selected, and to have such shape, this shape is complementary with the peculiar of coronary artery disease or type signal feature generally.As illustration, female small echo g is assumed to be with signal characteristic A and is directly proportional in this example model.In this example illustration, when female small echo is not moved and is not scaled, for example locate in (1,0), be supposed to have local maximum at the dexter wavelet transformation of formula (10).By the independent variable in the rightmost bracket of formula (10) is made as (1,0), as can be seen, the wavelet transformation WT[R that measures_i, g] and at s=s_iAnd τ=τ_iThe place has local maximum.Therefore, be tested and appraised at measured wavelet transformation WT[R_i, g] in the peak, can estimate diffusion parameter s to each sensor_iWith travel-time τ_iValue.Derive from the travel-time τ of wavelet transformation_iCan be used in the system and method that calculates narrow 820 position following further the discussion.

[0084] by many numerical techniques of knowing, the peak in wavelet conversion coefficient can be identified.In some embodiments, for example, the peak of the absolute value of wavelet coefficient is identified, and in other embodiments, the peak of the square value of wavelet coefficient is identified that the acoustic energy in signal more can be represented in such peak.In these data the existence at more than one peak may be illustrated in exist in patient's coronary artery more than one narrow.

[0085] example model discussed above intention is to provide the result's that can get from the wavelet analysis of acoustical signal illustrations, and described acoustical signal receives from organ or tissue.This example model is not intended to limit the scope of the wavelet analysis technology consistent with principle disclosed by the invention.Can be developed with these similar equatioies and result, be used to introduce the different mathematics of different hypothesis.For example, in some embodiments, a kind of reference signal that is used as of received signal, and select female small echo from the part of this reference signal.This part quilt is convergent-divergent and mobile suitably, is satisfied to guarantee small echo admissibility standard.In some these type of embodiments, each sensor is used as reference signal again, and with the data of bigger group of generation, this can increase accuracy and precision.Some preferred embodiment in, the peak of the wavelet transformation of received signal can be used for calculating acoustical signal diffusion parameter and travel-time.The details of the method relevant with these and other embodiment can be at United States Patent (USP) the 6th, 178, find in No. 386, it was published in January 23 calendar year 2001, be entitled as " Method and Apparatus for Fault Detection ", it all incorporates this paper reference of writing a composition thus into, and becomes the part of this instructions.

[0086] therefore, in some embodiments, each received acoustic energy signal is handled by wavelet transformation, and the peak of wavelet transformation can be used for determining diffusion parameter and travel-time parameter.In other embodiments, use further mathematics or statistical analysis method, for example such as average-variance analysis, diffusion parameter and travel-time parameter can be determined.

Determine narrow coordinate position

[0087] in some embodiments, Wavelet Transform discussed above is used to determine thatacoustic energy 830 propagates into each sensor 840a-840d time spent τ of institute from narrow 820_i(referring to Fig. 8).What oneself knew is: narrow 820 position can be inferred from the travel-time under some conditions.Use is from the data of Wavelet Transform discussed above, and several different methods can be used for calculating narrow 820 coordinate position (x_s, y_s, z_s).

[0088] some embodiments adopt and arrive mistimings (time difference of arrival, TDOA) method is determined narrow 820 position.In these embodiments, one of sensor is defined by reference sensor (for example, by first sensor of i=0 index), and TDOA measures with respect to this reference sensor and arrives difference on travel-time of one of other N-1 sensor.Therefore, the TDOA of i sensor determines by following formula:

Δτ_i＝τ_i-τ₀(i＝1，...，N-1) (11)

(range difference is from the narrow 820 length (d to the acoustic propagation path of i sensor RD) corresponding to the range difference of this TDOA_i) and from the narrow 820 length (d to reference sensor₀) between poor.Assumed speed of sound c is identical for all travel path 842a-842d, and then range difference can be poor related with Pythagoras equation (8) and time of arrival by utilizing constant motion to learn:

$\begin{array}{cc}\mathrm{c\&Delta;}{\mathrm{\&tau;}}_i=d_i-d_0& (i=1,...,N-1)\end{array}$

$=\sqrt{{(x_s-x_1)}^2+{(y_s-y_1)}^2+{(z_s-z_1)}^2}-\sqrt{{(x_s-x_0)}^2+{(y_s-y_0)}^2+{(z_s-z_0)}^2}---\left(12\right)$

Because velocity of sound c is assumed to be given value.And sensor coordinates and TDOA are the amounts through measuring, so N-1 equation of formula (12) expression contains described three narrow unknown coordinates.Therefore, sensor is counted N must be more than or equal to four, to find unique the finding the solution of narrow 820 location.Some preferred embodiment adopt such acoustic velocity value, and it is the representative value (1540m/s) of health soft tissue.

[0089] in some embodiments, centroid algorithm is used to find TDOA in formula (11).Be confirmed as the barycenter of a part of wavelet transformation of acoustical signal time of arrival, and TDOA is poor between time of arrival of two sensors, for example between i sensor and the reference sensor.Centroid algorithm utilizes weighted sum to determine time of arrival.In some embodiments, that part of wavelet transformation that uses in centroid algorithm is corresponding to the diastole of heartbeat.In some of these embodiments, this part is corresponding to the wavelet transformation under preselected scale parameter value, for example, and corresponding to the scale of feature turbulent flow frequency.In some these type of embodiments, selectivity scale j=12, it is corresponding to the sound under 750Hz.In some embodiments, for the scale value of selecting in advance (for example, j=12) and for all translations (k) that fall into signal part diastole, centroid algorithm uses the absolute value of wavelet coefficient | WT (j, k) | as weighting coefficient.In other embodiments, wavelet coefficient square---it represents acoustic energy, can be used as weighting coefficient, and perhaps different weighting functions can be selected.Many variations are possible.

[0090] in some embodiments, (for example, i=0) maximal value of the small echo array of the acoustical signal that is received is determined, and is stored as peak index k0 corresponding to the value of this peaked translation parameters by reference sensor.On each limit of peak index k0, in the small echo array of a part, the barycenter of signal to be estimated, the small echo array of a described part is corresponding to the interval (window) of a segment length L.The value of L can depend on signals sampling speed.In sampling rate is in the embodiment of 22kHz, and gap length equals five sampling periods.The barycenter of i signal is by C_iExpression also is defined as:

$C_i=\frac{\underset{k=k_0-\mathrm{<figure-callout\; label="L\; k"\; filenames="A20068000776400721.png,A20068000776400731.png"\; state="\{\{state\}\}">L</figure-callout>}}{\overset{k_{}}{\mathrm{\&Sigma;}}}k\left|W{T}_i(j,k)\right|}{\underset{k=k_0-\mathrm{<figure-callout\; label="L\; k"\; filenames="A20068000776400721.png,A20068000776400731.png"\; state="\{\{state\}\}">L</figure-callout>}}{\overset{k_{}}{\mathrm{\&Sigma;}}}\left|W{T}_i(j,k)\right|},---\left(13\right)$

WT wherein_iIt is the wavelet transformation of i signal.Formula (13) is used to determine the barycenter C of reference signal₀And by the barycenter C of the signal of each reception of other sensor_iThe TDOA[of i sensor is referring to formula (11)] be defined as the arithmetical difference between these values: C_i-C₀Use center of mass values, rather than the peak index location, the accuracy of estimating TDOA can be improved.

[0091] in other embodiment of centroid algorithm, the weighting coefficient that uses in formula (13) is corresponding to the mean value of wavelet coefficient, rather than uses preselected scale (for example, j=12).In this type of embodiment, in corresponding to the scale parameter of turbulent flow acoustical signal, wavelet coefficient is asked average.In other embodiments, wavelet coefficient square is used in the formula (13).

[0092] in the wavelet coefficient data existence at more than one peak can be illustrated in exist among the patient more than one narrow.Therefore, in some embodiments, a plurality of peaks are used to determine a plurality of narrow coordinate positions.

[0093] accuracy of determining narrow coordinate position will be depended on sample frequency, because the accuracy that TDOA is measured in the sample frequency restriction.Under higher sample frequency, can determine narrow coordinate position with accuracy higher under the lower sample frequency.In some embodiments of this diagnostic device, use the sample frequency of 22kHz, and narrow coordinate position can be determined the thoracic cavity that is positioned at the patient.In other embodiment of described device, the sample frequency that is higher than 22kHz can be used, for example, and such as 120kHz.In adopting the embodiment of upper frequency, narrow coordinate position can be defined in 1/4th the accuracy corresponding to for example heart.Under sufficiently high sample frequency, it is interior or littler that narrow coordinate position can be defined in 1cm.

[0094] in order to make narrow coordinate position related, needs the orientation of heart in the thoracic cavity with the physical location (for example with specific IC position) in the patient's heart.In some embodiments, the orientation of heart, position and other anatomical structure can be determined by extra medical step, and described extra step is for example such as cardiogram, ultrasonic, cat scan, magnetic resonance imaging (MRI) or X ray video picture.This type of information can be by the embodiment of electron transfer to sound sensor and treating apparatus.Utilize input media for example keyboard, touch screen, voice recognition or the like, this type of information can be transfused to sound processing apparatus.At other embodiment,, can estimate the orientation of heart by the inspection that the health care expert carries out.In other embodiments, can use other clinical method.

[0095] in some embodiments, wherein determined one group of TDOA (for example by preceding method any) and have the estimated value of velocity of sound c (for example, 1540m/s), narrow coordinate position can pass through equation (12) and be determined.In some embodiments,, equation (12) is found the solution, obtain the narrow location of " best-fit (best fit) " by interative least square method.In other embodiments, statistical method is maximum likelihood method (maximum likelihood algorithm) for example, and the most probable that is used to definite equation (12) is separated.Some preferred embodiment in, the closed form of equation (12) is separated and is used to directly to determine narrow location, produces accurately the position and requires lower on calculating than process of iteration, nonlinear method or statistic law because closed form is separated.Some embodiments have used by Mellen, et al., " Closed-Form Solution forDetermining Emitter Location Using Time Difference of Arrival Measurements; " IEEETransactions on Aerospace and Electronic Systems, pp.1056-1058, vol.39, No.3, the closed form algorithm that July2003 describes, it is all incorporated into this paper as a reference thus, and as the part of this instructions.In other embodiments, the velocity of sound can be used as unknown amount and handles, and it will be determined with narrow location.

The method of operating of preferred implementation

[0096] Fig. 9 has described process flow diagram 900, and it shows the embodiment of the method for one or more narrow existence, the order of severity and/or positions in the diagnosis patient coronary artery.Square frame 910-980 represents function, module or the operation that can carry out in the embodiment of described method.In other embodiments, extra or different square frames can be used, and extra or different square frames can be with different occurring in sequence.Process flow diagram 900 is for example understood an embodiment of method disclosed herein, yet process flow diagram 900 is not intended to limit the scope of described method, and more is intended to as the illustrative process flow diagram according to principle disclosed herein.

[0097] in square frame 910, one or more sonic transducers are positioned on the patient body, with prepare to determine narrow to exist, seriousness and/or position.For the purpose of the details of instructing some preferred implementations, following discussion will be supposed: four sonic transducers are used.Yet this is not the restriction to described method, and other embodiment can use more or less sensor.

[0098] Figure 10 A for example understands a preferred implementation of arranging sonic transducer.In this embodiment, foursensor 1036A-1066D are attached onpatient 1018 thechest 1064, attached to 1068 (xiphoid-process) known location relevant at the bottom ofheart 1022,rib 1066, the breastbone with center line C-C.Figure 10 A shows arteria coronaria dextra 1072 and arteria coroaria sinistra 1074, and is for reference.Come the left hand edge ofmark heart 1022 with reference numerals 1078.Narrow 1076 also are shown among Figure 10 A.

[0099] in some embodiments,sensor 1036A-1036D is configured, and to be electrically connected withdevice 1044, describeddevice 1044 is configured, to carry out the signal processing analysis relevant with square frame 920-980 discussed in this article.In the embodiment shown in Figure 10 A,electric wire 1038 is used atsensor 1036A-1036D and sets up between installing 1044 be electrically connected, although in other embodiments, can for example set up electrical connection such as the wireless connections of using electromagnetic radiation by method.

[0100] in some embodiments, 1068 can be used as reference point R at the bottom of the breastbone, and it has coordinate (x_R, y_R, z_R).For convenience's sake, reference point R can be selected as the initial point of coordinate system shown in Figure 8 810.In the embodiment shown in Figure 10 A,sensor 1036A is positioned at the A point, has coordinate (x_A, y_A, z_A);Sensor 1036B is positioned at the B point, has coordinate (x_B, y_B, z_B);Sensor 1036C is positioned at the C point, has coordinate (x_C, y_C, z_C); Sensor 1036D is positioned at the D point, has coordinate (x_D, y_D, z_D).

[0101] in some embodiments,sensor 1036A be arranged inheart 1022right hand edge 1070 near.For example,sensor 1036A can be positioned at the right ofchest 1064, just on the4th root bone 1067 and about one inch of the left side of distance center line C-C.In some of these embodiments,sensor 1036B is arranged in the opposite ofsensor 1036A, and about one inch of the right side of distance center line C-C.In the embodiment shown in Figure 10 A,sensor 1036B be arranged in artery left anterior descendingbranch 1080 near.In some embodiments,sensor 1036C aligns with the apex of theheart 1082 ofheart 1022 onpatient 1018 left sides betweenchest 1064 and the upper arm 1084.Sensor 1036D is positioned at apart from the right of center line C-C about one inch, and aligns with 1068 ends of breastbone.

[0102] Figure 10 B for example understands another embodiment of arranging sonic transducer on patient body.In this embodiment,sensor 1036A is positioned at the 3rd intercostal space, apart from through two inches on the right side of the center line C-C of 1068 (xiphoid-process) at the bottom of thebreastbone.Sensor 1036B is positioned at the 3rd intercostal space, two inches in the left side of the described center line C-C ofdistance.Sensor 1036B is positioned at the 5th intercostal space, two inches in the left side of the described center line C-C of distance.Sensor 1036D is positioned under thesensor 1036B, is positioned at the 5th intercostal space, two inches in the left side of the described center line C-C of distance.At last,sensor 1036C is positioned on the midaxillary line, basically with sensor 1036D level.All positions of being described are all with respect to patient's viewpoint.

[0103] in some embodiments of method disclosed herein,sensing station 1036A-1036D can be judged by the health care professional of carrying out diagnosis algorithm.For example, carry out auscultation (for example, listening with stethoscope) afterwards at the chest to the patient, health care professional can be based on the placement sensor as a result of auscultation.In these embodiments, health care professional can be used for transducer arrangements in useful position about the anatomical personal knowledge of patient.

[0104] in some embodiments, afterplacement sensor 1036A-1036D, the coordinate position of sensor can be determined.Figure 10 C illustrates an embodiment, and itsplacement sensor 1036A-1036D also determines their coordinates separately.In this embodiment,sensor 1036A-1036D is attached to thechest model 1090 of a known dimensions and shape, and it is put on by the patient at duration of test.Becausechest model 1090 has known size, the coordinate position ofsensor 1036A-1036D can accurately bedetermined.Chest model 1090 is arranged, so that when carrying out sound measurement, it surrounds patient 1018chest 1064 basically.In some embodiments,chest model 1090 can be by paper or fabric manufacturing, and can comprise hole or mark, andsensor 1036A-1036D will be positioned there.Chest model 1090 can be manufactured to all size and shape.In some embodiments,chest model 1090 can be by the Stretch material manufacturing, and this Stretch material can adapt to patient's chest.A benefit ofchest model 1090 is that it during checking makes the patient keep dignified.

[0105] in other embodiments, one of sensor (for example, first sensor 1036A) is located at the reference position R of the bottom of breastbone 1068.The coordinate of other sensor (for example, sensor 1036B-1036D) is determined along the length and the direction of the arc of patient 1018 body surface to other each sensor 1036B-1036D from first sensor 1036A by measuring.In some embodiments of this method, health care professional can be utilized ruler or tape measure, with determine described arc at one or more predetermined directions with respect to reference sensor or with respect to the length of one or more other sensors.Described health care professional measured value directly can be imported diagnostic device (for example) by keyboard, touch screen or pointing device or can with measured value on patient's recording chart or report or clinography with sign flag, be used for data input subsequently.Utilize the principle of Euclidean geometry, the length of described arc and direction can be converted to the Di Kaer coordinate of sensor.In one embodiment, health care professional is write down column distance at patient's recording chart or report subscript: along the sensor 1036A of patient's chest 1064 horizontal surveies and the distance between the sensor 1036B (for example, along with the vertical substantially line of center line C-C shown in Figure 10 A, the 10B); Along center line C-C from the reference position R at 1068 ends of breastbone distance to the line that connects sensor 1036A and 1036B; Distance between reference position R and the sensor 1036D; And the distance between sensor 1036D and the sensor 1036C.

[0106] in other embodiments, each of sensor can be transmitted the signal that is received by one or more other sensors.The echo location of use standard or triangulation technique can be determined sensor coordinates.Still in other embodiments, with reference to another point, the position on the mancarried device for example, coordinate is determined, and this is similar to satellite navigation system or identical with satellite navigation system substantially, for example, such as GPS (GPS).

[0107] in the square frame 920 of the embodiment of process flow diagram shown in Figure 9 900,, obtains acoustical signal by the sensor of in square frame 910, on patient body, arranging.Some preferred embodiment in, described acoustical signal is by the emission of patient's heart, and can comprise and can be used for diagnosing the existence of coronary artery disease and/or the signal characteristic of seriousness.

[0108] sensor is in response to acoustic energy, and described acoustic energy is by organ or for example heart emission of other biological entities, and it comprises from one or more narrow acoustical signals.Described sensor can shield out from neighbourhood noise, and is configured, to detect the acoustical signal of sending in the health.For example, in some embodiments, sensor is coupled on patient's the skin by sound.With reference to further institute's description of figure 8, each sensor is simulated acoustic energy, and will represent the signal of acoustic energy to be sent to the other hardware/software components that is used for signal Processing such as in this article.In some of these embodiments, the sensor transmissions simulating signal, this simulating signal is sampled and digitizing by other element, for example such as analog to digital converter (ADC).In other embodiments, sensor transmissions digital signal.In some embodiments, sensor comprises ultrasonic transducer, and it can comprise ultrasonic transmitter, receiver, loudspeaker and/or piezo-electric device.In some embodiments, one or more alignment purposes that are used to of sensor.The further details that are suitable for the sensor that the embodiment with square frame 910 and square frame 920 uses are described below.

[0109] in some embodiments, after sensor is placed on the patient body, before carrying out cardiac measurement, can carry out the affirmation process.Confirm step advantageously increased sensor correctly be arranged on the health possibility and from the signal of each sensor possibility corresponding to body signal, described body signal is heartbeat for example, but not extraneous signal, for example room noise.In addition, confirm that step has reduced the possibility that is used to subsequent analysis from the data of defectiveness sensor.

[0110] in some embodiments of confirming process, for example such as 350Hz, the acoustical signal from each sensor is sampled with speed.Inspection is from the data of each sensor, and with amplitude limit (clipping), for example signal amplitude is between the upper limit (for example 4090 countings) and lower limit (for example 0 counting).Calculate various statistics parameters, whether obtained by each sensor with indication body signal, extraneous noise signal or no signal (horizontal line).In some embodiments, the slope of the value of statistics variance and signal is periodically proofreaied and correct.For example, during the predetermined portions of each received signal, variance and slope can be recomputated.In one embodiment, the size of this predetermined portions is selected as: sampling rate multiply by the sampling time, for example 1/25 second.For example, if variance or slope outside the desired scope of signal, then diagnostic device can send error code to patient, user, doctor, clinician, diagnostician or health care professional.This error code indication, (or a plurality of) sensor may not detect body signal.Then, the health care professional of checking can rearrange sensor and restart and measure.This error code can comprise audible signal (for example, sound, for example the tinkle of bells or music).In some embodiments, this diagnostic device will stop further signals collecting, be eliminated up to this error code.Some preferred embodiment in, if the variance of the signal that receives from sensor in scope for example outside 10 to 500,000 (countings) 2, then error code is sent to health care professional.In other embodiments, signal that is received and wanted signal based on the comparison, for example such as the reference cardiac signal, the affirmation process can determine whether to send error code.

[0111] still in other embodiments, the affirmation process can comprise the self check step, and wherein one or more sensors transmit signal, and this signal is received by other sensor.If the signal that is transmitted is not received, is twisted or has for the low excessively signal to noise ratio (S/N ratio) of useful diagnostic measures, then error code can be sent out, to point out potential fault.

[0112] during signal acquisition process, preferred but also nonessential is that the patient vertically takes one's seat, and screen is lived his or her breathing.In some embodiments, about eight seconds data are gathered, and it generally includes about 6 to 16 heartbeats.In other embodiments, image data in the patient can cosily be shielded any time length of his or her breathing.In other embodiments, the sound of patient respiratory is identified and is filtered out, so that the sound measurement that can expect between respiratory period.

[0113] in the square frame 930 of the embodiment of process flow diagram shown in Figure 9 900, acoustical signal can be modulated, for example, be used for further processing by with other hardware or software module or parts amplification, filtering, synchronous, digitizing and/or the described signal of demultiplexing.Acoustical signal by narrow emission is weakened by geometric effect (for example inverse square law) and by systemic absorption and scattering.Therefore, in some embodiments, be exaggerated, and amplifier gain can be different for different sensors from the signal of each sensor.In some embodiments, analog acoustic signal is by low-pass filter, to remove unwanted high frequency noise components, guarantees that subsequently digital signal is by nyquist sampling.The passband of this acoustical filter must be high enough to make the echo signal frequency not have significantly to pass through with weakening.For example, in some embodiments, simulating signal is by low-pass filter, to remove the signal frequency on 2.5kHz.The selection of this low-pass filter has kept the turbulent flow acoustic energy that is produced by coronary occlusion, and it usually occurs in about 500Hz between about 1000Hz.The simulating signal of this filtration can be sampled with the speed more than the 5.0kHz, to guarantee there is not confusion effect in resulting digital signal.In one embodiment, use the sampling rate of 22kHz, it suitably is higher than the desired low-limit frequency of Nyquist standard.In other embodiments, analog acoustic signal can be by high-pass filter, to remove low frequency component, for example such as patient respiratory and heart valve.

[0114] after sampling, digital signal can be passed through one or more digital filters.In some embodiments, wave filter can be a linear filter, and can comprise finite impulse response (FIR) (finite impulse response, FIR) wave filter and/or infinite impulse response (infinite impulse response, IIR) wave filter.For example, an embodiment uses 100 grades FIR low-pass filter (anFIR lowpass filter oforder 100), and it has the passband frequency of 1100Hz, the stop-band frequency of 1500Hz and the passband ripple that is less than or equal to 0.5dB.This digital filter can advantageously be removed noise and other high fdrequency component of looking genuine in the signal.Can use other wave filter, for example, Hi-pass filter, bandpass filter, rejection filter, notch filter or other suitable filters.Wave filter can comprise for example S filter or Kalman filter.In some embodiments, digital signal is by high-pass filter, and to remove low frequency component, it is for example produced by the hear sounds of patient respiratory and the basic cardiac cycle of representative.In some such embodiment, (for example, after carrying out square frame 940) carries out high-pass filter after independent heartbeat is identified.In one embodiment, bandpass filter is used to weaken the frequency component at the extraneous signal of about 300Hz to 1500Hz.

[0115] in some embodiments, digital signal is carried out one or more regulating steps.Regulating step can comprise digital filtering, as mentioned above.In some embodiments, regulating step comprises the conversion that is applied to digital signal, so that produce the information relevant with the frequency spectrum of described digital signal.For example, in some such embodiment, digital signal is carried out Fourier transform, to produce wave spectrum, the acoustic energy in the frequency interval scope (or power) that its indication is for example received by sensor.Frequency spectrum can be used for some part of discriminating digit signal, and it comprises the turbulent flow acoustic energy of for example launching from coronary artery stenosis.In some embodiments, based on the result of frequency spectrum, can determine the feature of digital filter.For example, be tested and appraised the frequency range of frequency spectrum, can determine the passband of bandpass filters, described frequency spectrum may be included in the turbulent flow acoustic energy of the signal noise ratio level that is suitable for diagnostic analysis.In addition, frequency spectrum can be used for being characterized in the noise in the system, so that filter out noise suitably, is for example undertaken by S filter being applied to this digital signal.

[0116] in other embodiments, other regulating step can be applied to digital signal.For example, the parameter model method can be used, for example such as the method for moving average (moving average method), autoregressive model (autoregressive model) or ARMA model (autoregressive moving averagemodel).In some embodiments, regulating step can be included in the correlation method in time domain or the frequency domain, for example auto correlation or cross correlation method.

[0117] in some patient, compare other acoustical signal of sending from this patient body, may have low relatively amplitude from narrow acoustical signal.Therefore, it partly is favourable analyzing the acoustical signal that is in the amplitude acquisition of following time of attenuating when the background sound wave.In the square frame 940 of the embodiment of process flow diagram shown in Figure 9 900, the suitable part of the signal that sensor receives is selected, is used for the analysis of square frame 950-980.

[0118] Figure 11 A for example understands the synoptic diagram (Wiggers figure) 1110 that the popular feeling is rich, and it has marked the main action of cardiac cycle.Heartbeat can be divided into two Main Stage usually: heart contraction and diastole.Heart contraction is the contraction of cardiac muscle, and it extrudes ventricle with blood, and diastole is the lax of cardiac muscle after shrinking, and ventricle refills blood during it.During diastole, aortic valve closing reaches its maximal value through blood flow coronarius.Therefore, diastole partly is useful especially, because the sound of the turbulent flow that produces from coronary occlusion should reach maximal value, and because reaches minimum value from the sound of aorta petal.[0119] Figure 11 B for example understands theexample caardiophonogram 1120 that the popular feeling is fought.Heart contraction part and diastole partly are illustrated.Figure 11 B shows the amplitude from theacoustical signal 1130 of heart, and it is as passing the function of time.Figure 11 B shows, the amplitude of this acoustical signal during the diastole part of heartbeat than lower during the constriction at heartbeat.

[0120] Figure 11 C understands that for example described amplitude is the function of the time of passing from Figure 115 0 of the amplitude of theacoustical signal 1160 of volunteering the patient.First heart sound 1170a-1170c is that the heartbeat constriction is produced by the closure of atrioventricular valve when beginning.Closure by aorta petal and pulmonary valve whensecond heart sound 1180a-1180e is the end of heartbeat constriction produces.Shown in Figure 11 C, thediastole part 1190 of heartbeat is in the beginning ofsecond heart sound 1180a place, and the heartbeatfirst heart sound 1170b place end of following.Figure 11 C shows that the amplitude ofacoustical signal 1160 is during the diastole part of heartbeat low relatively (also referring to Figure 11 B).

[0121] therefore, in some embodiment of square frame 940, select thediastole part 1190 of heart signal to analyze, because during this diastole part, the unlatching of heart valve and the closed acoustical signal minimum that causes.In some these type of embodiments, thecore 1195 of diastolepart 1190 can be selected, and reason is signal to noise ratio (S/N ratio) or the further feature that it is useful.

[0122] in some embodiments of square frame 940,diastole part 1190 can be determined by following method.By using stethoscope to listen heart, the health care professional of measuring is determined patient's heart rate B.The representative value of B be about 70 heartbeats of per minute (beats per minute, bpm).Preferred but nonessential is, heart rate B is determined to ± 10bpm within.If patient's heart rate is under the 50bpm or on 120bpm, if perhaps heart murmur (atrial fibrillation or ectopic rhythm obstacle), if perhaps the patient shows serious low blood pressure (systolic pressure of＜90mm-Hg), it is worthless proceeding to measure for the patient.In some embodiments, health care professional can be imported heart rate B on clinical form or the hospital record, be used for later analysis, and in other embodiments, health care professional can directly be imported heart rate B in the diagnostic device, for example, undertaken by keyboard, touch screen or pointing device.

[0123] in some embodiments, by the cardiogram (EKG) that carries out simultaneously with sound measurement, can determine heart rate B.In some embodiments, diagnostic device can comprise one or more EKG sensors, and it is used to measure heart rate, for example, is undertaken by the duration of measuring between the continuous R ripple in the PQRST heart sequence.In other embodiments, diagnostic device can comprise one or more arterial pulse sensors, and it is configured, to detect for example pressure pulse in the arteria carotis of artery, so that determine heart rate.

[0124] based on the heart rate B that estimates by health care professional (or other method), corresponding to once the part of the digitized acoustic signals of heartbeat is selected separately.This part of described signal has length L_B, its equal sampling rate (representing) with Hz divided by heart rate (with p.s. the heartbeat number of times represent).The peak value finding algorithm that use is known (peak finding algorithms) is positioned at the maximal value of signal described in this part.The beginning of first heartbeat is represented in the position of peak value in this part.

[0125] second heartbeat is accredited as length L_BScope in the maximal value of signal, described scope begins and finishes at 130% sampled point through first peak at 30% sampled point through first peak.Be set to the valuation of the correction (with more accurate) of heartbeat duration and length L in the first and second peak-to-peak mistimings_BCorrespondingly proofreaied and correct.By the maximal value of checking that described signal is follow-up, follow-up heartbeat is determined.For example, in some embodiments, search has length L_BThe maximal value of scope, described scope is from beginning through 60% of a preceding heartbeat.The remainder of described signal can be searched, all identified until all heartbeats.In addition, some embodiments compare mutually to the maximal value of finding by the method, to verify that described maximal value is corresponding to hear sounds and be not corresponding to noise.If maximal value can not be a hear sounds, then the process of being discussed can be by repeatedly, up to obtaining the convergent result.

[0126] some preferred embodiment in, corresponding peaked position is stored, and L_BBe set equal in signal the length of short heartbeat.Before the analysis in the square frame 950-980 of process flow diagram 900, the position of storage signal, heartbeat and length L_BIn some this class embodiment, the signal maximum of finding by the method is corresponding to first heart sound.In other embodiments, similar step can be used to determine the position of second heart sound.

[0127] after the position of having determined each heartbeat, next described apparatus and method identify the part of heart signal, and it is corresponding to the diastole part of described heartbeat.In some embodiments, first and second hear sounds are used to discern the diastole part.First and second hear sounds are corresponding to the big peak in the sound amplitude (referring to Figure 11 B and 11C), and it is sought technology by peak discussed in this article or can be identified by any other peak finding algorithm that is suitable for the time-domain signal analysis.Can be extracted in these peak-to-peak acoustical signals among (for example, by time window (timewindow)), storage and the square frame 950-980 and use in flow process 900.

[0128] in other embodiments, the diastole of signal partly is assumed to be the part of signal, and it is in the heartbeat length L_BPreselected range in.For example, in some embodiments, this scope can be corresponding to theheartbeat length L_B35% to 81%.This scope can be different in different patients.In some of these embodiments, thecore 1195 of diastole part 1190 (referring to Figure 11 C) can be selected, is used for further analysis, and reason is its position away from valve sound, diastolic beginning of described valve voice mark and end.In addition, incore 1195, the turbulent flow acoustical signal can be maximum, because incore 1195, can reach its maximal value through velocity of blood flow coronarius.In some embodiments,core 1195 is corresponding to theheartbeat length L_B58% to 67% scope.In other embodiments, different scopes can be used.

[0129] in some embodiments, the step of square frame 940 is applied to each sensor signal.In other embodiments, this step is applied to a reference sensor, and the heartbeat evaluation that reference sensor is found is applied to other sensor.In such embodiment, reference sensor is corresponding to thesensor 1036B shown in Figure 10 A and the 10B, because its reception has the more signal of high s/n ratio, reason is that its position is on the artery left anterior descending branch.

[0130] in the embodiment of the square frame 940 that is provided for diagnosing the disease except coronary artery disease, the part of the acoustical signal that is received also can be selected for the further analysis in square frame 950-980; Yet the part of this selection can be corresponding to the acoustical signal part different with the diastole part.

[0131] in the square frame 950 of the embodiment of flow process shown in Figure 9 900, uses method described herein, the acoustical signal corresponding to the diastole part of heartbeat is carried out wavelet transformation with reference to figure 5-7.In some embodiments of square frame 950, analyzed from the diastole part of single heartbeat.In other embodiments, analyzed from the diastole part of above heartbeat once, this can improve the signal to noise ratio (S/N ratio) of data, and produces accuracy and the degree of accuracy that improves.As described in reference to figure 5-6D, some preferred implementations of Wavelet Transform adopt the femalesmall echo 500 of Morlet, to discern by one or more narrow acoustical signals of being launched in the coronary artery.

[0132] in the square frame 960 of the embodiment of flow process shown in Figure 9 900, analyzes the wavelet transformation of described acoustical signal, to detect one or more narrow existing in patient's heart.In some embodiments, wavelet coefficient can be combined into one or more parameters, inaccessible existence or the seriousness of described one or more parameter indications.For example, in some embodiment of square frame 960, by the wavelet coefficient that in square frame 950, produces, calculating small echo Diagnostic parameters (wavelet diagnostic parameter, WDP).Existence and/or seriousness that the indication of small echo Diagnostic parameters is narrow.

[0133] fluid turbulent can be intermittently on the space, fragmentary and unordered.Turbulent flow can also show self similarity (self-similarity), and wherein after suitable rescaling (rescaling), the part of acoustical signal is equivalent to another part statistically.Therefore, fluid turbulent can be characterized as being fractal process (fractal process), and it shows the statistics structure of self similarity in the scale of certain limit.The mathematic parameter that is called Hulst coefficient (Hurstcoefficient) is measuring of fractal process dimension.Test shows that Hulst coefficient H can indicate existence and/or seriousness inaccessible in coronary artery.By the statistics of the wavelet coefficient of heart signal, can estimate Hulst coefficient H.For example, in some embodiments of this method, under each scale, the variance of wavelet coefficient is determined.In the fractal process of self similarity, Hulst coefficient H is relevant to the slope γ of the logarithmic graph of scale with the logarithm of variance, wherein H=(γ-1)/2.By regretional analysis least-square analysis for example, can determine slope γ.For example, referring to " the Wavelet Applications in Medicine " of M.Akay, IEEESpectrum, pp.50-56, May 1997, and it is all incorporated into this paper as a reference thus, and as the part of this instructions.

[0134] in some embodiments of described apparatus and method, the small echo Diagnostic parameters is Hulst coefficient H, for example WDP=H.In other embodiments, the small echo Diagnostic parameters is the different functions of slope T, for example WDP$\mathrm{WDP}=(\sqrt{\mathrm{\&lambda;}}-1)/2.$In other embodiments, the different statistics parameters of being determined by wavelet coefficient can be selected as described WDP.In other embodiments, wavelet coefficient can make up in a different manner, to produce WDP.In addition, for example such as fourier coefficient, can estimate WDP by other signal Processing coefficient.Other theory of turbulent flow can obtain the extra parameter except the Hulst coefficient, and they indicate turbulent flow, and these new arguments can be used as WDP in some embodiments.

[0135] Figure 12 A is a schematic block diagram 1200, and it for example understands the further aspect of the embodiment of the method be used for the existence by acoustic data diagnosis coronaryocclusion.In block scheme 1200, in the ring that comprisessquare frame 1204 to 1230, analyze from the digitized acoustical signal of heartbeat each time.Insquare frame 1208, the diastole of heartbeat each time partly is stored.In some embodiments, as above describe with reference to figure 11A-11C and with reference to the square frame 940 of the flow process 900 shown in the figure 9, this diastole part can be identified.For example, this diastole part can be selected, with 35% to 81% part corresponding to the length of described heartbeat.Insquare frame 1212, the wavelet transform of the diastole of heartbeat part is carried out, and this has obtained the wavelet coefficient under each scale and translation parameters value on the sampling grid.For example, in some embodiments, can be used for wavelet transform with example grid similar sampling grid in the formula (7).In some such embodiment, scale parameter is j=1,2,4,8,12 and 16, and it is corresponding to frequency 62.5Hz, 125Hz, 250Hz, 500Hz, 750Hz and 1000Hz.

[0136] in some embodiments of square frame 1212,, can determine the value of wavelet coefficient by extracting summation method.For example, in one embodiment, the female small echo of the Morlet of 62.5Hz is used as analysis wavelet, and this small echo is stored in first array, and this first array has and the proportional length of sample number in the diastole part of signal.In one embodiment, the length of this array is 1860 samples.Sub-small echo is stored in second array, and this second array has such length, and its length that equals first array is divided by scaling exponent j.By extracting the value that (decimating) is stored in the female small echo in first array, obtain the value of sub-small echo with factor j.Do not correspond to the sampled point of female small echo as the sampled point of fruit small echo, then select the immediate sampled point of female small echo.Treat to be selected as from 35% to 81% part of heartbeat, and be stored in the tri-array by the relaxation signals of wavelet transformation.In some embodiments, by along the sub-small echo array of relaxation signals pe-array shift and obtain the dot product of the overlay region of described array, calculate wavelet coefficient from formula (6) (wherein replacing integration) with summation.The value of wavelet coefficient equals the value of dot product.In some embodiments, this dot product equal the value in sub-small echo array and the relaxation signals array arithmetic product and.In some embodiments, the instruction of use machine language multiply-accumulate can be calculated described dot product, and described instruction is fast with effective on calculating.In calculating some embodiments of wavelet coefficient, for translation parameters, edge effect may take place, and its neutron small echo array extends to outside first or last element in the relaxation signals array.In this case, can use the null value of this signal array to fill (zero-padding).In other embodiments, edge effect is lowered, because only the core 1195 of heartbeat (Figure 11 C) is used in the analysis subsequently.

[0137] in ring, estimates the statistics variance of wavelet coefficient corresponding to the square frame 1216-1222 in the synoptic diagram 1200.Shown insquare frame 1218, in some embodiments, for each value of scaling exponent j, only selected translation parameters scope is used to calculate variance.This scope is corresponding to the core 1195 (seeing Figure 11 C) of heartbeat, and selected, minimizing edge effect, and corresponding to the suitable part of diastole.For whole diastole part 1190 (referring to Figure 11 C), wavelet coefficient can be calculated, but can be left in the basket in calculating variance corresponding to the coefficient of the translation parameters outside the center range 1195.In some embodiments, for 35% to 81% diastole part 1190 corresponding to heartbeat length, wavelet coefficient can be calculated, butcore 1195 is corresponding to from 58% to 67% scope of heartbeat length.

[0138] insquare frame 1226, the slope γ of variance is calculated.In some embodiments, the variance data are assumed to be power function, and wherein γ power of variance and scale is proportional.Therefore, γ can be confirmed as the slope of the logarithm of variance to data point in the logarithmic graph of scale.In some embodiments, be that the logarithm at the end is used to the slope analysis with 2.[for example, formula (7) in] the embodiment, scaling exponent j is schemed, can determine slope γ at use two-value grid by the logarithm of variance.Linear regression analysis by standard can be determined slope γ for example such as least-square analysis.Determine the slope γ of patient's heartbeat each time.

[0139] insquare frame 1234, estimates small echo Diagnostic parameters (WDP) from the slope thatsquare frame 1226 obtains.As mentioned above, in some embodiments, WDP equals Hulst coefficient H, and calculates by (γ-1)/2.In other embodiments, have been found that different funtcional relationships provides the diagnostic message of usefulness.For example, in one embodiment, pass through relational expression

Obtain WDP.

[0140] insquare frame 1234, WDP can be confirmed as the mean value at the definite WDP of each time heartbeat.For example, in some embodiments, eight times heartbeat is used in the circulation of square frame 1204-1230, and WDP is the arithmetic mean of eight independent WDP.The use of arithmetic mean is useful reducing aspect wrong, and described mistake is partly caused by the low signal-to-noise ratio diastole in the subgroup of each heartbeat.Although some preferred embodiment in eight heartbeats be used to ask on average, the heartbeat of varying number can be used in other embodiments, and according to different arithmetic or statistical method, the WDP of each heartbeat can be combined.Still in other embodiments, each time heartbeat can be used to diagnostic purpose each time, for example, such as being undertaken by each value being exported to the health care professional of analyzing.Many variations are possible.

[0141] in the different embodiments of the described method of Figure 12 A, the heartbeat number of times that is used among the square frame 1204-1230 can be different.For example, have been found that eight heartbeats reduce mistake and improve precision.Yet in other embodiments, the heartbeat number of times can be once to 16 or scope more frequently.Heartbeat can be from single measurement or from repeatedly measuring.Although nonessential, preferably, heartbeat is measured in time to be right after together and is carried out, to be reduced in the possibility of the severity of symptoms of measuring the interim patient.In some embodiments, during measuring, the patient is instructed to shield his breathing, to minimize from the acoustical signal of breathing.Therefore, be used in heartbeat number of times among the square frame 1204-1230 and can depend on that the patient can shield the duration of his breathing.In other embodiments, health care professional can be carried out sound measurement to heartbeat many times, and selects a part in the described number of times heartbeat to carry out subsequently the processing in square frame 1204-1230.In some embodiments, a described part can be selected based on the diagnosis judgement of for example health care professional, and in other embodiments, a described part can be corresponding to the heartbeat with high s/n ratio.In other embodiments, method 1200 can comprise extra square frame, and wherein optimal heartbeat is selected, is used for further analysis.

[0142] Figure 12 B for example understands Figure 125 0 of wavelet coefficient, and it is as the function of scale parameter and translation parameters.Transverse axis is represented translation parameters, and measures with sample number.The longitudinal axis is represented the absolute value corresponding to the wavelet coefficient of themiddle auxocardia part 1195 of a heartbeat.Six value j=1,2,4,8,12 and 16 for scale parameter show wavelet coefficient, and described six values correspond respectively to frequency 62.5Hz, 125Hz, 250Hz, 500Hz, 750Hz and 1000Hz.Wavelet coefficient, for example those of setting forth in Figure 12 B are used in thesquare frame 1218 of the diagnostic method shown in Figure 12 A, and can be used for other purpose, for example determining such as narrow location.

[0143] in the square frame 970 of the embodiment of flow process shown in Figure 9 900, the small echo Diagnostic parameters that calculates in square frame 960 can be used to estimate the patient's coronary artery severity of disease.Figure 13 is the embodiment of flow process 1300, and it understands for example how the small echo Diagnostic parameters is associated with the seriousness of coronary artery disease.In square frame 1320, (ensemble) is obtained for the assemblage of small echo Diagnostic parameters.This assemblage can corresponding to from health to unsound a group patient.For the highest accuracy, preferably, described group represents significant one group of patient on the statistics.In square frame 1330, for each patient among the described group, one or more comparative diagnoses parameters are obtained.For example, in one embodiment, described comparative diagnoses parameter is inaccessible number percent, as passing through the determined number percent of invasive angiogram.In square frame 1340, based on measured small echo Diagnostic parameters and measured comparative diagnoses parameter, carry out statistical study, to determine the statistical correlations between described parameter.For example, in one embodiment, the association between small echo Diagnostic parameters and the inaccessible number percent determined by the invasive angiogram is estimated.The result of square frame 1340 can be used for related small echo Diagnostic parameters and severity of disease.Therefore, be not to carry out the invasive comparison step, health care professional can advantageously be carried out the embodiment of noninvasive method disclosed herein, to determine severity of disease.

[0144] some embodiments of disclosed method can be used as the diagnostic tool that detects the obstruction in the coronary artery, identify and the location stenosis or occlusion but other embodiment is used in the position except coronary artery.For example, in some embodiments, can diagnose narrow in encephalic vascular, leg vascular and other blood vessel.Some embodiments can be used for diagnosing for example aortic aneurysm.Other embodiment can be used for diagnosis function valve improperly in artery and vein.Some embodiment can be used in the antenatal paediatrics diagnosis of fetal disease, and described fetal disease comprises for example heart of fetus disease.

[0145] other embodiment can use with the intravascular ultrasound technical tie-up.For example, ultrasonic transducer can be inserted into artery, and diagnostic device as herein described can be used for detecting and analyzing the ultrasonic signal of being launched.Some embodiments can also with other diagnosis for example cardiogram or electroencephalogram unite use so that provide patient diagnosis analysis more completely for the diagnostician.

[0146] embodiment of acoustic method can be used to detect the acoustical signal that is caused by other disease.For example, described diagnostic device can be used for diagnosing pulmonary disease, and wherein lungs sound is changed by disease.Other embodiment can be used for detecting the change of the body sounds that is caused by tumour, cancer or other growth.

[0147] in addition, wavelet analysis method disclosed herein can be applied to acoustical signal or be applied to non-acoustical signal.In some embodiments, can carry out wavelet analysis to the electric signal that during for example cardiogram or electroencephalogram, produces.

[0148] in other embodiments, apparatus and method disclosed herein can be used in animal doctor's method, to diagnose the disease of inhuman animal.

The using method of preferred implementation

[0149] some embodiment of diagnostic device disclosed herein can be used for determining existence, seriousness and/or position inaccessible in the coronary artery.In some embodiments, this diagnostic device can be used for 20 one-year-old or above sex patients.Although nonessential, preferably, the patient shows the clinical symptoms of the possible acute coronary syndrome of indication, and the patient has in five minutes three screens and lives eight seconds ability of his or her breathing.As above described with reference to Figure 13, the patient who participates in research may need to be independent of them and participate in angiography outside this research, described research with small echo diagnostic result and other comparative diagnoses result for example such as the angioplasty comparison.In addition, for by the severe hypotension that systolic pressure confirmed that is lower than 90mm-Hg, heart murmur (auricular fibrillation or ectopic rhythm obstacle) or heart rate the patient under the 50bpm or on 120bpm, do not advise carrying out this diagnostic measures.

[0150] described diagnostic device can be used under the various environment, for example such as in clinic or hospital environment, doctor's office or the patients home.Some embodiments of described diagnostic device comprise that one or more sensors, configuration are used for connecting one or more electric wire of sensor and diagnostic device.This diagnostic device can comprise I/O unit (or independent input and output unit).In some embodiments, according to following step, people can use described diagnostic device, and described step is intended that illustrative, and is not intended to limit the scope of possible using method.

1. the user of described diagnostic device can prepare patient's chest for arranging one or more sensors.

If a. have too much hair, wipe too much hair off in the place that will place sensor.

B. for privacy, for the patient provides papery coat (if needs of patients).

C. adopt local alcohol to clean, to clean with the skin in the zone of placement sensor.

2. sensor is connected to electric wire.

3. will be wired to diagnostic device, for example such asdevice 1410,1431 or 1510.Guarantee that each sensor is connected to the sensor jack of the respective markers on this unit.

4. make the patient be sitting in comfortable position.

5. remove the bonding agent backing of each sensor, and for example sensor is administered on the patient in those positions shown in Figure 10 A and 10B in the position.

6. guarantee that mnemonic for example is inserted in the diagnostic device such as flash card.

A. in one embodiment, flash card should be inserted into, and wherein its label downwards and the top of corner cut indicator device.

B. in one embodiment, this device is with inoperative, unless flash card is correctly inserted.

7. by removing the external plug of Direct current power source socket, can starter gear.This external plug is used after can giving over to.

8. described device can comprise I/O unit.For example, in one embodiment, described device comprises touch screen, and it is shown as blank screen at first.The user can touch this blank screen, to proceed.

9. this I/O unit will remind the user to confirm that sensor is firmly connected on patient and the device.For example, in one embodiment, this touch screen will show " (Touch herewhen sensors are connected) please Click here " when sensor is connected.

10. on input/output device, import the ID sign indicating number of this device of sign.For example, in one embodiment, the ID sign indicating number is presented at the bottom of touch screen.

11. this device can point out the user to begin self-check program.For example, in one embodiment, the user touches touch screen, with the beginning self-check program.

12. this device can show the connection status of sensor on I/O unit.When all sensors are correctly connected, this device will remind the user to begin to gather the acoustical signal data.For example, in one embodiment, a form will be presented on this touch screen, and it has listed the connection status of each sensor and this sensor.If any sensor is listed in " connecting (Not Connected) ", then the user can check, to guarantee that they are firmly adhered on the patient and electric wire correctly is connected to described device.When all the sensors all is listed in " connecting (Connected) ", the button in the bottom will show " Clicking here to begin to detect (Touchhere to begin test) ".

13. indication patient screen is lived his/her and was breathed eight seconds and do not move or speak.

14. beginning diagnostic detection.For example, in one embodiment, the user can rap touch screen in the position that shows " (Touchhere) Clicks here ", with the beginning data acquisition.

A. in some embodiments, in case this touch screen is pressed, during the part of data acquisition of diagnostic test (for example, eight seconds), touch screen is with complete blackening.

15. after data acquisition is finished, this device will be reminded the user.For example, in some embodiments, " in the deal with data ... (Processing data...) " message box will be presented on the touch screen.In some embodiments, device can send audible sound.

A. at this moment, data acquisition is finished, and the patient can freely breathe, move and speak.

16. in case signal Processing finishes, this device can be reminded the user.For example, in some embodiments, touch screen will show the message box of " test is finished, and data store (Test Complete, Data Stored) ".

17. after the suitable stand-by period, this device carries out another time diagnostic measures and reminds the user allowing.For example, in some embodiments, the stand-by period can be about ten seconds, and the message box of " Clicking here to restart (Touchhere to restart) " will be presented on the touch screen.

18. in some embodiments, preferred but nonessential is to repeat this measurement test, to guarantee bigger accuracy and precision.For example, in some embodiments, can point out the user to carry outstep 11 to 17 twice again.In other embodiments, this test can be repeated twice again or do not repeated.

19. after the data of all groups all were collected, the user can determine the position of sensor.For example, in some embodiments, measure tape measure and can be provided for the user, to measure as above with reference to the distance between figure 10A and the described sensor of 10B.In some embodiments, the user can write down the distance of sensor on the case notes form, and in other embodiments, the user can should distance import described device by touch screen.

20. remove sensor from the patient.

21. disconnect sensor and electric wire and remove sensor.

22. insert external plug again, with stopping device.

23. work as described device not in use, it can be connected to power supply, for example battery charger.In some embodiments of this device, this may require external plug to remove from Direct current power source socket, and described battery charger inserts the connector on this device.

[0151] different using method are possible, and in other embodiments, different and/or extra step can be used.In addition, in some embodiments, described step can be carried out with similar order or different order.Described using method changes according to situation about measuring.For example, under the statistical research background of related small echo Diagnostic parameters and comparative diagnoses parameter, a kind of using method can be provided, and under the environment of doctor's office, clinic and/or hospital, different using method can be provided.

The hardware configuration of preferred implementation and electron device

[0152] Figure 14 A is the schematically illustrating of embodiment ofdevice 1410, and it is for example inaccessible thatdevice 1410 is used for the biological phenomenon of coronary artery of diagnosing human.Sensor 1414 can be collected the data relevant with this biological phenomenon (for example, analog acoustic signal).Described sensor can send data to diagnostic device 1418 (for example, by wired electrical connection or by utilizing the wireless connections of 802.11b radiotelegraphy or bluetooth).In some embodiments, the part that is depicted as the part of diagnostic device 1418 in Figure 14 A can be connected with sensor itself alternatively.

[0153] diagnostic device 1418 can comprise signal conditioning portions 1430, modulus (A/D) converter 1440, processor 1450 (for example digital signal processor (digital signal processor) or " DSP ") and I/O (I/O) processor 1460.In some embodiments,device 1410 may further include the external bus (not shown) that is connected to processor 1450, is used for external unit is connected to processor 1450.This diagnostic tool may further include nonvolatile memory, is used for the initialization of processor 1450.This nonvolatile memory can be installed in the processor 1450.

[0154] sub-component of diagnostic device 1418 can be the different device in the container, and perhaps they can make up (perhaps their processing effect is shared) in many different modes.For example, same computer chip can be exercised the effect of processor 1450 and I/O processor 1460.In some embodiments, A/D converter 1440 and signal conditioning portions 1430 can be in same chips or on same plate.In some embodiments, by for example digitizing, filtering, synchronous and/or demultiplexing signal, the signal that will handle then transmits or is transferred to other assembly, and diagnostic device 1418 can processing signals.

[0155] described I/O processor 1460 can dock with various devices and communicate by letter.This type of device can comprise output device 1470 (for example, as display, monitor, audio prompt, speech synthesis system, printing equipment or the like); Memory storage 1480 (for example, RAM (random access memory) card, disk or tape, flash disk, CD, printout, portable hard drive or the like); And input media 1490 (for example, as keyboard, mouse, touch screen, dialing, button (button), button (knob), switch, speech recognition system or the like).The function of these devices that dock with I/O processor 1460 can be combined.For example, output unit 1470 and input media 1490 can comprise touch screen.In some embodiments,device 1410 can comprise a plurality of processors and/or a plurality of sub-component.For example, can there be a plurality of displays or a plurality of option, be used for the user and obtain data from described device by various input medias 1490.The assembly that in Figure 14 A, illustrates and sub-component can with different combinations be combined with different structures and/or be connected.

[0156] in some embodiments, in the portable unit that Signal Regulation and/or analog to digital conversion can occur in sensor is connected, and the digital signal that obtains can be sent to independently processing unit, is further processed (for example wavelet analysis) there.Yetdevice 1410 needs not to be movably.In some embodiments,device 1410 can be arranged to from steady (self-standing) instrument, is assembling in the framework of other dependent diagnostic instrument of support perhaps.In some embodiments, handle by reducing the desired treatment capacity of portable unit and allow to carry out more Computer signal on the littler base station of mobility (base station), portability is enhanced.Thereby data can be collected and store to portable unit, can be downloaded to the base station of handling these data after it.Described base station can be included in the various assemblies shown in the diagnostic device 1418, and sensor can comprise internal memory extraly simultaneously, with the storage data.Yet in some embodiments, before being downloaded to the base station, Signal Regulation and/or analog to digital conversion can be carried out in portable unit.

[0157] embodiment that comprises the diagnostic device 1410 of portable unit 1431 and base station 1435 schematically is described in front perspective view (Figure 14 E) and the rear perspective (Figure 14 F).Portable unit 1431 is configured, to have size and the weight that is suitable for by the portable use of health care professional.Portable unit 1431 is configured, and to receive the input signal from one or more sensor (not shown), described sensor is from patient's image data, for example such as the simulated sound data from the artery turbulent flow.Portable unit 1431 can comprise power pack, and it offers portable unit 1431 with power supply.In some embodiments, this power pack comprises the battery that direct supply is offered unit 1431.In some embodiments, portable unit 1431 further is configured, to regulate input signal and to convert input signal to digital signal.In some this type of embodiment, Signal Regulation can comprise amplifies and/or filters described signal and conversion of signals can be utilized analog to digital converter.In some of these embodiments, portable unit 1431 can also be by confirming described input sensor signal with reference to the 920 described methods of the square frame among the figure 9.In other embodiments, portable unit 1431 can be configured, to store and/or to transmit described digital signal.For example, portable unit 1431 can comprise nonvolatile memory, and it stores digital signal, is used for downloading to subsequently base station 1435.In other embodiments, portable unit 1431 can be configured, by wired or wireless communication digital data transmission is arrived base station 1435.

[0158] in the embodiment shown in Figure 14 E and the 14F,portable unit 1431 comprisesdisplay screen 1433a and keypad 1434.Keypad 1434 is used to input is offeredportable unit 1431, for example such as patient's ID (identity number), patient information (age, sex, heart rate etc.), data, time or other appropriateinformation.Display screen 1433a is used to output information, for example the error code of whether correctly working such as indication sensor.In some embodiments,keypad 1434 is not used, anddisplay screen 1431 comprises touch screen, and it can be used for output and input function.

[0159] shown in Figure 14 E and 14F,base station 1435 can comprise one ormore docking ports 1432, and it is configured, with fixing not in use portable unit 1431.In the embodiment shown in Figure 14 E and the 14F, fourdocking ports 1432 are disposed in the upper surface ofbase station 1435, so that health care professional can be taken portable unit easily.In Figure 14 E and 14F, at three docking ports 1423 shown in the left-hand side ofbase station 1435 be " unloaded (empty) " (for example, they are fixingportable unit 1431 not), anddocking port 1432 is " fully loaded (full) " (for example, it fixedlyportable unit 1431).Unloadeddocking port 1432 is used in otherportable unit 1431 and accepts them after finishing using.In other embodiments,base station 1435 can be configured, and have still less ormore docking port 1432, anddocking port 1432 can be to be arranged with respect to 1435 different structure, direction and positions, base station.In some embodiments,docking port 1432 can be unit separately, and it separates withbase station 1435, but it is configured, to communicate by letter withbase station 1435.

[0160] except fixing not in useportable unit 1431, in some embodiments,docking port 1432 can be configured, so that provide power supply for portable unit 1431.For example, in some embodiments, chargeable power pack can be disposed in theunit 1431, and it can advantageously be charged in being arranged indocking port 1432 time.Some preferred embodiment in, lock system in Electricity Federation prevents that whenunit 1431 is connected to dockingport 1432portable unit 1431 is used to the patient and measures, and arrives described patient to prevent electric shock or electric current.In these embodiments, before this interlocking system allowed to measure,portable unit 1431 must separate (and therefore cutting off the power supply with base station 1435) fully with docking port 1432.In further embodiment,docking port 1432 is configured, so that digital signal can be downloaded to thebase station 1435 fromportable unit 1431, is used for other processing, analysis and/or storage.For example, in the embodiment shown in Figure 14 E and the 14F,, shift described digital signal fromportable unit 1431 by being included in the electrical connection in the docking port 1432.In other embodiments, by cordless communication network, digital signal can be transferred tobase station 1435.

[0161] in other embodiments,portable unit 1431 can comprise that (it can be used forbase station 1435 information interchanges to radio frequency identification for radiofrequency identification, RFID) device, for example, such as unique cognizance code of distributing to each portable unit 1431.Some embodiment has advantageously used cognizance code, to guarantee to be undertaken and download to byportable unit 1431 integrality, security and the privacy of the measurement ofbase station 1435.

[0162] in some embodiments,base station 1435 comprisesframework 1439, and it comprises the electron device that is used to analyze with processing digital signal.For example,base station 1435 can comprise processor, and it carries out the wavelet transformation of digital signal, so that produce the small echo Diagnostic parameters, and the existence or the seriousness of its indication disease, described disease is for example such as coronary heart disease.Shown in Figure 14 E,base station 1435 comprisesdisplay screen 1433b, and it can be used for the visual of result.For example,display screen 1433b can describe the text or the picture specification of existence, seriousness and/or the position of coronary occlusion.In some embodiments,base station 1435 can be transferred toportable unit 1431 with small echo Diagnostic parameters (or other relevant diagnostic information), to export on display screen 1433a.Shown in Figure 14 E,display screen 1433b can be pivotally connected tobase station 1435, so thatdisplay screen 1433b can be used with convenient by directedsuitably.Base station 1435 can be configured to from steady instrument or be installable in the framework of other diagnostic tool of support.

[0163] Figure 14 F schematically illustrates the rear perspective of the embodiment ofdevice 1410, and it showsAC power joint 1436, coolingfan delivery outlet 1438 and connector panel 1437.Connector panel 1437 can be configured, and connecting one or more peripheral device port and external bus, described bus links to each other with electron device in being arranged in framework 1439.Peripheral device port can comprise for example serial port, parallel port, USB (universal serial bus) (universal serial bus, USB) port, IEEE 1394 (live wire (Fire Wire)) port.Various peripherals can be connected tobase station 1435 byconnector panel 1437, comprise, for example keyboard, mouse, hard disk drive, CD-ROM drive, printer, plotting apparatus, display, scanner or other suitabledevice.Connector panel 1437 can also be configured, to comprise internal memory card reader, floppy disk, CD drive (for example, CD-ROM drive or DVD driver) or other suitable assembly.

[0164] in other embodiment of the diagnostic device shown in Figure 14 E and the14F 1410, signals collecting and signal analysis task can differently be distributed.For example, in one embodiment,portable unit 1431 can carry out the wavelet transformation of digital signal, and wavelet coefficient can be transferred tobase station 1435, further to be processed into the small echo Diagnostic parameters.In other embodiments, before described signal was transferred tobase station 1435,portable unit 1431 can be encrypted described digital signal, to increase patient data and result's security and privacy.Other changes and structure is possible, and Figure 14 E and 14F are not intended to limit the scope of the embodiment of thediagnostic device 1410 that comprisesportable unit 1431 andbase station 1435.

[0165] Figure 14 B schematically illustrates anembodiment 1412 of the device of the obturation that is used for detecting coronary artery.Diagnostic device 1412 is examples of thevague generalization device 1410 of Figure 14 A.Four sonic transducers are marked as 1416A, 1416B, 1416C and 1416D.Sensor 1416A-1416D is in response to by organ or other biological entities acoustic energy of heart emission for example, and it can comprise from narrow acoustical signal.Described sensor can be isolated with neighbourhood noise, and is configured to detect the acoustical signal of sending in the body.For example, in some embodiments, sensor 1416A-1416D is connected on patient's the skin by sound.As further describing with reference to figure 8 in this article, on behalf of the signal of acoustic energy, each sensor simulation acoustic energy also will be transferred to the other hardware/software components that is used for signal Processing.In some embodiments, sensor 1416A-1416D transmission of analogue signal, this simulating signal is for example sampled and digitizing such as analog todigital converter 1442 by other assembly.In other embodiments, the transmitting digitized signal of sensor 1416A-1416D.In some embodiments, sensor 1416A-1416D comprises ultrasonic transducer, and it can comprise ultrasonic transmitter, receiver, loudspeaker and/or piezo-electric device.

[0166] be suitable for the sensor that system and method disclosed herein uses for example comprise Androsonix biological sound sensor for example BM20A322P01 type acoustic transducer (Andromed, Inc., Quebec, Canada).In other embodiments, sensor comprises Andromed, the Inc. transducer, and it, is widely known by the people with " Biological Sound Monitor Sensor " listing because of by notice (K021389:10/01/2005) before the listing.

[0167] some preferred embodiment in, advantageously, sensor is in response to the acoustical signal that arrives from the direction of wide region.In addition, for the sensor of the quick material of sound more than comprising one deck, advantageously, described layer with enough little distance separately makes acoustical signal arrive each layer with the substantially the same time.This type of right sensors can be included in U.S. Patent application the 60/692nd, sonic transducer in No. 515, the exercise question of this application are " Acoustic Sensor ", submit on June 21st, 2005, it is all incorporated into this paper as a reference thus, and becomes the part of this instructions.

[0168] in some embodiments, right sensors is included in people such as authorizing Kassal on March 23rd, 1999, is entitled as the United States Patent (USP) the 5th of " Disposable Acoustic Pad Sensors ", 885, disclosed sensor in No. 222, it is all incorporated into this paper as a reference thus, and becomes the part of this instructions.Another kind of right sensors structure is described in people such as authorizing Reeves on November 22nd, 1994, is entitled as the United States Patent (USP) the 5th of " DisposableSensing Device with Contaneous Conformance ", 365, in No. 937, it is all incorporated into this paper as a reference thus, and becomes the part of this instructions.

[0169] in some embodiments, sensor is configured to comprise processing element, its can comprise microchip, microprocessor, radio frequency identification device (radio frequency identification device, RFID) or other treating apparatus.This processing element can be advantageously used in before being transferred todiagnostic device 1420 Signal Pretreatment is provided.Extraly and alternatively, this processing element can be used for docking with other assembly or device, to provide and sensor identification, location, to confirm or information that calibration is relevant.

[0170] in some embodiments,diagnostic device 1420 can be provided for the patient, is used for family and uses and self-monitoring.In this type of embodiment, sensor 1416A-1416D can be configured, to wear a period of time by the patient.Under the different time intervals, the patient can carry out self-examination to his or her symptom by for example sensor 1416A-1416D being connected todiagnostic device 1420 and carrying out acoustic measurement.The result of self-examination can be bydiagnostic device 1420 storages, and perhaps described result can be transferred to hospital, doctor or diagnostician, is used for analyzing.

[0171] in some embodiments, each sonic transducer 1416A-1416D is connected todiagnostic device 1420 byelectric wire 1421, and electric wire allows electric signal to pass through between other assembly of sensor 1416A-1416D and diagnostic device 1420.For example, electric signal can transmission sound data, and this data are corresponding to the vibration that detects by sensor 1416A-1416D.Advantageously,electric wire 1421 is flexible and long enough, to extend betweendevice 1412 andpatient.Electric wire 1421 can conductively-closed, to remain on the integrality of the electric signal that passes through betweensensor 1416 and the diagnostic device 1420.Although some embodiments of describing comprise four sensors, can use more or less sensor.In some embodiments, sensor 1416A-1416D can be configured, to communicate by letter withdiagnostic device 1420 by wireless communication protocol or by the photoelectricity agreement.

[0172]device 1412 further comprisesconnector 1422, and it allowselectric wire 1421 to be connected with the circuit that installs in 1412.Described circuit can comprisediagnostic device 1420, and it is the example of the vague generalization diagnostic device 1418 of Figure 14 A.Describeddiagnostic device 1420 comprises two different circuit boards, is used for signal Processing.The analog to digital conversion of some signal conditioning functions offirst circuit board 1442 combination, signal, and the required processing power ofdisplay screen 1472 that drives is provided in addition.Therefore,first circuit board 1442 is examples of composition element, and it exercises signal conditioning unit 1430, A/D converter 1440 and I/O processor 1460---each of Figure 14 A, all on same circuit board---function.

[0173] in some embodiments,display screen 1472 is touch screens, and it can also exercise the function of input media 1490.When working as touch screen, suitable,display screen 1472 can transmit a signal tofirst circuit board 1442 and fromfirst circuit board 1442 received signals.Therefore,display screen 1472 can allow the user to control diagnostic device 1418 and/or connect each other with diagnostic device 1418.

[0174]second circuit board 1452 provides digital signal processing capability, and it may be necessary for using wavelet transformation mathematics for example discussed above to carry out data analysis.Therefore,second circuit board 1452 is examples of the processor 1450 of Figure 14 A.Second circuit board 1452 can be the EZ-Lite plate, can be from EZ-Labs of Yonkers, and NewYork (ez-labs.com) obtains.Yet other circuit board also can be used.In some embodiments, system's operation C, C++, Visual DSP++, MATLAB_, Maple_, Mathematica_, BASIC, FORTRAN, Pascal, JAVA or other programming language.Therefore,circuit board 1452 can carry out calculating described in the above-mentioned process flow diagram and operation, to handle the data-signal from sonic transducer 1416A-1416D.In other embodiments, the instructions that carries out signal analysis can be included in software, hardware or the firmware module.

[0175]connector 1487 can be connected tosecond circuit board 1452 with first circuit board 1442.Thisconnector 1487 can be that enhancement mode module simulation front end (pass through between twocircuit boards 1442 and 1452 from multichannel electric signal and data for enhanced modular analog front end, EMAFE) connector by its permission.

[0176] and,device 1412 comprises " ON/OFF "control 1492, it can form complete circuit, this circuit allows DC current or the alternatingcurrent device 1412 of flowing through.In some embodiments, power supply is the form of direct current (DC), byelectric battery 1493supplies.Electric battery 1493 can provide portability for this device, and can reduce or eliminate the needs that this device inserted electrical network.In some embodiments,device 1412 can be byjack 1494 power supplies of direct supply.This direct supply can allowelectric battery 1493 is recharged, and improves the portability of this device.For example, in some embodiments, this device can be a hand held device movably, and it can be charged by placing it on the charge rack when not in use.In some embodiments, device 1412 (or its parts) are designed, to close minimum power consumption automatically.For example, after not using a period of time, this device can be closed self or switch to lower energy and be used pattern.Such a period of time can for example be five minutes.In some embodiments, before such inactive state was started automatically, the user can change the setting of this device, to extend or to shorten this time.

[0177] electric battery 1493 can comprise the electrical storage device or the portable energy generating technique of any kind.For example, some embodiments use such battery, and it is the disposable apparatus that single uses, and other embodiment uses chargeable device.In various embodiments, electric battery 1493 can comprise the battery of alkaline type, nickel-cadmium (NiCad) type, nickel-metal hydrides (NiMH) type, lithium ion type or other type.Electric battery 1493 can be configured, with have a period of time of carrying out (for example, such as one day the ability of) measurement or be many patients (for example, such as one in shifts during, the patient's that health care professional is seen typical number) ability measured.In the embodiment of device 1412, wherein install 1412 and comprise the less base station of movability that is configured to the portable unit of measuring and is configured to the enforcement analytic function, this portable unit can be configured, can charge on being placed on this base station or in the base station.In addition, in such embodiment, when this portable unit is placed on this base station or in the base station time, the DATA REASONING value can be downloaded.In some embodiments, described portable unit can be placed in butt joint carriage or the charge rack, and this butt joint carriage or charge rack are configured, with described base station communication.

[0178]electric battery 1493 can be configured, to comprise removable battery unit, so that the exhausted cell unit can be removed, and with being full of electric battery unit replacement.In some embodiments,electric battery 1493 can comprise electrooptical device, solar cell for example, and it can be configured, and with by environment light source chamber light for example, provides enough energy to device 1420.In other embodiments, other energy generating technique can be used, for example, and such as electrochemical appliance, fuel cell, mechanical energy or wind energy source or the like.

[0179]device 1412 can comprise stand-by power source, and for example, (uninterruptiblepower supply, UPS), it can advantageously be used, and measures during power cut-off and analyzes with permission such asUPS supply.Device 1412 can also comprise universal power adapter, and it is configured, to allow to use available in the world on a large scale input voltage (for example, from 110 volts to 240 volts with from 50 to 60HzAc).

[0180] as described at Figure 14 B, in some embodiments, memory storage 1480 can comprise storage card, and for example (it is configured to by slot in frames and is connected with diagnostic device 1420 for secure digital, SD) card 1482 such as safe digital.SD card 1482 can comprise for example Nonvolatile memory, and can be connected with diagnostic device 1420 disconnections.SD card 1482 can be connected to other device, so that for for example purpose of data storage, filing or processing, patient data or result is transferred to other device.In other embodiments, storage card 1482 can comprise volatibility or the Nonvolatile memory devices or the flash memory device of other type.In some embodiments, storage card 1482 can comprise safe digital (SD) card, standard flash memory (compact flash, CF) card, memory stick (memory stick, MS), multimedia card (multimedia card, MMC), xD-Picture card (xD) or intelligence (SmartMedia, SM) card.In various embodiments, storage card 1482 can comprise EEPROM (Electrically Erasable Programmable Read Only Memo) (electrically-erasable programmable read-only memory, EEPROM) or non-volatile read-write memory (nonvolatile read-write memory, NVRWM) or the semiconductor memory of any other type.In other embodiments, the memory storage of other type can be used, for example, such as battery-operated type random access memory (battery-backed random access memory), magnetic RAM (magnetic random access memory, MRAM), magnetic bubble memory, mini-hard disk or MEMS (micro electro mechanical system) (microelectromechanical systems, MEMS) memory storage.Still in other embodiments, device 1412 is configured, and communicates by letter with other device to connect by optical fiber connection or cable.

[0181] in some embodiments, the data ofdevice 1412 store patient in medium, this medium allows to fetch in the future data.This medium can be for example flash memory or other flash memory device, and this flash memory device allows user that patient's data or result are sent to the database in the storage medium or is sent to another diagnostic device or is sent to data network.In some embodiments, transmit data/result by wired connection (for example, metal cords, cable, optical fiber, telephone land line, modulator-demodular unit or the like).In other embodiments, for example use that blue tooth wireless technology or other are wireless, honeycomb fashion or satellite transmission protocol, patient data or result can be transmitted wirelessly to database or network.Wireless technology can comprise ground and/or satellite-signal transmission, and radio communication can take place by arrowband or broadband signal.Network can comprise Local Area Network or wide area network (WAN).In some embodiments,device 1412 can be configured, to carry out wire communication and radio communication.In some embodiments, the patient data thatdevice 1412 can real-time Transmission obtains, and in other embodiments, it can transmit data in the time afterwards, this depends on for example available network bandwidth and/or network or analyzes the queuing agreement.

[0182] in some embodiments,device 1412 can be configured, and make portable unit exercise signals collecting and measurement function, and signal analysis function (for example, calculating the small echo Diagnostic parameters) is exercised in the littler base station of mobility.In such embodiment,device 1412 can be configured, so that portable unit and base station communication, and communicate by letter with storage medium, data network or infosystem in described base station.In some such embodiment, portable unit can be configured, and to comprise radio frequency identification (RFID) device, it can provide for example device identification data, locator data, tracking data or the like.By portable unit and the base station communication that allows only to be registered, this RFID device can increase security.

[0183] patient data and/or measurement result can be stored in database, and it can allow the user that these data or result are compared to former measured value.This patient data or result can be stored in Local or Remote equipment, network or node.For example, in one embodiment, patient data or result are sent to hospital information system (Hospital Information System, HIS), these data or result can be shared by other health care professional that cures mainly this patient there.In some embodiments, according to the information among database or the HIS,device 1412 can be calibrated, to distinguish patient age group and body types.This type of information for example can be stored on the flash card, perhaps is stored on the externaldata base.Device 1412 can allow the user, and just for example age group and body types compare with diagnostic result.Diagnostic result can be encrypted, so that the security of raising to be provided.

[0184] in some embodiments,device 1412 comprises the ability that patient's measured value or result is outputed to graphic display device, and graphic display device is for example such as printer, plotting apparatus or display.For example, by wireless network, by comprising the cable that parallel port or serial port, USB (universal serial bus) (USB) or IEEE 1394 (for example, live wire) connect, or by movable storage device, can be sent to graphic display device from the data of device 1412.Device 1412 output for example can represent that perhaps it can be represented with color-coded form with numeral or alphabetical scale, and indicating inaccessible seriousness, and/or it can have such form, with the result's that provides scanning two dimension or three-dimensional representation.The result can be shown with patient's the inside or the expression of external structure simultaneously.In some embodiments,device 1412 can produce the description of the position of any obturation with suitable language.Such description can be for example clinical text description, anddevice 1412 can produce this text description automatically under the scanning conclusion.In some embodiments,device 1412 can produce acoustics output, and for example music, the tinkle of bells, audible signal perhaps can use speech synthesis system, so that patient information to be provided.

[0185] graphic display device can comprise printer, and for example such as laser printer, ink-jet printer, thermal printer or be configured to provide the miscellaneous equipment of true record, this is recorded truly for patient's data or result.This graphic display device can also comprise that display unit is for example such as monitor, cathode-ray tube (CRT) (cathode raytube, CRT), LCD (liquid crystal display, LCD), light emitting diode (light emittingdiode, LED) device, MEMS display or other monochrome, GTG or color display apparatus.In the embodiment of thedevice 1412 that comprises portable unit and base station, each unit or both can be configured, and to comprise graphic display device, wherein each can be configured, with identical or different form output datas.For example, described portable unit can output be confirmed relevant information with signals collecting and signal, and patient diagnosis information can be exported in described base station simultaneously, for example small echo Diagnostic parameters or occlusion locations.

[0186] graphic display device can be with text and/or graphical format output data.In some embodiments,device 1412 is configured, so that the data of standard industry form to be provided, for example such as portable document format (portabledocument format, PDF), (the hypertext markup language of supertext identifiable language, HTML), ASCII, rich text form (rich text format, RTF), Microsoft_Word_ or Office_ form, Joint Photographic Experts Group's form (joint photographic experts group, JPEG), GIF(Graphic Interchange format) (graphics interchange format, GIF), portable network figure form (portable networkgraphics, PNG), bitmap (bitmap, BMP) or the like.Patient data or result can be to be suitable for being included in the form output of other suitable procedure, other suitable procedure for example such as database program (for example, utilization structure query language (structured query language, SQL) or the form of Microsoft_Access_), mathematical analysis program (for example, MATLAB_, Maple_ or Mathematica_), computer graphics program (for example Autodesk_AutoCAD_, Microsoft_PowerPoint_ or Visio_) or other industry standard or proprietary program.In some embodiments, figure output can be to be suitable for the form that health insurance company uses.

[0187] graphical format can comprise two dimension or three-dimensional visualization agreement.In some embodiments, graphic display device can be exported patient data or result with film or video, described film or video are such forms, for example such as Motion Picture Experts Group's form (moving picture experts group format, MPEG), the Audio Video Interleaved form (audio video interleave format, AVI), Apple_QuickTime_ form or other suitable industry or proprietary format.

[0188] in some embodiments, graphic display device can be configured, and producing various figures, it can be used to provide, and patient data or result's is suitable visual.In one embodiment, graphic display device can be to be suitable for form that the patient uses and/or to be suitable for the form output data that doctor, clinician, diagnostician or health care professional are used.For example, the chart of the time history of the seriousness of expression patient's obturation may be useful for monitoring of diseases alleviates the validity of scheme.In addition, figure can be represented patient data or result's correlativity with other Diagnostic parameters.For example, in one embodiment, figure can show small echo Diagnostic parameters, heart rate, constitutional index, occlusion locations of patient or the like.In storage or read in the embodiment from other patient's data, graphic display device for example can show the many small echo Diagnostic parameters from all members of suitable patient's statistical packet.These type of data can advantageously be used, to follow the trail of the treatment results of the member in the described grouping.

[0189] in some embodiments,device 1412 and other diagnostic techniques compatibility are so that the result ofdiagnostic device 1420 can be integrated in the information that obtains by other method, to obtain better diagnosis.Except method discussed herein, other diagnostic techniques that can be suitable for using comprises for example magnetic resonance imaging (MRI), CAT (computer aided tomography, CAT), positron emission transaxial tomography (positron emission tomography, PET), X ray video picture, ultrasonic, cardiogram, electroencephalogram, blood pressure, blood chemistry, stress test and/or constitutional index (body mass index, BMI).Other diagnostic method also can be used.

[0190] Figure 14 C shows the cross-sectional schematic side view of thedevice 1412 of Figure 14 B.Figure 14 C shows the relative position of various assemblies, and described various assemblies are schematically shown in the mode of stack in Figure 14 B.In one embodiment,diagnostic device 1420 can have about 2 inches thickness 1498.Removable lid 1495 is illustrated, and its remainder with the main body ofdevice 1412 separates, and whereindisplay 1472 is attached to described covering.

[0191] Figure 14 D is the photo of an embodiment of diagnostic device 1413, and this diagnostic device 1413 comprises diagnostic device 1423, display 1473, cable 1419 and sonic transducer 1417.Diagnostic device 1421 can be included in the framework and by frame protection usually, metal box that described framework is for example solid but portable or fast hopper.

[0192] Figure 15 A is the schematically illustrating an of embodiment of thedevice 1510 of diagnosis biological phenomenon.Various sub-components are illustrated.Figure 15 A or process flow diagram, it shows signal and processing how to take place in order and how signal is transferred to each assembly in some way.

[0193]device 1510 comprises foursensor 1514A-1514D;Simulating signal regulator 1530; Analog to digital converter (ADC) 1540; Digital signal processor (DSP) 1550; I/O processor (I/O processor) 1560; And LCD display withtouch screen 1570;Removable data card 1580;Battery charger 1591;Electric battery 1593; And power supply supply 1595.In the embodiment shown in Figure 15 A, all component exceptbattery charger 1591 andsensor 1514A-1514D all is the part ofdiagnostic device 1518.

[0194] in some embodiments,device 1510 can be configured and can work according to followingcontent.Sensor 1514A-1514D is a piezoelectricity PVDF sonic transducer, and it is attached to subject's skin withbiocompatible adhesive.Sensor 1514A-1514D will be transformed into analog electrical signal from the acoustic energy of health, be used for further processing.The analog electrical signal that simulatingsignal regulator 1530 receives from sensor filters them with the low-pass filtering frequency overlapped-resistable filter and also amplifies them.

[0195] analog todigital converter 1540 receives the simulating signal of regulating, and with a certain sampling rate they is sampled, to produce digital signal.In some embodiments, sampling rate can be for example 2kHz, 4kHz, 5kHz, 22kHz, 44kHz, 120kHz, 500kHz, 1MHz or other suitable sampling rate.Although it is nonessential, but preferably, sampling rate is enough big, so that the simulating signal of low-pass filter is by Nyquist sampling (Nyquistsampled), for example with the sampling rate sampling more than or equal to the twice of the maximum frequency that exists in the simulating signal of described low-pass filter.During this process, four kinds of all signals are sampled simultaneously, are processed into then on the data bus (not shown) and can get, and are used for further processing.In other embodiments, four kinds of signals are by sequential sampling.

[0196]digital signal processor 1550 can be used for limiting the sampling rate of analog todigital converter 1540, data are moved into volatile memory (it can be the part of DSP1550), and carry out computing, withconfirm sensor 1514A-1514D connect, just in action with detect heartbeat.DSP1550 with another application of low pass filters to described digital signal, for example such as digital FIR filter, as with reference to the square frame 930 of figure 9 further as described in, and described digital signal resolved into single heartbeat diastole, be used for wavelet transformation analysis.In case wavelet analysis finishes, based on the existence of the frequency of the turbulent flow of indication in coronary blood flow or do not exist, the small echo Diagnostic parameters is produced.

[0197] I/O processor 1560 cooperates this system operation by LCD display 1570.I/O processor 1560 can comprise that (graphical user interface, GUI), it can format figure output with useful mode with information to graphic user interface.After pressing power supply (its can corresponding to the input that removes whereabouts battery charger 1591), described processor inspection be installed in this system to guarantee removable data card 1580 (for example non-volatile or flash card).If data card 1580 does not exist, error message is displayed on the LCD display 1570, and the indication user inserts card.In case card exists, various figures or text message are sent to LCD display 1570, and user's touch screen reply processed, to cooperate data aggregation and storage.I/O processor 1560 also distributes identifier to each data set that just is being recorded, and this identifier is made up of the sequence number of this unit and the recording mechanism that increases progressively (incremental record number).In addition, I/O processor 1560 is stored in the Nonvolatile memory on the removable data card 1580 with raw data and from the result of any processing of digital signal processor 1550.I/O processor 1560 is also monitored the inactive state from the signal of sensor 1514A-1514D, and for example enters battery saving mode after ten minutes in the suitable time.After entering battery saving mode, the touch screen activity will be restarted this unit.

[0198] LCD display withtouch screen 1570 provides visible instructions and the information that is produced by I/O processor 1560 for the user.It also obtains user's tactile response, and they are offered I/O processor 1560.

[0199] in some embodiments,removable data card 1580 comprises the device based on flash memory, and it receives from the data of I/O processor 1560 and stores thisdata.Remove card 1580 from installing 1510, be used for data to the transfer of mass-storage system (not shown) and the possible further analysis and the file of data.

[0200] in some embodiments, the assembly of being set forth can compriseportable unit 1520, and it can be configured, to have size and the weight that is fit to portableuse.Electric battery 1593 can comprise lithium ion battery, to provide electric energy to device 1510.Compriseportable unit 1520 if install 1510, prevent that then the various mechanism to user's electric shock from can be useful.For example, in some embodiments, have interlocking system, it has been got rid of portable unit 1520 (and/or installing 1510) and has carried out signal measurement whenbattery charger 1591 is connected.In these embodiments, for preparing signals collecting, before 1595 pairs of describedunit 1520 of power supply supply were provided with energy,portable unit 1520 must disconnect with battery charger 1591.Electric battery 1593 comprises additives for overcharge protection, crosses power consumption protection and low-voltage variation, to stop the further discharge ofelectric battery 1593.

[0201]power supply supply 1595 obtains electric energy fromelectric battery 1593, and it is regulated, to be used by all component of portable unit 1520.Power supply supply 1595 can comprise various voltage regulators, to provide described assembly requiredvoltage.Battery charger 1591 can be designed especially, with suitable voltage and the electric current that is provided forelectric battery 1593 is charged.Power supply supply 1520 can be configured, and accepting AC voltage, and can comprise universal power adapter, and this universal power adapter is configured, to accept suitable international exchangevoltage combination.Device 1510 can comprise interlocking, and to prevent: whenportable unit 1520 just had been used to measure patient's signal, electric energy flow to described portable unit 1520.This type of interlocking has prevented that electric shock or overcurrent from arriving the patient.

[0202] Figure 15 B and 15C show schematically illustrating of the electron device that is used forprocessing unit 1532, and describedprocessing unit 1532 can be similar to thedevice 1410 of Figure 14 A and/ordevice 1510 ground of Figure 15 A work.Yet in this optional embodiment, some assemblies can be different.For example, in the present embodiment, sixsonic transducer 1536A-1536F are connected toprocessing unit 1532 by electric wire 1538.In some embodiments,sensor 1536A-1536F is the ultrasonic paster (ultrasonic patches) that is attached on the patient's chest, is used to monitor patient's the heartbeat and the signal of transmission indication hear sounds.

[0203]prime amplifier 1538 can be connected on each ofsensor 1536A-1536F, is used to amplify from the signal ofsensor 1536A-1536F reception with amplifying signal be sent to a plurality of operational amplifiers 1540.In the embodiment of setting forth,operational amplifier 1540 is single-ended low noise amplifiers, and it has smooth frequency response to 1kHz, and wherein the nominal increment is about 18 decibels.Operational amplifier comprises the output with 1542 couplings of at least one analog to digital converter.Analog todigital converter 1542 is used for the digitizing, demultiplexing of the signal that receives fromoperational amplifier 1540, synchronously and location at least a, and be used for by dynamic storage (dynamic memory access, DMA)chip 1546 with digital data transmission to digital signal processor unit 1544.With shown in the mode of example, analog todigital converter 1542 is Analog Devices_AD 7864 or AD 7874 as Figure 15 B.

[0204] digitalsignal processor unit 1544 comprises Digital Signal Processor Core (DSP nuclear) 1518, and it is connected to analog todigital converter 1542, is used to handle the signal that receives from sensor 1536A-1536F.In one embodiment, digitalsignal processor unit 1544 comprises 32 Floating-point DSP of Analog Devices_ADSP-21065.By general input/output interface (general purpose input/output interface, GPIO) 1548, described DSP nuclear 1518 is connected to display 1528 and keyboard 1529.Processing unit 1544 also comprises the random access memory (RAM) 1550 that is connected to DSP nuclear 1518, andsdram interface 1554, and this interface is connected toSDRAM storer 1554 with DSP nuclear 1518.ROM (read-only memory) (ROM) 1556 is connected to DSP nuclear 1518, is used to store the startup or the key instruction of DSP nuclear 1518.External bus 1558 is connected to DSP nuclear 1518, is used forflash card 1531 is connected to DSP nuclear 1518, and modulator-demodular unit 1560 is connected to DSP nuclear 1518.Flash card 1531 and modulator-demodular unit 1560 all are provided, and are used for transmitting data between DSP nuclear 1518 andperipherals.Processing unit 1532 also comprises thebattery 1562 that is assemblied on the framework 1526, is used for toprocessor unit 1532 power supplies.

[0205] Figure 16 A-16N is a kind of schematic description of electron device of embodiment of device, and described device can be similar to thedevice 1410 of Figure 14 A and/or thedevice 1510 of Figure 15 A and/or theprocessing unit 1532 of Figure 15 B and 15C and work.

[0206] Figure 16 A schematically describes the connector from four lead-in wires 1602 of sonic transducer (for example, sensor 1416A-1416D or sensor 1516A-1516D).These lead-in wires can connect forexample signal conditioner 1430 or 1530 of sonic transducer and signal conditioner.Four kinds of passages are illustrated: passage A-D; Yet, still less or more passage can use in other embodiments.

[0207] Figure 16 B has schematically described a kind of frequency overlapped-resistable filter 1604.Described frequency overlapped-resistable filter can be the part of the simulatingsignal regulator 1530 of the signal conditioning portions 1430 of for example Figure 14 A and/or Figure 15 A.

The connector of passage A-D shown in Figure 16 A is connected to the connector of the passage A-D among Figure 16 B.The figure shows various electrical connections (solid black lines), capacitor (with C and the electric capacity mark represented with microfarad) and resistor (with R and the resistance mark represented with ohm).Several ground connection also are illustrated.

[0208] Figure 16 C has schematically describeddifferential amplifier 1614, and it is corresponding to analog input channel A and B.These differential amplifiers have identical gain.Input signal enters thesedifferential amplifiers 1614 along " input channel ", and is output along " output channel ".Each differential amplifier is connected to reference voltage.

[0209] Figure 16 D schematically describes differential amplifier 1616, and it is corresponding to analog input channel C and D.These differential amplifiers have identical gain, but have the different gain of gain with thedifferential amplifier 1614 of Figure 16 C.Input signal enters these differential amplifiers 1616 along " input channel ", and is output along " output channel ".Each differential amplifier is connected to reference voltage.

[0210] effect of the signal conditioning portions 1430 of Figure 14 A and/or the simulatingsignal regulator 1530 of Figure 15 A that the circuit of Figure 16 C and 16D amplifies and/or regulates signal from input channel, thereby serves as---serving as to small part---.

[0211] Figure 16 E has schematically described the electron device relevant with analog to digital converter (ADC) 1640.ADC1640 can comprise the Analog Devices_AD7864 ADC chip of for example describing 1642.Input toADC chip 1642 is marked as " output channel " A-D, because they are from thedifferential amplifier 1614 of Figure 16 C and 16ID and 1616 output.ThisADC chip 1642 becomes the analog signal conversion that enters digital signal and described digital signal is outputed to DSP, as shown.The for example effect of the analog todigital converter 1540 of the ADC 1440 of Figure 14 A and/or Figure 15 A that ADC1640 can serve as---serving as to small part---.

[0212] VoltageReference impact damper 1644 is connected to thedifferential amplifier 1614 and 1616 of Figure 16 C and 16D.1644 pairs of voltages of this impact damper can reach 2.5 volts bias voltage, to avoid needs anodal and the negative power supply supply.Figure 16 E also showsdecoupling capacitor 1646.

[0213] in the electrical schematic diagram of Figure 16 A-16N, (it is described DSP, be usually directed to the processor 1450 of Figure 14 A and thedigital signal processor 1550 of Figure 15 A) and the I/O processor (it is described, be usually directed to the I/O processor 1460 of Figure 14 A and the I/O processor 1560 of Figure 15 A) do not described particularly, although shown assembly several be designed to be connected with these processors.For example, I/O processor (not shown) can be ARM_ (Advanced Risc Machine) processor, and DSP can comprise EZ-Lite external member (EZ-Lite kit), as mentioned above.In some embodiments, DSP can comprise 16,32 or 64 reduced instruction set computer counter (reduced instruction set computer, RISC) equipment or other suitable microprocessor or computing machine.Signal from sensor can be sent to arm processor by dsp interface, this arm processor provides the interface support to input media (for example such as touch screen or keyboard), the data storage of management on memory storage (for example such as storage card), and formatted message, to go up with text or graphic presentation at display (for example such as the LCD monitor).

[0214] Figure 16 F is schematically illustrating of EMAFE connector (forexample connector 1487 of Figure 14 B), and this EMAFE connector can be connected to DSP the I/O processor.

[0215] Figure 16 G, 16H and 16J are schematically illustrating of Sharp_LH7A404 card engine connector, and this connector can be used for connecting electric component.

[0216] Figure 16 G has schematically described electrical cnnector, and it can connect I/O processor and other element.In some embodiments, this connector for example can be connected to the I/O processor on the display.

[0217] Figure 16 H has schematically described electrical cnnector, and it can connect the I/O processor and other element for example has the LCD display of touch screen.If the user touches the part (for example left side) of screen, described touch screen can transmit a signal to the I/O processor by touching passage (touch channels) 1652 (for example passage of mark " (touch left) touched on a left side ").

[0218] Figure 16 I has schematically described another kind of electrical cnnector, and it can connect the I/O processor and other element for example has the LCD display of touch screen.Connector shown in Figure 16 H and the 16I can help for example I/O processor 1460 is connected to input media 1470 and/or the output unit 1490 of Figure 14 A.In some embodiments, the connector shown in Figure 16 H and the 16I can help I/O processor 1560 is connected to the LCD display withtouch screen 1570 of Figure 15 A.

[0219] Figure 16 J and 16K schematically describe electrical cnnector, and it can connect for example storage card of I/O processor and other element.Connector shown in Figure 16 J and the 16K can help for example I/O processor 1460 is connected to the memory storage 1480 of Figure 14 A.In some embodiments, the connector shown in Figure 16 J and the 16K can help I/O processor 1560 is connected to themobile data card 1580 of Figure 15 A.

[0220] Figure 16 L has schematically described the circuit relevant with the voltage supply.Two powersource regulating circuits 1672 can be used for the power supply of supply digital circuit is gone to be connected with the power supply of supply mimic channel.Power supply order part (power sequencing portion) 1674 can be used for the various piece supply electric energy of correct order to each circuit and processor chips.

[0221] Figure 16 M and 16N have schematically described diagnostic circuit, and the various piece that it can be connected to other circuit as herein described is used for debugging purpose.These diagnostic circuits can be connected to for example DSP.

[0222] Xia Mian tabular has gone out the example of electrical equipment, and it can advantageously unite use with the described circuit of Figure 16 A-16N.

Describe	Marker character	Encapsulation name (Footprint)	Lib Ref	Model: encapsulation name (Footprint)	The packing reference number	Value	Code (IEC, IPC, JEDEC, JEITA)	Component type
									Capacitor	C1	CC3216- 1206	Cap	Chip capacitor; Device body 3.2 * 1.6mm (L * W type)		0.1μF		Cap
Capacitor	C2	CC3216- 1206	Cap	Chip capacitor; Device body 3.2 * 1.6mm (L * W type)		0.1μF		Cap
									Capacitor	C3	3225[1210]	Cap2	Chip resister; Device body 3.2 * 2.5mm (L * W type)		22μF		Cap2
Capacitor	C4	3225[1210]	Cap2	Chip resister; Device body 3.2 * 2.5mm (L * W type)		22μF		Cap2
									Capacitor	C6	3225[1210]	Cap2	Chip resister; Device body 3.2 * 2.5mm (L * W type)		22μF		Cap2
Capacitor	C7	3216[1206]	Cap	Chip resister; Device body 3.2 * 1.6mm (L * W type)		1μF		Cap
									Capacitor	C8	CC3216- 1206	Cap	Chip capacitor; Device body 3.2 * 1.6mm (L * W type)		0.1μF		Cap
Capacitor	C9	CC3216- 1206	Cap	Chip capacitor; Device body 3.2 * 1.6mm (L * W type)		0.1μF		Cap

Capacitor	C10	CC3216- 1206	Cap	Chip capacitor; Device body 3.2 * 1.6mm (L * W type)		0.1μF		Cap
									Capacitor	C11	CC3216- 1206	Cap	Chip capacitor; Device body 3.2 * 1.6mm (L * W type)		0.1μF		Cap
Capacitor	C12	CC3216- 1206	Cap	Chip capacitor; Device body 3.2 * 1.6mm (L * W type)		0.1μF		Cap
									Capacitor	C13	CC3216- 1206	Cap	Chip capacitor; Device body 3.2 * 1.6mm (L * W type)		0.1μF		Cap
Capacitor	C14	CC3216- 1206	Cap	Chip capacitor; Device body 3.2 * 1.6mm (L * W type)		0.1μF		Cap
									Capacitor	C15	CC3216- 1206	Cap	Chip capacitor; Device body 3.2 * 1.6mm (L * W type)		0.1μF		Cap
Capacitor	C16	CC3216- 1206	Cap	Chip capacitor; Device body 3.2 * 1.6mm (L * W type)		0.1μF		Cap
									Capacitor	C17	CC3216- 1206	Cap	Chip capacitor; Device body 3.2 * 1.6mm (L * W type)		0.1μF		Cap
Capacitor	C18	CC3216- 1206	Cap	Chip capacitor; Device body 3.2 * 1.6mm (L * W type)		0.1μF		Cap
									Capacitor	C19	3216 [1206]	Cap	Chip resister; Device body 3.2 * 2.5mm (L * W type)		1μF		Cap
Connector	J1A	2x4 0_HD_Hi	2x40_					DF12(3.0)-8

		rose	HD_Hi Rose					0DS-0.5V(8 0)
									Connector	J1B		2×40_HD_Hi rose	2×40_ HD_Hi Rose					DF12(3.0)-8 0DS-0.5V(8 0)
Connectorbody	J1C	SODIMM_1	44	SODI MM_144	144-pin SODIMM connector
									Base, the 30-pin, double	J2	HDR2X30	Header	30×2	Connector; Base; 30 * 2				LCD/ touch screen base
Connector	J3	SDCard_CC Mod-5761	CCM0 5_SD/ MMC_ Socket	SD card socket-ITT Cannon CCM05-5761				The SD/MMCsocket
									Connector	J4
	3×32conn	3×32CONN	3 rows * 32 pin connectors (EMAFE)				The EMAFE connector
								Jack assemblies, 9, the right angle	JD1	DSUB1.385-2H9	D Connector	9	Connector; The D microminiature; 9; The right angle; Spacing 1.385mm	788750			Debug serial port
Base, the 2-pin, double	JD2	HDR2X2	Header	2×2	Connector; Base; 2 * 2														Serial ports Config base
								Base, the 10-pin, double	JD3	HDR2X10	Header	10×2	Connector; Base; 10 * 2				The JTAG base

Base, the 2-pin, double	JD4	HDR2X2	Header	2×2	Connector; Base; 2 * 2				Serial ports Config base
										Base, the 6-pin	JD5	HDR1X6	Header	6	Connector; Base; 6				SD card debugging base
Base, the 6-pin	JD6	HDR1X6	Header	6	Connector; Base; 6				SPI debugs base
										Base, 3-pin, right angle	JP1	HDR1X3H	Header 3H	Connector; Base; 3; The right angle				Ch.D
Base, 3-pin, right angle	JP2	HDR1X3H	Header 3H	Connector; Base; 3; The right angle				Ch.C
									Base, 3-pin, right angle	JP3	HDR1X3H	Header 3H	Connector; Base; 3; The right angle				Ch.B
Base, 3-pin, right angle	JP4	HDR1X3H	Header 3H	Connector; Base; 3; The right angle				Ch.A
									Inductor	L1	INDC2012- 0805	Inductor	Chip inducer;Device body 2 * 1.2mm (L * W type)	0402-A		IEC：1005； JEITA：402	Ferrite bean
Inductor	L2	INDC2012- 0805	Inductor	Chip inducer;Device body 2 * 1.2mm (L * W type)	0402-A		IEC：1005； JEITA：402	Ferrite bean

Inductor	L3	INDC2012- 0805	Inductor	Chip inducer; Device body 2 * 1.2mm (L * W type)	0402-A		IEC：1005； JEITA：402	Ferrite bean
									Inductor	L4	INDC2012- 0805	Inductor	Chip inducer; Device body 2 * 1.2mm (L * W type)	0402-A		IEC：1005； JEITA：402	Ferrite bean
Resistor	R1	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		10K		Res1
									Resistor	R2	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		100K		Res1
Resistor	R3	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		10M		Res1
									Resistor	R4	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		100K		Res1
Resistor	R5	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		1K		Res1
									Resistor	R6	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		10M		Res1
Resistor	R7	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		1K		Res1
									Resistor	R8	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		1K		Res1
Resistor	R9	1608[0603]	Res21	Chip resister;		1K		Res1

				Device body 1.6 * 0.8mm (L * W type)
									Resistor	R10	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		10M		Res1
Resistor	R11	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		100K		Res1
									Resistor	R12	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		10M		Res1
Resistor	R13	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		100K		Res1
									Resistor	R14	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		100K		Res1
Resistor	R15	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		10M		Res1
									Resistor	R16	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		100K		Res1
Resistor	R17	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		1K		Res1
									Resistor	R18	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		10M		Res1
Resistor	R19	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		1K		Res1

Resistor	R20	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		1K		Res1
									Resistor	R21	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		1K		Res1
Resistor	R22	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		10M		Res1
									Resistor	R23	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		100K		Res1
Resistor	R24	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		10M		Res1
									Resistor	R25	1608[0603]	Res1	Chip resister; Device body 1.6 * 0.8mm (L * W type)		100K		Res1
Resistor	R26	C1608-0603	Res3	Chip resister; Device body 1.6 * 0.8mm (L * W type)		220K		Res3
									Resistor	R27	C1608-0603	Res3	Chip resister; Device body 1.6 * 0.8mm (L * W type)		220K		Res3
Resistor	R28	2012[0805]	Res3	Chip resister; Device body 2.0 * 1.3mm (L * W type)		100 milliohms		Res3
									Resistor	R29	2012[0805]	Res3	Chip resister; Device body 2.0 * 1.3mm (L * W type)		100 milliohms		Res3
Resistor	R30	2012[0805]	Res3	Chip resister;		100 milliohms		Res3

				Device body 2.0 * 1.3mm (L * W type)
									Resistor	R32	C1608-0603	Res3	Chip resister; Device body 1.6 * 0.8mm (L * W type)		22K		Res3
Resistor	R33	C1608-0603	Res3	Chip resister; Device body 1.6 * 0.8mm (L * W type)		10K		Res3
									Resistor	R34	C1608-0603	Res3	Chip resister; Device body 1.6 * 0.8mm (L * W type)		10K		Res3
Resistor	R35	C1608-0603	Res3	Chip resister; Device body 1.6 * 0.8mm (L * W type)		10K		Res3
									Resistor	R36	C1608-0603	Res3	Chip resister; Device body 1.6 * 0.8mm (L * W type)		220K		Res3
Resistor	R37	C1608-0603	Res3	Chip resister; Device body 1.6 * 0.8mm (L * W type)		22K		Res3
									Resistor	R38	C1608-0603	Res3	Chip resister; Device body 1.6 * 0.8mm (L * W type)		22K		Res3
Resistor	R39	C1608-0603	Res3	Chip resister; Device body 1.6 * 0.8mm (L * W type)		22K		Res3
									Resistor	R40	C1608-0603	Res3	Chip resister; Device body 1.6 * 0.8mm (L * W type)		22K		Res3
Resistor	R41	C1608-0603	Res3	Chip resister; Device body 1.6 * 0.8mm (L * W type)		22K		Res3

Resistor	R42	C1608-0603	Res3	Chip resister; Device body 1.6 * 0.8mm (L * W type)		22K		Res3
									Resistor	R43	C1608-0603	Res3	Chip resister; Device body 1.6 * 0.8mm (L * W type)		100		Res3
Resistor	R44	C1608-0603	Res3	Chip resister; Device body 1.6 * 0.8mm (L * W type)		100		Res3
									Switch	S1	EVQ- PPFA25	SW- PB					Reset
Precision, the micropower operational amplifier	U1	SO-8	OP193ES	Small size; 8 lead-in wires; Device body width 3.9mm; Spacing 1.27mm	SO-8		IPC：SO8； JEDEC：MS- 012-AA	OP193ES
									4 passage synchronized sampling A/D	U2	MQFP44	AD7864 AS-2					AD7864
Low-power, 250 mA output single power supply amplifier	U3	SO-14	AD8534 AR	Small size; 14 lead-in wires; Device body width 3.9mm; Spacing 1.27mm	SO-14		IPC：SO14； JEDEC：MS- 012-AB	AD8534 AR
									Low-power, 250 mA output single power supply amplifier	U4	SO-14	AD8534 AR	Small size; 14 lead-in wires; Device body width 3.9mm; Spacing 1.27mm	SO-14		IPC：SO14： JEDEC：MS- 012-AB	AD8534 AR
TinyLogic opens Lou NAND door	U6	SC70-6	NC7SZ38

Dual LDO voltage regulator	U7	TSSO10×6-G28	TPS767D	318	Shrink small size; 28 lead-in wires; Device body width 4.4mm; Spacing 0.65 mm				TPS767 D3xx
										1A low loss regulator	U8	TS3B	LM2940 CS-5.0	D2-PAK; 3 lead-in wires; Device body 14.4 (comprising lead-in wire) * 10.4mm (L * W max)	TS3B			LM2940 CS-5.0
± 15kV ESD-protection, 1 μ A, 3.0V/5.5V, 250kbps, the wireless set of RS-232 possesses automatic closing function	U9	WSO28	MAX324 3EEWI	Small size; 28 lead-in wires; Device body width 7.5mm; Spacing 1.27mm	WSO	28		IPC： SO28W	MAX324 3EEWI
										DSP model I/O processing unit				Analogue means 21065L EZ-Kit Lite Logic Product Development				ADDS- 21065L- EZLITE CENG-LH7
The LCD display panel				LH7A404 card engine Logic product development 3.5 "				A404-11-50 3HC LCD-3.5-Q
													Sharp LCD display module				VGA-10

[0223] the purpose of illustration and description for example, being presented of embodiments of the present invention in preceding description, and they be not intended to be limit or be not intended to limit the present invention to disclosed form.According to above-mentioned open, conspicuous change and variation are possible.Described embodiment is for example understood principle of the present invention and application in practice thereof, so that those of ordinary skills can utilize the present invention in various embodiments, and can use the various changes that are suitable for the concrete use considered.Under possible situation, feature described herein, step and assembly can be combined to form the other embodiment of disclosed invention.Scope intention of the present invention is limited by appended claim.

Claims (21)

1. diagnostic device, it is used for receiving and analyze the acoustic energy that the blood flow by coronary artery sends, and described device comprises:

One or more sensors, each sensor is configured, to produce signal in the response to the acoustic energy that received by described sensor;

Measurement module with framework, described module is configured, with: (i) receive from each the signal in described one or more sensors; (ii) produce one or more digital signals in response to the signal that is received;

Analysis module with framework, described module is configured, with: (i) reception is from described one or more digital signals of described measurement module; (ii) described one or more digital signals are carried out modulation step; (iii) the one or more parts in one or more modulated digital signals are carried out wavelet transformation, so that produce the small echo Diagnostic parameters, described small echo Diagnostic parameters is indicated unusual in the described coronary artery;

Confirm module, it is configured to determines to confirm parameter, the indication of described affirmation parameter: whether at least a portion from the signal of at least one described sensor is sent by heartbeat, described affirmation module further is configured, to communicate by letter, perhaps be positioned at described measurement module or described analysis module with described measurement module or described analysis module; With

Output module, it is configured to the described small echo Diagnostic parameters of reception from described analysis module, and the information of the described unusual seriousness of transmission indication.

2. the described diagnostic device of claim 1, wherein said measurement module and described affirmation module are positioned at same framework.

3. the described diagnostic device of claim 1, the described framework of wherein said measurement module is configured, with the described framework away from described analysis module.

4. the described diagnostic device of claim 3, wherein said measurement module is of portable form.

5. the described diagnostic device of claim 4, wherein said measurement module is portable.

6. the described diagnostic device of claim 1, wherein said modulation step comprises the conversion that described one or more digital signals are carried out, described conversion provides the information relevant with the frequency spectrum of described one or more digital signals.

7. the described diagnostic device of claim 6, wherein said conversion comprises Fourier transform.

8. the described diagnostic device of claim 1, wherein said wavelet transformation comprises female small echo, described female small echo is selected from Morlet small echo, Haar small echo, Daubechies small echo, Hermitian small echo, Mexican hat small echo and orthogonal wavelet.

9. the described diagnostic device of claim 1, wherein said wavelet transformation comprises female small echo of a part that is selected from one of described digital signal.

10. the described diagnostic device of claim 1, wherein said wavelet transformation comprise the described unusual female small echo of selected representative.

11. the described diagnostic device of claim 1, wherein said is the inaccessible or narrow of artery unusually.

12. the described diagnostic device of claim 1, wherein said analysis module is configured, and carries out described wavelet transformation to use one or more female small echos.

13. the described diagnostic device of claim 1, wherein said analysis module receives described one or more digital signal by cordless communication network.

14. the described diagnostic device of claim 1, wherein said output module are positioned on the framework of the framework of described measurement module or described measurement module.

15. a diagnostic device comprises:

One or more sonic transducers, each sonic transducer is configured, and on the outside that is arranged in biosome, and each sensor is configured, to produce signal, described signal response is in the acoustic energy of the scope of being sent by the blood flow in the coronary artery in about 300 hertz to about 1500 hertz;

Dissect sensor, it is configured to provides and the structure of anatomical structure or the information of directional correlation, and described dissection sensor is selected from Vltrasonic device, MR imaging apparatus, x-ray imaging device, cardiogram device, electroencephalogram device and CAT device;

Measurement module with framework, described module is configured, with: (i) reception is from the signal of one or more described sonic transducers; (ii) produce one or more digital signals in response to the signal that is received;

Analysis module with framework, described analysis module is configured, to receive described one or more digital signals from described measurement module, and one or more parts of described one or more digital signals are carried out wavelet transformation, so that produce the small echo Diagnostic parameters, described small echo Diagnostic parameters is indicated unusual in the described coronary artery, described analysis module is further configured, with the information of reception, and determine the structure of the unusual and described anatomical structure in described coronary artery or the anatomy association between the direction from described one or more dissection sensors; With

Output module, it is related with diagnosis from the described small echo Diagnostic parameters of described analysis module that it is configured to reception, and described unusual seriousness of transmission indication and the described unusual information related with the anatomy of described anatomical structure.

16. the described diagnostic device of claim 15, wherein said anatomical structure comprises heart.

17. the described diagnostic device of claim 15 further comprises the heartbeat sensor, it is configured to the signal that produces the indication heart rate.

18. the described diagnostic device of claim 17, wherein said heartbeat sensor comprises electrocardiography transducer or pulse transducer.

19. a diagnostic device comprises:

One or more sonic transducers, each sonic transducer is configured, and on the outside that is arranged in biosome, and each sensor is configured, and to produce signal, described signal response is in the acoustic energy that is sent by the blood flow in the coronary artery;

The heartbeat sensor, it is configured to the cardiac signal that produces the indication heartbeat;

Measurement module with framework, described module is configured, with: (i) receive from each of described one or more sonic transducers and the signal of described heartbeat sensor; (ii) produce one or more digital signals, it is in response to the signal that receives from described one or more sonic transducers; (iii) produce digital cardiac signal, it is in response to the cardiac signal that receives from described heartbeat sensor;

Analysis module with framework, described module is configured, with: (i) reception is from the described one or more digital signals and the described digital cardiac signal of described measurement module; (ii) determine one or more parts of one or more heartbeats from described digital cardiac signal; (iii) the part of described one or more digital signals is carried out wavelet transformation, the part of described one or more digital signals is corresponding to described one or more parts of described one or more heartbeats; And (iv) producing the small echo Diagnostic parameters, it indicates unusual in the described coronary artery; With

Output module, it is configured to the described small echo Diagnostic parameters of reception from described analysis module, and the information of the described unusual seriousness of transmission indication.

20. the described diagnostic device of claim 19, wherein said one or more heartbeat sensors comprise electrocardiography transducer or pulse transducer.

21. the described diagnostic device of claim 19, wherein said measurement module is of portable form.

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