WO2003003920A2

WO2003003920A2 - Method and device for non-invasive research of blood distribution and its circulatory characteristics in warm-blooded organism

Info

Publication number: WO2003003920A2
Application number: PCT/GE2002/000006
Authority: WO
Inventors: Gennady Gedevanishvili
Original assignee: Gennady Gedevanishvili
Priority date: 2001-07-05
Filing date: 2002-07-04
Publication date: 2003-01-16
Also published as: WO2003003920A3

Abstract

The invention refers to medicine and can be used for assessment of the current status of blood supply in all the regions and vital organs and the reserves of adaptation of an organism as a hemodynamic response of cardiovascular system to a way of life, dosed loading, latent or manifested pathology. Technical result of the invention is an increase in accuracy and self-descriptiveness of measurement. There is provided a connection of the high-frequency generator of a stable sounding current by attaching at least three or five current electrodes, each of the electrodes having at least two sections, to the upper part of a head and to the distal parts or the lower and/or upper extremities and pickup electrodes, each one having at least two sections, in the regions of head, neck, breast, stomach, pelvis, upper and lower extremities of a warm-blooded organism. Gathering and measuring of base impedances and plethysmogram is effected at single-stage, from all the regions of a warm-blooded organism. After processing the obtained data the conclusion is given about the fuctionalities and adaptation reserves containing the hemodynamic description of the current ststus of the warm-blooded organism.

Description

Method and Device for Non-Invasive Research of Blood Distribution and its Circulatory Characteristics in Warm -Blooded Organism

Technical Field

The invention refers to medicine and can be used for assessment of the current status of blood supply in all the regions and vital organs and the reserves of adaptation of an organism as a hemodynamic response of cardiovascular system to a way of life, dosed loading, latent or manifested pathology.

Background Art

Today, in an arsenal of the doctor there are more than 10 000 thousand methods of research of the various sides of functioning of the organism, allowing medicine to become more obvious and effective. The facts testify to the big successes of medicine in the struggle against cardiovascular diseases. The number of sharp diseases of cardiovascular system (CVS) has decreased, life expectancy of people has increased. The structure of diseases bringing to death has changed. Now chronic forms of pathology of CVS and their complications took the first place.

By the statistical data, only in the USA the death rate made 400 thousand persons from chronic heart failure (CHF) in 1990, and in 1999 - already 4,9 million, and this tendency of growth of death rate is kept all over the world.

The problem is in that the cardiovascular system is a realisator and a permanent participant of all the processes proceeding in a human organism. It is the most sensitively responsive to any influence upon an organism. However, due to organospecific and organopathologic orientations in perception of a patient's condition, the strategy of research based on research of separate parts of an organism is accepted in medicine.

Such an approach does not allow the doctor to receive the full awareness about the true state of a the patient's organism. The hemodynamics index bearing a lot of system information about the processes proceeding in an organism were not called for.

To overcome this contradiction is possible when studying a state of an organism by the parameters of hemodynamics, since the cardiovascular system is a realisator and a permanent participant of all processes proceeding in a human organism. It is most sensitively responsive upon any impact. The radionuclide and thermodilution researches of blood circulation are the well-known methods, but they are invasive. The thermodilution method as the most simple invasive one is usually applied in reanimation branch. The doctor, having inserted catheter in pulmonary artery of the patient and using an ice physiological solution is capable to determine the current condition of the basic hemodynamic parameters, with sufficient practice accuracy. However this method also suffers from obvious disadvantages which are inherent to any invasive procedure.

The indirect methods of measurement of parameters of blood circulation gain the increasing popularity in medical practice, since they allow to receive the measured hemodynamic values in an undistorted form, i.e. in the natural state of cardiovascular system, without intervention from the outside.

The obvious requirement for non-invasive techniques is the correlation of the received results with the data of the basic invasive methods. It was revealed, that echocardiographic researches in many cases do not meet these requirements technically. They do not allow to determine the functional side of vascular abnormalities (a level of blood-filling, a functional state of vessels, a degree of their insufficiency and also the compensatory capabilities of vessels).

Therefore, the non-invasive electrobioimpedance plethysmographic methods of researches are continued to be used for research of a complex of hemodynamic parameters.

Two types of electrobioimpedance plethysmographic methods of researches are known: local (segmentary), performed on a certain part of a body and an integrated one, which simultaneously covers several regions of a trunk, lower and upper extremities.

The analysis of segmentary system (patent of the USA) submitted by B. Sramek and Kubicek, has revealed the following disadvantages:

1. The calculation of the main hemodynamic parameter, i.e. the volume, is made by use of an impedance derivative dZ/dT, but not by the direct measurement of active bioimpedance component, which is the direct characteristic of liquid volume.

2. The dispersion of the measured current beyond the limits of measured segment gives a mistake in an end result.

3. The geometry of measured site itself has an influence upon result.

4. Errors arise from electrodes, from their arrangement and travel during respiratory movements.

5. The essential mistake in calculation is given by the fact, that the derivative dZ/dT does not correlate with an impedance of all body. 6. Apart from that, these methods do not provide reception of parameters characterizing respiratory system.

Therefore, the integrated electrobioimpedance measurements of all body are more informative in comparison with segmentary ones. For the first time this method was offered by M.I.Tishcenco. Using the empirical equation used by M.I.Tishcenco for integrated measurements the opportunity has appeared to receive the information concerning main hemodynamic parameters of the whole cardiovascular system of a body.

However, to exclude the influence of a reactive component of impedance on the result, this system, prior to each measurement, necessarily requires calibration, and during measurement requires tuning.

The other problem bringing a mistake into the final results is the presence of a contact reactive component, which arises between electrodes and skin. To exclude this mistake without tuning is practically impossible. Therefore, the accuracy of calculations by M.I.Tishcenco's method completely depends on quality of manual tuning, that makes this system unreliable. A method and system for non-invasive determination of main cardiorespiratory parameters of a human body offered by Tsoglin and Frinerman in the USA patent No 5,735,284 refers to integrated electrobioimpedance measurements of the whole body. The method is designed for determination of the basic cardiorespiratory parameter of an individual. According to this method, the electrodes are applied at least in two places, one - to hands and the other - to legs.

The integrated curve is obtained as a result of measurement of an alternating current of highly stable amplitude running through a body. The active, i.e. the resistive component is separated from an integrated bioimpedance.

The analysis of integrated system patented in the USA by Tsoglin and Frinerman, has revealed the following disadvantages.

1. The method continues to support organospecific and organopathologic approach to an organism and does not promote the system complete vision and the analysis of a patient's organism.

2. The method is invasive, since for calculation of the basic cardiorespiratory hemodynamic parameter of cardiac output (CO) according to the equation offered by authors: EQU1, 145+0,35 (Hct-40), the blood sampling is necessary for calculation of substitutional value in the basic equation haematocrit-Hct from the patient's blood. The factor (concentration) of electrolytic ions in blood of patient Kel- is also calculated as a result of the analysis of blood and is included in other calculations under the offered formulas for individual dialysis EQU4 and for others EQU5.

3. Epy integral method in a combination with segmentary one is not completely used by authors.

4. The fact, that the basic author's precondition is the ratio of the received data with the whole volume of a body testify the irregularity of the measurement circuit, however the electrodes are applied at least in two places, one - to hands and the other - to legs. In such a measurement circuit based on inventor's research of the whole body the fact is forgotten that the head is also a part of the body and contains at least 1/4 part of the general volume of blood of an organism not taken into account by them. Electric equivalent circuits given in patent US 5,735,284 on Fig.l A - Fig.lG do not allow to judge about a condition of the whole cardiorespiratory system under those conditions, which are provided in the patent, since they do not comprise such an important region as the head containing brain - the basis of nervous regulation of an organism. Authors Tsoglin and Finerman in the USA patent 5,735,284 under an integrated method mean the research of a body by means of connecting current electrodes between extremities, not taking into account the region of the head containing at least 25% of the volume of deposited blood, change of redistribution, which always brings an error, and the main thing is that it does not allow to assess the state of blood supply of the brain (a nervous regulation state) and the organism as a whole.

It is technically rather difficult, since any influence upon an organism causes change of hemodynamics parameters. The most simple method completely meeting the goal, appeared a method of non-invasive measurements of electric resistance of tissues of an organism. The method of impedance plethysmography is currently permanent and widely used in space medicine as well.

Disclosure of Invention

Technical result of the proposed invention comprises the increase in self-descriptiveness, sensitivity, and also increase in accuracy of measurement of the basic cardiorespiratory parameters of blood circulation, that is achieved by that in a method for non-invasive research of distribution of blood and its circulatory characteristics in the warm-blooded organism comprising connecting the high-frequency generator of a stable sounding current to a researched object by means of current electrodes, gathering and measuring a base impedance and electrical impedance plethysmogram by means of pickup electrodes, determining blood deposition, recognizing, measuring and calculating the averaged amplitude of systolic wave and the averaged period of cardiac output, connection of the high-frequency generator of a stable sounding current by means of attaching at least three or five current electrodes to the upper part of a head and to the distal parts of the lower and/or upper extremities, each of the electrodes having at least two sections, connecting pickup electrodes, each one having at least two sections, in regions of a head, a neck, a breast, a stomach, a pelvis, upper and lower extremities of a warm-blooded organism, whereas gathering and measuring of base impedances and plethysmograms are made at single-stage from all the regions of a warm-blooded organism, determining deposition of blood and its distribution is effected on all the regions of a warm-blooded organism, the received plethysmogram data are automatically exposed to statistical analysis and mathematical transformation to the averaged synthesized cardiac complexes of plethysmograms, which are synchronized by cardiac output, transforming them in a field of averaged plethysmograms, then recognising phases of the cardiac cycle and measuring their averaged amplitude-time parameters - amplitude of systolic wave, the period of cardiac output and parameters of distribution of cardiac output in all the regions of an organism and the frequency of stroke volume, or presenting visually the data received at research for subjective recognition of phases of a cardiac cycle in the allocated informative points, automatically measuring amplitude-time parameters of plethysmograms, characterising the cardiac output index and its distribution on the regions, then under the known formulas calculating the basic informative parameters of blood circulation, normalizing them on hit in ranges of values: "optimum" - "the latent functional abnormalities" - "pathology", and by the results of normalization assigning the codes of the current condition thereto, then according to anatomic representation about structure of system of blood circulation, determining the current condition of indexes, characterising the functional condition of blood circulation, analyzing the cumulative condition of the general characteristic and specific parameters connected by uniform hemodynamics, and by a known technique and statistical criteria assessing them, then on the basis of physiological knowledge making system analysis of status of blood circulation and blood supply of vitally important bodies of the organism and a status of regulation at all levels at rest, by inclusing in the process of research of various loading tests, and in end giving out the conclusion about functionalities and reserves of the adaptation, containing hemodynamic description of the current condition of a warm-blooded organism. The technical result is achieved also in that in the device for non-invasive researches of distribution of blood and its circulatory characteristics in a warm-blooded organism comprising the high-frequency stable generator of sounding current, current electrodes connected to the generator, pickup electrodes connected to the block of commutation, which by means of the channel of measurement of a base impedance and electroimpedance plethysmograms of matching device and the block of the analog-digital converter is connected to the system block of a computer, means of display and registration, a set of means for storage of programs and incoming data, the current and pickup electrodes have sections, each of electrodes having at least two sections, current electrodes, at least three or five thereof are capable of connection to the upper part of a head and to an upper or lower part of feet, the pickup electrodes are capable of connection to a warm-blooded organism in regions of a head, a neck, a breast, a stomach, a pelvis, upper and lower extremities, the device containing at least two channels of measurement of a base impedance and electroimpedance plethysmograms, a matching device containing at least four channels of coordination to the inputs of the block of the analog-digital converter, and the system block of a computer containing at least two processors working on uniform algorithm in a mode of single-stage gathering and processing of the information, according to application package.

The method and the device are proposed for non-invasive research of distribution of blood and its circulatory characteristics in regions, the vital bodies and an organism as a whole during the life. This is the electroimpedance-plethysmographic research, and also the device for determination of the basic hemodynamic parameters describing the state of organs providing blood circulation in an organism of an individual, the system analysis of which allows to assess the status of systems of blood circulation and blood supply and the state of regulation system at all researched levels and to provide monitoring of the current status of an organism as a whole.

This method of computer overall-differential impedance measuring is free from necessity of an additional blood sampling, tuning of the measuring device during research and is characterized in high self-descriptiveness, sensitivity, specificity, higher accuracy in measurement of the basic cardiorespitatory parameters of blood circulation.

Brief Description of the Drawings The proposed method and the device are realized as follows. Fig. 1 is general block diagram of the device. Fig. 2 is electroimpedance plethysmograms.

Fig. 3 is a synthesized plethysmographic cardiac complex

Fig. 4 is a field of synthesized plethysmograms

Fig. 5 are phases of cardiac cycle on plethysmograms.

Fig. 6 is a visual representation of informative points on plethysmograms

According to Fig. 1 the device comprises high-frequency stable generator of sounding current 1 and current electrodes I, II, III connected thereto, a block of commutation 2 and pickup electrodes a, b, c, d, e, f, g, h, i, j, k connected thereto, the channel of measurement of a base impedance 3, a matching device 4, which contains at least 4 channels of the coordination to to the inputs of the block of the analog-digital converter 5, at least two processors 6 of a system block of computer 7 containing also a printer 8, a monitor 9 and key board 10.

The current and pickup electrodes have at least two sections, e.g. as it is shown on Fig. 1, dl, d2 or el and e2.

The high-frequency generator of a stable electric current with the big internal resistance considerably exceeding integral resistance of a human body, through current sectional electrodes fixed between forehead or top of head and feet of both legs, or/and in places of the joint of forearm and hands, creates weak sounding current, which passing through the whole body of a patient, creates uniform conditions for measurement of an impedance by power failure, in the researched regions.

All electrodes, both current and pickup ones, have sections for detailed research of blood circulation in regions, that allows to achieve both the complete (integral) research of a state of volumes of blood deposition and cardiac output, and their distribution among the various parts in each region of a body. Besides, the availability of sections instead of integral electrodes allows to increase the reliability of research, reducing probability of influence of breakage of separate connecting wires upon the results of research.

The pickup sectional electrodes fixed in the regions of head, neck, breast, stomach, pelvis, hips, lower or/and upper extremities form the closed electric measuring circuit for synchronous registration and measurement of dynamics of impedance changes, that allows to judge about distribution of blood in an organism, regions and their parts. Gathering impedancemetric data is carried out simultaneously from all the researched regions of the patient's body, or at least in pairs - the region of breast and the region of periphery, the region of breast and the other region of periphery, etc. prior to accumulation of the data on all the peripheral regions of an organism.

The collected impedancemetric information comes to the multichannel device of measurement of a base impedance (Zo), describing the volume of deposited blood. Resistive components (dZ, and dZ/dT) reflecting blood circulatory characteristics are separated from an integral bioimpedance and come to the channels of measurement of electroimpedance plethysmograms, Fig. 2 (A, B).

The device of measurement contains a number of channels of measurement equal to the amount of the researched regions, or not less than two electroimpedance channels of measurement and program-controlled switchboard of connection of pickup electrodes. All the channels of measurement through the matching device containing at least four matching channels, through the block of analog-digital converter are connected to the system block of a computer, which contains at least two processors and the device for storage of programs and the coming information, its processing, display of results of processing and registration.

Such a structure of construction of the device allowing to investigate non-invasively the distribution of blood and its circulatory characteristics, is necessary for single-stage gathering and measurement of base impedances and plethysmograms, and processing of the information from all the regions of a warm-blooded organism.

The information collected in research is automatically, under the known statistical formulas (given in books of JI. 3aκc «CτaτHcτHHecκoe oueHHBaHκe», MocKβa, 1976 r. and M.H. BojibmoB, H.B. CMHPHOB «Ta6jικm>ι MaτeMaτHHecκoft cτaτHcτHKH», MocκBa, 1965r) is exposed to the statistical analysis, during which there is a filtration of this information from parasitic inducing (a background 50 hertz of electroradiointerference and various myograms) and separation of respiration parameters.

Further mathematical transformation of set of initial complexes of plethysmograms, reflecting the cardiac cycle, received during gathering the information from each region, in one averaged synthesized (FIG.3) plethysmographic cardiac complex reflecting a condition blood flow in region follows. This transformation is carried out by the standard software which works in operational environment DOC and WINDOWS.

Further, all the averaged synthesized cardiac complexes of plethysmograms of periphery, are synchronized in a field of plethysmogram, FIG 4. For this purpose from the time of achieving a maximum systolic wave in the region of breast, the time of achieving a maximum systolic wave in the region of periphery is subtracted.

The time delays connected to a state of distribution of pulse-wave in vessels are caused by a spatial arrangement of electrodes on a researched organism and state of distribution of pulse- wave, i.e. by physical parameters of vessels and blood.

The phases of a cardiac cycle of FIG.5 are reflected in the synthesized cardiac complexes of plethysmogram as auricular wave, presystolic wave, fast and slow phases of systolic and diastolic waves. They are recognized by the account of a time sequence of their display on rheogram, parameters of amplitudes, speeds of their change in points of an inflection, calculation of amount of the maximal amplitudes. The measured in these points amplitude-time parameters Ai and Ti, in all the regions of a warm-blooded organism characterize the circulatory parameters of blood flow bearing hemodynamic response to a way of life and the current status. Simultaneously, the heart rate (HR) is automatically is determined by counting up the amount of amplitudes of a systole in a unit of time.

The received results are visualized, both as graphic display of a field of averaged plethysmograms and as a set of digital values of parameter describing the results of recognition.

The method and the device allow in case of need, when working with initial plethysmographic curves, to recognize the phases of a cardiac cycle subjectively. For this purpose the curves are deduced visually on the means of display and registration - for example, on the screen of the display.

The researcher recognizes and marks informative points of plethysmograms, and the device automatically measures in these points the amplitude-time parameters describing parameters of cardiac output and its distribution on regions, FIG.6.

The algorithm of recognition of informative parameters is based on subjective, visual recognition by the researcher of at least 10 systolic complexes of cardiac cycle on the initial plethysmograms, where the device automatically measures amplitude-time parameters (Ai, Ti) of each cycle and the result is supplemented with their averaged values. Thus calculation of amount of cardiac cycles in time unit is counted up by the researcher independently from the screen of the display and the heart rate (HR) is brought in the device manually.

Further, received early values of parameters (Zo), (dZ, and dZ/dT) and their distribution on regions, and also amplitude-time parameters (Ai, Ti) and (HR) phases of a cardiac cycle, and other physiological characteristics: sex, age, height, weight, systolic and diastolic arterial pressure (SBP and DBP) in the position - laying and standing in rest, and received as a result of influence of test loading at various modes of research of distribution (Zo), (dZ, and dZ/dT) (Ai, Ti) and (HR) and (SBP and DBP) on regions, are substituted in known, modified mathematical formulas and calculated by the basic informative parameters of blood circulation. For example, the stroke volume (SV) is calculated under the formula proposed by Kubicek supplemented by J.G.Pushkar and co-authors (1986r), SV = (L/Z) *HCF*Ti*150 where L is a distance between electrodes; Z=Zo is an impedance of region of a breast; heart contractility function (HCF) is calculated by the known formula Ai of breast / 10 * K of breast, where Ai is an amplitude of a systole on plethysmogram, K is calibration index; the minute blood volume (MBV) is calculated under formula MBK=SV*HR. Other parameters: general vascular resistance (GVR), a volumic maintenance regimen of an organism (CBV-1), systemic circulation blood volume (SCBV) and pulmonary circulation blood volume (PCBV), respiration rate (RR) etc. describing the status of heart pump function (HPF), an arterial impedance of perfusion (AI Perfusion), an arterial impedance of pump function (AIPF), an arterial impedance of pressure (AI Pressure), arterial blood flow (ABF), venous blood flow (BBF), filling of veins (FV) etc. are calculated under the well-known, simple formulas, which are entered and realized by a program- mathematical software of the device.

Then the device, using incorporated in a software a set of the statistical data describing ranges limits, automatically normalizes all these parameters on hit in ranges of values "optimum" - "latent dysfunction" - "pathology". For this purpose, in statistical limits of an age norm accepted in medicine, the segments are allocated, which correspond to upper and lower limits of the age norm, in which dysfunction is compensated by an organism.

The range of values, which are higher or lower than these limits is taken as hypo- or hyper- pathology. Just the parameters, which are in the middle of the range of the age norm and not requiring the tense of its regulator systems in rest are the optimum for an organism. By the results of normalization they are assigned the codes corresponding to the current conditions.

Then the device, using incorporated in a mathematical software the set of the statistical data and algorithms of conversion of initial parameters and the basic informative parameters of blood circulation, which are connected with uniform hemodynamics, calculates and normalizes the indexes describing a functional status of organs and regimens of their functioning. For determination of a state of indexes the sums of the parameters, which have got in various ranges at normalization are calculated and are compared to the criteria allowing by coincidence to assess the current state of indexes. For example, for defining the state of an index - an arterial pressure regimen AP-1 the three-stage construction and calculation of criteria is necessary to make an arterial pressure regimen.

The first criterion includes the general group of the parameters reflecting the regimen of functioning of blood circulation organs, to which are referred the state of parameters of systemic blood circulation volume (SBCV), mean arterial pressure (MAP), HR, SV, MBV and arterial impedance to pressure (AI Pressure) regions etc.. The second criterion is a typical group of parameters, into which enter arterial pressure regimen (APR), GVR of SC and AI Pressure of all the regions. The third criterion is specific - it includes one parameter - MAP.

Each criterion is calculated as follows: the quantity of parameters got in a range "Optimum" is first summarized and the obtained result is compared to the criterion of recognition of the state, which was earlier determined on the basis of the statistical data. If the calculated value meets the criterion it is assigned the code of this state. If no, then the comparison with the other range "the latent dysfunction" proceeds.

Such a method of indexing was applied earlier in the works of medical institutions of Georgia, in particular in Tbilisi Scientific & Research Institute of Experimental and Clinical Therapy and Sukhumi Experimental Pathology and Therapy of the USSR AS.

The list of used indexes and abbreviations: (APR)- arterial pressure regimen, (HR) - heart rate (SBP) -systolic blood pressure, (DBP) -diastolic blood pressure, (PBC) - pulmonary blood circulation, (SBC) - systemic blood circulation, (HPF) - heart pump function, (RV) - right ventricle, (LV) - left ventricle,

(GVR) - general vascular resistance,

(PAOP) - pulmonary artery occluded pressure (wedge pressure)

(AIPF) - arterial impedance of pump function of heart,

(AI Pressure) - arterial impedance to pressure,

(AI Perfusion) - arterial impedance to perfusion,

(ABF in PC) - arterial blood flow in PC,

(PAR) - pulmoarterial resistance,

(VBF) - venous blood flow of PC,

(VF) - vein filling of PC,

(VBO of PC) - venous blood outflow of PC

(VF) - vein filling of PC

(ABI of SC) - arterial blood flow of SC

(AI Perfusion) - arterial impedance to perfusion

(AIPF) - arterial impedance to pump function

(AI Pressure) - arterial impedance to pressure

(VBO of SC) - venous blood outflow of SC

(VF of SC) - vein filling of SC

(GVR) - general vascular resistance

(MBV) -minute blood volume,

(SV) - stroke volume

After the current state of indexes is determined, the device automatically makes the system analysis of a state of blood circulation and blood supply of vital organs of an organism and a state of regulation at all levels in rest. For this purpose see the Extract from Medical Examination Protocol No. 000261 :

1. Value of an index of system arterial pressure regimen (APR) is in a range "latent dysfunction " -hyper-. The index of the total volume of circulating blood of a warm-blooded organism is in the range - "Optimum"-. The index - chronotropic cardiac regimen (CCR) is in the range "latent dysfunction" - hypo-. Value of an index - left ventricle pump function (LVPF) is in the range - "Optimum"-, but an index - the general vascular resistance of blood circulation system (GVR of BC), is in the range - "Pathology"-hyper-. The discrepancies between productivity of the heart pump and capacity (resistance) of arterial vessels in blood circulation system results in the increase in arterial pressure. According to the classification accepted in medicine such a state is identified, as Borderline hypertension, hypokinetic circulation type.

2. The pulmonary blood circulation is also characterized by the discrepancy between the index of right ventricle pump function (RVPF), which in the example is in the range "Optimum" and the index of pulmoarterial resistance, which is in the range - "Pathology"-hyper-. As a result there is the condition for increase of pressure in a pulmonary blood circulation, which in its turn is connected with the increase of the volume of circulating blood in a pulmonary circulation. The pulmonary artery occluded pressure (PAOP), which is calculated under the known formula has increased:

PAOP = A of systole / A of diastole *K. Increase of pulmonary artery occluded pressure (PAOP) and increase of blood volume in a pulmonary blood circulation is probably caused by diastolic dysfunction of heart, and it is a shock-organ.

3. The state of blood supply of brain, lungs, abdomen, liver, kidneys and the lower extremities, is assessed as optimum in rest, since everywhere in blood supply of tissues, which characterize the index of arterial impedance to perfusion (AI Perfusion), they are in the range "Optimum". Arterial inflow and venous outflow of blood circulation organs in the regions containing the vital organs are in the range "Optimum".

The indexes describing the mechanisms of ensuring perfusion on microcirculation level are changed under the effect of local nervous -humoral regulation, i.e. - the metarteriole tonus is in a range "latent dysfunction " - hyper-, and the capacity of a capillary bed is in the range "latent dysfunction " - hypo-. The index - chronotropic cardiac regimen (CCR) is in a range "latent dysfunction" - hypo-. Heart rate (HR) is reduced (bradycardia), i.e. the status of central regulation is characterized by a prevalence of parasympathetics.

Then during research the various test loading such as an active orthostatic sample, respiratory tests, medicaments tests, physical load, psychoemotional test are included. As an example we will consider an extract from Medical Examination Protocol No. 000261, from which it is clear, that in a researched organism after the influence of the active orthostatic sample (research of hemodynamics of a patient in two rest positions - lying and standing after adaptation endurance) and respiratory tests (a delay of breath in exhalation and exhalation in various positions of a patient's body). Since as it is obvious from the Examination Protocol of research, the tolerance to physical load, to delays of breath in exhalation and exhalation is reduced, then the general current reserve of adaptation is also reduced.

In the end of research the device automatically gives out the conclusion about functionalities of the warm-blooded organism, containing the hemodynamic description of its current condition. For example (see an extract from the report J ° 000261): "Borderline hypertension, hyperkinetic circulation type. In systemic blood circulation: the general vascular resistance is increased at the reduced minute volume of heart. In a pulmonary blood circulation: pulmonary artery occluded pressure is increased and the volume of circulating blood caused by diastolic dysfunction has increased. A shock organ - heart. The relative coronory blood supply insufficiency is caused by left ventricle hypertrophy." Extract from Medical Examination Protocol No. 000261

Patient: A A

Date and Hour of Examination: 21/02/2001 13:35 Sex, Age, Height/ Weight: Male 1953, 167 cm 80 kg 1. Active orthostatic sample

2. Integral Perfusion Mode

3. Central Blood Circulation

N* - Normal

5. Analysis of condition of a patient's vital organs

N* - Normal CONCLUSION

The examination revealedi Borderline hypertension, hyperkinetic circulation type. In systemic circulation: general capillary increased with lowered cardiac output. In pulmonary circulation: an increase of pulmonary artery occluded pressure (wedge pressure) and circulating blood volume caused by diastolic dysfunction. Shock organ: heart. In our view, relative coronary blood supply insufficiency is caused by left ventricle hypertrophy . Recommended: cardiologist's consultation FEASIBILITY OF THE PATENT

The method and the device for non-invasive research of distribution of blood and its circulatory characteristics in a warm-blooded organism as the method of functional research of blood circulation system allows the doctor to assess the real state of vital activity of an organism by the parameters of blood supply. It promotes reception of the new information, which is a basis for systematization of medical knowledge, allows the doctor to optimize the strategy of diagnostics and tactics of treatment. The method makes possible to re-classify a state of patients on the new hemodynamic basis, qualitatively improving standards existing in medicine.

The device as hemodynamic analyzer allows non-invasively, quickly, objectively and at single-stage to assess a state of blood supply of all regions and to identify hemodynamic response of an organism to a way of life, the dosed out loading, latent or a demonstrated pathology.

_*

High sensitivity, reliability and specificity of method of computer overall-differential impedance measuring in research of blood circulation allows quickly to reveal regions with the not optimum and disturbed blood supply to assess at single stage a state of blood supply of brain, heart, lungs, liver, kidneys, urinogenital organs, upper and lower extremities, that allows the doctor:

• to assess a degree of pressure and a coordination of functioning of the organs providing central and peripheral hemodynamics, to diagnose the early features of hypertension, to monitor a state of blood supply of the vitally important organs and to diagnose heart failure at all stages, beginning from the latent one;

• to reveal regions with the disturbed blood supply;

• to determine the borders of tolerance to the way of life and a state of health of a patient;

• to achieve the greater validity and efficiency in treatment being capable to assess quickly the results of influence of medicines and recommendations;

• to reveal and assess a prevalence of cardiac or extracardiac factors in development of insufficiency of blood circulation.

Strategic interest of each country is the preservation of population serviceability. Therefore the method and the device are necessary for doctors in polyclinics, hospitals, ambulance, to persons admitting drivers on public transport, the ships, planes, operators in the chemical, nuclear industries and also to family and sports doctors. The method and the device can be used in consulting rooms of functional diagnostics, hospitals, military draft commissions and sports.

It can present the great interest for the insurance companies, pharmaceutical firms, family doctors, etc..

Procedure of research is painless and completely safe, since there is no influence on the patient's organism, therefore contraindications are not present. The device is compact, no special conditions for operation is required.

On the created pre-production models of the device, at the Scientific & Research Institute of Experimental and Clinical Therapy of Ministry of Health of Georgia, during a number of years, the formation of hemodynamic response of an organism to the impact of various loading was studied by means of the above described method of impedance plethysmography and the statistical data collected and analyzed. More than 1000 patients with various cardiovascular and other diseases were examined including the parallel, double blind, multi-center research of new hypotensive preparation. The obtained results have confirmed high value of the method and the device for clinical practice.

Claims

Claims 1. A method for non-invasive research of distribution of blood and its circulatory characteristics in the warm-blooded organism, comprising connecting the high-frequency generator of a stable sounding current to a researched object by means of current electrodes, gathering and measuring a base impedance and electrical impedance plethysmogram by means of pickup electrodes, determining blood deposition, recognizing, measuring and calculating the averaged amplitude of systolic wave and the averaged period of cardiac output, characterized in that the connection of the high-frequency generator of a stable sounding current is effected by attaching at least three or five current electrodes to the upper part of a head and to the distal parts of the lower and/or upper extremities, each of the electrodes having at least two sections, connecting pickup electrodes, each one having at least two sections, in regions of a head, a neck, a breast, a stomach, a pelvis, upper and lower extremities of a warmblooded organism, whereas gathering and measuring base impedances and plethysmogram are made at single-stage, from all the regions of a warm-blooded organism, determining deposition of blood and its distribution on all the regions of a warm-blooded organism, automatically exposing the received plethysmogram data to the statistical analysis and mathematical transformation to the averaged synthesized cardiac complexes of plethysmogram, which are synchronized by cardiac output, transforming them in a field of averaged plethysmograms, then recognising phases of the cardiac cycle and measuring their averaged amplitude-time parameters - amplitude of systolic wave, the period of exile of cardiac output and parameters of distribution of cardiac output in all the regions of an organism and the frequency of stroke volume, or presenting visually the data received at research for subjective recognition of phases of a cardiac cycle in the allocated informative points, automatically measuring amplitude-time parameters of plethysmogram, characterising the cardiac output index and its distribution on the regions, then under the known formulas calculating the basic informative parameters of blood circulation, normalizing them on hit in ranges of values: "optimum" - "the latent functional abnormalities" - "pathology", and by the results of normalization assigning the codes of the current condition thereto, then according to anatomic representation about structure of system of blood circulation, determining the current condition of indexes, characterising a functional condition of blood circulation, analyzing the cumulative condition of the general characteristic and specific parameters connected by uniform hemodynamics, and by a known technique and statistical criteria assessing them, then on the basis of physiological knowledge making system analysis of a condition of blood circulation and blood supply of vitally important bodies of the organism and a condition of regulation at all levels at rest, by inclusing in the process of research of various loading tests, and in end giving out the conclusion about functionalities and reserves of the adaptation, containing hemodynamic description of the current condition of a warmblooded organism. , The device for non-invasive researches of distribution of blood and its circulatory characteristics in a warm-blooded organism comprises the high-frequency stable generator of sounding current, current electrodes connected to the generator, pickup electrodes connected to the block of commutation, which by means of the channel of measurement of a base impedance and electroimpedance plethysmograms of matching device and the block of the analog-digital converter is connected to the system block of a computer, means of display and registration, a set of means for storage of programs and incoming data, characterising in that the current and pickup electrodes have sections, each of electrodes having at least two sections, at least three or five current electrodes are capable of connection to the upper part of a head and to an upper or lower part of feet, the pickup electrodes are capable of connection to a warm-blooded organism in regions of a head, a neck, a breast, a stomach, a pelvis, upper and lower extremities, the device containing at least two channels of measurement of a base impedance and electroimpedance plethysmograms, a matching device containing at least four channels of the coordination to the inputs of the block of the analog-digital converter, and the system block of a computer containing at least two processors working on uniform algorithm in a mode of single-stage gathering and processing of the information, according to application package.