Method for assessing functional state of haemostasis system

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to haemocoagulogy, and can be used for detecting a group of individuals suffering a risk of haemocoagulation complications. Substance of the method: measuring initial blood coagulation trace amplitude, determining initial and final blood coagulation parameters and comparing them to corresponding normal blood coagulation parameters; if observing oppositely directed deviations, the disturbed functional state of the haemostasis system is diagnosed. A time constant is determined according to a calibration curve; the calibration procedure a priori covers two measured U1, U2 and known U01, U02 values of lower t1 and upper t2=kt1 limits of the adaptive range; the calibration curve U0i is a blood limit strength function compensating an uncertainty T* of the random time constant T0 and relating the reference Uri and measured Ui characteristics by normalising the measured values by the known ones the calibration curve U0i shows the actual values of the time constant T0 and blood limit strengthU0 which are used to draw the calibration curve of the blood limit strength, reference performance Uri

and to determine initial Ti and final Tf blood coagulation parameters wherein Ui, Uf are the normalised initial and final blood coagulation thresholds.

EFFECT: invention enables reducing a procedure error by tens orders, increasing a coagulation time accuracy by 4 orders, and reducing the efficiency three times as much that eventually provides higher metrological effectiveness of computer analysers applicable for the purpose of automating the process of detecting the individuals having a risk of haemocoagulation complications.

4 dwg

 

The present invention relates to medicine, namely to hemocoagulase, and can be used to identify individuals at risk of hemocoagulation complications.

Known instrumental method of assessing the functional state of the hemostatic system - thromboelastography (TEG), which consists in a graphical (or photooptical mechanical) registration viscosity characteristics of blood and plasma in the process of coagulation, with subsequent determination of indicators of thromboelastogram characterizing the investigated process [USSR Author's certificate N 1520450, M. CL G01N 33/86, publ. 07.11.89, BI N41].

The disadvantages of this method are the low sensitivity and reproducibility, inability to detect subtle changes in the blood clotting system and to provide an analytic assessment of the identified violations.

A method of determining the functional state of the hemostatic system by registering electrocochleography blood [see proc. Koblov L. F. Methods and devices for the study of hemostasis. - M.: Medicine, 1975, pp. 75-79], which consists in registration of the change of electrical resistance of the blood sample, poured into a cell with two electrodes. The cell oscillates, whereby the blood is alternately closes and interrupts the electrodes. Record the result of the research has the appearance of a number of perio�quarter of pulses with a repetition rate of 0.1 Hz (6 pulses per minute), the envelope which characterizes the process of blood clotting. The amplitude of the pulses corresponds to the resistance of blood being present in the moment between the electrodes of the measuring cell. When assessing electrocochleography take into account the following parameters: T1 is the starting time of coagulation: T2 - the end time of coagulation; T - duration of the drawdown; Am is the maximum amplitude; AO is the value of the minimum amplitude. To change these settings, you get the idea of the different disorders of blood coagulation.

The disadvantages of this method are inertness, relatively low accuracy and sensitivity of measurements due to leakage intensive side of physico-chemical processes related to movement of the electrodes and the test medium relative to each other.

A method of determining the functional state of the hemostatic system [see RF patent №2109297, G01N 33/86, 1998], which consists in the fact that conduct measurements of the amplitudes of the recording process of blood clotting in the beginning, then after one, two and three minutes from the beginning, determine the speed of blood clotting for the second and third minute, calculate return them to the magnitude and compare all four of the same coagulation parameters were normal. In the presence of mixed deviations diagnose violation fu�csinalni the status of the hemostasis system.

The disadvantages of this method are the low accuracy and the duration of its execution.

For the prototype accepted method of determining the functional state of the hemostatic system [see RF patent №2430380, G01N 33/86, 2011], which consists in the fact that conduct the measurement of the amplitude of the recording process of blood clotting in the beginning, define the parameters of beginning and end of the coagulation process electrocochleography blood and compare them with the same indicators of the process of blood coagulation in normal and multi-directional deviations diagnose violations of the functional state of the hemostatic system, record the current amplitude of the resistance of blood in the first time and measuring a second resistance of blood at multiple time from the initial time value, two resistances and the times are marginal blood resistance and time constant, which calculates the resistance of blood at the beginning and end of the coagulation process, and found the arguments specify the indices of the beginning and end of the process of blood coagulation.

The disadvantages of the prototype are relatively low precision and sensitivity of measurement and the duration of the measurement.

Technical challenge of this method are improvement of the metrological efficiency, namely the measurement accuracy, and reduce research time.

The stated technical problem is achieved as follows.

In the method of determining the functional state of the hemostatic system, consisting in the fact that conduct the measurement of the amplitude of the recording process of blood clotting in the beginning, define the parameters of beginning and end of the coagulation process electrocochleography blood and compare them with the same indicators of the process of blood coagulation in normal and multi-directional deviations diagnose violations of the functional state of the hemostatic system, unlike the prototype, determine the time constant for the calibration characteristic, the calibration is carried out a priori for two of the measured and known values of the upper and lower boundaries of the adaptive range of the calibration characteristic is a function of the limiting voltage of the blood that compensate for the uncertainty in the time constant chosen arbitrarily, and connecting the reference and the measured performance at the expense of normalization of the measured values is known, the calibration feature to find the actual value of the time constant and threshold voltage of the blood, which consecutively build the calibration characteristic limit stress of blood, the reference characteristic and determine the indices of the beginning and end of the process of blood coagulation.

Sunstoragetek method explained in Fig.1-4.

1. Determine the time constant T0the calibration function U0i(t).

2. Calibration is done a priori for two well-known reference to Ue(Fig.1 curve 1) and the measured Ui,i=1,2(Fig.1, curve 2) values of the upper and lower boundaries of the adaptive range of the process of hemostasis. In patients with a known value of voltage amplitude of blood UE1UE2for time interval measurements of t1and t2record the measured values of the voltage amplitude of blood U1and U2.

3. The calibration characteristic is the characteristic U0i(Fig.1, curve 3) limit stress of blood that compensate for the uncertainty of the time constant T* is arbitrary, and connecting the reference to Ueand measured Uidependencies due to the normalization of the measured values is known (Fig.1, curve 3)

U0i=U0UiUeiexp(tiT*-tei T0).(1)

The calibration characteristic U0irestore the characteristic Uiidentical reference

Ui=U0iexp(-tiT*),

which is as close to the reference curve Ue:

Uei=U0exp(-teiT0).

Reference characteristic Ue=U and characteristics, it is identical to, Uiobtained from exponential dynamic performance with desired informative parameters T0U0:

U=U0exp(-tT0), (2)

where T0- time constant of the process of hemostasis and U0- limit stress of the blood. The physical meaning of informative parameters follows from the limit ratios:

limt0U=U0exp(0T0)=U0i.e. U0- limit stress of the blood for t=0,

limUt0=U0exp(-T0T0)=U0exp=2.73U0, i.e., T0- time constant.

In practice, one of the informative parameters of the studied characteristics, as a rule, unknown. In this case, one parameter is specified arbitrarily T*, and the second takes the form of a function U0ithat compensates for the ignorance of the first informative parameter. With the help of this funk�AI is calibrated to the measured curve.

Asked by arbitrarily setting T*=const is the unknown actual value of the time constant T0. To compensate for the arbitrariness of the constant T* marginal blood stress U0to turn into the characteristic U0icompensating for the lack of knowledge of the time constant T0.

Calibration function for known parameters T0U0is exponential dynamic response (2).

The calibration characteristic U0iExpress from the system of equations with known parameters T0U0characteristics of Uewhich reference (obtained by fitting the experimental data), and characteristics of Uibeing measured, with an arbitrary constant T* and the characteristic U0i:

{Uei=U0exp(-teiT0)Ui=U0iexp(-tiT*).(3 )

Divide one equation of the system to another to Express the calibration feature:

UeiUi=U0U0iexp(tiT*-teiT0).

In accordance with the laws of the calibration and te=tishould the calibration characteristic U0irelating the reference and the measured curves:

U0i=U0UiUeiexp(tiT*-tiT0).(4)

Therefore, the calibration characteristic is f�NCCI limit stress blood compensating the uncertainty in the time constant selected at random (Fig.1, curve 3).

4. The calibration characteristic U0ifind the actual value of the time constant T0and limit stress blood U0that are informative parameters that delivers the optimum calibration characteristic. From specifications (4) form a system of equations fori=1,2:

{U01=U0exp(t1T*-t1T0)U02=U0exp(t2T*-t2T0).(5)

Dividing one equation of the system (5) to another and prologue�mirowave, define algorithm time constant T0:

T0=t2-t1ln(U01/U02)+t2-t1T*.(6)

Expressing T0from the first and second equations of system (5) and equating them to each other

t1t2=ln(U01/U0)ln(U02/U2)=k,

find an algorithm to determine the maximum operating voltage of the blood:

U0=(U01)kU02k-1. (7)

5. On the actual values of the time constant T0and limit stress blood U0consistently build the calibration characteristic U0ilimit stress of the blood and the reference characteristic Ue. The result of calibration is the identity of the measured characteristics of Uireference to Uei.e. Ui≡Ue.

For informative parameters (6) and (7) build (approximate) calibration characteristic U0i(4) (Fig.1 curve 3), which is found according to (3) the calibrated characteristic Udi(Fig.1 curve 4), identical with a desired reference feature.

Found informative parameters define the start and end of the clotting process:

{Tn=Tln(U0Un)TK=Tln(U0UK).(8)

The values obtained in the beginning of Tnand the end of TKthe clotting is compared in magnitude with the same parameters of clotting healthy people. Upon detection of mixed abnormalities diagnose the violation of the functional state of the hemostatic system.

1. Prove metrological effectiveness of the proposed method relative to the prototype of a methodical error of ε1(Fig.2):

ε1=|Uei-UiUei|.(9)

From the graph (Fig.2) shows that the truncation error of the prototype varies from 3% to 12%.

Rate truncation error ε2between reference 1 and calibrated 4 characteristics (Fig.1)

ε1=|Uei-UdiUei|.(10)

From the graph (Fig.3) shows that the relative error does not exceed 2.4*10-16or 2.4*10-14% through the use of calibration features in the adaptive range of the normalized values at the borders.

2. Rate metrological efficiency on clotting time.

The start time of coagulation to the reference characteristic (Fig.4, curve 1) TN1=170, end time coagulation TK1=460 for normalized amplitudes Un=7,34 UK=4,33. Found by the algorithms (7) and (8) limiting parameters U0=10, T0=550.

Find valid time values (Fig.4, curve 4) for the algorithms (8):

{Tn=550ln(107,34),TK=550ln(104,33).Tn=170,01 and TK=459,98.

Calculate the error start time coagulation characteristics between 4 and 1

εn=|Tn1-Tn4/mrow> Tn1|=|170-170,01170|=0,006%a

and the end of the coagulation

εK=|TK1-Tn4TK1|=|460-459,98460|=0,004%a.

In characteristic 2 (Fig.4, curve 2) normalized amplitude thresholds Un=7,34, UK=4,33 find clotting time of the prototype Th 2=130 and TK2=375.

Estimate the uncertainty end time coagulation 1 between the reference and measured 2 characteristics

εK=|TK1-TK2TK1| εK=|460-375460|=18,48%a

and error start coagulation

εn=|Tn1-Tn2Tn1|εn=|170-130170|=23,53%a.

The efficiency η on the accuracy of clotting time was calculated as the ratio of the first to the second error(ε1ε2), which shows that the effectiveness of the proposed solution is four orders of magnitude higher than the prototype, because correspond to ηK=2.17 E-4 and ηn=2,55 E-4.

Thus, the determination of the actual values due to the normalization of the measured values famous�mi on the calibration characteristic limit stress blood unlike known solutions, reduces truncation error by tens of orders of magnitude, the accuracy of the clotting time increases to about 4, and the speed reduces three times, which ultimately improves measurement efficiency of the computer analyzers to automate the identification of persons at risk of hemocoagulation complications.

Method for determining the functional state of the hemostatic system, consisting in the fact that conduct the measurement of the amplitude of the recording process of blood clotting in the beginning, define the parameters of beginning and end of the coagulation process electrocochleography blood and compare them with the same indicators of the process of blood coagulation in normal and multi-directional deviations diagnose violations of the functional state of the hemostatic system, characterized in that the determined time constant for the calibration characteristic, the calibration is carried out a priori for two measured U1U2and known U01U02values of the lower t1top and t2=kt1the boundaries of the adaptive range of the calibration characteristic U0iserves the function of limiting the voltage of the blood that compensate for the uncertainty of the time constant T0chosen arbitrarily T*, and connecting the reference to Ueand measured Uicharacteristics W� by normalization of the measured values is known

the calibration characteristic U0ifind the actual value of the time constant T0and the limit voltage U0blood

which consistently build the calibration characteristic limit stress of blood, the reference characteristic Ue

and define the parameters beginning with Tnand the end of TKthe process of blood clotting

where UnUK- normalized threshold voltage of the beginning and end of the process of blood clotting.



 

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