RU2764498C2 - Method and device for recording multiple leads of electrocardio signal - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: inventions group relates to medicine, namely to a method for recording leads of an electrocardiosignal (ECS) and a device for its implementation. In this case, the pacemaker is recorded, as well as the electrophysiological characteristics of the heart are determined and visualized. At the stage of registration of the pacemaker, the size of the damage to the epicardium

in the plane of the cross-section of the torso is set according to the formula

, where

is the size of the damage to the epicardium;

is the size of the area of damage to the epicardium. The angle γ between the radii R _heart of the sphere describing the heart in the plane of the cross-section of the torso is determined by the formula

, where

is the size of the damage to the epicardium, i.e. the length of the arc on the surface of the sphere in the plane of the cross-section of the torso. The number of k _el points of registration of potentials in the plane of the cross-section of the torso and the coordinates x and y of the electrodes in the plane of the cross-section of the torso are determined. The distance d _el between the rows of electrodes is set. The number of electrodes is determined by the formula

, where

is the number of rows of electrodes, [] is the designation of the integer part of the number, and L _z is the size of the torso region that encloses the heart in the plane of the vertical section of the torso. The device for recording ECS leads contains a serially connected module for recording ECS leads, a module for collecting, processing and storing data, and an analysis and visualization module. The registration module is implemented in the form of a vest with pre-installed N _el electrodes located evenly along the length of the contour l of the torso cross-section in r _el rows and connected by means of a harness, and contains serially connected analog and digital parts. The analog part contains N _el parallel channels for the transmission of ECS lead signals. The digital part contains a series-connected ADC, a computing device and a data reception/transmission unit.

EFFECT: invention provides non-invasive determination of the electrophysiological characteristics of the heart with increased accuracy using the number of electrodes required to identify the minimally soluble myocardial damage by means of electrocardiography, with a decrease in the complexity of the pacemaker registration process by the patients themselves at home.

4 cl, 13 dwg

Description

The present invention relates to medicine, in particular to cardiology, and can be used as an electrocardiographic method for diagnosing the state of the heart.

Registration of multiple leads of the electrocardiosignal (ECS) for ECG mapping of the heart [1, 2, 3, 4, 5, 6, 7] is one of the most informative methods for studying the electrical activity of the myocardium and the parameters of the equivalent electrical heart generator (EEGS). The method allows obtaining maximum information about the features of the electric field of the heart at any time of depolarization and repolarization of the ventricles. When registering an ECG, unipolar electrodes are located on the anterior, posterior and lateral surfaces of the chest, as well as on the upper abdomen - epigastrium (from the Greek words "epi" - "above" and "gaster" - "stomach"). The spatio-temporal and amplitude-temporal information obtained in this way about the electrical activity of the heart (EAS) can be represented in the form of several types of cartograms:

- isopotential (momentary) cartograms of the potential distribution, which are, as it were, “time slices” of successive moments of the cardiac cycle;

- integrated cartograms of the distribution of areas of the QRS complex, the RS-T segment and the entire QRST complex;

- iso-integral cartograms of the distribution of areas under the ECG curve for any period of interest in the cardiac cycle (for example, from the 1st to the 30th or from the 30th to the 60th ms of ventricular depolarization, etc.);

- isochronous cartograms (distribution maps of the activation time of the heart muscle), which allow visualizing the process of excitation spreading through the heart muscle.

Compared to standard electrocardiography, the method of ECG mapping of the heart:

- uses a large number of leads (from 60 to 240), located on the entire surface of the chest, which provides maximum information about the features of the structure of the electric field of the heart;

- provides the ability to synchronize all electrocardiosignals and present data not in the traditional (continuous) form, but in the form of sequential (momentary), integral and isointegral cartograms of potential distribution, which allows you to study in detail the dynamics of the processes of myocardial de- and repolarization:

- provides an opportunity to study multipole EEGS and more accurate assessment of the local electrical activity of the heart muscle.

A known method of non-invasive electrophysiological study of the heart [8]. In this method, registration of multiple leads of the ECS is carried out, then, based on hardware measurements, the surface of the torso and the surface of the epicardium are digitized, after which, according to the ECS, registered at certain points on the surface of the human torso, the distribution of the electric potential on the surface of the epicardium is reconstructed. The disadvantage of this method is significant hardware costs, focused on use in highly specialized centers and does not allow for the diagnosis of EAS on a large scale. In the known method, it is necessary to use:

- computed tomography or magnetic resonance imaging;

- a significant number of measuring electrodes (up to 240), which, according to the authors of the present invention, limits the use of the known method within the framework of a clinical examination and increases the time of the examination.

When assessing the state of the heart, information about the degree of myocardial damage is important. The combined use of computed tomography, echocardiography and ECG mapping of the heart in clinical conditions makes it possible to determine the area of myocardial damage up to 2 cm ² in size. When the heart surface area average male equal to 385 cm ² [9], it is about 0.5%.

There is a well-known work [10], which provides a theoretical substantiation of the spatial resolution of the epicardial potential on the patient's torso. According to this work, a decrease in the distance between the electrodes and, as a result, an increase to a significant number (up to 240) of measuring electrodes does not lead to a more accurate determination of the spatial resolution of the potential on the epicardium.

The disadvantage of the known work is the lack of substantiation of the required number of electrodes to solve with a given accuracy the inverse problem of electrocardiography (OZ ECG).

Devices are known that describe the features of the design of electrodes for recording multiple EKS leads:

- electrode device for registration of biopotentials, providing improved metrological parameters of electrodes [11];

- contactless active electrodes [12]. Their significant advantage is the ability to work through a thin layer of tissue. Non-contact electrodes do not require direct electrical contact with the body. For them, there is no need to prepare a skin area before taking measurements. They are completely immune to the condition of the skin and are integrated into clothing so that discomfort is minimized. The principle of their operation is based on the registration of capacitive parameters, in contrast to the classical registration of voltages.

There are a large number of wearable diagnostic devices for patients with a cardiological profile, which allow signaling a deviation in the parameters of cardiac activity and, at the same time, have features in the functioning and decision-making algorithm [13].

Known devices for recording multiple leads EX:

- AMIKARD 01 K. Hardware-software complex for non-invasive electrophysiological examination of the heart. Instructions for medical use [14]. To register the EKS, 30 disposable electrodes with 8 contacts (electrode tapes) are used, pasted on the chest and 4 disposable conventional electrodes, pasted on the limbs;

- cardio belt for registration of chest leads V1-V6. The measurement is performed by attaching electrodes to the patient's body at predetermined locations. The electrodes are placed around the heart at points between the patient's ribs [15];

- a device with a plurality of electrodes attached to a protective material for receiving cardio signals [16];

- a device with a plurality of overhead electrodes attached to the patch for receiving cardio signals [17];

A common disadvantage of devices that describe the design features of electrodes for recording multiple ECS leads and devices for recording multiple ECS leads is the lack of a reasonable calculation of the number of electrodes required when registering multiple ECS leads for non-invasive electrophysiological examination of the heart.

The closest in terms of the achieved result to the proposed invention is a method for non-invasive determination of the electrophysiological characteristics of the heart [18], which consists in the registration of electrocardiosignals, the determination of the electrophysiological characteristics of the heart and the visualization of the electrophysiological characteristics of the heart, while at the stage of registration of electrocardiosignals, the following is carried out:

- measuring the length of the contour l of the cross section of the torso;

относительно угла ϕ, где ϕ - угол между прямой, соединяющей подмышечные впадины и направлением на текущий электрод:

- нормальный эллиптический интеграл Лежандра второго рода:

- эксцентриситет поперечного сечения торса: а и b - антропометрические параметры торса пациента, равные большой и малой полуосям эллипса соответственно:- solution of the transcendental equation

relative to the angle ϕ, where ϕ is the angle between the straight line connecting the armpits and the direction to the current electrode:

is the normal elliptic Legendre integral of the second kind:

- eccentricity of the cross section of the torso: a and b - anthropometric parameters of the patient's torso, equal to the major and minor semiaxes of the ellipse, respectively:

- determination of the x and y coordinates of the electrodes;

- installation of electrodes;

- registration of electrocardiosignals,

at the stage of determining the electrophysiological characteristics of the heart, the following is carried out:

- interpolation of potentials on the surface of the torso;

- reconstruction of the epicardial model;

- reconstruction of the equivalent electric generator of the heart.

at the stage of visualization of the characteristics of the heart, visualization is carried out using computer graphics of the electrophysiological characteristics of the heart.

At the same time, the device for recording multiple leads of the known method for non-invasive determination of the electrophysiological characteristics of the heart contains a series-connected module for registering multiple leads of the EX, containing an electrode assembly and a data receiving/transmitting unit, a data acquisition, processing and storage module and an analysis and visualization module, the second inputs of the receiving/ data transmission, the data collection, processing and storage module and the analysis and visualization module are connected to the output of the control unit.

The figure 1 shows a diagram of the algorithm of the known method for non-invasive determination of the electrophysiological characteristics of the heart.

The figure 2 shows a diagram of the application of electrodes on the patient's torso (a) and an illustration of the determination in the plane of the cross section of the torso of the angle ϕ - the position of the electrode - (b) in a known method for non-invasive determination of the electrophysiological characteristics of the heart.

The figure 3 shows the steps for determining the coordinates of the electrodes in a known method for non-invasive determination of the electrophysiological characteristics of the heart.

The figure 4 shows an "enlarged" diagram of the device for recording multiple leads in a known method for non-invasive determination of the electrophysiological characteristics of the heart.

From the analysis of the claims, descriptions and figures, it follows that in the known method for non-invasive determination of the electrophysiological characteristics of the heart, there is no justification for the number of electrodes used to register the ECS.

So, on page 14 of the description of the well-known method of non-invasive determination of electrophysiological characteristics for the equivalent electrical generator of the heart (EEGS) [18], it is written that its essence “is to obtain spatial distributions of EEGS parameters. To do this, after determining the anthropometric parameters of the patient's torso and installing the electrodes, the pacemaker is recorded, then the stage of the main processing of the data obtained begins, which includes interpolation of potentials on the surface of the torso, reconstruction of the patient's epicardium model, reconstruction of the superficial type EEGS and reconstruction of the dipole type EEGS. The resulting spatial distributions of EEGS parameters are represented as functions of time, which is used to display these distributions in the visualization unit of the electrophysiological characteristics of the heart. This is illustrated by figure 1 of the materials of the present application. In the same place, on page 14 of the description of the known method for non-invasive determination of the electrophysiological characteristics of the heart [18], it is only noted that first “electrodes are installed in an amount of at least 30, placing them along the cross section of the torso in 4 rows” (see figure 2a of the materials of this application). Next, determine the coordinates of the electrodes. To do this, carry out (see figure 3 of the materials of this application):

1. Measurement of the length of the contour of the cross section of the torso.

2. Solution of the transcendental equation with respect to the angle ϕ.

3. Determination of the coordinates x and y of the electrodes through the angle ϕ and the parameters of the torso.

At the same time, according to the description of the known method for non-invasive determination of the electrophysiological characteristics of the heart, “the z-coordinate of the electrodes is measured from the acromial end of the clavicle to the current horizontal row of electrodes using a measuring tape with divisions applied to it (division value 1 mm). To determine the coordinates x and y of the electrodes, first, using a measuring tape, measure the length of the arc l , counted along the contour of the cross section of the torso from the straight line connecting the armpits to the current electrode ”(see figure 2b of the materials of this application).

In the description of the known method for non-invasive determination of the electrophysiological characteristics of the heart, there is no description of the operation of the device for recording multiple leads. According to the description of the functioning of the known method for non-invasive determination of the electrophysiological characteristics of the heart, the authors of the present invention believe that the following composition of technical means is necessary for its implementation (see figure 4):

- a module for recording multiple leads of the EX, containing an electrode assembly and a data receiving/transmitting unit;

- module for collecting, processing and storing data;

- module of analysis and visualization;

- Control block,

at the same time, a module for registering multiple leads of the EX-exchange is connected in series, containing an electrode assembly and a data receiving / transmitting unit, a module for collecting, processing and storing data and an analysis and visualization module, the second inputs of the block for receiving / transmitting data, a module for collecting, processing and storing data and a module analysis and visualization are connected to the output of the control unit.

At the same time, in the description of the known method for non-invasive determination of the electrophysiological characteristics of the heart, there is no information about the features of registration of multiple leads, except for the above quote (on page 14 of the description of the known method for non-invasive determination of the electrophysiological characteristics of the heart [18]).

Thus, according to the authors of the present invention, in the well-known method for non-invasive determination of the electrophysiological characteristics of the heart, along with the presence of an original solution to the inverse problem of electrocardiography (ECG ECG) in determining the electrophysiological characteristics of the heart, there is no justification for the number of electrodes necessary to solve the ECG EC at the stage of ECS registration.

Indeed, in the description of the well-known method for non-invasive determination of the electrophysiological characteristics of the heart, there is no answer to the question: how many electrodes are needed for the non-invasive determination of the electrophysiological characteristics of the heart? The only answer to the question is the above quote: "Electrodes are installed in an amount of at least 30, placing them along the cross section of the torso in 4 rows." At the same time, it is not clear where and why these figures came from.

The aim of the invention is to substantiate the required number of electrodes at the stage of registration of the ECS for the non-invasive determination of the electrophysiological characteristics of the heart when solving the ECG OZ with a given accuracy.

For this:

1. In the method, which consists in the fact that the registration of electrocardiosignals, the determination of the electrophysiological characteristics of the heart and the visualization of the electrophysiological characteristics of the heart are carried out, while at the stage of registration of electrocardiosignals, the following is carried out:

- measuring the length of the contour l of the cross section of the torso;

относительно угла ϕ, где ϕ - угол между прямой, соединяющей подмышечные впадины и направлением на текущий электрод:

- нормальный эллиптический интеграл Лежандра второго рода:

- эксцентриситет поперечного сечения торса: а и b - антропометрические параметры торса пациента, равные большой и малой полуосям эллипса соответственно:- solution of the transcendental equation

relative to the angle ϕ, where ϕ is the angle between the straight line connecting the armpits and the direction to the current electrode:

is the normal elliptic Legendre integral of the second kind:

- eccentricity of the cross section of the torso: a and b - anthropometric parameters of the patient's torso, equal to the major and minor semiaxes of the ellipse, respectively:

- determination of the x and y coordinates of the electrodes;

- installation of electrodes;

- registration of electrocardiosignals,

at the stage of determining the electrophysiological characteristics of the heart, the following is carried out:

- interpolation of potentials on the surface of the torso:

- reconstruction of the epicardial model;

- reconstruction of the equivalent electrical generator of the heart,

- at the stage of visualization of the characteristics of the heart, visualization is carried out using computer graphics of the electrophysiological characteristics of the heart, characterized in that at the stage of registration of electrocardiosignals, the following is additionally performed:

в плоскости поперечного сечения торса по формуле

, где

- размер повреждения эпикарда;

- размер площади повреждения эпикарда;- setting the size of epicardial damage

in the plane of the cross section of the torso according to the formula

, where

- the size of the damage to the epicardium;

- the size of the area of damage to the epicardium;

где

- размер повреждения эпикарда, т.е. длина дуги на поверхности сферы в плоскости поперечного сечения торса.- determination of the angle γ between the radii R _{heart of the} sphere describing the heart in the plane of the cross section of the torso according to the formula

where

- the size of the damage to the epicardium, i.e. the length of the arc on the surface of the sphere in the plane of the cross section of the torso.

регистрации потенциалов в плоскости поперечного сечения торса по формуле

- determination of the number of points

registration of potentials in the plane of the cross section of the torso according to the formula

- determination of the coordinates x and y of the electrodes in the plane of the cross section of the torso according to the formulas

where

n = (1… k _el ) - electrode number;

между рядами электродов по формуле- distance setting

between rows of electrodes according to the formula

, где

- количество рядов электродов, [] - обозначение целой части числа, а L _z - размер области торса, охватывающей сердце в плоскости вертикального сечения торса.- determination of the number of electrodes by the formula

, where

- the number of rows of electrodes, [] - the designation of the integer part of the number, and L _z - the size of the area of the torso, covering the heart in the plane of the vertical section of the torso.

2. In the method according to claim 1, characterized in that the installation of electrodes is carried out by putting on a vest with a size of Small with a length of the perimeter of the torso in cross section l = 70÷90 cm with a size of Medium with l = 90÷110 cm with a size of Large with l = 110÷ 130 cm with pre-installed electrodes.

3. In the device for recording multiple leads according to claim 1, containing a series-connected module for registering multiple leads of the EX, containing an electrode assembly and a data transmission unit, a module for collecting, processing and storing data and an analysis and visualization module, the second inputs of the data transmission unit, the collection module , data processing and storage and the analysis and visualization module are connected to the output of the control unit, which is characterized in that the module for recording multiple EKS leads is implemented in the form of a vest Small size at l = 70÷90 Medium size at l = 90÷110 Large size at l = 110÷130 with pre-installed N _el electrodes, evenly spaced along the length of the contour l of the cross section of the torso in r _el rows, and contains serially connected analog and digital parts, while:

- the analog part contains N _el parallel channels for transmitting ECS lead signals, while each of the channels for transmitting ECS leads signals contains a series-connected electrode, a defibrillator pulse protection device, an amplifier and a break detector, and the outputs of amplifiers and break detectors of each of the channels for signal transmission leads EX-connected to the inputs of the first and second multiplexers, respectively;

- the digital part contains a serially connected analog-to-digital converter, a computing device and a data receiving / transmitting unit, while the second output of the computing device is connected to the input of the display unit, the third, fourth and fifth outputs of the computing device are connected to the second inputs of the defibrillator protection device against pulses, break detector and the first and second multiplexers, respectively, and the sixth output of the computing device is connected through a connector in the vest to an external memory unit.

4. In the lead recording device according to claim 3, characterized in that:

- the data receiving/transmitting unit is configured to carry out wireless transmission of the digital code of electrocardiosignals;

- the external memory unit is configured to record the digital code of electrocardiosignals;

- the harness is a product consisting of N _el insulated and shielded conductors fixed on the vest, conductor tips, made with the possibility of connecting to the electrodes on one side of the harness and to the connector for connecting to the nodes of the EX-lead recording module on the other side of the harness;

the power supply unit is configured to provide autonomous power supply to the module for recording multiple leads of the electrocardiosignal.

The proposed method for registration of EKS leads and the device for its implementation is based on the use of an original system of electrodes located on the surface of the torso using a “multi-electrode vest”. A distinctive feature of the proposed approach is the substantiation of the number of electrodes required to detect the minimally resolvable myocardial damage by means of electrocardiography. The essence of the invention is to justify the required number of electrodes to detect myocardial damage of a given size, commensurate with the size of myocardial damage detected in the clinical setting.

It is known [19] that the mortality from non-extensive (myocardial damage less than 30% of the working surface of the left ventricle (LV)) acute myocardial infarction (AMI) is 22.2%. Therefore, according to the authors, the proposed method and device for recording multiple leads of the electrocardiosignal, which ensure the detection of an area of myocardial damage up to 4 cm ² in size, which is about 1% of the surface area of the heart, correspond to the goals and objectives of modern functional diagnostics as a measure for detecting myocardial damage.

The technical result [20] of the invention is:

- development of new methods and tools for processing cardiographic information available for mass use, providing increased accuracy and visual representation of the localization of myocardial damage on a realistic model of the patient's heart;

- equipping people at risk of CVD with devices with improved characteristics for diagnosing the state of the heart, ensuring timely identification of risk factors;

- reducing the complexity of the process of registering the pacemaker by the patients themselves at home, which corresponds to the conditions for the implementation of the national project "Healthcare" in terms of combating CVD [21].

The figure 5 shows a diagram of the algorithm that implements the proposed method for recording multiple leads of the pacemaker for non-invasive determination of the electrophysiological characteristics of the heart.

The figure 6 shows the operations carried out at the stage "Registration of electrocardiosignals" when performing the action "Determining the coordinates of the electrodes" of the proposed method for registering multiple EKS leads.

Figure 7 shows the sequence of operations at the "Visualization" stage when applying the "Damage" texture to a three-dimensional model of the patient's heart [22], illustrating the setting of the spatial resolution of the epicardial injury.

The figure 8 shows illustrations explaining the performance of additional operations carried out at the stage "Registration of electrocardiosignals" when performing the action "Determining the coordinates of the electrodes" of the proposed method for registering multiple EKS leads:

- a - topography of the cross section of the heart (see [23]);

- b - cross section of a graphical representation of the location of the heart in the torso and the sphere described around the heart;

- c - determination of the size of the heart (see [24]);

- d - determination of the coordinates of the electrodes on the patient's torso.

The figure 9 shows the calculated coordinates x and y of the electrodes in the plane of the cross section of the torso (coordinate z=0) at a=20 cm; b=15 cm in figure 8b.

The figure 10 shows illustrations explaining the execution of the action "Installing electrodes":

- a - dimensional table of the vest with electrodes;

- b - the location of the electrodes on the patient's torso;

- c - an example of the implementation of a combination of electrodes and a lead harness.

The figure 11 shows a typical block diagram of the information-measuring system [see. 33, 34].

The figure 12 shows a block diagram of the device for registering multiple leads in the proposed method.

The figure 13 shows a block diagram of the module for registering multiple leads in the proposed device.

From the analysis of the presented figures, it follows that at the stage "Registration of electrocardiosignals" of the proposed invention, the number of electrodes necessary to obtain the spatial distributions of the parameters of the equivalent electrical heart generator (EEGS) is reasonably determined with a predetermined minimum amount of possible myocardial damage. This is done with:

- additional operations when performing the action "Determining the coordinates of the electrodes" of the proposed method for registering multiple leads of the EX (see figure 6);

- another implementation of the action "Installation of electrodes".

Let us consider in more detail these distinctive features of the present invention.

. При площади поверхности сердца среднего мужчины, равной 385 см² [26], это составляет около 0,7%. По мнению авторов предлагаемого изобретения, выявление повреждения 0,7% эпикарда в условиях двигательной активности пациента достаточно для определения параметров ЭЭГС.1. Additional operations. Additional operations ensure the process of registering multiple leads of the ECS using a reasonable number of electrodes, that is, actions are performed on a material object (EX) using material means (electrodes). According to Figure 6, "Myocardial Injury Sizing" is first performed. Figure 7 illustrates the setting of information about the degree of damage to the myocardium. Let's assume that the side of the square of the "Damage" object mask is 1.9 cm, then the area of the "Damage" object will be equal to

. When the heart surface area average male equal to 385 cm ² [26], it is about 0.7%. According to the authors of the present invention, the detection of damage to 0.7% of the epicardium in the conditions of the patient's motor activity is sufficient to determine the parameters of the EEGS.

равным половине поперечника сердца (см. фигуру 8в). Фигура 8 иллюстрирует определение угла γ:The next additional operation is "Determining the angle γ". To do this, a virtual sphere is described around the heart with a radius

equal to half the diameter of the heart (see figure 8c). Figure 8 illustrates the definition of the angle γ:

- figure 8a shows the topography of the cross section of the heart (see [23]);

- figure 8b shows a cross section of a graphical representation of the location of the heart (right and left ventricles, indicated by the number 3) in the torso (large oval, indicated by the number 1) and the sphere described around the heart (circle, indicated by the number 2);

- Figure 8c shows the dimensions of the heart (see [24]);

- Figure 8d illustrates the steps required to determine the x and y coordinates of the electrodes in the torso cross-sectional plane.

. Сектор ACB на фигуре 8б иллюстрирует процесс описания сердца сферой: стороны AC и BC являются радиусами

сферы, описывающей сердце, а дуга длиной

на поверхности сферы между этими радиусами характеризует размер повреждения миокарда.According to the authors of the present invention, the configuration of the topography of the cross section of the heart (see figure 8a) and the configuration of the dimensions of the frontal section of the heart (see figure 8c) allow the description of the heart by a sphere with a radius

. The sector ACB in figure 8b illustrates the process of describing the heart by a sphere: the sides AC and BC are radii

sphere describing the heart, and the arc is long

on the surface of the sphere between these radii characterizes the size of myocardial damage.

The configuration of the heart is the shape, the contours showing the expansion or reduction of the atria, ventricles, vascular bundle. It includes the borders of the heart (upper, left and right), the waist of the heart (narrowing at the junction of the bundle of vessels to the left ventricle), the angles between the diaphragm (reflecting the tilt of the axis) and the arcs of the chambers of the heart, as well as the length of the heart (the length of the heart from the apex to the right cardiodiaphragmatic angle, the length should be within 11.5-12.7 cm) and the diameter of the heart (the width of relative cardiac dullness from the right border to the midline and from the left, most protruding part, to the middle, normally 11-13 cm). Measurement of the diameter of the heart is carried out by adding two sizes - right and left. The diameter of the heart in a healthy person is 11-13 cm. The right size is the distance from the right border of the relative dullness of the heart to the anterior midline. Normally, it is 3-4 cm. The left size is the distance from the left border of the relative dullness of the heart to the anterior midline. Normally, it is 8-9 cm (see figure 8c. [24]). The mass of the human heart is: 300 grams for men, 250 grams for women, 350 grams for athletes. The average dimensions of the human heart are: 12-15 cm in height (vertical size), 9-11 cm in width (transverse size), 6-8 cm in thickness (anteroposterior size), [24].

сферы, описывающей сердце в плоскости поперечного сечения торса, можно определить по формуле

, где

- размер повреждения миокарда (длина дуги на поверхности сферы в плоскости поперечного сечения торса). Так, при радиусе

и размере повреждения миокарда

= 1.9 угол равен

- The value of the angle γ between the radii

sphere describing the heart in the plane of the cross section of the torso can be determined by the formula

, where

- the size of myocardial damage (arc length on the surface of the sphere in the plane of the cross section of the torso). So, with a radius

and extent of myocardial damage

= 1.9 the angle is

регистрации потенциалов в плоскости поперечного сечения торса» по формуле

= 360/γ = 18 (при γ=20°).The next additional operation is "Determining the number of points of the number of points

registration of potentials in the plane of the cross section of the torso" according to the formula

= 360/γ = 18 (at γ=20°).

The next additional operation is "Determining the X and Y coordinates of the electrodes in the plane of the cross section of the torso". Figure 8b shows a cross section of a graphical representation of the location of the heart in the torso and a virtual sphere described around the heart. From figure 8b it follows that the center of the heart - vertex C of the ACB sector - is displaced relative to the center of the cross section of the torso - point O - by X _c along the X coordinate and by Y _c along the Y coordinate.

The result of the additional operation "Determining the X and Y coordinates of the electrodes in the plane of the cross section of the torso" is the coordinates x and y of the electrodes in the plane of the cross section of the torso. The figure 8d shows the image of the plane of the cross section of the torso with the points of application of the electrodes, located through 20° from each other. Their coordinates are determined by the formulas:

where

- номер электрода.

- electrode number.

The x and y coordinates of the electrodes in the plane of the cross section of the torso, calculated by these formulas, are shown in the table in figure 9.

между рядами электродов по формуле

При b=15 см,

The next additional operation is "Set distance

between rows of electrodes according to the formula

At b=15 cm,

где

- количество рядов электродов.

- обозначение целой части числа, L _z - размер области торса, охватывающей сердце в плоскости вертикального сечения торса с коэффициентом запаса. При катете прямоугольного треугольника, гипотенузой которого является длинник сердца, равный 15 см (см. фигуру 8в), а другим катетом - поперечник сердца, равный 11 см (см. фигуру 8в), получаем

где коэффициент 1,7 вводится для учета электрического потенциала на торсе над сердцем и под сердцем [5]. Тогда

а

(см. фигуру 10б).The next additional operation is "Determination of the number of electrodes" according to the formula

where

- the number of rows of electrodes.

- designation of the integer part of the number, L _z - the size of the torso area, covering the heart in the plane of the vertical section of the torso with a safety factor. With the leg of a right triangle, the hypotenuse of which is the length of the heart, equal to 15 cm (see figure 8c), and the other leg is the diameter of the heart, equal to 11 cm (see figure 8c), we get

where the coefficient 1.7 is introduced to take into account the electrical potential on the torso above the heart and below the heart [5]. Then

a

(see figure 10b).

Thus, the introduced additional operations make it possible to reasonably determine the number of electrodes, taking into account the predetermined minimum size of possible myocardial damage, when registering multiple ECS leads.

After a reasonable determination of the number of electrodes, taking into account the predetermined minimum size of possible damage to the myocardium, the next operation is "Installation of electrodes".

High-quality recording of the pacemaker with a minimum noise level and the absence of artifacts, as a rule, guarantees a good quality of the analysis of the recording and the formation of a correct cardiological conclusion. This problem becomes especially urgent when conducting cardiomonitoring records and outpatient (Holter) monitoring. In these situations, the requirements for the quality of electrodes and lead cables increase significantly. Technical characteristics of modern electrodes and lead cables are given in [25] and [28], and examples of the implementation of a set of electrodes and lead wires are presented in [16] and in [17].

An analysis of the state of the art shows that the necessary elements for implementing the proposed method for recording multiple leads of an electrocardiosignal are electrodes, lead wires, connectors and a vest.

The authors propose another implementation of the “Installation of electrodes” action: the installation of electrodes for the implementation of the proposed method for recording multiple leads of an electrocardiosignal is carried out by putting on a vest in size Small with a length of the perimeter of the torso in cross section l = 70÷90 cm in size Medium with l = 90÷110 cm in size Large at l = 110÷130 cm with pre-installed electrodes (see figure 10c).

After the electrodes are installed, the EKS is registered. This operation ends the stage "Registration of electrocardiosignals" (see figure 6).

Then the stage of the main processing of the obtained data begins (see figure 5), which includes the interpolation of potentials on the surface of the torso, the reconstruction of the model of the patient's epicardium, the reconstruction of the equivalent electric heart generator (EEGS) of the surface type and the reconstruction of the EEGS of the dipole type [18, 29, 30, 31 ].

The spatial distributions of EEGS parameters obtained at the stage of determining the characteristics of the heart are represented as functions of time, which is used to display these distributions at the stage of visualization of the electrophysiological characteristics of the heart (see figure 5), including on a realistic 3D model of the patient's heart (see figure 7).

Thus, according to the authors of the present invention, the number of electrodes substantiated with the help of additional operations ensures the process of registering multiple EKS leads with the possibility of determining a predetermined size of epicardial damage.

2. Another implementation of the device for registering multiple EKS leads. According to the authors of the present invention, in the claimed device for recording multiple EKS leads, due to a different interaction of distinctive features (additional operations at the stage "Registration of electrocardiosignals"), due to a different interaction than in the prototype, a new property or, in other words, an attribute characterizing the distinctive affiliation of the claimed device, is acquired. This distinctive feature of the claimed device for recording multiple leads of the EX provides him with the determination of the electrophysiological characteristics of the heart using a reasonable number of electrodes.

In general, the claimed device for registering multiple leads of the EX is a multi-channel information-measuring system (IMS), which is a set of functionally related devices and software that implements the necessary information service of a controlled object, including automated collection, presentation, transmission, processing and storage measurement information. If data transmission is carried out over a radio channel, then IMS is called radiotelemetric [33, 34]. The figure 10 shows a generalized block diagram of the IMS, which contains the following devices:

- a measuring device, including primary (PMT) and secondary measuring transducers (VMT) that perform the operations of registration, comparison with a measure, quantization and coding of measurement information, and a switch that performs the operation of switching measurement information;

- measurement information processing device that processes measurement information according to a certain algorithm (redundancy reduction, mathematical operations, modulation, etc.);

- information storage device;

- device for displaying information in the form of recorders and indicators;

- a control device that serves to organize the interaction of all IMS nodes.

Information from the object of study enters a certain set of PIP (in our case, electrodes) and VIP of the measuring device, in which it is converted into an electrical form and transmitted to the means of measuring and converting information of the measuring device, where it undergoes the following operations: filtering, scaling, analog-to-digital transformation. Then, the signals in digital form are transmitted to a digital device for processing measurement information for processing according to certain programs or accumulation, as well as to an information display device (IDD) for indication or registration [33, 34].

According to figures 12 and 13, the device for implementing the proposed method has a different implementation compared to the prototype, which provides a new opportunity that manifests itself in the implementation of the method and its use: determination of the electrophysiological characteristics of the heart in conditions of free activity of the patient based on the registration of multiple EKS leads with a reasonable number of electrodes. To do this, the registration module for multiple EKS leads is structurally implemented in the form of a vest and contains analog and digital parts. In this case, the analog part contains:

электродами, закрепленными определенным образом с внутренней стороны жилета и расположенными равномерно по длине контура l поперечного сечения торса в

рядов;- unit for recording electrocardiosignals with

electrodes fixed in a certain way on the inside of the vest and spaced evenly along the length of the contour l of the cross section of the torso in

rows;

изолированных и экранированных проводников, закрепленных определенным образом на жилете, наконечников проводников, подключаемых к электродам и разъема для подключения к другим узлам модуля регистрации множественных отведений ЭКС [32];- tourniquet, a product consisting of

insulated and shielded conductors fixed in a certain way on the vest, conductor tips connected to the electrodes and a connector for connecting to other units of the EX-lead multiple registration module [32];

- node of protection against impulses of the defibrillator;

- node amplification of electrocardiosignals;

- a node for determining the breakage of electrodes during the registration of electrocardiosignals;

- a multiplexer designed to switch one of the registered electrocardiosignals from input lines to one common output line using a control signal,

and the digital part contains:

- analog-to-digital converter of electrocardiosignals;

- the first computing device;

- block of indication and control;

- external storage device;

- radio transceiver.

The module for collecting, processing and storing data contains: a radio transceiver; a second computing device; persistent storage device; modem.

The analysis and visualization module contains: modem; a third computing device; database; video card driver; video card; display.

Let us explain the operation of the device for the implementation of the proposed method, focusing on the functioning of the module for recording multiple leads of the EKS, since it contains all the distinguishing features of the proposed invention.

First of all, it should be noted that modern microelectronic technologies make it possible to simplify the implementation of the module for registering multiple EKS leads. So, the signal chain can be greatly simplified using a microcontroller, which allows you to replace amplifiers, ADCs, filters and a computing unit with a single integrated circuit. Additional benefits include the flexibility to tune the filter parameters and the isolation of the digital interface.

Recently, a number of integrated circuits have appeared on the market, designed specifically for use in ECG devices. These microcircuits are called a complete analog interface - analog front-end [35, 36]. They are highly integrated, containing all the necessary amplifiers, multiplexers, ADCs, built-in voltage references and a control device. It would be appropriate to use these microcircuits in the proposed device.

In order to avoid output saturation, the gain must be set such that the output voltage swing corresponds to the maximum voltage at the maximum rated input signal voltage.

A feedback circuit designed to compensate for common-mode signals requires a low-power, precision operational amplifier (op-amp) with a high common-mode rejection ratio. This circuit applies a voltage to the patient's body that compensates for the common-mode component of the signal in order to eliminate the effect of the common-mode signal.

There must also be protection circuits against defibrillator pulses and leakage currents that ensure patient safety in accordance with the requirements of the National Standard of the Russian Federation [37] and the American AAMI standard [38]. These standards require that the rms value of the earth leakage current or fault current not exceed 50 µA.

To filter the signal, you can use both analog filters and microcontroller resources. The performance of modern microcontrollers is sufficient to fully process complex signals without resorting to analog filtering. However, such microcontrollers are relatively expensive and consume significant power. The way out of this situation is to combine analog and digital filtering. In the analog part, you can leave easily implemented active or passive filters, for example, apply one high-pass filter. This eliminates a significant part of the calculations in the microcontroller. Complex filters that require tuning and the use of precision elements can be implemented in software. Such a scheme makes it possible to significantly simplify the implementation and reduce the cost of the design. At the same time, the mounting area occupied by the elements practically does not increase compared to the circuit without analog processing, since modern discrete elements and analog microcircuits are very tiny, and a decrease in the required computing power allows the use of small low-power microcontrollers.

To communicate with the module for collecting, processing and storing data and with the module for analysis and visualization, the module for registering multiple leads of the pacemaker must use a common wireless protocol using low power technology.

The registration module for multiple EKS leads works as follows. An electrocardiosignal (ECS) from one of the multiple leads is fed to the input of the ECS multiple leads registration module through the appropriate harness conductor, the tip of which is connected to the skin electrode. At the input of the module for registration of multiple EKS leads, there is protection against electrostatic discharges and a defibrillator discharge. During defibrillation, a pulse, the amplitude of which can reach 4 kV, hits the ECG electrodes. Defibrillator protection is provided by two-way diode clipping by default-off diodes or similar devices. The reverse resistance of the diodes is large and has almost no effect on the input impedance. In addition, the input current can be limited using resistors.

The signal from the electrodes is fed to the input of a high-pass filter, which does not pass high radio frequencies to the input of the amplifiers. The signal is then sent to the input amplifiers. To compensate for common mode noise, additional feedback is introduced into the circuit. From the output of the amplifier, through an additional op amp, the antiphase signal arrives at the patient's body. For this, an additional electrode is used. After the amplifiers, the signal is fed to the input of the ADC.

To control the input EKS, an electrode break detector (DO) is used, which gives a signal when the connection with one or more electrodes is broken. The break detector is made in the form of a comparator that compares the input signal voltage with a given value U _cf . In the absence of the EX, the DO sends a signal to the computing device, which transmits it further through the radio module (RM) to the module for collecting, processing and storing data. At the same time, the “Electrode break” indicator on the vest is activated.

To convert the EKS received from the electrodes into a digital form convenient for analysis and evaluation, an analog-to-digital converter (ADC) is used. After the ADC, digital filtering of the EX is carried out, which is software implemented in the computing device. Then pre-treatment of the pacemaker is carried out to detect critical heart conditions that precede sudden cardiac death (SCD), such as atrial fibrillation and hemodynamic arrhythmias and myocardial infarction [39]. In the event that SCD factors are detected, information about this is urgently and repeatedly transmitted through the communication interface to the module for collecting, processing and storing data. At the same time, the indicator "Operation mode / Alarm" is activated on the vest. The transceiver is a module of one of the most common interfaces for data transmission via a radio channel, for example, Bluetooth Low Energy (BLE) [40]. Such modules have interfaces for matching with microcontrollers and other devices and do not require configuration.

According to the authors of the present invention, the implementation of the proposed method and device for recording multiple derivations of the electrocardiosignal will improve the existing systems of non-invasive cardiodiagnostics and expand their functionality. This implements:

- the possibility of recording and analyzing data with high accuracy and in real time;

- detection of critical conditions of the heart and symptoms of SCD at an early stage autonomously, with subsequent signal transmission to the server of a medical institution;

- the ability to register and analyze the ECS in conditions of free motor activity with a sufficient level of noise immunity and accuracy;

- the possibility of scaling and specialization of the system, interaction with other systems for monitoring the functional state of a person;

- simplicity and convenience of use, ergonomics;

- the possibility of self-diagnosis and auto-tuning of parameters in autonomous operation, energy efficiency;

- affordable price for a wide range of users and providing the maximum sales market.

According to the authors of the proposed invention, the solution presented in the application materials has novelty, inventive step and industrial applicability.

The technical result [20] of the proposed invention, when used in conditions of free activity of a patient at risk of CVD, is to justify the number of electrodes required when registering multiple ECS leads to detect a predetermined size of epicardial damage. The technical result of the invention consists in the development of new, available for mass use, means of processing cardiographic information, providing an approximation of their functionality to the functionality of non-invasive cardiac diagnostic tools in a clinical setting. In other words, the technical result of the invention is an objectively improved characteristic for diagnosing the condition of the heart, which ensures the timely identification of risk factors and the provision of the necessary cardiac care. At the same time, according to the authors of the present invention, the technical result is presented in such a way as to enable the specialist to understand its semantic content based on the prior art.

Thus, the proposed invention performs the registration of multiple EKS leads with a reasonable number of electrodes and provides, under conditions of free activity of patients, the determination of the parameters of the electrophysiological characteristics of the heart, comparable to the determination of parameters and clinical conditions.

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Claims (32)

1. A method for recording leads of an electrocardiosignal, which includes the following steps: registration of electrocardiosignals, determination of the electrophysiological characteristics of the heart, and visualization of the electrophysiological characteristics of the heart, while at the stage of registration of electrocardiosignals, the following is carried out: - measuring the length of the contour l of the cross section of the torso; - solution of the transcendental equation l = a E(ϕ,e) with respect to the angle ϕ, where ϕ is the angle between the straight line connecting the armpits and the direction to the current electrode;

is the normal elliptic Legendre integral of the second kind;

- eccentricity of the cross section of the torso; a and b - anthropometric parameters of the patient's torso, equal to the major and minor semi-axes of the ellipse, respectively; - determination of the x and y coordinates of the electrodes; - installation of electrodes; - registration of electrocardiosignals, at the stage of determining the electrophysiological characteristics of the heart, the following is carried out: - interpolation of potentials on the surface of the torso; - reconstruction of the epicardial model; - reconstruction of the equivalent electrical generator of the heart, at the stage of visualization of the characteristics of the heart, visualization is carried out using computer graphics of the electrophysiological characteristics of the heart, characterized in that at the stage of registration of electrocardiosignals, the following is additionally carried out: - setting the size of epicardial damage

in the plane of the cross section of the torso according to the formula

, where

- the size of the damage to the epicardium;

- the size of the area of damage to the epicardium; - determination of the angle γ between the radii R _{hear t of the} sphere describing the heart in the plane of the cross section of the torso according to the formula

, where

- the size of the damage to the epicardium, i.e. the length of the arc on the surface of the sphere in the plane of the cross section of the torso; - determination of the number of points k _{el for} registration of potentials in the plane of the cross section of the torso according to the formula k _el = 360/γ; - determination of the coordinates x and y of the electrodes in the plane of the cross section of the torso according to the formulas

where

n = (1,…, k _el ) - electrode number; - setting the distance d _el between the rows of electrodes according to the formula

- determination of the number of electrodes by the formula

, where

- the number of rows of electrodes, [] - the designation of the integer part of the number, and L _z - the size of the area of the torso, covering the heart in the plane of the vertical section of the torso. 2. The method according to claim 1, characterized in that the installation of electrodes is carried out by putting on a vest of Small size with a torso perimeter length in cross section l = 70÷90 cm, Medium size at l = 90÷110 cm, Large size at l = 110 ÷130 cm with pre-installed electrodes. 3. The device for recording the leads of the electrocardiosignal for implementing the method according to claim 1, containing a series-connected module for recording the leads of the EX, containing an electrode assembly and a data receiving/transmitting unit, a module for collecting, processing and storing data and an analysis and visualization module, the second inputs of the receiving/ data transmission module, the data collection, processing and storage module and the analysis and visualization module are connected to the output of the control unit, characterized in that the EX-lead recording module is implemented in the form of a vest with a Small size at l = 70÷90 cm, a Medium size at l = 90÷ 110 cm, Large size at l = 110÷130 cm with pre-installed N _el electrodes, spaced evenly along the length of the contour l of the cross section of the torso in r _el rows and connected by a bundle, and contains serially connected analog and digital parts, while: - the analog part contains N _el parallel channels for transmitting ECS lead signals, while each of the channels for transmitting ECS leads signals contains a series-connected electrode, a defibrillator pulse protection device, an amplifier and a break detector, and the outputs of amplifiers and break detectors of each of the channels for transmission EKS lead signals are connected to the inputs of the first and second multiplexers, respectively; - the digital part contains a serially connected analog-to-digital converter, a computing device and a data receiving / transmitting unit, while the second output of the computing device is connected to the input of the display unit, the third, fourth and fifth outputs of the computing device are connected to the second inputs of the defibrillator pulse protection device, break detector and the first and second multiplexers, respectively, and the sixth output of the computing device is connected through a connector in the vest to an external memory unit. 4. The device for recording the leads of the electrocardiosignal according to claim 3, characterized in that: - the data receiving/transmitting unit is configured to carry out wireless transmission of the digital code of electrocardiosignals; - the external memory unit is configured to store the digital code of electrocardiosignals; - the harness is a product consisting of N _el insulated and shielded conductors fixed on the vest, conductor tips, made with the possibility of connecting to the electrodes on one side of the harness and to the connector for connecting to the nodes of the EX-lead recording module on the other side of the harness; - the power supply unit is configured to provide autonomous power supply to the module for recording electrocardiosignal leads.

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