Method and apparatus for electroacoustic analysis of cardiopulmonary dynamics

Abstract

The subject of this invention is an electroacoustic cardiopulmonary dynamics method comprising the following steps: A) recording a three-dimensional cardiac ECG; B) recording a three-dimensional impedance blood flow measurement of the chest; C) recording chest sounds emitted by internal organs in a frequency range up to 20 kHz; D) recording ultrasound waves from the chest generated by the movement of internal organs in a frequency range above 20 kHz; E) determining characteristic events related to a given organ from the data from steps A), B), C), and D), particularly detecting respiratory phase, respiratory rhythm, and respiratory rate, especially detecting cardiac contraction phase using data from steps A) and B), and detecting sounds from the lungs; F) determining the temporal and / or phase correlation of events from the data from steps A), B), C), and D); G) comparing the temporal and / or phase correlation of events from steps A), B), C), and D) with baseline data; H) determining the relationship between the determined temporal and / or phase correlation of events and the baseline time and / or phase correlation of events. The invention also aims to provide an apparatus for implementing this method. (15 claims)

Description

TECHNICAL FIELD

[0001] The object of the present invention is to provide a method for electroacoustic analysis of cardiopulmonary dynamics by measuring electrical parameters of the heart and acoustic parameters of other organs, and a device for implementing the method. BACKGROUND

[0002] Known devices are used for monitoring various cardiac parameters, such as blood pressure, heart rate (HR) by ECG, cardiac output (volume per minute) by cardiac impedance or hemoglobin oxygen saturation (SpO2) by pulse oximeter. The contraction process itself can be observed by echocardiography, magnetic resonance imaging, computed tomography and nuclear medicine methods. These all require expensive equipment, well-trained personnel and extensive experience.

[0003] Document US20110295127A discloses a device and a method for vibratory acoustic detection of cardiac disorders. Measurements are made on vibrations, from which, depending on the frequency and amplitude variations, it is possible to determine whether a disturbance exists and what kind of disturbance it is. Due to the multiple independent rhythm control systems, the dynamics of the heart are non-linear. For this reason, linear frequency analysis is not within the scope of the invention.

[0004] Document US20150374256A1 discloses a device that can measure cardiac dynamics and study fluid flow. The measurements are made by using leads on the patient's body, in addition to which, current and voltage, pressure and vibrations are also examined. The dynamics determined by the disclosed device are related to blood, the parameters detected are blood dynamics parameters and their determination is based on the use of a model that allows the estimation of blood movement and the determination of, for example, cardiac output. The solution discussed is not limited to the assessment of blood dynamics.

[0005] Document W02021250048A1 discloses a method for measuring the multidimensional dynamics of cardiac activity, comprising simultaneous measurement of: three-dimensional ECG, three-dimensional impedance hemometry, tissue movement, wherein the measurement of tissue movement is performed by a sensor located outside the patient's body, selected from the group of sensors comprising: diaphragm, stethoscope funnel, accelerometer, microphone, piezoelectric sensor, wherein the measurement of impedance hemometry comprises simultaneously generating different frequencies of external current on three orthogonal axes, and measuring impedance on the same or other three orthogonal axes, and wherein the measurement of impedance hemometry and the measurement of ECG are performed on the same three orthogonal axes. The document does not disclose a method or device for determining the relationship between cardiopulmonary function using ultrasound signals, audible band sound signals and electrical signals.

[0006] The object of this invention is an improved solution that enables the analysis of the temporal relationship between electrical and acoustic signals from the heart and lungs, sounds generated by organs during the respiratory cycle, additional sounds generated in the lungs during the exhalation or inhalation phase, and murmurs from returning blood.

[0007] The measurement device described below will enable advanced signal analysis to differentiate between heart and lung diseases by the temporal relationship between signals from different organs. Summary of the Invention

[0008] The subject of this invention is a method for measuring the electroacoustic dynamics of at least the heart and lungs, comprising the following steps: A) Record 3D ECG; B) Record the three-dimensional impedance blood flow measurement of the chest; C) Record chest sounds produced by internal organs in a frequency range up to 20 kHz; D) Record ultrasound waves from the chest, generated by the movement of internal organs in a frequency range above 20 kHz. E) Identify organ-specific characteristic events from the data from steps A), B), C), and D), particularly the detection of respiratory phase, respiratory rhythm, and respiratory rate, especially using the data from steps A) and B) to detect cardiac contraction phase and detect sounds from the lungs; F) Determine the temporal and / or phase correlation of events in the data from steps A), B), C), and D); G) Compare the temporal and / or phase correlation of the events in steps A), B), C), and D) with the baseline data; H) Determine the relationship between the temporal and / or phase correlation of the identified event and the baseline time and / or phase correlation of the event.

[0009] Advantageously, electrodes in the Frank or Leyko-Jamrozy configuration can be used to perform three-dimensional ECG measurements and / or three-dimensional impedance blood flow measurements.

[0010] Advantageously, impedance blood flow measurement and ECG measurement are performed against the same three orthogonal axes.

[0011] Advantageously, ultrasound waves from the chest generated by internal organ compression can be recorded using an acoustic microphone in a frequency range up to 20 kHz.

[0012] Advantageously, piezoelectric microphones can be used to record sounds from the chest produced by the movement of internal organs in the frequency range of 20 kHz and above.

[0013] Advantageously, the Doppler effect can be used to record sounds from the chest produced by the movement of internal organs in a frequency range of 20 kHz.

[0014] Advantageously, measurements can be performed discontinuously using timing markers that are equivalent to a single time base.

[0015] Advantageously, measurements can be performed simultaneously using a single time base.

[0016] Advantageously, the signals recorded at steps A), B), C) and / or D) originate from organs within the chest, including the heart, lungs, diaphragm, and blood vessels involved in body movement.

[0017] Advantageously, deterministic algorithms (including nonlinear algorithms supported by machine learning methods) are used to determine characteristic events in the data of step A) and / or step B) and / or step C) and / or step D).

[0018] Advantageously, it further includes the steps of measuring blood pressure using a common time base relative to the measurements in steps A) and / or B) and / or C) and / or D), determining characteristic events in the blood pressure data, determining the temporal correlation of the characteristic events in the blood pressure data relative to the data in steps A) and / or B) and / or C) and / or D), and determining the difference between the temporal correlation of the determined events and the reference temporal correlation of the events.

[0019] Another object of the present invention is a device for multidimensional analysis of cardiac dynamics, suitable for simultaneous measurement of ECG and impedance blood flow measurement, comprising: A) A system used for recording 3D ECG; B) A system for recording three-dimensional thoracic impedance blood flow measurements; C) Systems for recording acoustic signals from the chest, including acoustic microphones operating within a bandwidth of up to 20 kHz; D) Systems for recording acoustic signals from the chest, including piezoelectric microphones operating in bandwidths of 20 kHz and above; E) Circuitry for time synchronization of data obtained from steps A), B), C), and D) (by bringing this data to a common time base), including digital memory, processor, data input interface, clock circuit and main data input circuit, and digital data comparison circuit; E) An interface for receiving and sending digital data.

[0020] Advantageously, all circuits in the device have a common time base provided by the clock circuit.

[0021] Advantageously, the device includes a wireless interface for transmitting data, preferably a BLE and / or GSM and / or LTE and / or Wi-Fi interface.

[0022] Advantageously, the device includes a blood pressure measuring circuit configured to perform measurements using a common time base relative to the clock circuit. Detailed Implementation

[0023] This device is part of a system that receives and analyzes signals. The system's task is to extract overall information about the dynamics of the heart and lungs, including not only hemodynamics but also the tissue movement of the heart, lungs, diaphragm, and other organs in the chest.

[0024] According to an advantageous embodiment, the method includes measuring acoustic signals from the chest at audible frequencies (up to 20 kHz), measuring three-dimensional ECG signals (vector cardiography), and measuring three-dimensional impedance (bioimpedance) of the chest. The measurements are performed synchronously (in a single time base), which allows for further joint (correlation) analysis. As a result of the measurements, signals are obtained that determine electrical and acoustic (mechanical) phenomena occurring in the heart and lungs, as well as the motion of other tissues and organs. Simultaneous measurement of these three signals allows for analysis of each signal individually, as well as analysis of their interactions. These signals describe: • Electromechanical coupling that occurs in the heart, i.e. how the electrical excitation (ECG) of the heart and the measured ionic currents (ECG-based and bioimpedance-based measurements) are translated into cardiac contraction (measured via acoustic signal energy).

[0025] • Cardiac dynamics, which involves modeling the repeatability and predictability of the aforementioned electromechanical cycles.

[0026] • Synchronization of cardiac and pulmonary analysis measurements. As a result of analyzing the collected signals, the operation of these two organs and how their operation drifts and influences each other can be analyzed simultaneously. Linking lung and cardiac operation in the same time state is particularly important. Lung capacity measurements and ECGs can be performed to track signal changes over a time period and detect abnormalities in their correlation.

[0027] The features defined above allow for the analysis of conditions such as chronic obstructive pulmonary disease, chronic heart failure, valvular defects, arrhythmias, or reduced cardiac ejection fraction. Obtaining the same correlations requires echocardiography, spirometry, and dynamic ECG testing. However, the information obtained in this way is collected separately at different times, making it impossible to analyze direct interrelationships between them. The available devices measure these relationships simultaneously (with a common time base). In an advantageous embodiment, deterministic algorithms are used to analyze the collected data, analyzing the temporal correlations between phenomena appearing in the signals, such as: ECG signal refraction, the sound produced by the closure of heart valves, changes in bioimpedance signals caused by diaphragmatic movement during respiratory circulation, impedance changes related to cardiac hemodynamics, vibrations from the myocardium during the diastolic phase, additional sounds from the lungs during the expiratory or inspiratory phases, murmurs from receding blood, and a third tone from blood striking the left ventricular wall during diastolic dysfunction measured with a microphone, etc.

[0028] The method according to the embodiment measures the electromechanical coupling between the heart and lungs. It allows for the measurement or estimation of the mechanical and electrical energy of the heart, the relationship between their operation, and their interaction with each other.

[0029] The apparatus for multidimensional analysis of cardiac dynamics according to the invention comprises leads for ECG measurements and leads for impedance flow measurement on three orthogonal axes. The leads are connected to the body using electrodes. The array of leads for impedance flow measurement is advantageously located at the center of the cardiac region. The apparatus includes three electrode signal measurement circuits, three applied current generation circuits, and at least one tissue motion sensor. Advantageously, the apparatus has a user communication interface. The signal receiving system and the applied current generation system are configured to measure simultaneously on the three orthogonal axes. The frequency of the applied current is different for each of the three orthogonal axes.

[0030] Correct data collection must meet the following conditions: Impedance measurements must be performed on the three orthogonal axes at three different frequencies. The measurements cannot be performed in sequence, and the electrode layout can differ from the wire layout (only the orthogonality of the axes is important).

[0031] Impedance and voltage measurements do not have to be on the same axis.

[0032] - All measurements must be performed simultaneously; sequential measurements of consecutive axes are not permitted.

[0033] The real and imaginary parts of impedance are measured simultaneously on each axis of the ECG measurement. This measurement makes it possible to use information about tissue resistance and voltage changes along the vertical axis. This allows for the estimation of currents, energy, and processes related to myocardial function.

[0034] Functionally, according to embodiments, the device can be divided into several systems, namely a measurement system, a communication system, a control system, a storage system, a power supply system, an information display system, and a user communication system. It should be noted that information display and communication with the user or the communication system are optional.

[0035] In an advantageous embodiment, the device uses an electrode array forming a Frank or Leyko-Jamrozy wire array. These are known in the prior art.

[0036] Advantageously, the device has a lead configuration for ECG measurement and a lead configuration for impedance blood flow measurement, the centers of which are substantially in the same location, and even more advantageously, the lead configurations for ECG measurement and impedance blood flow measurement are identical. In the most advantageous variant, impedance and voltage measurements are performed on the same axis.

[0037] Advantageously, the wires are connected to the body via two or three electrodes.

[0038] In rheological measurements, the measurement system and the system that generates the applied current can use different or the same electrodes. Advantageously, all systems in the device share a common time base. Synchronization is possible without a common time base, but achieving synchronization via a common time base is easier and more practical.

[0039] The method according to the invention includes the following steps: attaching lead electrodes to the body; simultaneously measuring ECG and impedance flow measurements on three orthogonal axes by simultaneously generating applied currents at different frequencies for each axis; measuring the voltage between the electrodes; and calculating current, energy, and operation related to myocardial function based on the measurement data. Advantageously, the apparatus or system for analyzing the data evaluates the dynamics of changes in signal waveforms based on the data.

[0040] The device according to the invention advantageously has a fixed or portable form. It can be integrated into a single device with other peripheral devices (screens, touchscreens, keyboards, mice, virtual reality goggles, etc. on a mobile structure), or it can consist of components connected to each other in various ways (e.g., a main unit and pluggable cards / accessories / function extenders). This connection can be wired or wireless. The measuring device can also be of the Holter type—for multi-hour signal recording or a fixed bedside device.

[0041] Both stationary and portable devices can be battery-powered, using disposable batteries, rechargeable batteries, or other alternative power sources. Stationary devices can optionally operate using a mains power supply. These devices can be equipped with wired interfaces (e.g., USB, SD card, MMC memory, RJ45 network input) and wireless interfaces (e.g., Wi-Fi, Bluetooth, interfaces on cellular modems) for uploading and retrieving data from the device. Both desktop and portable devices can have receptacles for connecting measurement cables. This allows for the integration of wireless measurement devices rather than wired solutions.

[0042] In a favorable example, the performance of electroacoustic measurements of cardiac and pulmonary dynamics includes the following steps: A) Record 3D ECG; B) Record the three-dimensional impedance blood flow measurement of the chest; C) Recording chest sounds produced by the work of internal organs in a frequency range up to 20 kHz; D) Record ultrasound waves from the chest, generated by the movement of internal organs in a frequency range above 20 kHz. E) Identify characteristic events associated with specific organs from the data from steps A), B), C), and D), particularly detecting respiratory phase, respiratory rhythm, and respiratory rate, especially using the data from steps A) and B) to detect cardiac contraction phase and detect sounds from the lungs; F) Determine the temporal and / or phase correlation of events in the data from steps A), B), C), and D); G) Compare the temporal and / or phase correlation of the events in steps A), B), C), and D) with the baseline data; H) Determine the relationship between the temporal and / or phase correlation of the identified event and the baseline time and / or phase correlation of the event.

[0043] Three-dimensional ECG and / or three-dimensional impedance flowmetry measurements were performed using electrodes of Frank or Leyko-Jamrozy configuration. Impedance flowmetry and ECG measurements were performed on the same three orthogonal axes. The recorded acoustic signals from the chest involved sounds emitted by internal organs, up to 20 kHz, and were recorded using an acoustic microphone, and from 20 kHz to 1 GHz using a piezoelectric microphone or other microphone operating in the ultrasound band. In another advantageous embodiment, the acoustic signals from the chest recorded in the ultrasound band used the Doppler effect to determine the motion and dimensional changes of the chest organs. The recorded electrical, acoustic, and ultrasound signals were digitally processed.

[0044] Specifically, typical parameters in digital signal analysis, such as amplitude, frequency, phase (phase change), correlation, autocorrelation, and other parameters, as well as processing methods (filtering, Fourier transform), are analyzed. In one advantageous example, measurements are performed separately from a timing marker that allows the time base to be assimilated into a single time base. In another advantageous example, measurements are performed simultaneously using a single time base derived from an internal clock system with high accuracy (preferably down to 1 ms, more preferably down to 1 μs).

[0045] The acoustically recorded sounds originate from organs within the chest, including the heart, lungs, diaphragm, blood vessels involved in body movement, and other tissues that emit acoustic signals. Each recorded signal has its own characteristic elements. These include known typical elements of the ECG signal (e.g., ECG waveform, amplitude-time correlation, and amplitude-phase correlation), typical sounds (e.g., the sound of valve closure, the sound of airflow in the lungs), and typical changes in bioimpedance (e.g., caused by diaphragmatic movement). The determination of these characteristic elements typically involves an evaluation of the signal waveform by a trained expert (e.g., a physician). In advantageous embodiments, deterministic algorithms (including nonlinear algorithms supported by machine learning methods) are used for their determination. Such algorithms using image recognition or matching specific known signal waveforms with measured signals are well known in the art. These algorithms search for features in the recorded waveforms, such as signal transitions via a zero line, continuity perturbations, derivative analysis, time autocorrelation, and signal phase analysis. In advantageous embodiments, typical waveform events are labeled on each waveform, such as the onset of inspiration, the ECG waveform, the valve closure phase, and diaphragmatic contraction. For these and other events, the temporal relationships between them are calculated, such as the time elapsed from diaphragmatic contraction to the start of inspiration, and the number of heart valve closures. The data thus determined is then compared manually or by machine with standards (i.e., with historical data from the same patient used for disease detection or data from healthy individuals). In an advantageous embodiment, the collected data is compared with typical data for the disease to determine its probability of occurrence. In an advantageous embodiment, the method includes the step of measuring blood pressure using a common time base relative to other measurements and identifying characteristic events in the blood pressure data. Subsequently, the temporal correlation of the characteristic events in the blood pressure data relative to other measurements is determined, and the difference between the determined event temporal correlation and the event standard temporal correlation is determined.

[0046] This embodiment also includes a device for multidimensional analysis of cardiac dynamics, adapted to simultaneously measure ECG and impedance blood flow measurement, the device comprising: A) A system used for recording 3D ECG; B) A system for recording three-dimensional thoracic impedance blood flow measurements; C) Systems for recording acoustic signals from the chest, including acoustic microphones operating within a bandwidth of up to 20 kHz; D) Systems for recording acoustic signals from the chest, including piezoelectric microphones operating in bandwidths of 20 kHz and above; E) Circuitry for time synchronization of data obtained from steps A), B), C), and D) (by bringing this data to a common time base), including digital memory, processor, data input interface, clock circuit and main data input circuit, and digital data comparison circuit; F) An interface for receiving and sending digital data.

[0047] In an advantageous embodiment, all circuits of the device have a common time base provided by a clock circuit, and the device includes a wireless interface for data transmission, which is advantageously a BLE and / or GSM and / or LTE and / or Wi-Fi interface.

[0048] Advantageously, the device includes a blood pressure measuring circuit configured to perform measurements using a common time base relative to the clock circuit.

[0049] In an advantageous embodiment, acoustic measurements are performed via a microphone (acoustic-sound phenomenon) having an infrasound component (tissue motion measured using, for example, the Doppler phenomenon), which is advantageously connected to the stethoscope funnel or diaphragm that acts as a stethoscope.

[0050] This article not only analyzes tissue movement but also acoustic phenomena in the chest. For example, signal analysis was used, the first step of which was: - Detect respiratory phase (blood flow measurement + ECG) (rhythm, respiratory rate).

[0051] - Detect additional sounds from the lungs.

[0052] - Detect the phase of cardiac contraction (based on ECG waveform analysis); - The process of mechanical contraction is assessed by comparing the infrasound signal waveform with a previous waveform corresponding to the previous cardiac contraction - assessing the amplitude and phase of the signal (the phase of the signal cannot be heard by the ear / microphone). - Evaluate the direction of impedance change over time.

[0053] The parameters of cardiac and pulmonary phenomena are then displayed side-by-side on a time axis to allow for the detection and quantitative measurement of the relationship between them.

[0054] Examples of observations and conclusions: -A healthy, calm, and relaxed person -the heart and lungs do not affect their function when at rest -there exists a state of rest -the instantaneous and long-term parameters of the two organs' operation are constant and stable.

[0055] People with heart disease may experience shortness of breath, difficulty breathing, orthopnea, or even Cheyne-Stokes breathing. The heart struggles to overcome these difficulties depending on the type of heart disease, which manifests as its operating parameters frequently interfering with lung function.

[0056] - People with lung disease - In response to a decrease in saturation, the heart compensates for the loss of blood oxygen by changing its operating mechanism, based on the temporary efficiency of the respiratory system. Lung disease can overload the right ventricle of the heart, which is associated with changes in the operating parameters of a healthy heart.

[0057] - People in a state of severe anxiety or depression - their heart works with an increased heart rate, their breathing is shortened and irregular, their state of tension regulates the process of inhalation and exhalation, sometimes with an increased respiratory rate and hyperventilation, and reduced respiratory control.

[0058] Therefore, it is helpful to determine which organ is most affected and first affected, and which organ is secondary to the former. Is the diseased heart causing the lung disease, or is the diseased lung disturbing the heart? Therefore, it is also helpful to determine whether the symptoms originating from the heart and lungs are related to an organic disease of an organ being treated by a cardiologist or pulmonologist, or whether the person may be mentally ill.

[0059] The method according to the invention allows for a holistic assessment of the coordination of operating organs and makes it possible to observe the interaction between one organ and another. The object of the invention is to make it possible to observe this interaction between organs.

[0060] Analyzing the relationships between these phenomena makes it possible to detect “zodiac” traits of anxiety or depression.

Claims

1. A method for measuring the electroacoustic dynamics of the heart and lungs, comprising the following steps: A) Record 3D ECG; B) Record the three-dimensional impedance blood flow measurement of the chest; C) Record chest sounds emitted by internal organs in a frequency range up to 20 kHz; D) Record ultrasound waves from the chest, the ultrasound waves being generated by the movement of internal organs in a frequency range above 20 kHz; E) Identify organ-specific characteristic events from the data from steps A), B), C), and D), particularly detecting respiratory phase, respiratory rhythm, and respiratory rate, especially using the data from steps A) and B) to detect cardiac contraction phase and detect sounds from the lungs; F) Determine the temporal and / or phase correlation of events in the data from steps A), B), C), and D); G) Compare the temporal and / or phase correlation of events from steps A), B), C), and D) with the baseline data; H) Determine the relationship between the temporal and / or phase correlation of the identified event and the baseline time and / or phase correlation of the event.

2. The method according to any one of the preceding claims, characterized in that, Measurements of three-dimensional ECG and / or three-dimensional impedance blood flow measurement are performed using electrodes in the Frank system or the Leyko-Jamrozy system.

3. The method according to any one of the preceding claims, characterized in that, Impedance flow measurement and ECG measurement were performed on the same three orthogonal axes.

4. The method according to any one of the preceding claims, characterized in that, Ultrasound waves from the chest, generated by compression of internal organs, were recorded via an acoustic microphone in a frequency range up to 20 kHz.

5. The method according to any one of the preceding claims, characterized in that, Ultrasound waves from the chest, generated by the movement of internal organs in the frequency range of 20 kHz and above, are recorded using a piezoelectric microphone.

6. The method according to any one of the preceding claims, characterized in that, Sounds from the chest produced by the movement of internal organs in the frequency range of 20 kHz and above were recorded using the Doppler effect.

7. The method according to any one of the preceding claims, characterized in that, The measurements were performed separately using timing markers that could approximate a single time base.

8. The method according to any one of the preceding claims, characterized in that, Measurements are performed simultaneously using a single time base.

9. The method according to any one of the preceding claims, characterized in that, The signals recorded in steps A), B), C) and / or D) originate from organs inside the chest, including the heart, lungs, diaphragm, blood vessels, and body movements.

10. The method according to any one of the preceding claims, characterized in that, Deterministic algorithms, including nonlinear algorithms supported by machine learning methods, are used to determine characteristic events in the data of steps A) and / or B) and / or C) and / or D).

11. The method according to any one of the preceding claims further comprises the steps of measuring blood pressure using a common time base relative to the measurements of step A) and / or step B) and / or step C) and / or step D), determining characteristic events in the blood pressure data, determining the temporal correlation of the characteristic events in the blood pressure data relative to the data of step A) and / or step B) and / or step C) and / or step D), and determining the difference between the determined temporal correlation of the events and the reference temporal correlation of the events.

12. A device for multidimensional analysis of cardiac dynamics, suitable for simultaneous measurement of ECG and impedance blood flow measurement, comprising: A) A system used for recording 3D ECG; B) A system for recording three-dimensional thoracic impedance blood flow measurements; C) Systems for recording acoustic signals from the chest, including acoustic microphones operating within a bandwidth of up to 20 kHz; D) A system for recording acoustic signals from the chest, including a piezoelectric microphone operating in a bandwidth of 20 kHz and above; E) A circuit for time synchronization of the data obtained from steps A), B), C), and D), the circuit bringing such data to a common time base, the circuit including a digital memory, a processor, a data input interface, a clock circuit and a main data input circuit, and a digital data comparison circuit; F) An interface for receiving and sending digital data.

13. The apparatus according to claim 12, characterized in that, All circuits of the device have a common time base provided by a clock circuit.

14. The apparatus according to claim 12 or 13, characterized in that, The device includes a wireless interface for data transmission, advantageously a BLE and / or GSM and / or LTE and / or WiFi interface.

15. The apparatus according to claim 12 or 14, characterized in that, The device includes a blood pressure measurement system configured to perform measurements using a common time base relative to a clock system.