A non-invasive continuous real-time blood pressure and hemodynamics and ECG and heart sound heart function integrated device and data calculation method thereof

Abstract

The application discloses a non-invasive continuous real-time blood pressure and hemodynamics and heart function integrated device and a data calculation method thereof, which comprises a signal acquisition module, a statistical and weighted calculation module, a communication module and a display module which are electrically connected with a main control board, wherein the signal acquisition module comprises an ECG and heart sound digitization detection module and a real-time continuous blood pressure and hemodynamics calculation module.The application has the beneficial effects that: the device combines the heart sound and ECG with the non-invasive hemodynamics acquisition device, and the blood pressure parameters obtained by the device are mutually calibrated, so that the device not only solves the problems of real-time continuous blood pressure and hemodynamics detection, but also synchronously outputs ECG parameters, heart sound logarithms, cardiac output, stroke volume, vascular resistance, cardiac contractility and other parameters.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a non-invasive, continuous, real-time integrated device for blood pressure, hemodynamics, electrocardiogram, heart sounds, and cardiac function. Background Technology

[0002] Blood pressure is one of the important physiological parameters. Electronic blood pressure monitors are generally divided into two main categories based on the measurement site: upper arm type and wrist type. Both are based on the oscillometric method and use an air pump to complete one measurement process. They cannot provide real-time continuous measurement of blood pressure per stroke and are intermittent blood pressure monitors. Since real-time continuous monitoring of blood pressure changes has very important clinical value, finding a new method to achieve non-invasive and real-time continuous measurement of arterial blood pressure is a fundamental problem that urgently needs to be solved.

[0003] Before blood pressure changes, hemodynamic parameters such as cardiac output, stroke volume, vascular resistance, and cardiac contractility have already changed. In clinical monitoring, this allows for early prediction of blood pressure changes, reducing the incidence of clinical accidents. In health management, it can assess cardiovascular status, whether vascular regulatory capacity has declined, and whether measures have been taken early to prevent blood pressure rise. Hemodynamic parameters such as cardiac output, vascular resistance, cardiac contractility, and heart rate are also important factors inducing blood pressure changes. Combining electrocardiogram and heart sounds allows for a more comprehensive detection of cardiac function and whether electrophysiology is normal. Currently, there is a gap in non-invasive real-time arterial blood pressure, hemodynamics, and synchronous intelligent digital detection of electrocardiogram and heart sounds. Therefore, we propose a non-invasive, continuous, real-time integrated device for blood pressure, hemodynamics, electrocardiogram, heart sounds, and cardiac function to solve the above technical problems. Summary of the Invention

[0004] The purpose of this invention is to overcome the shortcomings of the prior art and provide a non-invasive, continuous, real-time integrated device for blood pressure, hemodynamics, electrocardiogram, heart sounds, and cardiac function, as well as its data calculation method.

[0005] The objective of this invention is achieved through the following technical solution:

[0006] A non-invasive, continuous, real-time integrated device for blood pressure, hemodynamics, electrocardiogram, heart sounds, and cardiac function includes a signal acquisition module, a statistical and weighted calculation module, a communication module, and a display module electrically connected to a main control board. The signal acquisition module includes a digital detection module for electrocardiogram and heart sounds and a real-time continuous blood pressure and hemodynamics calculation module.

[0007] A further technical solution is that the ECG and heart sound digital detection module includes an ECG and heart sound acquisition module and an ECG and heart sound comprehensive processing module. The ECG and heart sound acquisition module includes an ECG acquisition module, a heart sound acquisition module, and a heart rate acquisition module. The ECG and heart sound comprehensive processing module includes a filtering circuit, an ECG signal baseline stabilization circuit, a signal amplification circuit, a computing chip, and an AD conversion circuit.

[0008] A further technical solution is that the real-time continuous blood pressure hemodynamics calculation module includes a radial artery pressure wave analysis module and a parameter diagnosis module, wherein the radial artery pressure wave analysis module includes a pressure waveform feature extraction module, a pressure waveform feature amplification module, a pressure waveform feature calculation module, and a pressure calculation module.

[0009] A further technical solution is that both the blood pressure calculation module and the pressure calculation module are connected to the input terminal of the statistics and weighted calculation module.

[0010] A further technical solution is that the ECG acquisition module includes a wrist-based one-lead ECG signal acquisition module and a chest ECG signal acquisition module.

[0011] A further technical solution is that the ECG acquisition module also includes a limb ECG signal acquisition module.

[0012] A data calculation method for a non-invasive, continuous, real-time integrated device for blood pressure, hemodynamics, electrocardiogram, heart sounds, and cardiac function:

[0013] Step 1: Acquire the electrocardiogram signal, heart sound signal, and radial artery pressure wave acquired by the signal acquisition module;

[0014] Step 2: Extract features from the electrocardiogram signals, heart sound signals, and radial artery pressure waves collected in Step 1;

[0015] Step 3: Perform data calculations based on the features extracted in Step 2;

[0016] Step 4: Calculate the real-time continuous blood pressure based on the blood pressure regression model.

[0017] Step 5: The continuous blood pressure data obtained in Step 4 is cross-calibrated and weighted with the blood pressure data obtained from the real-time continuous blood pressure hemodynamics calculation module. The weighted real-time continuous blood pressure is then displayed through the display module. Other data in Step 4 that do not involve blood pressure calculation can be directly displayed through the display module after processing.

[0018] Compared with the prior art, the beneficial effects of the present invention are:

[0019] 1. This device combines heart sound and electrocardiogram with a non-invasive hemodynamic acquisition device, and the blood pressure parameters obtained after their separate measurement and calculation are cross-calibrated to make the blood pressure output data more accurate. This device not only solves the problem of real-time continuous non-invasive blood pressure and hemodynamic detection, but also can simultaneously output parameters such as electrocardiogram parameters, heart sound parameters, cardiac output, stroke volume, vascular resistance, and cardiac contractility. Attached Figure Description

[0020] Figure 1 This is a flowchart illustrating the implementation of the present invention.

[0021] Figure 2 This is a block diagram of the functional modules of the present invention.

[0022] Figure 3 This is a diagram of the architecture of the present invention.

[0023] Figure 4 This is a schematic diagram combining the radial artery pressure waveform, phonocardiogram, and electrocardiogram of the present invention.

[0024] Figure 5 This is a magnified schematic diagram of the radial artery pressure waveform of the present invention.

[0025] Figure 6 This is an enlarged schematic diagram of the phonocardiogram and electrocardiogram of the present invention.

[0026] Figure 7 This is a schematic diagram of the electrocardiogram and heart sound localization measurement of the present invention. Detailed Implementation

[0027] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0028] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0029] It should be noted that, unless otherwise specified, the embodiments and features described in this invention can be combined with each other.

[0030] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0031] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this invention is in use, or the orientation or positional relationship commonly understood by those skilled in the art. They are only used for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention. In addition, the terms "first," "second," etc., are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0032] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0033] Example 1:

[0034] Please refer to Figure 1-7 As shown, a non-invasive, continuous, real-time integrated device for blood pressure, hemodynamics, electrocardiogram, heart sounds, and cardiac function is provided. This device is used in conjunction with a monitor or wearable device and includes a signal acquisition module, a statistical and weighted calculation module, a communication module, and a display module electrically connected to a main control board. The signal acquisition module includes a digital detection module for electrocardiogram and heart sounds and a real-time continuous blood pressure and hemodynamics calculation module. All three modules are connected to the main control board.

[0035] The ECG and heart sound detection module acquires ECG signals and simultaneously acquires heart sound signals from the same source, converting them into digital signals. The blood pressure and hemodynamics calculation module acquires the pressure wave of the radial artery using the flattening tension method. One lead of the acquired ECG signal is collected at the wrist, while the other leads are located at the chest. Real-time continuous blood pressure, cardiac output, cardiac contractility, and other hemodynamic parameters are calculated based on the flattening tension method pressure wave.

[0036] The communication module can be a wired or wireless communication module, which is used to transmit the collected ECG and heart sound signals and calculation results to the device or application end via a data cable or wireless module, while the display module is used to display the collected ECG and heart sound signals and parameters on the device.

[0037] The ECG and heart sound digital detection module includes an ECG and heart sound acquisition module and an ECG and heart sound comprehensive processing module. The ECG and heart sound acquisition module includes an ECG acquisition module, a heart sound acquisition module, and a heart rate acquisition module. The ECG and heart sound comprehensive processing module includes a filtering circuit, an ECG signal baseline stabilization circuit, a signal amplification circuit, a computing chip, and an AD conversion circuit. That is, the ECG and heart sound comprehensive processing module is used to filter noise, stabilize the baseline, calculate individual ECG parameters and individual heart sound parameters, as well as the parameters between ECG and heart sound, and perform AD conversion processing on the acquired ECG and heart sound signals.

[0038] The ECG acquisition module includes a wrist-based one-lead ECG signal acquisition module and a chest ECG signal acquisition module. Furthermore, the ECG acquisition module also includes a limb ECG signal acquisition module, namely, the acquisition of ECG and heart sound signals from the chest. The ECG acquisition module and the heart sound acquisition module simultaneously acquire ECG and heart sound signals and display them on the terminal device. The ECG and heart sound acquisition sensing points can overlap at the same location on the chest or be located at different locations.

[0039] Radial artery pressure wave acquisition can also simultaneously acquire ECG signals from the wrist: the pressure sensor is located directly above the radial artery to acquire the pressure waveform. If wrist ECG acquisition is also available, the ECG acquisition location and the radial artery pressure sensor are offset or specially treated to overlap.

[0040] The chest ECG signal acquisition module and the heart sound acquisition module can be acquired separately, or an integrated ECG and heart sound synchronous acquisition focusing head can be used. The structure of this ECG and heart sound synchronous acquisition focusing head has been disclosed in Chinese Patent Publication No. CN208509235U, entitled "Novel Multifunctional Focusing Head". The ECG and heart sound synchronous detection module acquires the ECG signal from the chest and simultaneously acquires the heart sound signal from the same source and converts it into a digital signal. The working principle of its ECG and heart sound synchronous acquisition is to use an electrode catheter to replace the V2 lead position in the existing 12-lead ECG. The electrode catheter is equipped with a vibrating diaphragm and a probe, with the probe located on the vibrating diaphragm. When the electrode catheter is attached to the V2 lead, the vibration of the vibrating diaphragm can monitor the heart sound, and at the same time, the probe, as an electrode, can monitor the ECG signal. The two signals occur simultaneously and are simultaneously transmitted to the main control board for processing and then displayed on the display terminal, thus achieving the purpose of synchronous acquisition of ECG and heart sound from the same source.

[0041] The real-time continuous blood pressure hemodynamics calculation module includes a radial artery pressure wave analysis module and a parameter diagnosis module. The parameter diagnosis module can calculate real-time continuous blood pressure, cardiac output, cardiac contractility and other hemodynamic parameters. The radial artery pressure wave analysis module includes a pressure waveform feature extraction module, a pressure waveform feature amplification module, a pressure waveform feature calculation module and a pressure calculation module. The pressure calculation module mainly calculates the stroke volume systolic blood pressure and diastolic blood pressure or cardiac output.

[0042] This real-time continuous blood pressure hemodynamics calculation module acquires radial artery pressure waves using the flattening tension method, and then calculates real-time continuous blood pressure or cardiac output and other hemodynamic parameters based on the flattening tension method pressure waves. More specifically, the real-time continuous blood pressure hemodynamics calculation module includes a flattening tension method radial artery pressure wave analysis module and a real-time continuous blood pressure or cardiac output and other hemodynamic parameter diagnosis module. Specifically, the flattening tension method radial artery pressure wave analysis module is used to extract, amplify, and calculate the features of the acquired pressure waveform; the real-time continuous blood pressure or cardiac output and other hemodynamic parameter diagnosis module is used to diagnose the calculated stroke volume, systolic and diastolic blood pressure, cardiac output, and cardiac contractility.

[0043] Both the ECG and heart sound integrated processing module and the parameter diagnosis module are connected to the input of the statistics and weighted calculation module. The output of the weighted calculation module is electrically connected to the communication module, and the communication module is electrically connected to the display module. That is, after processing by the ECG and heart sound integrated processing module, real-time continuous blood pressure is obtained from the ECG and heart sound, while the radial artery pressure signal is used to obtain real-time continuous blood pressure from the radial artery after feature extraction and data calculation. The two blood pressures are then weighted by the statistics and weighted calculation module to obtain a weighted real-time continuous blood pressure value, which is the final blood pressure value. At the same time, after feature extraction and data calculation of the ECG and heart sound signals and the radial artery pressure wave signal, not only are the parameters for calculating blood pressure obtained, but also some other parameters reflecting the ECG, heart sound, and hemodynamics are obtained. These parameters can be directly transmitted to the display module for display after data processing via the communication module.

[0044] The display module is used to display the collected ECG and heart sound signals and parameters on the device. The wired or wireless communication module is used to transmit the collected ECG and heart sound signals and calculation results to the device or application end via a Type-C or wireless module.

[0045] A data calculation method for a non-invasive, continuous, real-time integrated device for blood pressure, hemodynamics, electrocardiogram, heart sounds, and cardiac function:

[0046] For electrocardiogram (ECG) signal acquisition, the ECG signal acquisition includes at least chest ECG signal acquisition and wrist one-lead ECG signal acquisition. Then, the highest point of the R wave group and the RR interval time are extracted as ECG signal features based on the acquired ECG signals. For heart sound signal acquisition, the heart sound signals are generally collected in the tricuspid auscultation area. Then, the peak value of the first heart sound S1, the peak value of the second heart sound S2, the R wave group, and the P wave group are extracted as signal features. For radial artery pressure wave acquisition, the pressure sensor is located directly above the radial artery to collect the pressure waveform. The peak point, dicrotic wave point, descending isthmus point, and trough point of the pressure waveform are extracted as signal features.

[0047] For the electrocardiogram signal, the time required for the pre-ejection phase (PEP) is estimated based on the RR interval, the time from the peak of the R wave group to the onset of the rapid ejection phase u of the pressure waveform (RWPWTT), and the time from the peak of the R wave group to the peak point of the first heart sound S1 (M1) (RWPWIT). Finally, the time difference PWTT1 is calculated using the formula PWTT1 = RWPWTT - RWPWIT. At the same time, the heart rate HR1 is calculated based on the R wave peak interval obtained in the above steps.

[0048] The pulse transit time (PWTT2) is calculated by taking the time difference between the peak point A2 of the second heart sound (S2) in the heart sound signal and the dicrotic wave point In of the pressure waveform. Simultaneously, the heart rate (HR2) is calculated using the interval between the main wave peaks of the pressure waveform obtained in the previous steps. Based on the calculated PWTT1, PWTT2, HR1, and HR2, real-time continuous blood pressure is calculated using a blood pressure regression model. This calculated real-time continuous blood pressure value is then cross-calibrated with the blood pressure value measured using hemodynamic principles. If there is a discrepancy between the two data, a weighted average is used. The data measured using the flattening tension method (i.e., by hemodynamic equipment) accounts for 60%-90%, while the calculated continuous blood pressure value accounts for approximately 10%-40%. The weighted average yields the real-time continuous blood pressure value.

[0049] Other parameters besides blood pressure analysis obtained through signal acquisition and feature extraction, such as EMAT, EMAT%, LVST, LVST%, QRSD, QTD, Q-Td, R-Rv5+SvI, MeanRR, SDNN, RMSSD, CV, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), continuous cardiac output (CCO), isovolumetric systolic index (dP / dt max), systemic vascular resistance (SVR), stroke volume (SV), stroke volume variability (SVV), cardiac output (CPO), cardiac output index (CPI), continuous cardiac index (CCI), systemic vascular resistance index (SVRI), stroke volume index (SVI), and pulse pressure variability (PPV), are processed by the other parameter data calculation module and then transmitted to the display module for display via wireless communication module or wired communication module.

[0050] Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A data calculation method for a non-invasive, continuous, real-time integrated device for blood pressure, hemodynamics, electrocardiogram, heart sounds, and cardiac function, characterized in that: The non-invasive continuous real-time blood pressure and hemodynamics and electrocardiogram, heart sound and cardiac function integrated device includes a signal acquisition module, a statistical and weighted calculation module, a communication module and a display module electrically connected to the main control board, wherein the signal acquisition module includes an electrocardiogram and heart sound digital detection module and a real-time continuous blood pressure and hemodynamics calculation module. The ECG and heart sound digital detection module includes an ECG and heart sound acquisition module for acquiring ECG signals and heart sound signals, and an ECG and heart sound comprehensive processing module for processing the acquired ECG and homologous heart sound signals. The ECG and heart sound acquisition module includes an ECG acquisition module, a heart sound acquisition module, and a heart rate acquisition module. The ECG and heart sound comprehensive processing module includes a filtering circuit, an ECG signal baseline stabilization circuit, a signal amplification circuit, a computing chip, and an AD conversion circuit. The ECG signal and heart sound signal are acquired synchronously and are homologous, and the ECG and heart sound acquisition sensing points can overlap at the same location on the chest. The computing chip contains a blood pressure calculation module for blood pressure calculation and an electrocardiogram and heart sound parameter diagnosis module for diagnosing the electrocardiogram and heart sound parameters. The ECG and heart sound processing module and the parameter diagnosis module are both connected to the input of the statistics and weighted calculation module. The output of the weighted calculation module is electrically connected to the communication module, and the communication module is electrically connected to the display module. The real-time continuous blood pressure hemodynamics calculation module includes a radial artery pressure wave analysis module and a parameter diagnosis module. The radial artery pressure wave analysis module includes a pressure waveform feature extraction module, a pressure waveform feature amplification module, a pressure waveform feature calculation module, and a pressure calculation module. The radial artery pressure wave analysis module is a flattened tension method radial artery pressure wave analysis module. The ECG and heart sound detection module acquires ECG signals and heart sound signals from the same source, and converts them into digital signals. One of the ECG signals is acquired at the wrist, and the other leads are at the chest. The ECG and heart sound integrated processing module is used to filter noise, stabilize the baseline, calculate individual ECG and heart sound parameters and parameters between ECG and heart sound, and perform AD conversion processing on the acquired ECG and heart sound signals. The parameter diagnosis module calculates real-time continuous blood pressure, cardiac output, and cardiac contractility, while the pressure calculation module calculates stroke pressure, diastolic blood pressure, and cardiac output. The real-time continuous blood pressure hemodynamics calculation module acquires the radial artery pressure wave based on the flattening tension method, and then calculates the real-time continuous blood pressure or cardiac output based on the flattening tension method pressure wave. The radial artery pressure wave analysis module is used to extract features, amplify, and calculate the acquired pressure waveform. The data calculation method includes: Step 1: Use the signal acquisition module to acquire electrocardiogram (ECG) signals, heart sound signals, and radial artery pressure waves. ECG signal acquisition includes at least chest ECG signal acquisition and wrist one-lead ECG signal acquisition. Heart sound signals are acquired in the tricuspid auscultation area. The pressure sensor is placed directly above the radial artery to acquire the pressure waveform. The radial artery pressure wave acquisition is performed simultaneously with the wrist ECG signal acquisition. The position of the wrist ECG acquisition is offset from or overlaps with the position of the radial artery pressure sensor. Step 2: Extract features from the ECG signals, heart sounds, and radial artery pressure waves acquired in Step 1; extract the highest point of the R wave group and the RR interval as ECG signal features based on the acquired ECG signals; extract the peak value of the first heart sound S1, the peak value of the second heart sound S2, the R wave group, and the P wave group as signal features; extract the peak point, dicrotic wave point, descending isthmus point, and trough point of the pressure waveform as signal features; Step 3: Perform data calculations based on the features extracted in Step 2. For the ECG signal, estimate the time required for the pre-ejection phase (PEP) based on the RR interval, the time from the highest point of the R-wave group to the rapid ejection phase initiation u of the pressure waveform (RWPWTT), and the time from the highest point of the R-wave group to the peak point M1 of the first heart sound S1 (RWPWIT). Finally, calculate the time difference PWTT1 using the formula PWTT1 = RWPWTT - RWPWIT. Simultaneously, calculate the heart rate HR1 based on the highest point interval of the R-wave group obtained in the above steps. Calculate the pulse transit time PWTT2 based on the time difference from the peak point A2 of the second heart sound S2 in the heart sound signal to the dicrotic wave point In of the pressure waveform. Simultaneously, calculate the heart rate HR2 based on the main wave peak interval of the pressure waveform obtained in the above steps. Calculate PWTT1, PWTT2, HR1, and HR2 respectively. Step 4: Calculate the real-time continuous blood pressure based on the blood pressure regression model. Step 5: The continuous blood pressure data obtained in Step 4 and the blood pressure data obtained from the real-time continuous blood pressure hemodynamic calculation module are cross-calibrated and weighted to obtain the weighted real-time continuous blood pressure, which is then displayed through the display module. The data obtained by the flat tension method, i.e., the data obtained by the hemodynamic device, accounts for 60%-90%, while the continuous blood pressure value obtained by calculation accounts for 10%-40%. The weighted average is used to obtain the real-time continuous blood pressure value. Other data in Step 4 that do not involve blood pressure calculation can be directly displayed through the display module after calculation and processing.

2. The data calculation method for a non-invasive, continuous, real-time integrated device for blood pressure, hemodynamics, electrocardiogram, heart sounds, and cardiac function according to claim 1, characterized in that: Both the blood pressure calculation module and the pressure calculation module are connected to the input of the statistics and weighted calculation module.

3. The data calculation method for a non-invasive, continuous, real-time integrated device for blood pressure, hemodynamics, electrocardiogram, heart sounds, and cardiac function according to claim 1, characterized in that: The ECG acquisition module includes a wrist-based one-lead ECG signal acquisition module and a chest ECG signal acquisition module.

4. The data calculation method for a non-invasive, continuous, real-time integrated device for blood pressure, hemodynamics, electrocardiogram, heart sounds, and cardiac function according to claim 3, characterized in that: The ECG acquisition module also includes other limb ECG signal acquisition modules.

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