A device for functional assessment of coronary arteries

Abstract

The present application relates to the technical field of medical evaluation. A device for evaluating the function of coronary arteries is provided, comprising: a data acquisition module for synchronously acquiring multi-modal physiological data of a target coronary artery; the data acquisition module comprises a contrast image acquisition unit, a pressure waveform acquisition unit, an electrocardiogram acquisition unit and a blood flow velocity acquisition unit; a data processing module is in communication connection with the data acquisition module, and is internally provided with a hemodynamic parameter calculation circuit for filtering, fusing and parameter operation on the multi-modal physiological data, and outputs instantaneous blood flow state parameters, instantaneous blood flow resistance parameters, blood flow dynamic simulation parameters and reserve function derivative parameters; an evaluation module is in communication connection with the data processing module, and is used for outputting quantitative evaluation data of the function of the coronary artery based on a preset hardware evaluation model. The device can comprehensively and quantitatively and accurately evaluate the blood flow and function of the coronary artery, while maintaining high accuracy, reducing operation complexity and cost burden.

Description

Technical Field

[0001] This invention relates to the field of medical assessment technology, and more specifically to a device for assessing the function of coronary arteries. Background Technology

[0002] In the field of cardiovascular medicine, coronary artery disease (CAD) is a highly prevalent disease that continues to pose a serious threat to global public health. Therefore, accurate diagnosis of CAD, optimized selection of treatment plans, systematic evaluation of treatment effects, and dynamic adjustment of treatment plans are particularly important.

[0003] Currently, the main methods used clinically for CAD assessment include coronary angiography, intravascular ultrasound, optical coherence tomography (OCT), and fractional flow reserve (FFR). Coronary angiography, intravascular ultrasound, and OCT primarily assess coronary artery lesions by providing anatomical information about the degree of stenosis. However, these methods mainly focus on local lesions and cannot comprehensively quantify the cumulative effect of diffuse epicardial vascular disease. Although fractional flow reserve (FFR) provides a functional evaluation standard, mainly used to assess the degree of epicardial vascular stenosis, its ability to assess microcirculatory disturbances is limited, and it cannot directly measure the specific value of the total coronary blood flow, thus limiting its value in assessing myocardial perfusion. Furthermore, to assess coronary microcirculation function, clinical practice has introduced indicators such as the Index of Microcirculatory Resistance (IMR) and Coronary Flow Reserve (CFR). However, these indicators still face challenges in clinical application, including high operational complexity, heavy costs, and accuracy issues influenced by the specific coronary artery condition.

[0004] Given the many shortcomings of existing assessment methods in CAD evaluation, it is particularly urgent to develop a new technology that can comprehensively, accurately, and cost-effectively assess coronary blood flow and function. Summary of the Invention

[0005] This invention provides a coronary artery function assessment device to address the shortcomings of existing technologies in assessing coronary artery blood flow and function that are not comprehensive or accurate enough.

[0006] This application provides a coronary artery function assessment device, comprising:

[0007] A data acquisition module is used to simultaneously acquire multimodal physiological data of the target coronary artery. The data acquisition module includes an angiography image acquisition unit, a pressure waveform acquisition unit, an electrocardiogram acquisition unit, and a blood flow velocity acquisition unit. The blood flow velocity acquisition unit directly acquires the function of blood flow velocity changing over time through a velocity-measuring guidewire inserted into the target blood vessel, and simultaneously acquires pressure waveforms and electrocardiogram signals to obtain the multimodal physiological data.

[0008] The data processing module is communicatively connected to the data acquisition module and has a built-in hemodynamic parameter calculation circuit for filtering, fusing and calculating parameters of the multimodal physiological data, and outputting instantaneous blood flow state parameters, instantaneous blood flow resistance parameters, blood flow dynamic simulation parameters and reserve function derived parameters.

[0009] The evaluation module, which is communicatively connected to the data processing module, is used to output quantitative evaluation data of coronary artery function based on a preset hardware evaluation model.

[0010] According to the coronary artery functional assessment device described above, the data processing module performs the following calculation steps through the built-in hemodynamic parameter calculation circuit to obtain the hemodynamic parameters:

[0011] Based on the angiography images acquired by the angiography image acquisition unit in the data acquisition module, the instantaneous blood flow state parameters are determined by the preset image analysis algorithm circuit; the instantaneous blood flow state parameters include: instantaneous coronary artery blood flow velocity prediction ICFVE and instantaneous coronary artery blood flow volume prediction ICBFVE;

[0012] Based on the pressure waveform signal acquired by the pressure waveform acquisition unit in the data acquisition module, and combined with the instantaneous coronary blood flow rate prediction (ICBFVE), the instantaneous blood flow resistance parameter is determined by further calculation through the resistance calculation circuit; the instantaneous blood flow resistance parameter includes: the instantaneous cardiac blood supply system resistance prediction (ICCRE);

[0013] Based on the instantaneous cardiac blood supply system resistance prediction value ICCRE, combined with the time-varying pressure waveform function acquired by the data acquisition module, the blood flow dynamic simulation parameters are determined through dynamic simulation calculation circuit; the blood flow dynamic simulation parameters include: real-time coronary artery blood flow simulation value RCFVS, and multi-cardiac cycle blood flow total simulation value MCFS.

[0014] Based on the multimodal physiological data collected by the data acquisition module in both resting and congested states, the parameter comparison and calculation circuit of the data processing module calculates the instantaneous coronary flow rate prediction (ICBFVE) and the instantaneous cardiac blood supply system resistance prediction (ICCRE) for the corresponding states, thereby generating derived parameters for assessing coronary artery reserve function and microcirculation status. The derived parameters include: coronary flow reserve prediction (CFR-e), microcirculation residual reserve fraction (CMR-RHR), and resistance variability index (RVI).

[0015] Based on the coronary artery functional assessment device described above, the hemodynamic parameter calculation circuit of the data processing module determines the instantaneous coronary artery blood flow velocity (ICFVE) using the following formula:

[0016] ICFVE=Vmax / 2

[0017] Where Vmax is the maximum blood flow velocity in the central region of the target coronary artery at the P wave node during diastole and the T wave node during systole.

[0018] Based on the coronary artery functional assessment device described above, the hemodynamic parameter calculation circuit of the data processing module determines the instantaneous coronary artery blood flow rate (ICBFVE) using the following formula:

[0019] ICBFVE=ICFVE×S

[0020] Wherein, ICFVE corresponds to the estimated blood flow velocity at the P wave node during diastole and the T wave node during systole, respectively; S is the cross-sectional area of ​​the target vessel.

[0021] Based on the coronary artery functional assessment device described above, the hemodynamic parameter calculation circuit of the data processing module determines the instantaneous cardiac blood supply system resistance prediction value (ICCRE) using the following formula:

[0022] ICCRE=[U 冠脉开口 -U 冠状静脉窦 ] / ICBFVE

[0023] Among them, the instantaneous cardiac blood supply system resistance prediction (ICCRE) corresponds to the blood flow prediction at the diastolic P wave node and the systolic T wave node, respectively; U 冠脉开口 These correspond to the pressure values ​​at the coronary artery ostia at the P wave node during diastole and the T wave node during systole, respectively; U 冠状静脉窦 The pressure values ​​of the coronary sinus correspond to the P wave nodes during diastole and the T wave nodes during systole, respectively.

[0024] Based on the coronary artery functional assessment device described above, the dynamic simulation circuit of the data processing module determines the real-time coronary artery blood flow simulation value (RCFVS) using the following formula:

[0025] RCFVS = f(t) / ICCRE (p / t)

[0026] Where f(t) is the time-pressure function, and ICCRE(p / t) corresponds to the ICCRE(p) of the P wave node during diastole and the ICCRE(t) of the T wave node during systole, respectively.

[0027] Based on the coronary artery functional assessment device described above, the dynamic simulation circuit of the data processing module determines the total simulated value (MCFS) of the multi-cardiac cycle blood flow using the following formula:

[0028] MCFS=∫(x)I(t)dt+∫(y)I(t)dt

[0029] Wherein, I(t) represents the simulated value function of real-time coronary blood flow rate calculated by the formula RCFVS=f(t) / ICCRE(p / t); x is the blood flow rate during the systolic phase of a single cardiac cycle (the systolic phase is uniformly taken as the R wave peak to the T wave end in the ECG signal); y is the blood flow rate during the diastolic phase of a single cardiac cycle (the diastolic phase is uniformly taken as the T wave end to the R wave peak in the ECG signal); and MCFS is the total simulated blood flow rate obtained by accumulating the actual integrals over multiple cardiac cycles.

[0030] Based on the coronary artery functional assessment device described above, the parameter comparison calculation circuit of the data processing module determines the estimated coronary flow reserve (CFR-e) using the following formula:

[0031] CFR-e=ICBFVE 无腺苷诱导 / ICBFVE 腺苷诱导

[0032] Among them, ICBFVE 无腺苷诱导 ICBFVE is the estimated instantaneous coronary blood flow at the P-wave node during diastole, measured in a natural resting state without adenosine use. 腺苷诱导 This is the estimated value of instantaneous coronary blood flow at the P wave node during diastole after maximal congestion is achieved by intracoronary injection of adenosine solution.

[0033] Based on the coronary artery functional assessment device described above, the parameter comparison calculation circuit of the data processing module determines the residual reserve fraction of microcirculation (CMR-RHR) using the following formula:

[0034] CMR-RHR=(ICCRE 无腺苷诱导 -ICCRE 腺苷诱导 ) / ICCRE 无腺苷诱导

[0035] Among them, ICCRE 无腺苷诱导 ICCRE is the estimated instantaneous cardiac blood supply resistance measured at the P wave node during diastole, with the target coronary artery at rest. 腺苷诱导 This is the estimated instantaneous cardiac blood supply system resistance measured at the P wave node during diastole after the blood vessels have reached maximum congestion following intracoronary injection of the vasodilator adenosine.

[0036] Based on the coronary artery functional assessment device described above, the parameter comparison and calculation circuit of the data processing module determines the resistance variability index (RVI) using the following formula:

[0037] RVI = (ICCRE) 收缩期 -ICCRE 舒张期 ) / ICCRE 收缩期 *100%

[0038] Among them, ICCRE 收缩期 ICCRE is the estimated transient cardiac blood supply resistance of the target coronary artery measured at the T-wave node during cardiac systole. 舒张期 The instantaneous cardiac blood supply system resistance estimate measured at the P wave node during cardiac diastole in the target coronary artery; the RVI is used to quantify the temporal modulatory intensity of myocardial mechanical compression on coronary artery resistance.

[0039] According to the coronary artery functional assessment device described above, the data processing module also incorporates a specialized analysis and computation circuit for performing at least one of the following specialized measurement functions based on the collected multimodal physiological data and calculated hemodynamic parameters:

[0040] Vasospasm-specific measurement: This is used to calculate the vasospasm relief rate by comparing diastolic blood flow parameters of the target blood vessel before and after nitroglycerin injection, in order to assess the degree of coronary artery spasm;

[0041] Coronary artery myocardial bridging appropriate heart rate determination: This is used to determine the individualized optimal heart rate range that enables optimal coronary blood supply by measuring and comparing the simulated total blood flow through the multi-cardiac cycle under different heart rate regulation states.

[0042] Measurement of safe blood pressure reduction range for hypertension: This is used to determine an individualized safe blood pressure reduction range under the premise of maintaining adequate coronary perfusion by measuring and comparing the simulated values ​​of total blood flow through multiple cardiac cycles under different blood pressure regulation states.

[0043] Furthermore, when the angiography image acquisition unit acquires DSA image data of the contrast agent flowing in the target coronary artery, it excludes the first frame image data after the contrast agent injection and selects the second or third frame and the image frame from which the contrast agent flow tends to be stable as the effective velocity measurement frame.

[0044] The coronary artery functional assessment device provided in this application, on the one hand, achieves a comprehensive quantitative assessment of coronary artery blood flow and function by simultaneously acquiring multimodal physiological data of the target coronary artery, including angiographic images, pressure waveforms, electrocardiograms, and blood flow velocities. On the other hand, the device's built-in hemodynamic parameter calculation circuit can perform real-time filtering, fusion, and parameter calculation on the acquired multimodal data, outputting various key indicators, including instantaneous blood flow state parameters and instantaneous blood flow resistance parameters. This real-time calculation capability allows physicians to obtain the hemodynamic characteristics of the patient's coronary arteries during surgery, providing a scientific basis for timely adjustments to the treatment plan. Furthermore, the output of blood flow dynamic simulation parameters and reserve function derived parameters is of great significance for predicting myocardial blood supply under different activity loads, helping to identify potential cardiovascular risks in advance and take preventive measures. Attached Figure Description

[0045] Figure 1 This is a schematic diagram of the coronary artery functional assessment device provided by the present invention. Detailed Implementation

[0046] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this invention. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0047] The applicant summarized the shortcomings of existing assessment methods as follows: First, coronary angiography, intravascular ultrasound, and optical coherence tomography (OCT) techniques are insufficient to reflect the impact of diffuse lesions on coronary function. Second, the accuracy of FFR in assessing epicardial vessels is affected by microcirculatory disturbances, and FFR has limited ability to assess microcirculatory function. Third, myocardial perfusion cannot be clearly determined without the aid of MRI and other methods. Fourth, quantitative control of heart rate is not possible in patients with coronary artery myocardial grafts. Although lowering the heart rate can prolong coronary perfusion time, excessively low heart rates can affect overall perfusion efficiency, and there is currently a lack of methods to determine the individualized optimal heart rate range and threshold. Fifth, the dynamic changes in epicardial vessel lesions and microvascular resistance, and their interaction, increase the difficulty of assessment. For patients with simple microcirculatory disturbances, the assessment difficulty is relatively small, but repeated hospitalizations for IMR and CFR measurements place a huge economic burden on the medical system and the patients themselves, and there are also additional surgical risks due to the complexity of the procedures. In this repeated process, patients are prone to reduce the frequency of follow-up examinations due to economic burden. Importantly, for patients with both elevated microvascular resistance and severe epicardial vascular stenosis, the reliability of assessment remains controversial, even when using FFR and CFR to separately evaluate epicardial vascular and microcirculatory function. One reason is that in patients with microcirculatory disturbances, vasoactive drugs may not minimize microcirculatory resistance, and intramyocardial pressure may increase, leading to inflated FFR values. Secondly, CFR is affected by both epicardial and microvascular resistance, potentially overestimating microvascular dysfunction. While IMR is less affected by epicardial vascular stenosis, its relatively complex measurement process and low availability of consumables limit its application. Although various existing examination methods can assess cardiovascular disease at different levels, they all have limitations and cannot fully meet actual clinical needs, necessitating the development of new assessment techniques.

[0048] Therefore, this application provides a coronary artery function assessment device. This device integrates the instantaneous coronary blood flow velocity estimation (ICFVE), instantaneous coronary blood flow volume estimation (ICBFVE), instantaneous cardiac blood supply system resistance estimation (ICCRE), real-time coronary blood flow volume simulation value (RCFVS), multi-cardiac-cycle total blood flow volume simulation value (MCFS), coronary flow reserve estimation (CFR-e), and coronary microvascular residual reserve. Eight functional indicators, including Fraction (CMR-RHR) and Resistance Variability Index (RVI), are used to assess coronary blood flow and function in the most cost-effective way.

[0049] The following section first introduces the operational methods involved in this application:

[0050] System Connection: Insert a 5F or 6F sheath via the radial or femoral artery approach, and inject 2000-3000 units of heparin intravenously. Connect the angiography catheter to the Y-valve, and the other end of the Y-valve is connected to a triple-port valve via an extension tube (the remaining connections of the triple-port valve are basically the same as those for coronary angiography, including saline, contrast agent, and pressure sensor. Except that the ring-handle syringe is replaced with a high-pressure syringe, the rest is identical). Connect the end of the triple-port valve to the high-pressure syringe via an extension tube. Advance the angiography catheter along the guidewire to the ascending aorta, remove the guidewire, vent air as in coronary angiography, and administer a small amount of contrast agent to ensure the catheter is filled with contrast agent. Rotate the angiography catheter into the ostium of the coronary artery to be measured. Insert a graduated guidewire into the angiography catheter through the Y-valve, until the tip of the guidewire reaches the proximal-mid segment of the coronary artery (the graduated guidewire is for more accurate measurement; skip this step if no graduated guidewire is available).

[0051] (2) Injection of contrast agent: After opening the pressure valve and recording the pressure value U for a period of time (i.e., the pressure curve), close the pressure channel of the three-way valve and open the contrast agent injection channel simultaneously. After injecting a standard amount of contrast agent using an ECG-triggered high-pressure injector, acquire images of the contrast agent's flow in the blood vessels. If microcirculatory dysfunction is suspected, vasodilators such as adenosine injection can be pumped in after angiography, and the above operation can be repeated to prepare for the subsequent calculation of CFR and CMR-RHR.

[0052] Data collection

[0053] 1. Distance measurement:

[0054] In postoperative digital subtraction angiography (DSA) image analysis, the frame-by-frame tracking method was used to measure the movement distance L of the contrast agent tip between two adjacent frames of the target coronary artery. To ensure measurement accuracy, a calibrated guidewire (with the same diameter as the standard PCI working guidewire and metal markers spaced per millimeter) was used for calibration to eliminate image shortening errors caused by coronary artery tortuosity or different projection positions. Furthermore, since the guidewire moves synchronously with the heartbeat, motion compensation correction was performed using the guidewire markers to eliminate the influence of heartbeat on distance measurement. To reduce subjective bias in human interpretation, all image analyses were performed using Fiji / ImageJ software and followed the standardized workflow: Color coding and quantitative analysis: pseudo-color processing was applied to the coronary angiography images to enhance contrast. Time-density curve analysis (Time Series Analyzer V2): Time-density curves were plotted within the region of interest (ROI) to improve data reliability. The acquisition process is as follows: trigger one contrast agent injection during systole (at the onset of the T wave) and another during diastole (at the onset of the P wave) and acquire a DSA image for each of these phases, which will be used for subsequent hemodynamic analysis.

[0055] 2. Frame count timing:

[0056] The DSA image frame rate is 30 frames per second, and the single frame time is t=1 / 30s.

[0057] 3. Selection of representative nodes in the cardiac cycle:

[0058] In the subsequent calculations, this application requires identifying a point of strong cardiac contraction and a point of significant diastole during the systolic phase as measurement points. Therefore, the systolic phase is uniformly defined as the start of the T wave, at which point the heart is in the slowing ejection phase and in a contracted state; the diastolic phase is defined as the start of the P wave, at which point the heart has just passed the slowing filling phase and is in a diastolic state. These two time points are referred to below as the P-wave node and the T-wave node. High-pressure injection of contrast agent is performed to meet the injection of contrast agent at the P-wave and T-wave nodes through R-wave triggering delay.

[0059] The following is a description of the coronary artery functional assessment device provided in this application, such as... Figure 1 As shown, the device includes:

[0060] The data acquisition module 101 is used to synchronously acquire multimodal physiological data of the target coronary artery; the data acquisition module includes an angiography image acquisition unit, a pressure waveform acquisition unit, an electrocardiogram acquisition unit, and a blood flow velocity acquisition unit.

[0061] Specifically, the data acquisition module, as the data input terminal, integrates the angiography image acquisition unit (DSA equipment captures the contrast agent flow trajectory), the pressure waveform acquisition unit (barometer records the coronary artery ostium pressure curve), the electrocardiogram acquisition unit (synchronously segmenting cardiac cycle nodes), and the blood flow velocity acquisition unit, simultaneously acquiring multi-dimensional physiological data to provide a complete data source for subsequent analysis. For the blood flow velocity acquisition unit, this application directly acquires the function of blood flow velocity over time using a velocity-measuring guidewire inserted into the target blood vessel, and simultaneously acquires pressure waveforms and electrocardiogram signals to obtain multi-modal physiological data.

[0062] The angiography image acquisition unit utilizes DSA equipment and employs a frame-by-frame tracking method to acquire angiographic images of the target coronary artery. Specifically, after injecting contrast agent using a high-pressure injector pellet, the flow trajectory of the contrast agent within the blood vessel is simultaneously recorded. The focus is on capturing image data during cardiac systole (T wave node) and diastole (P wave node), providing a basis for calculating blood flow velocity and vessel cross-sectional area. The quantity, velocity, and pressure of the contrast agent supplied by the high-pressure injector are adjusted according to the needs of different subjects to ensure image clarity. Furthermore, the principle is that parameters should not be changed during multiple measurements of a single subject.

[0063] It should be noted that when the angiography image acquisition unit acquires DSA image data of the contrast agent flowing in the target coronary artery, a velocity frame selection strategy is adopted: the first frame image data after contrast agent injection is excluded, and the second or third frame onwards, before the outline of the contrast agent tip becomes blurred, are selected as valid velocity frames for calculating blood flow velocity-related parameters. Specifically, to avoid the influence of the initial unstable flow velocity of the contrast agent on the velocity measurement, this application adopts a strategy of excluding the first frame data: in previous experimental observations, it was found that the flow velocity of the contrast agent in the first frame is relatively slow, possibly in the process of being accelerated by blood pressure (possibly due to the inertia of the contrast agent, initially in a relatively static state), therefore the first frame is not included in the velocity calculation. From the second or third frame onwards, the flow of the contrast agent tends to be stable, and the distance change measured at this time is more reflective of the true blood flow velocity. Conversely, after too many frames, the outline of the contrast agent tip becomes blurred, making it difficult to calculate L.

[0064] The pressure waveform acquisition unit records the pressure curve at the coronary artery ostium via a pressure sensor connected to the angiography catheter. During acquisition, it is necessary to avoid pressure signal loss caused by contrast agent injection, select pressure values ​​from adjacent stable cardiac cycles, and ensure synchronization with the electrocardiogram time to provide key parameters for blood flow resistance calculation.

[0065] The electrocardiogram (ECG) acquisition unit simultaneously records the patient's ECG, primarily to determine the heart's current diastolic / systolic state, i.e., to identify P and T wave nodes, enabling precise ECG triggering for contrast agent injection and ensuring the matching of image acquisition, pressure measurement, and cardiac rhythm. It also prepares for subsequent cardiac cycle segmentation.

[0066] The blood flow velocity acquisition unit is used to acquire multimodal physiological data via a velocity-measuring guidewire (for measuring blood flow velocity). This application provides a method for acquiring multimodal physiological data using a velocity-measuring guidewire. A function curve of blood flow velocity changing over time can be obtained using the velocity-measuring guidewire. This application acquires synchronously timed blood flow velocity-time curves, electrocardiograms (ECGs), and pressure curves. The integral of the blood flow velocity curve and time, multiplied by the lumen area, yields a reference value for blood flow rate within that time period. The blood flow velocity-time function curve (i.e., the blood flow velocity-time function) multiplied by the lumen area yields a blood flow throughput-time function. Combining the ECG and pressure curves allows for the acquisition of other multimodal physiological data.

[0067] In summary, this application provides two methods for measuring multimodal physiological data: one is the image derivation method, and the other is the direct measurement method using a velocity guidewire.

[0068] The data processing module 102 is connected to the data acquisition module and has a built-in hemodynamic parameter calculation circuit. It is used to filter, fuse and perform parameter calculations on multimodal physiological data, and output instantaneous blood flow state parameters, instantaneous blood flow resistance parameters, blood flow dynamic simulation parameters and reserve function derived parameters.

[0069] Specifically, the data processing module standardizes the collected multimodal data through its built-in hemodynamic parameter calculation circuit to output four types of key parameters. Instantaneous blood flow state parameters directly reflect the basic hemodynamic characteristics of the coronary arteries at key nodes of the cardiac cycle and are fundamental indicators for assessing coronary blood supply capacity. These include the instantaneous coronary blood flow velocity (ICFVE) and the instantaneous coronary blood flow volume (ICBFVE). Instantaneous blood flow resistance parameters reflect the blood flow resistance level throughout the entire coronary artery pathway from the ostium to the microcirculation, with the core indicator being the instantaneous cardiac blood supply system resistance (ICCRE). Dynamic blood flow simulation parameters overcome the limitations of static measurement at a single node, dynamically reflecting the changes in coronary blood flow over time and the cumulative perfusion volume. These include the real-time coronary blood flow volume simulation value (RCFVS) and the multi-cardiac cycle total blood flow volume simulation value (MCFS). Coronary flow reserve parameters, derived from the comparison of resting and congestion-based dual-state data, assess the potential coronary blood supply capacity and microcirculatory function. These parameters include the predicted coronary flow reserve (CFR-e), the residual microcirculatory reserve fraction (CMR-RHR), and the resistance variability index (RVI). The data processing involves filtering the raw data (removing pressure signals and interference noise from imaging) and fusing the data (linking imaging, pressure, and ECG time axes) to ensure data consistency. These four parameters correspond to baseline blood flow, blood supply resistance, dynamic perfusion, and reserve function, respectively, achieving a comprehensive assessment of the epicardial vessels, microcirculation, and myocardial perfusion.

[0070] The evaluation module 103 is connected in communication with the data processing module and is used to output quantitative evaluation data of coronary artery function based on a preset hardware evaluation model.

[0071] Specifically, the assessment module, based on a pre-set hardware assessment model, transforms the four types of parameters output by the data processing module into clinically interpretable quantitative conclusions, including: epicardial vascular function, microcirculatory reserve capacity, total myocardial perfusion, and the effect of myocardial compression on coronary blood flow.

[0072] The coronary artery functional assessment device provided in this application, on the one hand, achieves a comprehensive quantitative assessment of coronary artery blood flow and function by simultaneously acquiring multimodal physiological data of the target coronary artery, including angiographic images, pressure waveforms, electrocardiograms, and blood flow velocities. Compared to traditional single-modal assessment methods (such as coronary angiography, intravascular ultrasound, and optical coherence tomography (OCT) which only provide anatomical information, and FFR which only provides functional information), this device can provide richer information dimensions, thus more accurately reflecting the true condition of the coronary arteries. On the other hand, the hemodynamic parameter calculation circuit built into this device can perform real-time filtering, fusion, and parameter calculation on the acquired multimodal data, outputting multiple key indicators including instantaneous blood flow state parameters and instantaneous blood flow resistance parameters. This real-time calculation capability allows doctors to obtain the hemodynamic characteristics of the patient's coronary arteries during surgery, providing a scientific basis for timely adjustment of treatment plans. Furthermore, through the output of blood flow dynamic simulation parameters and reserve function derived parameters, this device can simulate the changes in coronary artery blood flow under different physiological states and assess its reserve function. This is significant for predicting myocardial blood supply under different activity loads, helping to identify potential cardiovascular risks early and take preventative measures. Furthermore, compared to existing microcirculation function assessment indicators (such as IMR and CFR), this device maintains high accuracy while reducing operational complexity and cost. Its modular design makes each acquisition unit easy to integrate and maintain, and the high degree of automation in data processing reduces human error and improves assessment efficiency.

[0073] Furthermore, the data processing module provided in this application performs the following calculation steps through a built-in hemodynamic parameter calculation circuit to obtain the hemodynamic parameters:

[0074] Based on the angiography images acquired by the angiography image acquisition unit in the data acquisition module, instantaneous blood flow state parameters are determined through calculations using a preset image analysis algorithm circuit. These instantaneous blood flow state parameters include: the instantaneous coronary artery blood flow velocity prediction (ICFVE) and the instantaneous coronary artery blood flow volume prediction (ICBFVE). Based on the pressure waveform signal acquired by the pressure waveform acquisition unit in the data acquisition module, combined with the instantaneous coronary artery blood flow volume prediction (ICBFVE), further calculations are performed by the resistance calculation circuit to determine the instantaneous blood flow resistance parameters. These instantaneous blood flow resistance parameters include: the instantaneous cardiac blood supply system resistance prediction (ICCRE). Based on the instantaneous cardiac blood supply system resistance prediction (ICCRE), combined with the time-varying pressure waveform function acquired by the data acquisition module, and further calculations are performed using the resistance calculation circuit, the instantaneous blood flow resistance parameters are determined. The dynamic simulation circuit calculates and determines the dynamic simulation parameters of blood flow. These parameters include: real-time coronary blood flow volume simulation value (RCFVS) and multi-cycle blood flow volume simulation value (MCFS). Based on the multimodal physiological data collected by the data acquisition module in both resting and congested states, the parameter comparison circuit of the data processing module calculates the instantaneous coronary blood flow volume prediction value (ICBFVE) and the instantaneous cardiac blood supply system resistance prediction value (ICCRE) for the corresponding states. This generates derived parameters for assessing coronary artery reserve function and microcirculation status. These derived parameters include: coronary blood flow reserve prediction value (CFR-e), microcirculation residual reserve fraction (CMR-RHR), and resistance variability index (RVI).

[0075] Specifically, this application, based on DSA images from the angiography image acquisition unit, uses image analysis algorithm circuits to track the contrast agent flow distance and time, derives ICFVE, and then, combined with the target vessel cross-sectional area S, calculates the instantaneous coronary blood flow prediction value ICBFVE, which essentially reflects the baseline velocity and flow level of coronary blood flow. Combining the coronary artery ostium pressure signal from the pressure waveform acquisition unit, a resistance calculation circuit calculates the instantaneous cardiac blood supply system resistance prediction value ICCRE according to Poiseuille's law, using pressure difference / blood flow, reflecting the total resistance from the coronary artery ostium to the microcirculation. Based on ICCRE and the time-varying pressure waveform function f(t), a dynamic simulation calculation circuit constructs the real-time coronary blood flow simulation value RCFVS; then, through an integral algorithm, the blood flow during systole and diastole of a single cardiac cycle is accumulated to obtain the multi-cardiac cycle total blood flow simulation value MCFS, realizing the quantification of dynamic changes in blood flow and cumulative perfusion. Based on two sets of multimodal data from the data acquisition module under resting and adenosine-induced hyperemia states, the corresponding ICBFVE and ICCRE are calculated by the parameter comparison and calculation circuit, and the estimated coronary flow reserve (CFR-e), microcirculation residual reserve fraction (CMR-RHR), and resistance variability index (RVI) are further derived to accurately assess coronary flow reserve function and microcirculation status.

[0076] The device provided in this application forms a complete computational chain from basic blood flow status (velocity, flow rate) to resistance, and then to dynamic simulation values ​​and reserve function parameters, forming a basic index-core index-derived index chain, thereby enabling comprehensive and accurate assessment of coronary artery function. Since adenosine injection hardly alters epicardial vascular resistance, CMR-RHR measurements under different conditions are used to offset epicardial vascular resistance interference, specifically assessing residual microcirculatory reserve function. RVI is used to quantify the impact of myocardial mechanical compression on coronary artery resistance, which helps identify the causes of ischemia (such as coronary artery spasm, microcirculatory disturbances, and myocardial bridging). The calculation of derived parameters based on resting / congestion dual-state data not only satisfies the etiological diagnosis of diseases such as coronary heart disease and non-obstructive coronary artery disease, but also directly assesses functional changes before and after treatment, providing quantitative evidence for efficacy monitoring.

[0077] Furthermore, the hemodynamic parameter calculation circuit of the data processing module provided in this application determines the estimated instantaneous coronary artery blood flow velocity (ICFVE) using the following formula:

[0078] ICFVE = Vmax / 2 = L / (2t)

[0079] Where Vmax is the maximum blood flow velocity in the central region of the target coronary artery at the P wave node during diastole and the T wave node during systole.

[0080] Specifically, Vmax is the maximum blood flow velocity in the central region of the target coronary artery. Based on the principle of parabolic blood flow velocity distribution in laminar flow under fluid dynamics, the velocity is fastest in the center of the vessel and slowest at the vessel wall. Its maximum value can be directly captured by the contrast agent flow trajectory or a velocity-measuring guidewire. Vmax is strictly limited to the onset of the P wave during diastole and the onset of the T wave during systole. The T wave node corresponds to the slowing ejection phase of the heart, when the ventricle is in a systolic state, and the P wave node corresponds to the moment after the slowing filling phase of the heart, when the ventricle is in a diastolic state. It can accurately reflect the hemodynamic characteristics of different cardiac cycle stages.

[0081] Under the physiological condition of laminar coronary blood flow, the average velocity of blood flow within the vessel is approximately half of the maximum velocity at the center. This application indirectly derives the average blood flow velocity (ICFVE) using the easily measurable Vmax, which simplifies the calculation process while ensuring that the results conform to physiological reality.

[0082] In the image derivation method, Vmax is calculated by the movement distance (L) of the contrast agent tip in the DSA image and the corresponding time (t) (Vmax = L / t), and then substituted into the formula to obtain ICFVE; in the direct measurement method by the velocity guidewire, Vmax is extracted from the blood flow velocity-time curve directly acquired by the velocity guidewire, without the need for image derivation.

[0083] The device provided in this application calculates the instantaneous coronary blood flow velocity (ICFVE) based on the blood flow velocity distribution characteristics under laminar flow conditions. It employs a simplified formula that halves the maximum velocity, avoiding complex fluid dynamics modeling. This reduces the computational load on the data processing module while ensuring the physiological reasonableness of the results, solving the problem of complex algorithm fitting required for traditional blood flow velocity measurements. Furthermore, Vmax can be obtained through conventional DSA image tracking (low cost) or direct acquisition via a velocimetry guidewire (high precision), requiring no additional specialized equipment. This perfectly adapts to the dual measurement scheme design, catering to the needs of both primary hospitals and high-end medical scenarios. In addition, this application limits Vmax measurements to two core time points: the P wave and the T wave, fully considering the influence of cardiac contraction and relaxation on coronary blood flow velocity, avoiding errors caused by random time point measurements, and enabling ICFVE to accurately reflect the blood flow state at different cardiac cycle stages.

[0084] Furthermore, the hemodynamic parameter calculation circuit of the data processing module of this application determines the estimated instantaneous coronary artery blood flow rate (ICBFVE) using the following formula:

[0085] ICBFVE = ICFVE × S = (L / 2t) * S

[0086] Wherein, ICFVE corresponds to the estimated blood flow velocity at the P wave node during diastole and the T wave node during systole, respectively; S is the cross-sectional area of ​​the target vessel.

[0087] Specifically, the instantaneous coronary blood flow rate prediction (ICBFVE) in this application specifies that it must correspond to the blood flow velocity predictions at the diastolic P wave node and the systolic T wave node, respectively (ICFVE). 舒张期 ICFVE 收缩期 This ensures that the calculation of blood flow rate is accurately matched with the critical state of the cardiac cycle. The core physical definition of blood flow rate (flow rate) is average flow velocity × flow cross-sectional area. Based on this fundamental principle, this application directly derives the flow rate parameter through simple multiplication, which not only conforms to the basic laws of fluid mechanics but also simplifies the calculation process and ensures the physical rationality of the results.

[0088] In the image derivation method, S is calculated from the diameter measured by DSA image; in the direct measurement method using the velocity guide wire, S can be determined by measuring the opening diameter.

[0089] It should be noted that the measurement location of the target blood vessel cross-sectional area S in this application must meet the following criteria:

[0090] Blood vessel segment selection:

[0091] ①The measurement point of S is located in the proximal or mid-segment of the coronary artery (left anterior descending artery, circumflex artery, right coronary artery), and this segment should meet the following requirements: before the branch originates (to avoid underestimating the total blood flow due to shunt), and without severe atherosclerotic plaques or aneurysmal dilatations (to ensure that the vascular geometry is close to normal and to avoid turbulent segments).

[0092] ② Avoid the opening of blood vessels: Since the contrast agent has a low flow rate in the initial segment (determined by inertia from a static state to a dynamic state), it is necessary to wait for its flow rate to stabilize before measurement. Therefore, the proximal segment is preferred for measurement.

[0093] Multi-position imaging verification: The diameter of blood vessels is measured by multi-position DSA. When the difference is <15%, the area is calculated as a circular cross-section, and the area S is calculated based on the diameter.

[0094] The device provided in this application is based on the fundamental physical principle that velocity × area = flow rate. It eliminates the need for complex fluid dynamics modeling or multi-parameter fitting, reducing the computational load on the data processing module and minimizing human error, thus ensuring stable and repeatable calculation results across different scenarios. Furthermore, this application clearly defines the dual-node value requirements for ICFVE and strictly specifies the measurement location and verification method for S, avoiding result deviations caused by non-standard parameter measurements. This addresses the pain point of arbitrary blood vessel cross-section measurements in traditional flow calculations.

[0095] Furthermore, the hemodynamic parameter calculation circuit of the data processing module described in this application determines the instantaneous cardiac blood supply system resistance estimate ICCRE by calculating the following formula:

[0096] ICCRE=[U 冠脉开口 -U 冠状静脉窦 ] / ICBFVE

[0097] Among them, the instantaneous cardiac blood supply system resistance prediction (ICCRE) corresponds to the blood flow prediction at the diastolic P wave node and the systolic T wave node, respectively; U 冠脉开口 These correspond to the pressure values ​​at the coronary artery ostia at the P wave node during diastole and the T wave node during systole, respectively; U 冠状静脉窦 The pressure values ​​of the coronary sinus corresponding to the P wave node during diastole and the T wave node during systole are ignored in the calculation and are equivalent to ICCRE=U. 冠脉开口 / ICBFVE.

[0098] Specifically, combining Poiseuille's law, we know that ICCRE = [U 冠脉开口 -U 冠状静脉窦 ] / ICBFVE, U 冠状静脉窦 Negligible, therefore ICCRE=U 冠脉开口 / ICBFVE. The U value is taken from the pressure curve corresponding to the P-wave and T-wave nodes. Since the pressure curve is lost due to contrast agent injection, this application adopts the method of stopping the contrast agent injection, reopening the pressure valve, and waiting for the pressure curve to reappear and stabilize before selecting the pressure value corresponding to the pressure curve of the adjacent cardiac cycle. At the same time, it is necessary to ensure that the pressure curve and the electrocardiogram correspond in time. ICCRE represents the total resistance of blood flow from the coronary artery ostium to the microcirculation. Microcirculation resistance can be affected by many factors. Therefore, the subject is required to remain calm during the measurement to remove interference factors other than myocardial contraction and relaxation, so that the measured ICCRE can represent the resistance value at rest. The setting of calculating ICCRE separately for P-wave and T-wave nodes is based on the fact that coronary blood supply is generally higher in the diastolic state than in the systolic state, and coronary resistance is higher in the systolic state than in the diastolic state due to mechanical compression, etc. Therefore, one ICCRE is taken in the diastolic state and one in the systolic state to make it more representative.

[0099] In this application, the pressure difference is the pressure difference between the coronary artery ostium and the coronary sinus (reflecting the driving force of blood flow), and the flow rate is ICBFVE (reflecting the efficiency of blood flow). This fully complies with Poiseuille's law (the core law in fluid mechanics describing the relationship between resistance, pressure difference, and flow rate when laminar flow passes through a circular pipe), i.e., resistance = pressure difference / flow rate. The resistance parameters are directly derived from this law, ensuring that the results conform to physiological and engineering principles.

[0100] This application, based on Poiseuille's law, a well-established principle of fluid mechanics, directly derives resistance through the core relationship between pressure difference and flow rate. This avoids errors caused by complex modeling or empirical formulas, ensuring that the ICCRE accurately reflects the total resistance state of the coronary artery from its ostium to the microcirculation, thus conforming to the physiological essence of hemodynamics. Furthermore, this application clearly defines the dual-node value requirements for ICCRE, strictly regulating the timing of data acquisition and time synchronization calibration at the U-coronary ostium. Simultaneously, it ignores coronary sinus pressure, reducing interference from irrelevant parameters and avoiding result deviations caused by arbitrary value selection. This solves the problem of inconsistent parameter acquisition in traditional resistance measurements.

[0101] Furthermore, the dynamic simulation circuit of the data processing module of this application determines the simulated value of real-time coronary artery blood flow (RCFVS) using the following formula:

[0102] RCFVS = f(t) / ICCRE (p / t)

[0103] Where f(t) is the time-pressure function, and ICCRE(p / t) corresponds to the ICCRE(p) of the P wave node during diastole and the ICCRE(t) of the T wave node during systole, respectively.

[0104] Specifically, the theoretical value of real-time coronary blood flow is obtained from the time-pressure curve obtained on the monitor, yielding the time-pressure function U=f(t). Simultaneously, a function R=g(t) is established to represent the change in coronary blood flow resistance over time. Poiseuille's law is then applied to establish the function I(t)=f(t) / g(t) for the change in real-time coronary blood flow over time. Considering the inability to directly obtain the curve of the aforementioned R function, this application selects the ICCRE values ​​measured at the P-wave and T-wave nodes—two fixed resistance values ​​corresponding to the systolic and diastolic phases of the heart, respectively—as substitute indicators for R, thereby constructing the dynamic blood flow function RCFVS=f(t) / ICCRE(p / t). Based on this, the results calculated in this application are all simulated values ​​close to the theoretical values.

[0105] The device provided in this application addresses the limitation of traditional techniques that fail to capture dynamic changes in blood flow. Traditional indicators (such as ICBFVE and ICCRE) only reflect static parameters at specific nodes, while RCFVS combines dynamic pressure functions with dual-node resistance to generate a simulated curve of blood flow variation over time throughout the entire cardiac cycle. This provides a clear view of blood flow fluctuations during systole and diastole, overcoming the limitation of traditional techniques in capturing dynamic changes in blood flow. Furthermore, it avoids the technical challenges of directly obtaining continuous resistance functions (such as requiring high-frequency sampling and complex modeling). By employing a simplified design that substitutes typical node resistance, it reduces the computational load on the data processing module. Since the dual-node resistance already covers key states of the cardiac cycle, the simulation results error is kept within a clinically acceptable range, achieving a balance between efficient computation and accurate simulation.

[0106] Furthermore, the dynamic simulation circuit of the data processing module of this application determines the simulated total flow rate (MCFS) of the multi-cardiac cycle blood flow through the following formula:

[0107] MCFS=∫(x)I(t)dt+∫(y)I(t)dt

[0108] Where I(t) represents the simulated real-time coronary blood flow rate calculated by the formula RCFVS=f(t) / ICCRE(p / t); x is the blood flow rate during the systolic phase of a single cardiac cycle (the systolic phase is uniformly taken as the R-wave peak to the T-wave end in the ECG signal); y is the blood flow rate during the diastolic phase of a single cardiac cycle (the diastolic phase is uniformly taken as the T-wave end to the R-wave peak in the ECG signal). Note: RR is one cardiac cycle, with the systolic phase taken as the R-wave peak to the T-wave end in the ECG; and the diastolic phase taken as the T-wave end to the R-wave peak. Since real-time resistance changes cannot be obtained, we uniformly use the resistance value of the T-wave node, representing the heart's contraction state, instead of the systolic resistance value during the systolic phase. Similarly, the resistance value of the P-wave node is used instead of the diastolic resistance value. Therefore, the RCFVS, MCFS, etc., obtained are all simulated values. MCFS = ∫(x)I(t)dt + ∫(y)I(t)dt is the simulated total blood flow over multiple cardiac cycles. It equals the sum of the integral values ​​of systolic and diastolic blood flow within a single cardiac cycle, and is then accumulated based on the actual integral results from multiple cardiac cycles to obtain the total simulated blood flow. The pressure curve recording time is extended (e.g., 10 seconds), and the total perfusion volume within that time is calculated. It is particularly important to note that MCFS ≠ heart rate * [∫(x)I(t)dt + ∫(y)I(t)dt]. Here, I(t) directly uses the calculation result of the real-time coronary artery blood flow simulation function RCFVS = f(t) / ICCRE(p / t), which dynamically reflects the change in blood flow over time throughout the entire cardiac cycle, providing the basic data for the integration calculation. ∫(x)I(t)dt is the integral of I(t) during cardiac systole (R peak - end T), representing the total blood flow during the systolic phase of a single cardiac cycle; ∫(y)I(t)dt is the integral of I(t) during cardiac diastole (end T - R peak), representing the total blood flow during the diastolic phase of a single cardiac cycle. The sum of the two is the total blood flow during a single cardiac cycle. MCFS is not simply the total blood flow multiplied by the heart rate during a single cardiac cycle. Instead, it is obtained by extending the pressure curve recording time (e.g., 10 seconds) and summing the integrals of the systolic and diastolic phases over multiple consecutive cardiac cycles. This avoids the bias caused by fluctuations in a single cardiac cycle and better reflects the true level of continuous coronary blood supply. The fundamental physical principle that the integral of flow over time equals fluid volume means that the integral of blood flow (flow rate) over time represents the blood fluid volume (perfusion) within a specific time period. This application achieves accurate simulation of the total cumulative perfusion of the coronary arteries by integrating the real-time blood flow function during systole and diastole separately and then summing the results of multiple cardiac cycles, which conforms to the quantitative logic of hemodynamics.

[0109] The device provided in this application addresses the limitation of traditional techniques that cannot assess overall myocardial perfusion levels, as traditional indicators (such as ICBFVE) only reflect instantaneous blood flow at specific points. MCFS, however, directly quantifies the total continuous coronary perfusion through multi-cycle integration and accumulation, thus providing a direct quantitative basis for determining the adequacy of coronary blood supply. Furthermore, the design employing time-segmented integration and multi-cycle accumulation distinguishes between systolic and diastolic blood supply differences (aligning with the physiological characteristic of predominant diastolic blood supply in the coronary arteries) while avoiding the coarse estimation error of single-cycle × heart rate. This makes it particularly suitable for patients with fluctuating heart rates or unstable blood flow, resulting in more reliable results.

[0110] Furthermore, the parameter comparison and calculation circuit of the data processing module determines the estimated coronary flow reserve (CFR-e) using the following formula:

[0111] CFR-e = ICBFVE 无腺苷诱导 / ICBFVE 腺苷诱导

[0112] Among them, ICBFVE 无腺苷诱导 ICBFVE is the estimated instantaneous coronary blood flow at the P-wave node during diastole, measured in a natural resting state without adenosine use. 腺苷诱导 This is a predicted value of instantaneous coronary blood flow at the P-wave node during diastole, after intracoronary injection of adenosine to achieve maximum congestion. In patients suspected of having microcirculatory disturbances, assessment can be performed by calculating CFR-e, which includes an additional step of intracoronary injection of vasodilators to obtain ICBFVE under adenosine-induced conditions. Note: In the calculation of CFR-e, ICBFVE is consistently compared using the value at the P-wave node. The natural resting state refers to a relatively stable state of vital signs such as heart rate and blood pressure, as well as emotional state, without the use of vasoactive drugs or with sufficient drug washout time.

[0113] The device provided in this application quantifies the potential for increased blood flow in the coronary arteries under vasodilatory stimulation by comparing resting and congested states, directly reflecting coronary reserve function (including epicardial vasodilatory capacity and microcirculatory reserve capacity), thus solving the problem that traditional single-state measurements cannot assess reserve potential. Furthermore, adenosine is a routinely used vasodilator in clinical practice, readily available and inexpensive; the measurement process requires no additional specialized equipment, only an additional adenosine injection and data acquisition on top of the existing dual-measurement protocol. The operation is simple, with a low learning curve, suitable for both image-based derivation methods in primary hospitals and direct measurement methods using guidewires in high-end institutions, making it highly widely applicable.

[0114] Furthermore, the parameter comparison and calculation circuit of the data processing module of this application determines the microcirculation residual reserve fraction CMR-RHR by calculating the following formula:

[0115] CMR-RHR=(ICCRE 无腺苷诱导 -ICCRE 腺苷诱导 ) / ICCRE 无腺苷诱导

[0116] Among them, ICCRE 无腺苷诱导 ICCRE is the estimated instantaneous cardiac blood supply resistance measured at the P wave node during diastole, with the target coronary artery at rest. 腺苷诱导 This is the estimated instantaneous cardiac blood supply system resistance measured at the P wave node during diastole after the blood vessels have reached maximum congestion following intracoronary injection of the vasodilator adenosine.

[0117] Specifically, the fractional residual reserve of microcirculation is equal to the estimated instantaneous cardiac blood supply system resistance at rest (ICCRE). 无腺苷诱导 ) and the estimated transient cardiac blood supply system resistance under adenosine-induced maximal congestion (ICCRE) 腺苷诱导 The difference is then divided by the resting ICCRE. 无腺苷诱导 This value is specifically designed to quantify the overall reserve potential of coronary circulation and assess the body's exercise tolerance under high myocardial oxygen consumption conditions. It is a core indicator for achieving a comprehensive assessment of complex coronary artery lesions. This indicator simultaneously incorporates the inherent effects of epicardial vascular lesions, the microcirculatory resting compensatory effect caused by epicardial lesions, and the functional status of the microcirculation itself. It can achieve a quantitative assessment of the cumulative effects of multiple epicardial and microcirculatory lesions. The value ranges from 0 to 1, with higher values ​​indicating a greater space for microcirculatory adjustment of blood flow resistance. It does not require differentiation of lesion origin and directly reflects the overall reserve function of coronary circulation. Its value lies in quantifying exercise tolerance and providing guidance for rehabilitation throughout the entire disease course.

[0118] This application requires no additional specialized equipment or consumables. It only adds an adenosine injection and data acquisition to the existing dual measurement protocol. The operation process and CFR-e measurement can be completed simultaneously without increasing the operation time or the patient's financial burden. It is suitable for the image derivation method in primary hospitals and the direct measurement method of the velocity guidewire in high-end institutions.

[0119] Furthermore, the parameter comparison and calculation circuit of the data processing module determines the resistance variation index RVI by calculating the following formula:

[0120] RVI = (ICCRE) 收缩期 -ICCRE 舒张期 ) / ICCRE 收缩期 *100%

[0121] Among them, ICCRE 收缩期 ICCRE is the estimated transient cardiac blood supply resistance of the target coronary artery measured at the T-wave node during cardiac systole.舒张期 The RVI is an estimated value of the instantaneous cardiac blood supply system resistance measured at the P-wave node during diastole of the target coronary artery; the RVI is used to quantify the temporal modulatory intensity of myocardial mechanical compression on coronary artery resistance. Essentially, it describes the contribution of cardiac compression to coronary artery resistance.

[0122] Specifically, the resistance variability index specifically reflects the temporal modulatory strength of coronary artery resistance caused by myocardial mechanical compression. Essentially, it describes the contribution of cardiac compression to coronary artery resistance.

[0123] The device provided in this application addresses the challenge of traditional techniques failing to accurately distinguish between ischemia caused by myocardial compression and ischemia caused by vascular stenosis / microcirculatory disturbances. By using Relative Viscosity Index (RVI), it transforms the abstract impact of myocardial mechanical compression into a quantifiable percentage indicator, providing direct evidence for identifying diseases with myocardial compression as a core cause, such as coronary artery bridging and myocardial hypertrophy. RVI is presented as a percentage; a higher value indicates a greater regulatory effect of myocardial compression on coronary resistance (e.g., RVI is typically significantly elevated in patients with coronary artery bridging). Physicians can quickly determine the cause based on the numerical value; if RVI is significantly elevated, myocardial compression-related diseases should be considered first.

[0124] Furthermore, the data processing module also incorporates a specialized analysis and computation circuit for performing at least one of the following specialized measurement functions based on the collected multimodal physiological data and calculated hemodynamic parameters:

[0125] Specific measurement for vasospasm: This method compares diastolic blood flow parameters in a target vessel before and after nitroglycerin injection to calculate the vasospasm relief rate, thereby assessing the degree of coronary artery spasm. That is, Coronary Spasmolysis Rate (CSR) = (MCFS) 使用硝酸甘油后 -MCFS 使用硝酸甘油前 ) / MCFS 使用硝酸甘油后 *100%;

[0126] Coronary artery myocardial bridging appropriate heart rate determination: This is used to determine the individualized optimal heart rate range for achieving optimal coronary blood supply by measuring and comparing the simulated total blood flow through the multi-cardiac cycle under different heart rate control states; Hypertension lowering safe range measurement: This is used to determine the individualized safe blood pressure lowering range under the premise of maintaining adequate coronary perfusion by measuring and comparing the simulated total blood flow through the multi-cardiac cycle under different blood pressure control states.

[0127] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A device for assessing the function of coronary arteries, characterized in that, include: The data acquisition module is used to simultaneously acquire multimodal physiological data of the target coronary artery; The data acquisition module includes an angiography image acquisition unit, a pressure waveform acquisition unit, an electrocardiogram acquisition unit, and a blood flow velocity acquisition unit. The blood flow velocity acquisition unit directly acquires the blood flow velocity as a function of time through a velocity-measuring guidewire inserted into the target blood vessel, and simultaneously acquires pressure waveforms and electrocardiogram signals to obtain the multimodal physiological data. The data processing module, communicatively connected to the data acquisition module, has a built-in hemodynamic parameter calculation circuit for filtering, fusing, and calculating parameters of the multimodal physiological data, outputting instantaneous blood flow state parameters, instantaneous blood flow resistance parameters, blood flow dynamic simulation parameters, and reserve function derived parameters. Based on the angiography images acquired by the angiography image acquisition unit in the data acquisition module, the instantaneous blood flow state parameters are determined by the preset image analysis algorithm circuit; the instantaneous blood flow state parameters include: instantaneous coronary artery blood flow velocity prediction ICFVE and instantaneous coronary artery blood flow volume prediction ICBFVE; Based on the pressure waveform signal acquired by the pressure waveform acquisition unit in the data acquisition module, and combined with the instantaneous coronary blood flow rate prediction (ICBFVE), the instantaneous blood flow resistance parameter is determined by further calculation through the resistance calculation circuit; the instantaneous blood flow resistance parameter includes: the instantaneous cardiac blood supply system resistance prediction (ICCRE); Based on the instantaneous cardiac blood supply system resistance prediction value ICCRE, combined with the time-varying pressure waveform function acquired by the data acquisition module, the blood flow dynamic simulation parameters are determined through dynamic simulation calculation circuit; the blood flow dynamic simulation parameters include: real-time coronary artery blood flow simulation value RCFVS, and multi-cardiac cycle blood flow total simulation value MCFS. Based on the multimodal physiological data collected by the data acquisition module in both resting and congested states, the parameter comparison and calculation circuit of the data processing module calculates the instantaneous coronary flow rate prediction (ICBFVE) and the instantaneous cardiac blood supply system resistance prediction (ICCRE) for the corresponding states, thereby generating derived parameters for assessing coronary artery reserve function and microcirculation status. These derived parameters include: coronary flow reserve prediction (CFR-e), microcirculation residual reserve fraction (CMR-RHR), and resistance variability index (RVI). The hemodynamic parameter calculation circuit of the data processing module determines the estimated instantaneous coronary blood flow velocity (ICFVE) using the following formula: ICFVE=Vmax / 2 Where Vmax is the maximum blood flow velocity in the central region of the target coronary artery at the P wave node during diastole and the T wave node during systole. The hemodynamic parameter calculation circuit of the data processing module determines the estimated instantaneous coronary blood flow rate (ICBFVE) using the following formula: ICBFVE=ICFVE×S Wherein, ICFVE corresponds to the estimated blood flow velocity at the P wave node during diastole and the T wave node during systole, respectively; S is the cross-sectional area of ​​the target vessel. The hemodynamic parameter calculation circuit of the data processing module determines the instantaneous cardiac blood supply system resistance estimate ICCRE by calculating the following formula: ICCRE=[U 冠脉开口 -IN 冠状静脉窦 ] / ICBFVE Among them, the instantaneous cardiac blood supply system resistance prediction (ICCRE) corresponds to the blood flow prediction at the diastolic P wave node and the systolic T wave node, respectively; U 冠脉开口 These correspond to the pressure values ​​at the coronary artery ostia at the P wave node during diastole and the T wave node during systole, respectively; U 冠状静脉窦 The pressure values ​​of the coronary sinus corresponding to the P wave node during diastole and the T wave node during systole, respectively; The dynamic simulation circuit of the data processing module determines the real-time coronary blood flow simulation value (RCFVS) using the following formula: RCFVS = f(t) / ICCRE (p / t) Where f(t) is the time-pressure function, and ICCRE(p / t) correspond to the ICCRE(p) of the P wave node during diastole and the ICCRE(t) of the T wave node during systole, respectively. The dynamic simulation circuit of the data processing module determines the total simulated value (MCFS) of the multi-cardiac cycle blood flow through the following formula: MCFS=∫(x)I(t)dt+∫(y)I(t)dt Where I(t) is the simulated value function of real-time coronary blood flow rate calculated by the formula RCFVS=f(t) / ICCRE(p / t); x is the blood flow rate during the systolic phase of a single cardiac cycle, and y is the blood flow rate during the diastolic phase of a single cardiac cycle. During systole, the flow rate is uniformly taken as the R-wave peak to the T-wave end in the ECG signal, and during diastole, the flow rate is uniformly taken as the T-wave end to the R-wave peak in the ECG signal. ∫(x)I(t)dt represents the blood flow rate of I(t) during cardiac systole. The integral operation of I(t) during the systolic phase represents the total blood flow during the systolic phase of a single cardiac cycle; ∫(y)I(t)dt is the integral operation of I(t) during the diastolic phase of the heart, representing the total blood flow during the diastolic phase of a single cardiac cycle; the MCFS is the simulated total blood flow over multiple cardiac cycles, which is equal to the sum of the integral values ​​of the systolic and diastolic blood flow in a single cardiac cycle, and then the simulated total blood flow is obtained by summing the actual integral results of multiple cardiac cycles; The parameter comparison and calculation circuit of the data processing module determines the microcirculation residual reserve fraction CMR-RHR by calculating the following formula: CMR-RHR=(ICCRE 无腺苷诱导 -ICCRE 腺苷诱导 ) / ICCRE 无腺苷诱导 Among them, ICCRE 无腺苷诱导 ICCRE is the estimated instantaneous cardiac blood supply resistance measured at the P wave node during diastole, with the target coronary artery at rest. 腺苷诱导 The instantaneous cardiac blood supply system resistance is estimated at the P wave node during diastole after the blood vessels have reached maximum congestion following intracoronary injection of the vasodilator adenosine. The parameter comparison and calculation circuit of the data processing module determines the estimated coronary flow reserve (CFR-e) using the following formula: CFR-e=ICBFVE 无腺苷诱导 / ICBFVE 腺苷诱导 Among them, ICBFVE 无腺苷诱导 ICBFVE is the estimated instantaneous coronary blood flow at the P-wave node during diastole, measured in a natural resting state without adenosine use. 腺苷诱导 This is the estimated value of instantaneous coronary blood flow at the P wave node during diastole after maximal congestion is achieved by intracoronary injection of adenosine solution. The parameter comparison and calculation circuit of the data processing module determines the resistance variation index RVI by calculating the following formula: RVI=(ICCRE 收缩期 -ICCRE 舒张期 ) / ICCRE 收缩期 100% Among them, ICCRE 收缩期 ICCRE is the estimated transient cardiac blood supply resistance of the target coronary artery measured at the T-wave node during cardiac systole. 舒张期 The RVI is the instantaneous cardiac blood supply system resistance estimate measured at the P wave node during cardiac diastole; the RVI is used to quantify the temporal modulation intensity of myocardial mechanical compression on coronary artery resistance. The evaluation module, which is communicatively connected to the data processing module, is used to output quantitative evaluation data of coronary artery function based on a preset hardware evaluation model.

2. The coronary artery function assessment device according to claim 1, characterized in that, The data processing module also has a built-in specialized analysis and calculation circuit, which is used to perform at least one of the following specialized measurement functions based on the collected multimodal physiological data and the calculated hemodynamic parameters: Vasospasm-specific measurement: This is used to calculate the vasospasm relief rate by comparing diastolic blood flow parameters of the target blood vessel before and after nitroglycerin injection, in order to assess the degree of coronary artery spasm; Coronary artery myocardial bridging appropriate heart rate determination: This is used to determine the individualized optimal heart rate range that enables optimal coronary blood supply by measuring and comparing the simulated total blood flow through the multi-cardiac cycle under different heart rate regulation states. Measurement of safe blood pressure reduction range for hypertension: This is used to determine an individualized safe blood pressure reduction range under the premise of maintaining adequate coronary perfusion by measuring and comparing the simulated values ​​of total blood flow through multiple cardiac cycles under different blood pressure regulation states.

3. The coronary artery function assessment device according to claim 1, characterized in that, When the angiography image acquisition unit acquires DSA image data of the contrast agent flowing in the target coronary artery, it excludes the first frame image data after the contrast agent injection and selects the second or third frame and the image frame from which the contrast agent flow tends to be stable as the effective velocity measurement frame.

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