Non-invasive determination of resting state diastolic hemodynamic information

Abstract

A diastolic-based hemodynamic index, such as an instantaneous flow reserve fraction (IWFR), can be non-invasively calculated for a patient by receiving image data for each of the patient's anatomical regions, creating an electronic model of the anatomical region, creating one or more sets of boundary condition model values ​​representing flow conditions during diastole, calculating one or more pressure drops at a location within the anatomical region, and determining a hemodynamic index value, such as an IWFR, for the location based on the calculated pressure drop(s) and based on a reference pressure.

Description

[Technical field]

[0001] The present disclosure relates generally to the determination and display of patient hemodynamic information based on non-invasive imaging and computational fluid dynamics, including the determination and display of resting-state diastolic-based hemodynamic information, such as instantaneous wave-free ratio (IWFR).

[0002] [CROSS REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62 / 788,914, filed January 6, 2019, the entire contents of which are incorporated herein by reference. [Background technology]

[0003] Coronary heart disease (CHD) is the most common cause of death in the United States, with direct and indirect annual costs estimated at hundreds of billions of dollars. CHD is caused by atherosclerosis, which can progress to ischemia, angina, myocardial infarction, and death. Depending on the severity and complexity of the patient's lesions and clinical status, the patient may be offered a variety of treatment options, including medical therapy, endovascular stents, and coronary artery bypass graft (CABG) surgery. A typical diagnosis and treatment plan includes clinical evaluation, non-invasive stress testing, and, for suitable patients, invasive coronary angiography followed by medical therapy and / or coronary revascularization. Typically, if the patient undergoes medical therapy but has no change in symptoms or if a significant defect in myocardial perfusion is found, medical personnel will perform an invasive coronary angiogram on the patient. In such patients, the decision to revascularize using coronary stents or CABG surgery is made based on angiographic anatomy and, more recently, using hemodynamic information such as invasively measured fractional flow reserve (FFR). Measurement of FFR in the catheterization laboratory requires insertion of pressure wires into the patient's coronary arteries, and FFR values ​​below 0.8 are generally considered to indicate clinically significant obstructive lesions and would warrant revascularization in the appropriate clinical circumstances.

[0004] The instantaneous fractional flow reserve (IWFR) is a hemodynamic index that has been proven to have a diagnostic accuracy comparable to that of the FFR for identifying obstructive coronary lesions. Like the FFR, the IWFR is measured invasively using a pressure wire. Also like the FFR, the IWFR is defined as the ratio of the intravascular pressure (Pd) distal to the lesion(s) to the pressure (Pa) in the aorta. The IWFR differs from the FFR in several ways. First, the FFR requires the introduction of hyperemia during the measurement of the pressure ratio, whereas the IWFR does not. As a result, the FFR involves a more complicated measurement procedure than does the IWFR measured under resting conditions. Second, the FFR uses pressure averaged over the cardiac cycle, whereas the IWFR utilizes pressure measurements averaged during the so-called wave-free period of diastole, when the resistance to flow is approximately constant at a minimum value.

[0005] IWFR is not the only hemodynamic parameter measured under resting conditions during diastole. Other pressure ratio indices measured under resting conditions during diastole are the diastolic pressure ratio (dPR), which averages the ratio over 25% to 75% of the diastolic period, and the pressure ratio (dPR ) measured at the midpoint of diastole. mid ), both of which have been shown to have diagnostic accuracy comparable to IWFR. Summary of the Invention

[0006] A non-invasive determination of resting state diastolic hemodynamic information is disclosed herein. A first exemplary method for providing respective hemodynamic information of a patient can include obtaining a three-dimensional electronic model of the patient's coronary arteries and obtaining a set of boundary condition model values ​​representative of a diastolic period of the patient's cardiac cycle in the patient's resting state. The method can further include performing a three-dimensional computational fluid dynamics (CFD) simulation of the coronary artery model based on the set of boundary condition model values ​​and calculating a pressure drop between a first location of the coronary artery and a second location of the coronary artery according to the CFD simulation. The method can further include determining a hemodynamic index value indicative of the presence of a lesion at the location based on the calculated pressure drop and based on a reference pressure.

[0007] In one embodiment of the first exemplary method, the boundary condition model value set represents the entire diastolic period of the patient's cardiac cycle.

[0008] In one embodiment of the first exemplary method, the boundary condition model value set represents a wave-free period during the diastole of the patient's cardiac cycle.

[0009] In one embodiment of the first exemplary method, the boundary condition model value set represents a mid-diastolic point in the patient's cardiac cycle.

[0010] In one embodiment of the first exemplary method, the method further comprises creating the electronic model of the anatomical region.

[0011] In one embodiment of the first exemplary method, the method further includes receiving image data for each of the anatomical regions of the patient and creating the electronic model based on the received image data.

[0012] In one embodiment of the first exemplary method, the boundary condition model value set includes an inlet flow rate at the inlet of the coronary artery representing the patient's resting state, and two or more outlet flow rates calculated according to the inlet flow rate and a flow partitioning model.

[0013] In one embodiment of the first exemplary method, the method further includes identifying the flow partitioning model according to a shape of the three-dimensional model of the coronary artery, and calculating the inlet flow rate and the two or more outlet flow rates according to the flow partitioning model.

[0014] An exemplary embodiment of a system for providing hemodynamic information of a patient may include a non-transitory computer-readable memory storing instructions, and a processor configured to execute instructions to: obtain a three-dimensional electronic model of the patient's coronary arteries and obtain a set of boundary condition model values ​​representative of a diastolic period of the patient's cardiac cycle when the patient is in a resting state. The processor may be further configured to execute instructions to: perform a three-dimensional computational fluid dynamics (CFD) simulation of the coronary artery model based on the set of boundary condition model values, calculate a pressure drop between a first location of the coronary artery and a second location of the coronary artery according to the CFD simulation, and determine a hemodynamic index value indicative of a presence of a lesion at the location based on the calculated pressure drop and based on a reference pressure.

[0015] In one embodiment of the exemplary system, the boundary condition model value set represents the entire diastolic period of the patient's cardiac cycle.

[0016] In one embodiment of the exemplary system, the boundary condition model value set represents a wave-free period during the diastole of the patient's cardiac cycle.

[0017] In one embodiment of the exemplary system, the boundary condition model value set represents a mid-diastolic point in the patient's cardiac cycle.

[0018] In one embodiment of the exemplary system, the memory further stores instructions that, when executed by the processor, cause the processor to create the electronic model of the anatomical region.

[0019] In one embodiment of the exemplary system, the memory further stores instructions that, when executed by the processor, cause the processor to receive image data for each of the anatomical regions of the patient and create the electronic model based on the received image data.

[0020] In one embodiment of the exemplary system, the boundary condition model value set includes an inlet flow rate at the inlet of the coronary artery representing the patient's resting state, and two or more outlet flow rates calculated according to the inlet flow rate and a flow partitioning model.

[0021] In one embodiment of the exemplary system, the memory further stores instructions that, when executed by the processor, cause the processor to calculate the flow partitioning model according to a shape of the three-dimensional model of the coronary artery, and to calculate the two or more outlet flow rates according to the inlet flow rate and the flow partitioning model.

[0022] A second exemplary method of providing respective hemodynamic information of a patient may include obtaining a three-dimensional electronic model of an anatomical region of the patient, obtaining a boundary condition model representative of the patient in a resting state, and calculating a first pressure drop across a portion of the patient's anatomical region at a first time point in the patient's cardiac cycle based on the three-dimensional model and the boundary condition model. The second exemplary method may further include calculating a second pressure drop across the portion of the anatomical region at a second time point in the patient's cardiac cycle different from the first time point based on the three-dimensional model and the boundary condition model, calculating respective pressure drops across the region according to the first pressure drop and the second pressure drop for a range of time points in the patient's cardiac cycle, and determining a hemodynamic index value indicative of the presence of a lesion at the location based on the calculated pressure drops for the range of time points and based on a baseline pressure.

[0023] In one embodiment of the second exemplary method, the anatomical region is a blood vessel and the portion of the anatomical region extends from an entrance to the blood vessel to a location within the artery.

[0024] In one embodiment of the second exemplary method, the anatomical region is a coronary artery.

[0025] In one embodiment of the second exemplary method, the method further includes receiving image data for each of the anatomical regions of the patient and creating the electronic model based on the received image data. [Brief description of the drawings]

[0026] [Figure 1] FIG. 1 illustrates an exemplary embodiment of an electronic system for determining hemodynamic information of a patient. [Diagram 2] 1 is a flow chart illustrating one exemplary embodiment of a method for determining patient hemodynamic information based on electronic patient data. [Diagram 3]1 is a flow chart illustrating an exemplary embodiment of a method for determining hemodynamic information based on a single set of values ​​of a boundary condition model representing average flow conditions for a single point in time within a cardiac cycle or a portion of a cardiac cycle. [Figure 4] 1 is a flow chart illustrating an embodiment of a method for determining hemodynamic information based on two sets of boundary condition model values ​​representing two different cardiac cycle states. [Diagram 5] FIG. 1 illustrates an exemplary geometric model of an anatomical region of a patient that may be identified and find use in the methods of the present disclosure. [Figure 6] 1 is a plot showing an example range of pressure drop for an example range of flow rates for a set of patients. [Figure 7] FIG. 1 illustrates an example embodiment of a user computing environment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] Given the diagnostic accuracy of invasive IWFR and other diastolic pressure ratio indices, methods for calculating them using non-invasive imaging and numerical hemodynamics would be useful as tools in selecting patients who should or should not proceed to invasive diagnostic angiography. Because known hemodynamic indices, such as FFR, dPR, and IWFR, are measured invasively, and because approximately 50 percent of patients who undergo such invasive measurements are found to be free of obstructive disease, there is a clinical need for non-invasive diagnostic methods for determining IWFR and similar diastolic indices as screening tools.

[0028] Non-invasively acquired imaging data, such as CT images, and computational fluid dynamics (CFD), can be used to rapidly calculate the hemodynamic relationship between pressure and coronary flow over the range of expected blood flow requirements that a particular individual is likely to experience in their daily activities. This relationship can be used to non-invasively calculate certain indices of intra-arterial pressure loss, including IWFR and other diastolic pressure ratios that describe the degree of flow obstruction caused by coronary artery disease. In combination with other clinically derived information, a decision can be made whether an invasive diagnostic procedure or intervention is advisable.

[0029] Current approaches to calculating FFR assume hyperemic flow, which requires the assumption of an increase in flow from resting conditions to hyperemic conditions for a particular individual. This flow increase depends on the pathophysiological state of the individual and can vary from factors as large as 4 or 5 to as small as slightly more than 1, depending on the individual. Therefore, using an assumed resting flow (as required for IWFR) rather than an assumed hyperemic flow (for FFR) can reduce the uncertainty in the assumed inflow conditions of the CFD and therefore provide improved accuracy for CFD-based FFR.

[0030] Individuals vary in resting flow requirements depending on their physical condition and metabolic demands. Estimating resting flow for potentially diseased populations may be less variable than estimating flow under hyperemic conditions due to underlying pathophysiology, e.g., microvascular disease and other factors. Basing decisions to recommend invasive diagnostic procedures using calculations based on hyperemic flow conditions may not be appropriate for the general population. The present disclosure provides a non-invasive computational approach that simulates pressure drop during diastolic flow to provide important diagnostic information.

[0031] The present disclosure may further provide an improvement over known CFD-based FFR calculation methods by taking into account the patient's specific metabolic demands. In some embodiments, a more accurate CFD-based IWFR value may be calculated for a patient by incorporating information from the patient's daily metabolic activity. This patient-specific metabolic workload information may be used to provide the flow rate utilized in the IWFR calculation.

[0032] IWFR and other hemodynamic indices can be calculated based on flow fields in the patient's vasculature, which can be based on the Navier-Stokes equations of fluid motion. The Navier-Stokes equations can be used to describe flow fields in the coronary arteries, such as intravascular pressure and velocity in a region of interest (ROI), in some forms as a function of time and three-dimensional (3D) space, and in other forms as a function of 3D space only. From these flow fields, quantities of clinical interest can be calculated, such as pressure drop, FFR, instantaneous fractional flow reserve (IWFR), other diastolic pressure indices, intravascular pressure fluctuations, and forces on the arterial wall caused by viscous shear stress (wall shear stress (WSS)). CFD is used to solve the Navier-Stokes equations, which includes imposing boundary conditions on the ROI. The subject's vessel lumen geometry (obtained from CT or other imaging) is also included in the CFD, along with some combination of inflow flow rates (e.g., at a selected inflow boundary) and flow distribution in the vessel branch (e.g., one or more outflow flows). The pressure field within the ROI can be calculated as a deviation from a reference pressure, and therefore, the absolute level of pressure within the ROI, e.g., Pa, may not be necessary when calculating the pressure field. If a reference pressure (e.g., Pa) is identified, the absolute pressure within the field can be identified once the deviation from the reference is calculated.

[0033] For many clinical applications in coronary flow such as pressure drop, FFR and IWFR, the Navier-Stokes equations can be treated as time-independent (i.e., independent of the time dimension, but in three dimensions of space). For example, the time average of the pressure ratio Pd / Pa represents the average of the instantaneous pressure ratios, where Pd is the pressure in the ROI and Pa is the reference pressure. This means that three-dimensional CFD models are suitable for calculating these pressure indices, and therefore allow faster calculations than four-dimensional models (i.e., models that incorporate the three dimensions of space and time).

[0034] The pressure field within the ROI can be determined, for example, based on the flow rate within and around the ROI. For coronary flow and pressure, the relationship between flow rate and the pressure gradient (ΔP) between proximal and distal locations within the region of interest can be well approximated by a quadratic equation, as shown in Equation (1) below. ΔP=aQ+bQ 2 (Formula 1) where a and b are constants that depend on the patient's individual vascular geometry and blood viscosity and can be calculated for a given patient in a manner described below. Equation (1) has both physical and mathematical basis. Physically, the aQ term is related to the pressure loss that is directly due to blood viscosity, while bQ 2 The term is related to the pressure loss resulting from flow separation and turbulence (if present). 2 The term can be significant if the stenosis is large enough to cause flow separation. Mathematically, this equation can be viewed as the first two terms in a polynomial series expansion for ΔP=fcn(Q). Equation (1) determines the pressure drop across a region of the vasculature of a test patient whose flow field is determined via computational fluid dynamics.

[0035] To calculate a and b, the three-dimensional Navier-Stokes equations can be solved for two values ​​of Q. For example, a first value Q1 can represent the flow rate for the beginning of diastole (or another time point), and a second value Q2 can represent the flow rate for the end of diastole (or another time point). In other embodiments, Q1 can represent a first physiological state, and Q2 can represent a different second physiological state. These calculations will provide two values ​​for ΔP such that once Q1, Q2, ΔP1, and ΔP2 are known, the following equations (2) and (3) can be solved for a and b. ΔP1=aQ1+bQ1 2 (Formula 2) ΔP2=aQ2+bQ2 2 (Formula 3)

[0036] Once the coefficients a and b are known for a given patient, it is possible to calculate ΔP over a range of flow conditions (e.g., a range of physiologically relevant flow conditions) without requiring additional CFD for each flow condition within that range.

[0037] The clinical definition of IWFR is shown in equation (4) below. IWFR=Pd / Pa (Equation 4) where Pd and Pa are the distal coronary artery pressure and the aortic pressure, respectively, averaged over the diastolic wave-free period. Alternatively, the IWFR can be defined using the wave-free period value, as shown in equation (5) below. IWFR=1-ΔP / Pa (Equation 5)

[0038] Equations (4) and (5) can also be applied to calculate other indices by calculating Pd and Pa (in the case of equation (4)) or ΔP and Pa (in the case of equation (5)) at different parts or points of the cardiac cycle. For example, the diastolic pressure ratio (dPR) can be calculated by performing the calculation for the entire diastole.

[0039] Once Q1 and Q2 are determined (to determine ΔP at the beginning and end of the diastolic wave-free period, respectively, for IWFR) and Pa is determined for the beginning and end of the diastolic wave-free period, the IWFR value can then be calculated. For example, in one embodiment, a pressure vs. flow curve for diastole can be calculated, and the curve integrated and averaged to non-invasively calculate the IWFR value.

[0040] As described above, the IWFR value can be calculated by performing CFD under two different conditions (e.g., two different points in the cardiac cycle). Alternatively, in one embodiment, a single calculation can be performed to non-invasively calculate the IWFR based on a single representative Q value for the diastolic waveless period and a single representative Pa value. The representative Q value can be calculated according to the shape of the anatomical region of interest in some embodiments (as discussed below with respect to equation (9)).

[0041] As described above, one or more Pa values ​​are required as a reference pressure for IWFR calculation. In one embodiment, an upper arm cuff pressure measurement can be used to estimate this mean diastolic pressure. The cuff pressure provides the peak systolic pressure (SP) and the minimum diastolic pressure (DP). The resting mean aortic diastolic pressure (Pa) during the wave free period is calculated as dmean or dPa), which can be used for IWFR calculation, can in some embodiments be estimated from the SP and DP cuff values ​​according to the transfer function described in Equation 6 below. Pa dmean =(SP+3DP) / 4 (Equation 6) In other embodiments, other transfer functions can be used to relate the cuff pressure value to the reference pressure.

[0042] In another embodiment, the mean aortic diastolic pressure at rest (Pa) dmeanor dPa) can be calculated from the cuff pressure as shown in Equation 7 below. dPa=Pc+offset (Equation 7) where Pc is the resting upper arm cuff pressure given by Equation 8 below. Pc=dPc+FF*PP (Equation 8) where dPc is the diastolic cuff pressure, FF is a scalar form factor, and PP is the cuff pulse pressure (e.g., the difference between the systolic (SP) cuff pressure and the diastolic (DP) cuff pressure of the subject patient at rest). The scalar form factor FF can have a value between 0.15 and 0.45 and can be dependent on patient-specific characteristics including, for example, heart rate, age, height, systolic pressure, and / or augmentation index. In some embodiments, FF can be approximately 0.2, 0.25, or 0.33. In some embodiments, the offset value in Equation 7 can be between about 0 mmHg and -10 mmHg. In one embodiment, the offset value in Equation 7 can be approximately -7 mmHg. The value of the offset can be dependent, in some embodiments, on the value of the form factor FF, the desired hemodynamic index (and thus the portion of the cardiac cycle under test), and the physiological condition of the patient.

[0043] In other embodiments, the mean aortic diastolic pressure can be estimated using a transfer function that relates the cuff pressure to the aortic pressure during diastole. For example, the diastolic Pa value can be determined from the cuff pressure of a test patient by finding a form factor FF value and / or offset value that fits a data set that includes the invasively measured cuff pressure and the central diastolic resting pressure of a patient population. Once this function is known, it can be used to obtain an estimate of the diastolic resting pressure from the non-invasively measured cuff pressure.

[0044] In another embodiment, the mean aortic diastolic pressure can be estimated from a combination of an optical finger device or other wearable pressure measurement device (e.g., a radial tonometry device) and a brachial cuff pressure device. For example, a Fourier analysis can be performed on the optical finger device output and mathematically combined with the brachial cuff pressure to determine a value for Pa.

[0045] Referring to the drawings, in which like reference numbers refer to the same or similar features in the various drawings, Figure 1 is a diagram of an exemplary embodiment of an electronic system 10 for determining hemodynamic information. The exemplary system 10 may include a patient image source 12, a user input device 14, a hemodynamic information computing system 16, and a display 18. As described in more detail below, the system 10 may find use in calculating hemodynamic information for a patient based on electronic patient data (e.g., images and other data of a patient's region of interest) and / or making recommendations regarding further testing (e.g., further non-invasive or interventional evaluation) and / or interventional treatment for the patient based on the determined hemodynamic information.

[0046] In one embodiment, one or more aspects of system 10 may be deployed in a clinical environment. For example, in some embodiments, patient image source 12, user input device 14, hemodynamic information computing system 16, and display 18 may all be provided in a common clinical setting, such as a hospital. In some embodiments, components of system 10 may be embodied in a laptop or desktop computer or workstation. In some embodiments, some components of system 10, such as hemodynamic information computing system 16, may be remote from the clinical setting, such as in a cloud computing based implementation.

[0047] The patient image source 12 may include a medical image acquisition device configured to acquire one or more medical images of the vasculature of the subject patient. For example, the patient image source 12 may be a non-invasive image acquisition device. In some embodiments, the patient image source 12 may include, but is not limited to, a computed tomography (CT) acquisition device, an intravascular ultrasound (IVUS), a biplane angiogram, an optical coherence tomography (OCT), a magnetic resonance imaging (MRI), or a combination thereof, among others.

[0048] Additionally or alternatively, the patient image source 12 may include a store of existing image data of the patient under test. In some embodiments, the patient image source 12 may include a medical image storage device, such as a database or other local electronic data store, or a remote storage device (e.g., cloud-based storage) configured to store medical images.

[0049] User input device 14 may be or include one or more devices for input to a computing system, such as a mouse, a touchpad, a touchscreen, a keyboard, a microphone, a camera, or other input device.

[0050] The hemodynamic information computing system 16 may include a processor 20 and a non-transitory computer-readable memory 22 configured to store data and instructions. In one embodiment, the memory 22 may store images from a subject patient and thus function as the patient image source 12, or an aspect thereof. The processor 20 may be configured to execute instructions stored in the memory 22 to perform one or more of the steps, methods, algorithms, etc. of the present disclosure. In particular, the memory 22 may be configured to store various functional modules in the form of instructions, including a shape identification module 24, a boundary condition identification module 26, a flow field identification module 28, a pressure identification module 30, and a hemodynamic information identification module 32.

[0051] While the various modules 24, 26, 28, 30, 32 in memory 22 will be described separately, it should be understood that such separateness is merely for ease of discussion. The instructions in which the various modules are embodied may be in a common file, storage device, etc., and similarly, one or more of the modules described herein may be separate in multiple separate files, storage devices, etc.

[0052] The shape identification module 24 may be configured to generate an electronic shape representation (e.g., a model) of an anatomical region of interest (ROI) from images obtained from a patient image source. In some embodiments, the ROI may be a portion of the cardiovascular system of a subject patient, such as one or more arterial segments. The one or more arterial segments may include portions of one or more arteries and one or more branches extending therefrom.

[0053] In some embodiments, the one or more arterial segments may include one or more coronary artery segments. The one or more coronary artery segments may include portions of one or more coronary arteries originating from the subject's aorta and one or more branches extending therefrom. The one or more coronary artery segments may include, but are not limited to, one or more portions of the left coronary artery (LCA) and / or the right coronary artery (RCA). The one or more coronary artery segments of the left coronary artery (LCA) may include, but are not limited to, the left main coronary artery (LM), the left anterior descending artery (LAD), the left circumflex artery (also referred to as the "circumflex artery"), or a combination thereof, among others.

[0054] This disclosure will refer to coronary artery segments. However, it will be understood that the one or more arterial segments are not limited to the coronary artery segments discussed, and can include, among others, other coronary artery segments, other types of arterial segments, or combinations thereof. For example, the one or more arterial segments can include cerebral artery segment(s), femoral artery segment(s), iliac artery segment(s), popliteal artery segment(s), carotid artery segment(s), renal artery segment(s), etc.

[0055] In some embodiments, the shape representation generated by shape identification module 24 can be a three-dimensional (3D) electronic model of the spatial volume of one or more arterial segments. For example, the shape representation of one or more arterial segments can be discretized into a three-dimensional volumetric mesh, e.g., polyhedrons (e.g., tetrahedrons). In some embodiments, the shape representation can include a surface mesh that represents the boundary of the lumen of each arterial segment.

[0056] In some embodiments, boundary condition identification module 26 can be configured to identify boundaries for each arterial segment. A "boundary" can refer to a cross-section of the representation of the arterial segment and can include, among others, but is not limited to, an inflow boundary corresponding to a cross-section through which blood flows, one or more outflow boundaries corresponding to cross-sections downstream or distal from the inflow boundary through which blood flow is directed outward, one or more vessel wall boundaries corresponding to the interface between the inner surface of the arterial wall and the flowing blood, or a combination thereof.

[0057] In some embodiments, the one or more outflow boundaries can include an outflow boundary located at or adjacent to a junction (e.g., bifurcation, trifurcation, etc., and combinations thereof). In some embodiments, the one or more outflow boundaries can include an outflow boundary located at or adjacent to the left circumflex artery. In some embodiments, the one or more outflow boundaries can include a first outflow boundary and a second outflow boundary located between the inflow boundary and the first outflow boundary. In some embodiments, the first outflow boundary can correspond to a distal boundary of the segment (i.e., a cross-section located downstream or distal from the inflow boundary). In some embodiments, for example, if the shape representation includes the left coronary artery, the second outflow boundary can correspond to the circumflex artery. In some embodiments, the first outflow boundary and the second outflow boundary can be separated by one or more further outflow boundaries, e.g., at least a third outflow boundary. The third outflow boundary can correspond to or adjacent to a junction, such as a bifurcation or bifurcation.

[0058] In some embodiments, the boundary condition identification module 26 can be configured to identify shape data for each boundary using the shape representation generated by the shape identification module 24. In some embodiments, the shape data can include, but is not limited to, the radius, diameter, circumference, length, area of ​​the vessel, the volume of the epicardial coronary artery, or a combination thereof, among others.

[0059] In some embodiments, the boundary condition identification module 26 can be configured to identify boundary conditions for each boundary for each arterial segment. By way of example, the boundary conditions for each segment can include, among others, an inflow boundary condition, an outflow boundary condition, one or more vessel wall boundary conditions, or a combination thereof. The inflow boundary condition can be a value, or a range of values, of a velocity, flow rate, pressure, or other characteristic. Each outflow boundary condition can be a percentage of a velocity, flow rate, pressure, an inflow condition, or a value, or a range of values, of other characteristic. Each vessel wall boundary condition can be a value, or a range of values, of a velocity, flow rate, pressure, a combination thereof, or other characteristic.

[0060] In some embodiments, the inflow boundary condition and / or outflow boundary condition can be determined based on, among other things, patient information, the relevant physiological state (e.g., resting state, hyperemic state), the type of segment (e.g., LCA or RCA), or a combination thereof. In some embodiments, the inflow boundary condition can be determined according to an expected patient activity level (e.g., according to information provided by the patient). In some embodiments, the inflow boundary condition can be a stored value and / or can be specified by a user.

[0061] In some embodiments, the inflow boundary condition can be specified according to the shape of the anatomical ROI, such as the radius, diameter, length, or volume of the vessel portion (e.g., the volume of an epicardial coronary artery). For example, the flow rate can be calculated according to a model based on the lumen volume of the region of interest, as shown in Equation 9 below. Q in = αV β (Formula 9) Here, Q in is the flow rate at the inlet of the anatomical model, V is the luminal volume of the region of interest, α is a coefficient that depends on the physiological state of the patient, and β is a coefficient that depends on the vascular tree structure and, in some embodiments, the resolution of the images used to generate the 3D model of the anatomical region.

[0062] In embodiments where the region of interest is the coronary artery tree, V may be the luminal volume of the LCA or RCA defined from the proximal origin to a location where the diameter of the segmented vessel is a particular diameter, which may depend on the resolution of the images used to create the model of the patient's anatomy. For example, the location may be defined as 3 or 4 voxel diameters in the image dataset in some embodiments. In particular examples, the location may be where the lumen has a diameter of 1 mm or 1.5 mm.

[0063] In some embodiments, the parameters α and β can be constant across all patients and can be determined from an example data set having both non-invasive and invasive data against which the values ​​of α and β can be verified.

[0064] In some embodiments, the outflow boundary conditions can be identified using an outflow distribution model. The outflow distribution model can be identified using the shape data and / or the stored hemodynamic data. The stored hemodynamic data can define, or the stored hemodynamic data can be used to define, an empirical relationship between the shape (e.g., radius, diameter, length, volume, etc.) of the outflow boundary and the respective flow rate. For example, the boundary condition generation module can identify the outflow distribution model using the stored hemodynamic data and the radius, diameter, length, volume, etc. of the first outflow boundary and the second outflow boundary of the segment. In another example, the boundary condition generation module can identify the outflow distribution model using only the shape data, e.g., the radius, diameter, length, volume, etc. of the first outflow boundary (distal boundary) of the segment or the vessel portion proximal to the boundary. The outflow distribution model can be used to identify the outflow flow (e.g., velocity, flow rate, percentage of inflow flow) for each outflow boundary, thereby identifying each outflow boundary condition.

[0065] By way of example, the boundary conditions identified by the boundary condition identification module 26 can be used in steady and / or unsteady flow calculations to identify flow fields (e.g., blood flow, wall shear stress, etc.) and hemodynamic information (e.g., FFR, IWFR, etc.). The boundary condition identification module also uses optimization techniques to define flow partitioning of arterial segments. Thus, the boundary condition generation module 26 can provide versatility, accuracy, and efficiency in identifying boundary conditions.

[0066] The flow field identification module 28 can be configured to identify a flow field for each arterial segment using the shape representation identified by the shape identification module 24, the one or more boundary conditions identified by the boundary condition identification module 26, and the patient's respective pressure data. The pressure data can be, for example, the patient's cuff pressure at rest. In some embodiments, the flow field can include, but is not limited to, a pressure field, a velocity field, a wall shear stress field, an axial plaque stress field, or a combination thereof, among others.

[0067] In some embodiments, the flow field parameters (e.g., pressure fields, velocities, etc.) may be based solely on the geometric data and boundary conditions. In this manner, the flow field characterization module may be configured to characterize the flow field based solely on spatial position (i.e., independent of time).

[0068] Pressure determination module 30 can be configured to determine blood pressure at one or more points within the patient's anatomy using the flow field determined by flow field determination module 28. In some embodiments, pressure data can be determined from, among other things, a calculated flow field / pressure field, a non-invasive determination of the patient's mean blood pressure, for example as determined by a blood pressure cuff, or a combination thereof.

[0069] The pressure identification module 30 may be configured to identify a particular pressure at a particular location in the patient's anatomy in response to a user (e.g., physician) selection of the particular location. The user may input the selection using the user input device 14 in response to a representation of a geometric model of the patient's region of interest (e.g., an artery) on the display 18. In an embodiment, the pressure identification module may be configured to identify pressures upstream and / or downstream from the user-selected location to identify a pressure drop at the user-selected location.

[0070] The hemodynamic information computing system 32 can be configured to calculate one or more hemodynamic parameters, such as an IWFR or dPR, for each of the patients. Calculating the patient's IWFR can, in some embodiments, include calculating a range of pressure drops for one or more points in the patient's anatomy, for example, for a range of flow rates. In other embodiments, calculating the patient's IWFR, dPR, or other diastolic index can include calculating a single pressure drop using an average flow rate for some or all of the diastole (e.g., the diastolic waveless period). Based on the calculated IWFR value for the patient, the system 16 or a clinician can determine whether further diagnostic and / or interventional procedures should be performed.

[0071] 2 is a flow chart illustrating one exemplary embodiment of a method 40 for determining hemodynamic information for a patient. The method 40, or one or more aspects of the method 40, may be performed, in embodiments, by the hemodynamic information computing system 16 of FIG.

[0072] The method 40 may include receiving patient data at block 42. The patient data may include, for example, basic information about the patient, such as the patient's age, sex, upper arm cuff blood pressure, a description of the user's symptoms, etc. The patient data, in an embodiment, may further include patient metabolic data, such as the user's typical activity level (e.g., sedentary or active, amount of exercise per week, amount of specific activities per week, such as amount of walking and running, etc.). The patient data, in an embodiment, may further include patient data from one or more diagnostic tests, such as a cardiac ultrasound examination.

[0073] The method 40 may further include receiving an image of the patient's anatomy at block 44. The received patient image may, in embodiments, be a CT image, an MRI image, or other non-invasively obtained image. The image may include the patient's anatomical region of interest. In one embodiment, for example, the received image may include one or more coronary arteries or other vasculature of interest. The image may be received from a patient image source, for example, an imaging device or a database or other computer memory.

[0074] The method 40 may further include, at block 46, creating an anatomical model of each of the patient regions of interest based on the images received at block 44. In one embodiment, the anatomical model may be created by segmenting an anatomical structure of interest from the images received at block 44. The anatomical structure of interest may be, for example, one or more coronary arteries. FIG. 5 illustrates an exemplary anatomical model 58 of a coronary artery. The anatomical model may be created, in one embodiment, by the shape identification module 24 of FIG. 1. In some embodiments, the anatomical model may be obtained by a computing system (e.g., hemodynamic information computing system 16), created by a computing system, or by receiving an existing model of the subject patient.

[0075] Method 40 may further include identifying one or more diastolic-based boundary condition model value sets at block 48. The one or more boundary condition value sets, in one embodiment, may be respective sets of values ​​for the same boundary condition model (e.g., respective sets of condition values ​​for the same inflow boundary, outflow boundary, wall boundary, etc.). Block 48 may, in some embodiments, include subportions 48a and 48b. Thus, method 40 may include obtaining an inflow flow rate at block 48a. The inflow flow rate, in some embodiments, may be a flow rate at an entrance of the patient's anatomical ROI. In other embodiments, the blood flow rate may be a flow rate at another portion of the ROI.

[0076] The inflow rate obtained in block 48a may represent a particular physiological state of the patient. For example, in some embodiments, the inflow rate obtained in block 48a may represent a resting state of the patient.

[0077] The inflow flow rate obtained at block 48a, in some embodiments, may represent a desired point or portion of the patient's cardiac cycle. For example, in some embodiments, the inflow flow rate obtained at block 48a may represent an average flow rate over the entire waveless period of the patient's diastole. In other embodiments, the inflow flow rate may represent an average flow rate over the entire diastole of the patient. In other embodiments, the inflow flow rate may represent a particular point in time within diastole, for example, the midpoint of diastole.

[0078] In some embodiments, obtaining the inflow flow rate in block 48a may include calculating the inflow flow rate according to the shape of an anatomical model of the patient as discussed above with respect to equation (9). In one embodiment, the value of α selected for the inflow flow rate may represent a particular period or point in time within the cardiac cycle (e.g., start of diastole, end of diastole, start of diastolic wave-free period, end of diastolic wave-free period, etc.).

[0079] In other embodiments, instead of calculating the input flow rate according to Equation 9 above, obtaining the blood flow rate in block 48a may include receiving a user input of the input flow rate. The input flow rate may be received via a user manual input (e.g., using the user input device 14 of the system 10). In one embodiment, the input flow rate in block 48a may be specified (e.g., by a clinician or an electronic system) based on metabolic needs and patient conditions.

[0080] Block 48 may further include calculating, in block 48b, the outlet flow rates according to the inlet flow rates obtained in block 48a and according to a flow partitioning model. The flow partitioning model may be calculated or otherwise specified according to the geometry of a three-dimensional electronic model of the patient's anatomical region or may have been performed. The flow partitioning model may in some embodiments be calculated according to relative radii, diameters, circumferences, lengths, volumes, and / or surface areas of the blood vessels in the electronic model.

[0081] In conjunction with the flow obtained in block 48a, the outlet flow calculated in block 48b may include a boundary condition model of the patient's anatomical region. The boundary condition model may thus represent a particular physiological state of the patient (e.g., a resting state) and a particular portion or point in the patient's cardiac cycle (e.g., the entire diastole, a waveless portion of diastole, a point in diastole, etc.).

[0082] In embodiments where the anatomical region is a patient's coronary artery, the inflow flow rate obtained in block 48a may be the inlet flow rate of the coronary artery, and the flow partitioning model may be calculated according to the shape of the portion of the coronary artery downstream of the inlet in the electronic model. The flow partitioning model may be calculated according to the relative radius, diameter, circumference, length, surface area, or volume of the portion of the coronary artery downstream of the inlet. In some embodiments, the flow partitioning model may be calculated according to the volume of the epicardial coronary artery in the electronic model.

[0083] The method 40 may further include, at block 50, calculating one or more fluid dynamics flow fields of blood flow through the patient's anatomy based on the anatomical model (e.g., model 58), one or more boundary condition model value sets, and, in some embodiments, patient data. Block 50 may include identifying a flow field for each arterial segment using the anatomical model, the boundary conditions, and the patient's respective pressure data (e.g., aortic pressure data). In some embodiments, the pressure data may be obtained for the patient, e.g., for cuff pressure, and / or may be a stored value. In some embodiments, the flow field may include, but is not limited to, a pressure field, a velocity field, or a combination thereof, among others. The fluid dynamics may be calculated, in one embodiment, by flow field identification module 28 of FIG. 1.

[0084] In some embodiments, the velocity and / or pressure fields can be determined based only on boundaries and boundary conditions, without consideration of time. For example, the velocity and / or pressure fields can be determined using the steady flow Navier-Stokes equations, where the velocity and pressure variables are functions of spatial position only (i.e., time is not considered). In this way, pressures and velocities can be determined accurately and efficiently in near real time to enable point-of-care analysis by clinicians.

[0085] The method 40 may further include, at block 52, calculating diastolic based hemodynamic information for each of the patients based on the patient data and the calculated fluid dynamics. The hemodynamic information, in one embodiment, may be or may include a diastolic based index, such as an IWFR. Calculating the IWFR may include calculating one or more pressure drops for one or more locations in the patient's vasculature. The set of pressure drops may be analyzed with respect to aortic pressure during diastole to determine a hemodynamic index value.

[0086] Block 52 may include receiving a user designation of one or more clinically relevant distal points on the anatomical model of the patient at block 52a. For example, a user may input annotations of one or more distal points on the anatomical model of the patient's vasculature using a user input device, whereby the hemodynamic information computing system may receive the one or more annotations from the user. The indicated points may be, for example, one or more locations distal to a suspected stenosis in a coronary artery.

[0087] Block 52 may further include, at block 52b, calculating a respective pressure drop at each of the user-specified points for a first cardiac cycle state. The first state may be, for example, the beginning of diastole. The pressure drop may be calculated based on the flow field calculated for the first cardiac cycle at the one or more user-specified points. The remaining aspects of method 80 may be performed for each indicated point, in one embodiment, to determine whether the indicated point is likely to have a clinically significant stenosis.

[0088] The method 60 may further include displaying the flow rate, pressure, and / or hemodynamic information at block 54. The display may include, for example, one or more indicators of the flow rate, pressure, and / or hemodynamic information at one or more locations in the patient's vasculature superimposed on or adjacent a geometric model of the patient's anatomy.

[0089] The method 40 may further include recommending a further procedure for the patient based on the calculated hemodynamic information at block 56. For example, if the hemodynamic information is below a threshold that indicates the presence of a stenosis in the patient's vasculature, a further diagnostic procedure may be recommended for the patient, such as an invasive angiogram and pressure measurement at the site of the suspected stenosis. Additionally or alternatively, a corrective procedure may be recommended to address the stenosis, such as the placement of a stent at the suspected location of the stenosis.

[0090] 3 is a flow chart illustrating one exemplary embodiment of a method 60 for determining hemodynamic information based on a single set of values ​​of a boundary condition model that represents the average flow conditions for a single point in time within a cardiac cycle or a portion of a cardiac cycle. Method 60, or one or more aspects of method 60, may be performed, in an embodiment, by hemodynamic information computing system 16 of FIG 1. Method 60 may be considered an embodiment of blocks 48, 50, and 52 of method 40.

[0091] Method 60 may include, at block 62, identifying a boundary condition model value set that represents average flow conditions during a period of diastole. For example, in one embodiment, block 62 may include identifying a boundary condition model value set that represents average flow for the entirety of diastole. In another embodiment, block 62 may include identifying a boundary condition model value set that represents a wave-free period of diastole. The boundary condition model may be identified as discussed with respect to block 48 of method 40 in some embodiments.

[0092] Method 60 may further include identifying a boundary condition model value set that represents a single point in diastole, such as the midpoint of diastole, at block 64. The boundary condition model value set may, in some embodiments, be identified as discussed with respect to block 48 of method 40.

[0093] Either or both of blocks 62 or 64 may be performed in embodiments according to the desired hemodynamic index desired for calculation. For example, if an IWFR calculation is desired, block 62 may be performed for the waveless period of diastole, and if a dPR calculation is desired, block 62 may be performed for the entire diastole, and dPR may be calculated. mid Block 64 may be performed for the mid-diastolic point if a calculation is desired.

[0094] Method 60 may further include calculating flow velocities and pressures based on a single set of boundary condition model values ​​(e.g., either block 62 or 64) at block 66. The flow velocities may be calculated in a single time-independent CFD simulation at block 66. For example, the velocity and / or pressure fields may be determined using the steady-flow Navier-Stokes equations, where the velocity and pressure variables are functions of spatial position only (i.e., time is not considered). The flow velocities and pressures may be determined, for example, by flow field determination module 28 of system 10 of FIG. 1. In an embodiment, multiple instances of block 66 may be performed, each of which may result in a separate hemodynamic index calculation.

[0095] The method 60 may further include calculating a baseline pressure at block 68. The baseline pressure may be an aortic pressure in some embodiments. As disclosed herein, one or more aortic pressures may be identified based on the patient's respective cuff pressures. The aortic pressure may be an aortic pressure for the beginning, ending, and / or mid-diastole in one embodiment. The baseline pressure calculated at block 68 may represent the same point or portion of the cardiac cycle as the boundary condition model value set used as the basis for the calculation at block 66.

[0096] The method 60 may further include calculating hemodynamic information at block 70 based on the single time-independent CFD at block 66 and the reference pressure at block 68. The hemodynamic information may be or may include a hemodynamic index value. In one embodiment, the hemodynamic index value may be an IWFR value. The index value may be, in one embodiment, an average of the ratio of local pressure to aortic pressure over diastole, where the local pressure is determined by the calculated pressure field at the location of interest, such as distal to the stenosis.

[0097] 4 is a flow chart illustrating one embodiment of a method 80 for determining hemodynamic information based on two sets of boundary condition model values ​​representing two different cardiac cycle states. Method 80, or one or more aspects of method 80, may be performed, in an embodiment, by hemodynamic information computing system 16 of FIG 1. Method 80 may be considered one embodiment of blocks 48, 50, and 52 of method 40.

[0098] The method 80 may include obtaining an inflow flow rate at a first cardiac cycle state of the patient at block 82. The first blood flow rate may be, for example, an expected flow rate for the patient at the beginning of diastole. The flow rate at block 62 may be received via a user manual input of a flow rate (e.g., using the user input device 14 of the system 10). In one embodiment, the flow rate at block 62 may be specified (e.g., by a clinician or an electronic system) based on metabolic demand and patient condition.

[0099] The method 80 may further include calculating flow velocities and pressures within the region of interest at a first cardiac cycle state of the patient, at block 84. The first cardiac cycle state may be, for example, the beginning of diastole. In some embodiments, the velocity and / or pressure fields may be determined based on the defined boundaries and boundary conditions of each of the regions of interest (which may in turn be based on the flow velocities received at block 82).

[0100] The method 80 may further include calculating a first pressure drop (e.g., at one or more user-specified points and / or other points) for the first cardiac cycle state, at block 86. The pressure drop may be a drop in pressure from a vessel inlet to an associated point (e.g., user-specified or otherwise). The first state may be, for example, the start of diastole. The pressure drop may be calculated based on the flow field calculated for the first cardiac cycle state.

[0101] The method 80 may further include obtaining an input flow rate at a second cardiac cycle state of the patient, different from the first cardiac cycle state, at block 88. The second input flow rate may be, for example, an expected flow rate for the patient at end of diastole. The flow rate at block 88 may be received via a user manual input of a flow rate (e.g., using the user input device 14 of the system 10). In one embodiment, the input flow rate at block 88 may be specified (e.g., by a clinician or an electronic system) based on metabolic demand and patient condition.

[0102] The method 80 may further include calculating flow velocity and pressure in the region of interest at a second cardiac cycle state of the patient, at block 90. ​​The flow velocity and pressure may be calculated substantially as described above with respect to block 84, except that the boundary conditions identified according to the second blood flow rate are used.

[0103] The method 80 may further include calculating a second pressure drop at one or more points for a second cardiac cycle state, at block 92. The second cardiac cycle state may be, for example, end of diastole. The pressure drop may be calculated based on the flow field calculated for the second cardiac cycle state at the one or more user specified points.

[0104] The method 94 may further include calculating a range of pressure drops at relevant (e.g., user-specified) points for a range of cardiac cycle states based on the first pressure drop and the second pressure drop. The range of pressure drops may be calculated for a range of cardiac cycle states from (or spanning) Q1 to Q2, where Q1 is the inflow flow rate at the first cardiac cycle state and Q2 is the inflow flow rate at the second cardiac cycle state. The pressure drop for a given flow rate may be calculated according to a quadratic equation, shown in this disclosure as equation (1) and repeated below. ΔP=aQ+bQ 2 where Q is the flow rate at a given cardiac cycle state, and a and b are patient-specific constants. As explained above, to calculate a and b, the three-dimensional Navier-Stokes equations can be solved for two values ​​of Q (e.g., the flow rate at a first cardiac cycle state and a second cardiac cycle state) as discussed herein with respect to equations (2) and (3). Once the coefficients a and b are known, ΔP over diastole can be calculated without requiring CFD for every time point within diastole. That range of ΔP can then be used, in embodiments, to calculate an average value to identify a hemodynamic index, such as IWFR.

[0105] 6 is a plot 100 showing an example range of pressure drop for an example range of activity levels for a set of patients. The plot 100 of FIG. 6 includes pressure drop (in mmHg / 100) on the vertical axis and flow rate (in ml / sec) on the horizontal axis, with six plot lines 102, 104, 106, 108, 110, 112 for each of six patients, and two horizontal threshold lines 114, 116. The first threshold line 114 may generally indicate a clinically significant pressure drop for hyperemic blood flow. The second threshold line 116 may generally indicate a clinically significant pressure drop for resting flow.

[0106] As a result of method 80, flow and / or pressure fields may be calculated (and, in embodiments, displayed or otherwise output) for one or more locations in the patient's vasculature and for one or more cardiac cycle states of the patient. For example, in one embodiment, flow and pressure fields may be calculated and output for the start and end of diastole. Such flow fields may be used to determine respective hemodynamic information for the patient, such as an IWFR value or other diastolic-based hemodynamic value.

[0107] The method 80 may further include determining a baseline pressure, e.g., one or more aortic pressures, at block 96. The aortic pressures may be determined based on the patient's respective cuff pressures, as described herein. The aortic pressures may be aortic pressures for the beginning, ending, and / or mid-diastole, in one embodiment. In some embodiments, the baseline pressures calculated at block 96 may represent a portion of a cardiac cycle that spans the first and second cardiac cycle states of blocks 82, 84, 86, 88, 90, 92.

[0108] The method 80 may further include determining a hemodynamic index value based on the range of pressure drop and the baseline pressure at block 98. In one embodiment, the hemodynamic index value may be an IWFR value. The index value may be an average of the ratio of local pressure to aortic pressure over diastole, where the local pressure is determined by the calculated pressure field at a location of interest, such as distal to the stenosis, in one embodiment. In one embodiment, the pressure vs. flow curve for diastole (e.g., as shown in FIG. 6) may be integrated and averaged to calculate the IWFR value. For example, referring to FIG. 6, a given plot line (e.g., plot line 104) may be integrated and averaged to calculate an IWFR value for the patient associated with plot line 104.

[0109] 7 is a diagram of an exemplary embodiment of a user computing environment including a general-purpose computing system environment 190, e.g., a desktop computer, a laptop, a smartphone, a tablet, or any other such device capable of executing instructions, such as instructions stored in a non-transitory computer-readable medium. Additionally, while described and illustrated in the context of a single computing system 190, those skilled in the art will appreciate that various tasks described hereinafter may also be performed in a distributed environment in which multiple computing systems 190 are linked via a local or wide area network in which executable instructions may be associated with and / or executed by one or more of the multiple computing systems 190. Computing environment 190, or a portion thereof, may, in an embodiment, include system 10 of FIG.

[0110] In its most basic configuration, the computing system environment 190 typically includes at least one processing unit 192 and at least one memory 194, which may be linked by a bus 196. Depending on the exact configuration and type of computing system environment, the memory 194 may be volatile (such as RAM 200), non-volatile (such as ROM 198, flash memory, etc.), or some combination of the two. The computing system environment 190 may have additional features and / or functionality. For example, the computing system environment 190 may also include additional storage devices (removable and / or non-removable), including, but not limited to, magnetic or optical disks, tape drives, and / or flash drives. Such additional memory devices may be accessible to the computing system environment 190, for example, via a hard disk drive interface 202, a magnetic disk drive interface 204, and / or an optical disk drive interface 206. As will be appreciated, these devices that will be linked to the system bus 196 each enable reading from and writing to the hard disk 208, reading from or writing to the removable magnetic disk 210, and / or reading from or writing to a removable optical disk 212, such as a CD / DVD ROM or other optical media. The drive interfaces and their associated computer-readable media enable non-volatile storage of computer-readable instructions, data structures, program modules and other data for the computing system environment 190. Those skilled in the art will further appreciate that other types of computer-readable media capable of storing data may be used for this same purpose.Examples of such media devices include, but are not limited to, magnetic cassettes, flash memory cards, digital video disks, Bernoulli cartridges, random access memory, nano drives, memory sticks, other read / write and / or read-only memory and / or any other method or technology for storage of information, such as computer readable instructions, data structures, program modules or other data. Any such computer storage media may be part of the computing system environment 190.

[0111] Many program modules may be stored in one or more of the memory / media devices. For example, a basic input / output system (BIOS) 214, containing the basic routines that help to transfer information between elements within the computing system environment 190, such as during start-up, may be stored in ROM 198. Similarly, the RAM 200, the hard drive 208, and / or the peripheral memory devices may be used to store computer-executable instructions including an operating system 216, one or more application programs 218 (e.g., modules 24, 26, 28, 30, 32 of FIG. 1), other program modules 220, and / or program data 222. Furthermore, computer-executable instructions may be downloaded to the computing environment 190 as needed, for example, via a network connection.

[0112] An end user, e.g., a clinician, can enter commands and information into the computing system environment 190 through input devices such as a keyboard 224 and / or a pointing device 226. Although not shown, other input devices can include a microphone, joystick, game pad, scanner, etc. These and other input devices are typically connected to the processing unit 192 by a peripheral interface 228, which in turn is coupled to the bus 196. The input devices can be connected directly or indirectly to the processor 192 via an interface such as, for example, a parallel port, game port, firewire, or universal serial bus (USB). For viewing information from the computing system environment 190, a monitor 230 or other type of display device can likewise be connected to the bus 196 via an interface such as a video adapter 232. In addition to the monitor 230, the computing system environment 190 can also include other peripheral output devices (not shown), such as speakers and printers.

[0113] The computing system environment 190 may also utilize logical connections to one or more computing system environments. Communications between the computing system environment 190 and a remote computing system environment may be exchanged via a further processing device responsible for network routing, such as a network router 242. Communications with the network router 242 may be performed via a network interface component 244. It will therefore be understood that within such a networked environment, such as the Internet, the World Wide Web, a LAN, or other similar types of wired or wireless networks, program modules depicted relative to the computing system environment 190, or portions thereof, may be stored in a memory storage device(s) of the computing system environment 190.

[0114] The computing system environment 190 may also include location determination hardware 186 for determining the location of the computing system environment 190. In an embodiment, the location determination hardware 246 may include, by way of example only, a GPS antenna, an RFID chip or reader, a WiFi antenna, or other computing hardware that may be used to capture or transmit signals that may be used to determine the location of the computing system environment 190.

[0115] Although the present disclosure has described certain specific embodiments, it will be understood that the claims are not intended to be limited to these embodiments, except as expressly recited in the claims. On the contrary, the present disclosure is intended to encompass alternatives, modifications, and equivalents that may be included within the spirit and scope of the present disclosure. Moreover, in the detailed description of the present disclosure, numerous specific details are described in order to provide a thorough understanding of the disclosed embodiments. However, it will be apparent to those skilled in the art that systems and methods consistent with the present disclosure may be practiced without these specific details. In other instances, well-known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure various aspects of the present disclosure.

[0116] Some portions of the detailed description of this disclosure have been presented in terms of procedures, logic blocks, processes, and other symbolic representations of operations on data bits within a computer or digital system memory. These descriptions and representations are the means used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. A procedure, logic block, process, or the like, is herein, and generally, conceived to be a self-consistent sequence of steps or instructions leading to a desired result. The steps are those requiring physical manipulations of physical quantities. Usually, but not necessarily, these physical manipulations take the form of electrical or magnetic data capable of being stored, transferred, combined, compared, and otherwise manipulated in a computer system or similar electronic computing device. For reasons of convenience, and in keeping with common usage, such data will be referred to as bits, values, elements, symbols, characters, terms, numbers, or the like in reference to the various embodiments disclosed herein.

[0117] However, it should be kept in mind that these terms are merely convenient labels that should be interpreted to refer to physical operations and quantities and should be further interpreted in light of the terms commonly used in the art.Unless otherwise specifically stated, and as is evident from the discussion herein, throughout the discussion of the present embodiments, discussions utilizing terms such as "identifying / determining / seeking / determining" or "outputting" or "transmitting" or "recording" or "locating" or "storing" or "displaying" or "receiving" or "recognizing" or "utilizing" or "generating" or "providing" or "accessing" or "checking" or "notifying" or "communicating" are understood to refer to the actions and processes of a computer system or similar electronic computing device that manipulates and transforms data, as well as the processes of the present invention. Data is represented as physical (electronic) quantities in the registers and memory of a computer system and converted to other data that is similarly represented as physical quantities in the memory or registers of a computer system, or other such information storage, transmission, or display device, as described herein or as otherwise understood by those skilled in the art.

Claims

1. 1. A method of operation of a system for determining respective hemodynamic index values ​​of a patient, comprising: The system includes a processor, and the method of operation includes: the processor obtaining a three-dimensional electronic model of the patient's coronary arteries; the processor obtaining a set of values ​​of a boundary condition model representative of a diastolic period of a cardiac cycle of the patient when the patient is in a resting state; the processor performing a three-dimensional computational fluid dynamics (CFD) simulation of the three-dimensional electronic model of the coronary artery based on the boundary condition model; the processor calculating, according to the CFD simulation, a pressure drop between a first location of the coronary artery and a second location of the coronary artery; determining a hemodynamic index value indicative of a presence of a lesion at the first location or the second location based on the calculated pressure drop and based on a baseline pressure, the hemodynamic index value being indicative of a presence of a lesion at the first location or the second location; A method of operation comprising:

2. The method of claim 1 , wherein the set of values ​​of the boundary condition model represents an entire diastolic period of the patient's cardiac cycle.

3. The method of claim 1 , wherein the set of values ​​of the boundary condition model represents a wave-free period during a diastolic phase of the patient's cardiac cycle.

4. The method of claim 1 , wherein the set of values ​​of the boundary condition model represents a mid-diastolic point in the patient's cardiac cycle.

5. The method of claim 1, further comprising the processor creating the three-dimensional electronic model of the anatomical region.

6. The method of claim 1, further comprising: receiving image data of the anatomical region of each of the patients; generating the three-dimensional electronic model based on the received image data; The method of claim 5 further comprising:

7. The set of boundary condition model values ​​may be: an inlet flow rate at the inlet of the coronary artery, the inlet flow rate representing the patient's resting state; two or more outlet flow rates calculated according to the inlet flow rate and flow splitting model; The method of claim 1 , comprising:

8. The processor determining the flow partitioning model according to a shape of the three-dimensional electronic model of the coronary artery; and the processor calculating the two or more outlet flow rates according to the inlet flow rate and the flow splitting model; The method of claim 7 further comprising:

9. 1. A system for determining a respective hemodynamic index value of a patient, comprising: a non-transitory computer readable memory storing instructions; 1. A processor comprising: obtaining a three-dimensional electronic model of the patient's coronary arteries; obtaining a set of values ​​of a boundary condition model representative of a diastolic period of a cardiac cycle of the patient when the patient is in a resting state; performing a three-dimensional computational fluid dynamics (CFD) simulation of the three-dimensional electronic model of the coronary artery based on the boundary condition model; calculating a pressure drop between a first location of the coronary artery and a second location of the coronary artery according to the CFD simulation; determining a hemodynamic index value indicative of a presence of a lesion at the first location or the second location based on the calculated pressure drop and based on a baseline pressure; A processor configured to execute instructions to perform A system comprising:

10. The system of claim 9 , wherein the set of values ​​of the boundary condition model represents an entire diastolic period of the patient's cardiac cycle.

11. The system of claim 9 , wherein the set of values ​​of the boundary condition model represents a wave-free period during a diastolic phase of the patient's cardiac cycle.

12. The system of claim 9 , wherein the set of values ​​of the boundary condition model represents a mid-diastolic point in the patient's cardiac cycle.

13. 10. The system of claim 9, wherein the memory further stores instructions that, when executed by the processor, cause the processor to create the electronic model of an anatomical region.

14. The memory, when executed by the processor, causes the processor to: receiving image data for each of the anatomical regions of the patient; generating the three-dimensional electronic model based on the received image data; and 14. The system of claim 13, further storing instructions to:

15. The set of boundary condition model values ​​may be: an inlet flow rate at the inlet of the coronary artery, the inlet flow rate representing the patient's resting state; two or more outlet flow rates calculated according to the inlet flow rate and flow splitting model; The system of claim 9 , comprising:

16. The memory, when executed by the processor, causes the processor to: determining the flow partitioning model according to a shape of the three-dimensional model of the coronary artery; calculating the two or more outlet flow rates according to the inlet flow rate and the flow splitting model; 20. The system of claim 15, further storing instructions to:

Images