A computer-implemented method for performing virtual stress tests for patients

Abstract

A virtual stress test can be performed for a patient by creating an electronic model of the patient's anatomy, e.g., a region of interest in one or more coronary arteries, determining the pressure drop across the region of interest at two different activity levels of the patient based on computational fluid dynamics, and determining a range of pressure drop for a range of activity levels based on the flow rates associated with the two activity levels. Based on the range of pressure drop, it can be determined whether the patient has a clinically significant pressure drop (indicative of an obstructive stenosis) at an activity level related to the patient's metabolic demands.

Description

[Technical field]

[0001] The present disclosure generally relates to the determination and display of patient hemodynamic information based on non-invasive imaging and computational fluid dynamics, including the determination and display of blood pressure in the coronary arteries over a range of simulated patient activity levels.

[0002] [CROSS REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62 / 788,911, 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, if advanced, can lead 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 diagnostic 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 angiography on the patient. In such patients, the decision to revascularize with coronary stents or CABG surgery is based on angiographic anatomy and, more recently, also using invasively measured hemodynamic information such as 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 disease and would warrant revascularization in the appropriate clinical circumstances. Summary of the Invention [Problem to be solved by the invention]

[0004] A system and method for virtual stress testing based on electronic patient data is disclosed. [Means for solving the problem]

[0005] patient for Virtual stress testing conduct Computer Implementation methodAn exemplary embodiment of the method may include receiving medical image data of the patient, including an arterial segment, and generating a geometric representation of the arterial segment from the medical image data. The method may further include receiving information of metabolic needs of the patient and determining a threshold value according to the information of metabolic needs. The method may further include identifying a first flow field for the arterial segment using the geometric image, the first flow field corresponding to a first activity level of the patient, identifying a first pressure drop in the arterial segment based on the first flow field, identifying a second flow field for the arterial segment using the geometric image, the second flow field corresponding to a second activity level of the patient different from the first activity level, and identifying a second pressure drop in the arterial segment based on the second flow field. The method may further include calculating a range of pressure drops for a range of activity levels based on the first pressure drop and the second pressure drop, comparing the range of pressure drops to the threshold value, and displaying a result of the comparison.

[0006] In one embodiment, the first activity level is associated with a first flow rate and the second activity level is associated with a second flow rate different from the first flow rate, and calculating a range of pressure drop for the range of activity levels includes calculating a range of pressure drop for a range of flow rates.

[0007] In one embodiment, the range of flow rates is between the first flow rate and the second flow rate.

[0008] In one embodiment, calculating the pressure drop range for the range of activity levels includes calculating the pressure drop range according to a quadratic relationship between pressure drop and flow rate.

[0009] In one embodiment, displaying the results of the comparison includes displaying a plot of the pressure drop range and the threshold value.

[0010] In one embodiment, the first activity level is a resting state.

[0011] In one embodiment, the second activity level is a hyperemic state.

[0012] In one embodiment, the method further includes identifying an activity level at which the pressure drop exceeds the threshold.

[0013] In one embodiment, the first flow field and the second flow field comprise a first flow velocity field and a second flow velocity field, respectively.

[0014] In one embodiment, identifying the first flow field for the arterial segment using the shape image may include obtaining a first inflow flow rate for the arterial segment, calculating a first outflow flow rate for the arterial segment according to the first inflow flow rate, and calculating the first flow field within the arterial segment according to the shape image, the first inflow flow rate, and the first outflow flow rate. In one embodiment, determining the second flow field for the arterial segment using the shape image includes obtaining a second inflow flow rate for the arterial segment, calculating a second outflow flow rate for the arterial segment according to the second inflow flow rate, and calculating the second flow field within the arterial segment according to the shape image, the second inflow flow rate, and the second outflow flow rate.

[0015] patient for Virtual stress testing conduct Computer Implementation method An exemplary embodiment of the method includes obtaining a geometric image of an arterial segment of the patient, the geometric image including an inflow boundary and two or more outflow boundaries, receiving information of metabolic demand of the patient, and determining a threshold value according to the metabolic demand information. The method may further include obtaining a first inflow rate for the inflow boundary, calculating a first outflow rate at the two or more outflow boundaries according to the first inflow rate, calculating a first flow field in the arterial segment according to the shape image, the first inflow rate, and the first outflow rate, and determining a first pressure drop in the arterial segment based on the first flow field. The method may further include obtaining a second inflow rate for the inflow boundary different from the first inflow rate, calculating a second outflow rate at the two or more outflow boundaries according to the second inflow rate, calculating a second flow field in the arterial segment according to the shape image, the second inflow rate, and the second outflow rate, and determining a second pressure drop in the arterial segment based on the second flow field. The method may further include calculating a range of pressure drop for a range of inlet flow rates based on the first pressure drop and the second pressure drop, comparing the range of pressure drop to the threshold value, and displaying a result of the comparison.

[0016] In one embodiment, the first inflow flow rate is associated with a first activity level and the second inflow flow rate is associated with a second activity level different from the first activity level, and calculating a range of pressure drop for the range of flow rates includes calculating a range of pressure drop for a range of activity levels.

[0017] In one embodiment, the range of flow rates is between the first flow rate and the second flow rate.

[0018] In one embodiment, calculating the range of pressure drop includes calculating the range of pressure drop according to a quadratic relationship between pressure drop and inlet flow rate.

[0019] In one embodiment, displaying the results of the comparison includes displaying a plot of the pressure drop range and the threshold value.

[0020] In one embodiment, the method further includes identifying an activity level at which the pressure drop exceeds the threshold.

[0021] In one embodiment, the first inflow rate is for a resting state of the patient.

[0022] In one embodiment, the second inflow rate is related to the hyperemic state of the patient.

[0023] In one embodiment, the first flow field and the second flow field comprise a first flow velocity field and a second flow velocity field, respectively.

[0024] In one embodiment, the first flow field and the second flow field are calculated according to a three-dimensional, time-independent equation. [Brief description of the drawings]

[0025] [Figure 1] FIG. 1 illustrates an exemplary embodiment of an electronic system for performing virtual stress tests. [Diagram 2] 1 is a flow chart illustrating an exemplary embodiment of a method for performing a virtual stress test based on electronic patient data. [Diagram 3] 1 is a flow chart illustrating an exemplary embodiment of a method for performing a virtual stress test based on electronic patient data. [Figure 4] FIG. 1 illustrates an exemplary geometric model of a patient's anatomical region that may be identified and that may find application in the methods of the present disclosure. [Diagram 5] 1 is a graph showing an example range of pressure drop for activity levels for each patient. [Figure 6] FIG. 1 illustrates an exemplary embodiment of a user computing environment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] Screening for arterial disease by non-invasive clinical diagnosis and traditional stress testing can be inaccurate, resulting in unnecessary coronary angiography procedures in patients with false-positive test results, and false-negative results in patients with significant disease. A recent study showed that 55.3% of patients who underwent traditional non-invasive testing and proceeded to invasive coronary angiography (ICA) did not have obstructive CHD. In 2006, an estimated 1.115 million hospitalized patients underwent cardiac catheterization in the United States alone, so a highly accurate non-invasive test that would prevent unnecessary ICA procedures would save billions of dollars annually. Furthermore, while ICA procedures are generally very safe for patients, negative results are rare and can cause considerable patient anxiety, so reducing the number of unnecessary ICA procedures could improve outcomes and patient experience. Additionally, studies have demonstrated that deferring revascularization based on nonischemic FFR values ​​results in better outcomes than stenting, and FFR-guided stenting reduces the number of stents, deaths, heart attacks, and need for repeat stenting by approximately 30% compared to standard angiogram-guided care, as well as reducing costs.

[0027] Originally, FFR was defined as the ratio of the maximum blood flow distal to the stenotic lesion to the normal maximum flow in the same vessel. However, in actual clinical practice, FFR is usually defined as the pressure distal to the stenosis (Pd) relative to the aortic pressure (Pa) under hyperemic flow conditions (i.e., FFR=Pd / Pa). Due to the high percentage of unnecessary invasive angiograms, there is a great deal of interest in developing methods to assess FFR non-invasively. From fundamental principles of physics, FFR is in fact a variable that depends on the detailed hemodynamic flow field, which is a function of the arterial geometry, pressure, and flow conditions. Therefore, it is possible to calculate FFR from the equations of motion of fluid mechanics, which can be called virtual FFR or FFRv. This requires numerical procedures that are part of the field of Computational Fluid Dynamics (CFD). CFD involves determining the overall flow field and pressure within a region of interest (ROI) using the detailed vessel geometry of the region of interest and the blood flow (or alternatively, applied pressure) at the boundaries of the computational domain.

[0028] Coronary flow requirements vary from person to person and depend on several physiological factors, including age, sex, body mass index (BMI), and level of physical activity. Exercise stress tests can be performed to assess whether coronary flow is sufficient in a patient and therefore the absence of significant coronary stenosis. This involves an increase in the level of exercise, which in turn leads to an increase in heart rate, systolic blood pressure, and myocardial contractility. To maintain exercise, coronary blood flow increases sufficiently to supply blood to the myocardium to meet its increased demand. If a patient has significant epicardial stenosis, the upper limit of autoregulatory reserve is exceeded and the corresponding myocardial bed becomes ischemic. This manifests as chest pain or dyspnea, ST segment depression on the electrocardiogram, abnormal wall motion if supplemental cardiac ultrasound is used, or abnormal myocardial perfusion if supplemental myocardial perfusion imaging is performed. Although this approach is an indirect assessment of the presence of coronary stenosis, it does provide a patient-specific estimate of ischemic burden that informs the decision to perform further testing (e.g., angiography) and / or revascularize the patient.

[0029] An alternative diagnostic approach is to perform a direct anatomical assessment of the coronary arteries using either invasive coronary angiography or non-invasive CT angiography. This provides information about the presence and extent of coronary artery disease and is particularly useful in ruling out disease or diagnosing severe blockages. However, in the frequent scenario of intermediate coronary lesions (40%-80% stenosis in diameter), anatomical assessment cannot accurately assess whether the narrowing is limiting flow or causing ischemia. To overcome this limitation of anatomical assessment, invasive FFR and non-invasive virtual FFR have been developed to supplement anatomical information. Invasive FFR has become the technical standard for functional assessment of coronary lesions and incorporates some patient-specific physiological data. For example, the response of the myocardial bed to hyperemic agents administered during invasive FFR measurement reflects the individual's coronary microvascular function. In contrast, for virtual FFR, a hypothetical flow rate is typically prescribed for the proximal vessels that supply the myocardial bed. However, the true blood flow rate for a given stenosis depends on the patient's microvascular function and cardiopulmonary capacity (e.g., an active 30-year-old patient will have a much higher flow rate than an 85-year-old wheelchair-bound patient, even if the two patients have similar anatomy.) Thus, current calculation methods for assessing a patient's coronary stenosis do not sufficiently take into account the patient's specific coronary flow rate to provide calculations and judgments.

[0030] To provide a more patient-specific computational hemodynamic assessment, one or more physiological indices of blood flow describing pressure loss, such as FFR or Instantaneous Wave-Free Ratio (IWFR), can be calculated under a range of simulated activity levels or metabolic demands. Estimated or calculated information about the patient's physical and metabolic activity levels can be used to provide a patient-specific computed FFR or IWFR for a given coronary lesion. Patient-specific physical activity or metabolic data can be obtained, for example, from a validated activity or lifestyle questionnaire. For example, such a questionnaire can ask about what activities the patient performs and identify the metabolic demands associated with those activities. An exemplary methodology for relating metabolic demand to activity is described in Sidney et al., "Metabolic Equivalents (METS) in Exercise Testing, Exercise Prescription, and Evaluation of Functional Capacity," 13 Clin. Cardiol. 555-565 (1990), which is incorporated herein by reference in its entirety. Briefly, the metabolic demand associated with a given activity can be defined as a multiple of metabolic equivalents (METs), where one metabolic equivalent is the amount of oxygen consumed by a patient at rest. Metabolic demands can range from 1 MET (at rest) to over 15 METs for certain high-intensity aerobic activities. The value of 1 MET can be patient-specific and dependent on the patient's weight. The number of METs for a given activity can depend on the intensity and difficulty of the particular activity. 1 MET can be defined in one embodiment as the amount of oxygen consumed per minute. Because the amount of oxygen per minute can scale linearly with the patient's flow rate, a direct relationship can be established between the flow rate at a given point in the patient's vasculature and the metabolic demand covered by that flow (i.e., the number of METs).

[0031] In addition to, or instead of, determining metabolic needs based on an activity questionnaire, a patient's metabolic needs can be determined from a standardized exercise test, such as the Bruce protocol, which many patients with suspected coronary heart disease undergo as part of a pre-procedure evaluation. An exemplary protocol for such exercise testing is described in Lear et al., "Exercise Stress Testing: An Overview of Current Guidelines," 27(5) Sports Med. 285-312 (May 1999), which is incorporated by reference in its entirety. Briefly, based on the exercise test, a patient-specific maximum MET value can be determined, i.e., the MET value associated with the maximum level of activity the patient engages in.

[0032] This patient-specific metabolic workload provides a defined coronary flow (e.g., one or more boundary conditions) for hemodynamic calculations and can be used to improve the diagnostic accuracy of the calculated FFR value or other hemodynamic value(s) over known methods.

[0033] The Navier-Stokes equations can be used to describe flow fields in coronary arteries, e.g., 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, e.g., pressure drop, FFR, instantaneous fractional flow reserve (IWFR), 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 vascular lumen geometry (obtained from Computed Tomography (CT) or other vascular imaging) is also included in the CFD, along with some combination of inflow flow rates (e.g., at a selected inflow boundary) and flow distributions in the vessel branches (e.g., one or more outflow flows). The pressure field within the ROI may be calculated as a deviation from a reference pressure, and therefore, an absolute level of pressure within the ROI, e.g., Pa, may not be necessary for CFD when calculating the pressure field. If a reference pressure (e.g., Pa) is identified, then the absolute pressure within the field can be identified once the deviation from the reference is calculated. However, it should be noted that not all pressure-related identifications require a reference pressure, such as some embodiments of the virtual stress tests disclosed herein, but may instead be based on a pressure field without a baseline reference.

[0034] 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 ratio, 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).

[0035] 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 attributable 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.

[0036] To calculate a and b, the 3D Navier-Stokes equations can be solved for two different values ​​of Q. For example, for the first value Q 1 may represent the flow rate typical for resting conditions, and the second value Q 2can represent the flow rate typical of exercise (or hyperemia). These calculations are 1 , Q 2 , ΔP 1 and ΔP 2 Once known, this gives us two values ​​for ΔP so that we can solve Equations 2 and 3 below for a and b. ΔP 1 =aQ 1 +bQ 1 2 (Formula 2) ΔP 2 =aQ 2 +bQ 2 2 (Formula 3)

[0037] 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.

[0038] In addition to uncertainties in geometry and flow partitioning, there are two other sources of uncertainty in noninvasively calculating FFR: (1) unknown Pa (intraaortic pressure under hyperemia) and (2) unknown Q (inflow flow under hyperemia).

[0039] CFD is independent of Pa and provides ΔP directly. FFR (calculated as the ratio Pd / Pa), on the other hand, depends directly on the patient-specific value of Pa. As a result, for a calculated FFR, a value of Pa must be assumed once ΔP is calculated. The assumed value of Pa can be derived, for example, from cuff blood pressure measurements or can be assumed to be Pa=100 mmHg across all subjects.

[0040] There are clinical data suggesting that ΔP can be used as a diagnostic index for obstructive CAD. To demonstrate this possibility, consider a population mean of Pa=100 mmHg. For such a mean Pa value, (a) FFR=0.8 (generally considered to indicate obstructive lesions) corresponds to ΔP=20 mmHg, and (b) IWFR=0.9 (also generally considered to indicate obstructive lesions) corresponds to ΔP=10 mmHg.

[0041] Therefore, it is reasonable to use the computational method as a virtual stress test in the following scheme: (1) calculate ΔP for two different hypothetical flow rates based on images of the patient ROI, e.g., CT images or other non-invasively obtained images; (2) use the quadratic relationship described in Equations 1 and 2 above to determine coefficients a and b for a subject; (3) present a curve of ΔP vs. Q over a range of flow rates; (4) determine flow rates corresponding to critical values ​​of ΔP (e.g., 20 mmHg for FFR=0.8; 10 mmHg for IWFR=0.9); and (5) determine whether the resulting ΔP values ​​are indicative of obstructive CAD based on the patient's expected flow requirements at rest and under anticipated lifestyle activities. This methodology will be discussed in more detail below.

[0042] Referring to the drawings, where like reference numbers refer to the same or similar features in the various views, Figure 1 is a diagram of an exemplary embodiment of an electronic system 10 for performing a virtual stress test. The exemplary system 10 may include a patient image source 12, a user input device 14, a virtual stress test computing system 16, and a display 18. As described in more detail below, the system 10 may find use in performing virtual stress tests based on electronic patient data (e.g., images and other data of the patient's area of ​​interest) to identify various hemodynamic information about the patient and / or to make recommendations regarding further testing, interventional evaluation, and / or interventional treatment for the patient.

[0043] In one embodiment, one or more aspects of the system 10 may be deployed in a clinical environment. For example, in some embodiments, the patient image source 12, the user input device 14, the virtual stress test computing system 16, and the display 18 may all be provided in a common clinical setting, such as a hospital. In some embodiments, the components of the system 10 may be embodied in a laptop or desktop computer or workstation. In one embodiment, one or more components of the system, such as the virtual stress test computing system 16, may be provided remotely from the clinical setting, such as in a cloud computing service deployment.

[0044] 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, intravascular ultrasound (IVUS), biplane angiography, optical coherence tomography (OCT), magnetic resonance imaging (MRI), or a combination thereof, among others.

[0045] Additionally or alternatively, the patient image source 12 may include a store of pre-existing image data. 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.

[0046] 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.

[0047] The virtual stress test computing system 16 may include a processor 20 and a non-volatile computer readable memory 22 configured to store data and instructions. In one embodiment, the memory 22 may store images from a test patient and thus may 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, and a virtual stress test module 32.

[0048] 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.

[0049] The shape identification module 24 may be configured to generate an electronic shape image (e.g., a model) of an anatomical region of interest (ROI) from images obtained from the patient's image source 12. In some embodiments, the ROI may be a portion of the subject patient's cardiovascular system, 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.

[0050] 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 a portion 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.

[0051] This disclosure will refer to coronary artery segments. However, it will be understood that the one or more artery segments are not limited to the coronary artery segments discussed and can include, among others, other coronary artery segments, other types of artery segments, or combinations thereof. For example, the one or more artery 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, etc.

[0052] In some embodiments, the shape images generated by shape identification module 24 can be three-dimensional (3D) electronic models of the spatial volumes of one or more arterial segments. For example, the shape images 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 images can include a surface mesh that represents the boundary of the lumen of each arterial segment.

[0053] 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 a cross-section located 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.

[0054] 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 image 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.

[0055] In some embodiments, the boundary condition identification module 26 can be configured to identify shape data for each boundary using the shape images generated by the shape identification module 24. In some embodiments, the shape data can include, but is not limited to, the radius, diameter, circumference, area of ​​the vessel, the volume, length of the epicardial coronary artery, or a combination thereof, among others.

[0056] 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, pressure, or other characteristic. Each outflow boundary condition can be a percentage of a velocity, flow, 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, pressure, a combination thereof, or other characteristic.

[0057] In some embodiments, the identification of inflow and / or outflow boundary conditions may be 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 conditions may be identified according to an expected patient activity level (e.g., based on information provided by the patient). In some embodiments, the inflow boundary conditions may be stored values ​​and / or may be user specified.

[0058] 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. 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 4 below. Q in = αV β (Formula 4) 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.

[0059] In embodiments where the region of interest is the coronary artery tree, V may be the lumen volume of the LCA or RCA defined from the proximal origin to the 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.

[0060] 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 validated.

[0061] 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, or other shape characteristic) 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, and / or other shape characteristics 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, and / or other shape characteristics of the first outflow boundary (distal boundary) of the segment. 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.

[0062] 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.

[0063] The flow field identification module 28 can be configured to identify a flow field for each arterial segment using the shape image identified by the shape identification module 24, the one or more boundary conditions identified by the boundary condition identification module 26, and pressure data for the patient. 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.

[0064] 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 location (i.e., independent of time).

[0065] 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.

[0066] The pressure determination module 30 may be configured to determine 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 determination module may be configured to determine pressures upstream and downstream from the user-selected location to determine a pressure drop at the user-selected location.

[0067] The virtual stress test module 32 can be configured to simulate a stress test, i.e., perform a virtual stress test, on the patient's anatomy. The virtual stress test can, in embodiments, include calculating a range of pressure drops for one or more points in the patient's anatomy for a range of activity levels, as disclosed herein. Based on the results of the virtual stress test, the virtual stress test computing system can identify a patient activity level at which the pressure drop indicates a clinically significant stenosis in the patient's anatomy. Based on the identified level of activity, the computing system 16 or a clinician can determine whether further diagnostic and / or interventional procedures should be performed.

[0068] In some embodiments, the virtual stress test performed by virtual stress test module 32 can be performed based on a pressure gradient within the anatomical region of interest without determining an absolute pressure, a baseline pressure, or an absolute pressure-based hemodynamic index. In other embodiments, the virtual stress test can include determining a baseline pressure and calculating one or more hemodynamic index values, such as IWFR, FFR, dPR, etc.

[0069] To calculate absolute pressure or absolute pressure based hemodynamic indices, one or more Pa values ​​can be calculated, for example, the mean diastolic aortic pressure. 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 mean aortic diastolic pressure (Pa) at rest during the wave free period can be calculated using the mean aortic diastolic pressure (PPA) or the mean aortic diastolic pressure (PPA) at rest during the wave free period. 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 a transfer function described in Equation 5 below: Pa dmean =(SP+3DP) / 4 (Equation 5) In other embodiments, other transfer functions can be used to relate the cuff pressure value to the reference pressure.

[0070] In another embodiment, the mean aortic diastolic pressure at rest (Pa) dmean or dPa) can be calculated from the cuff pressure as shown in Equation 6 below. dPa=Pc+offset (Equation 6) where Pc is the upper arm cuff pressure at rest given by Equation 7 below. Pc=dPc+FF*PP (Equation 7) 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 6 can be between about 0 mmHg and -10 mmHg. In one embodiment, the offset value in Equation 6 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.

[0071] In other embodiments, the mean aortic diastolic pressure can be estimated using a transfer function that relates cuff pressure to aortic pressure during diastole. For example, a diastolic Pa value can be determined from a test patient's cuff pressure by finding a form factor FF value and / or offset value that fits a data set that includes invasively measured cuff pressures and central diastolic resting pressures of a patient population. Once this function is known, it can be used to obtain an estimate of diastolic resting pressure from non-invasively measured cuff pressures.

[0072] 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.

[0073] 2 is a flow chart illustrating an example embodiment of a method 40 for performing a virtual stress test. The method 40, or one or more aspects of the method 40, may be performed, in an embodiment, by the virtual stress test computing system 16 of FIG.

[0074] 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 one embodiment, may further include patient data from one or more diagnostic tests, such as a cardiac ultrasound.

[0075] 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, such as an imaging device or a database or other computer memory.

[0076] The method 40 may further include, at block 46, creating an anatomical model of the patient's region 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. 4 illustrates an exemplary anatomical model 56 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.

[0077] Method 40 may further include identifying a model value set for one or more boundary conditions at block 48. The model value set for one or more boundary conditions may, in one embodiment, be respective sets of values ​​for a model of the same boundary condition (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 may, in some embodiments, 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.

[0078] The inflow flow rate obtained at block 48a may represent a particular activity level or physiological state of the patient. For example, in some embodiments, the inflow flow rate obtained at block 48a may represent a resting state of the patient. In another embodiment, the inflow flow rate may represent a hyperemic state of the patient. In yet other embodiments, the inflow flow rate obtained at block 48a may represent any activity level of the patient (e.g., any possible flow rate of the patient given the patient's age, health, etc.).

[0079] The inflow flow rate obtained in block 48a, in some embodiments, can represent a desired point or portion of the patient's cardiac cycle. For example, in some embodiments, the inflow flow rate obtained in block 48a can represent an average flow rate over the patient's entire cardiac cycle, or the patient's entire diastolic waveless period, or the patient's entire diastolic period. In other embodiments, the inflow flow rate can represent a particular point in the cardiac cycle, for example, the midpoint of diastole.

[0080] In some embodiments, obtaining the input flow rate in block 48a may include calculating the input flow rate according to the shape of the anatomical model of the patient as discussed above with respect to Equation 4. As discussed above with respect to Equation 4, the input flow rate Q in includes an α term that depends on the physiological state of the patient. Thus, obtaining the input flow rate in block 48a may include determining or selecting a value of α that is appropriate for the desired activity level.

[0081] In other embodiments, instead of calculating the input flow rate according to Equation 4 above, obtaining the blood flow rate in block 48a can include receiving a user input of the input flow rate. The input flow rate can 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 can be specified (e.g., by a clinician or an electronic system) based on metabolic needs and patient conditions.

[0082] Block 48 may further include calculating, at block 48b, an outlet flow rate according to the inlet flow rate obtained at block 48a and according to a flow partitioning model (sometimes referred to herein as an outflow distribution 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 the relative radius, diameter, circumference, length, volume, and / or surface area of ​​the blood vessels in the electronic model.

[0083] In conjunction with the flow obtained in block 48a, the outlet flow calculated in block 48b may include a model set of boundary conditions for the patient's anatomical region, which may represent a particular physiological state or activity level of the patient (e.g., resting state, hyperemic state, or other state) and a particular portion or point in the patient's cardiac cycle (e.g., entire cardiac cycle, diastole, a point in the cardiac cycle, etc.).

[0084] 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 epicardial volume of the electronic model.

[0085] The method 40 may further include, at block 50, calculating fluid dynamics of blood flow through the patient's anatomy based on the anatomical model (e.g., model 56), the model value set of one or more boundary conditions, 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 pressure data for the patient (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 the flow field identification module 28 of FIG. 1.

[0086] 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 location only (i.e., time is not considered). In this manner, pressures and velocities can be determined accurately and efficiently in near real-time to enable point-of-care analysis by clinicians.

[0087] The method 40 may further include performing a virtual stress test based on the patient data and the calculated fluid dynamics at block 60. Performing the virtual stress test may include calculating a set of pressure drops for one or more locations within the patient's vasculature across a range of activity levels, and thus a range of blood flow levels, for the patient. The set of pressure drops may be analyzed to determine whether the patient has a clinically significant pressure drop (indicative of a stenosis) at an activity level associated with the patient.

[0088] In some embodiments, block 60 may additionally or alternatively include calculating baseline pressures, absolute pressures, and / or one or more hemodynamic index values ​​over a range of activity levels. The absolute pressures and / or hemodynamic index values ​​may be analyzed (e.g., compared to thresholds) to determine whether a patient has a clinically significant pressure or hemodynamic index value (indicative of a stenosis) at a clinically significant activity level.

[0089] The method 40 may further include recommending a further procedure for the patient based on the virtual stress test at block 54. For example, if the virtual stress test indicates a clinically significant pressure drop at a location in the patient's vasculature for an activity level associated with the patient, a further diagnostic procedure may be recommended for the patient, such as an invasive angiogram and pressure measurement at the suspected site of the stenosis. Additionally or alternatively, a corrective procedure may be recommended to address the stenosis, such as placement of a stent at the suspected location of the stenosis.

[0090] 3 is a flow chart illustrating an example embodiment of a method 60 for performing a virtual stress test. The method 60, or one or more aspects of the method 60, may be performed, in an embodiment, by the virtual stress test computing system 16 of FIG. 1. The method 60 may be considered one embodiment of blocks 48, 50, and 52 of the method 40.

[0091] The method 60 may include obtaining a first inflow flow rate at a first activity level of the patient in block 62. The first inflow flow rate may be an expected flow rate for the patient in a first physiological condition (e.g., may be correlated with the first activity level). The first activity level may be any activity level within a relevant range of activity for the patient. For example, the first blood flow rate may be an expected resting flow rate for the patient corresponding to a low level of physical activity (i.e., a resting state). The flow rate in block 62 may be obtained 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 in block 62 may be specified (e.g., by a clinician or an electronic system) based on metabolic demand and patient condition (e.g., determining an appropriate value of α for the first activity level according to Equation 4 herein). In one embodiment, the first inflow flow rate obtained in block 62 may be any flow rate within a relevant range of flow rates for the patient (i.e., a flow rate that the patient may be expected to experience during the patient's normal activity).

[0092] The method 60 may further include calculating flow velocities and pressures within the region of interest at the patient's first activity level, at block 64. In some embodiments, the velocity and / or pressure fields may be determined based on boundaries and boundary conditions defined for the region of interest, which may in turn be based on the flow velocities received at block 62. 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 location 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.

[0093] The method 60 may further include calculating a first pressure drop (e.g., one or more user-specified points and / or other points) for the first activity level (i.e., for the first inflow flow rate) at block 66. The pressure drop may be the drop in pressure from the vessel inlet to an associated point (e.g., user-specified or otherwise). The pressure drop may be calculated based on the flow field calculated for the first activity level.

[0094] The method 60 may include obtaining a second inflow flow rate at a second activity level of the patient at block 68. The second inflow flow rate may be an expected flow rate for the patient at a second physiological condition (e.g., may be correlated with the second activity level), where the second flow rate is different from the first inflow flow rate. The second activity level may be any activity level within a relevant range of activity for the patient. For example, the second blood flow rate may be an expected blood flow rate of the patient corresponding to a high level of physical activity (i.e., a state of maximum exertion). The flow rate at block 68 may be obtained 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 68 may be determined (e.g., by a clinician or an electronic system) based on metabolic demand and patient condition (e.g., determining an appropriate value of α for the second activity level according to Equation 4 herein). In one embodiment, the second inflow flow rate obtained in block 68 may be any flow rate within the relevant range of flow rates for the patient (i.e., a flow rate that the patient may be expected to experience during the patient's normal activities).

[0095] Blocks 62, 68 have been described above with reference to an example where the first flow rate represents a resting flow rate and the second flow rate represents a hyperemic flow rate. However, it should be noted that the first and second flow rates obtained in blocks 62, 68 can be any two different flow rates within a range related to the metabolic needs of the patient.

[0096] As discussed herein, the boundary condition flow rates can be specific to a portion or time in the cardiac cycle. For example, the inflow flow rate can represent an average flow rate over the entire cardiac cycle of the patient, or the entire waveless period of the patient's diastole, or the entire diastole of the patient, or can represent a particular time point in the cardiac cycle, such as the midpoint of diastole. Thus, both the first inflow flow rate and the second inflow flow rate obtained in blocks 62, 68 can represent the same portion or point of the cardiac cycle, and the associated boundary condition model value sets and subsequent calculated flow fields for the first inflow flow rate and the second inflow flow rate can also represent that same portion or point of the cardiac cycle.

[0097] The method 60 may further include calculating flow velocities and pressures in the region of interest at a second activity level of the patient, at block 70. The flow velocities and pressures may be calculated substantially as described above with respect to block 64, except that the boundary conditions identified according to the second inflow flow rate are used.

[0098] The method 60 may further include calculating a second pressure drop at the one or more points for the second activity level, at block 72. The pressure drop may be calculated based on the flow field calculated for the second activity level at the one or more user-specified points.

[0099] The method 60 may further include, at block 74, calculating a range of pressure drops at the relevant (e.g., user-specified) points for a range of activity levels based on the first pressure drop and the second pressure drop. The range of pressure drops may be calculated as Q 1 From Q 2 can be calculated for a range of activity levels up to (or including) Q 1 is the first inlet flow rate, Q 2 is the second inlet flow rate. The pressure drop for a given flow rate can be calculated according to a quadratic equation, shown in this disclosure as Equation 1 and repeated below: ΔP=aQ+bQ2 where Q is the flow rate at a given activity level, 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 first inlet flow rate and the second inlet flow rate) as discussed herein with respect to Equations 2 and 3. Additionally or alternatively, other computational methods, such as the Lattice Boltzmann method or the one-dimensional Navier-Stokes equations, can be used to determine a and b. Once the coefficients a and b are known, ΔP over a range of inlet flow rates (and therefore over a range of activity levels) can be calculated without requiring CFD for each activity level.

[0100] Figure 5 is a graph 100 showing an example range of pressure drop versus activity level for each patient. Graph 100 of Figure 5 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 six patients, and a horizontal threshold line 114 (shown at 20 mmHg) that may indicate a clinically significant pressure drop due to obstructive disease. In graph 100, the pressure drop plots for three patients (plot lines 102, 104, and 106) exceed the threshold at different flow rates and therefore different levels of physical activity.

[0101] It should be noted that the pressure drop plots and thresholds shown in Figure 5 are merely exemplary. In some embodiments, the threshold shown (20 mmHg) (corresponding approximately to an FFR of 0.8 under hyperemic conditions) may be deemed clinically relevant for a particular patient and therefore may be applied. In other embodiments, values ​​lower or higher than 20 mmHg may be deemed clinically relevant and therefore may be applied as the threshold.

[0102] As described above, the level of physical activity at which each patient's pressure drop range exceeds a threshold may or may not actually be related to that particular patient's lifestyle. For example, the patient represented by plot line 104 may live a very active lifestyle and therefore may regularly experience high blood flow, and therefore a pressure drop exceeding a threshold at a very high flow may be clinically significant for that patient. As a result, further diagnostic or interventional procedures may be recommended for that patient. In contrast, the patient represented by plot line 102 may live a non-active lifestyle and therefore may rarely (if ever) experience high blood flow, and therefore a pressure drop exceeding a threshold at a somewhat higher flow may not be clinically significant for that patient.

[0103] The method 60 may further include identifying an activity level at which the pressure drop exceeds a threshold based on the range of the pressure drop at block 76. The threshold may, in embodiments, be set to a clinically relevant pressure drop value or may be manually selected based on clinical judgment. For example, the threshold may, in some embodiments, be selected according to a maximum MET value associated with the patient's lifestyle. The threshold may also be selected according to the portion of the cardiac cycle at which the calculations at blocks 64, 66, 70, 72 are performed. Thus, in one embodiment, a threshold may be selected that is appropriate to both the patient's expected or estimated metabolic needs, as well as the portion of the cardiac cycle at which the analysis was performed in method 60. The activity level at which the user's pressure drop exceeds the threshold may then be compared to the patient's lifestyle and overall level of activity to determine whether further diagnostic or interventional procedures are warranted.

[0104] The method 60 may further include, at block 78, displaying the flow rate and / or pressure drop at the first activity level and / or the second activity level, and / or the flow threshold applied at block 76 or the activity level at which the patient flow rate exceeds a threshold. The display may include, for example, one or more indicators of the flow rate and / or pressure at one or more locations in the patient's vasculature superimposed on or presented adjacent to a geometric model of the patient's anatomy.

[0105] As a result of method 60, 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 hemodynamic information about the patient, such as an IWFR value or other diastolic-based hemodynamic value.

[0106] 6 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, laptop, smartphone, tablet, or any other such device capable of executing instructions, such as instructions stored in a non-volatile computer-readable medium. Additionally, while described and illustrated in the context of a single computing system environment 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 system environments 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 system environments 190. The computing system environment 190, or a portion thereof, may, in an embodiment, include the system 10 of FIG. 1.

[0107] 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.

[0108] 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.

[0109] 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 processing unit (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.

[0110] 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.

[0111] The computing system environment 190 may also include location determination hardware 246 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.

[0112] 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.

[0113] 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.

[0114] 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 computer-implemented method for conducting a virtual stress test for a patient, comprising: the computer includes a processor; the virtual stress test includes simulating an exercise stress test by calculating a range of pressure drops in a blood vessel for a range of activity levels; receiving medical image data of the patient, the medical image data including an arterial segment; said processor generating a geometric image of said arterial segment from said medical image data; receiving information of the patient's metabolic needs; the processor determining a threshold value according to the metabolic demand information; the processor identifying a first flow field for the arterial segment using the shape image, the first flow field corresponding to a first activity level of the patient; the processor identifying a first pressure drop within the arterial segment based on the first flow field; the processor identifying a second flow field about the arterial segment using the shape image, the second flow field corresponding to a second activity level of the patient, the second activity level being different from the first activity level; determining a second pressure drop in the arterial segment based on the second flow field; and the processor calculating a range of pressure drops for a range of activity levels based on the first pressure drop and the second pressure drop; the processor comparing the extent of the pressure drop to a threshold; the processor displaying a result of the comparison; and A method comprising:

2. 2. The method of claim 1, wherein the first activity level is associated with a first flow rate and the second activity level is associated with a second flow rate different from the first flow rate, and wherein the processor calculating a range of pressure drop for the range of activity levels includes calculating a range of pressure drop for a range of flow rates.

3. The method of claim 2 , wherein the range of flow rates is between the first flow rate and the second flow rate.

4. The method of claim 2, wherein the processor calculating the range of pressure drop for the range of activity levels includes calculating the range of pressure drop according to a quadratic relationship between pressure drop and flow rate.

5. The method of claim 1, wherein the processor displaying the results of the comparison includes displaying a plot of the pressure drop range and the threshold value.

6. The method of claim 1 , wherein the first activity level is a resting state.

7. The method of claim 1 , wherein the second activity level is a hyperemic state.

8. The method of claim 1, further comprising the processor identifying an activity level at which the pressure drop exceeds the threshold.

9. The method of claim 1 , wherein the first flow field and the second flow field comprise a first flow velocity field and a second flow velocity field, respectively.

10. The processor using the shape image to identify the first flow field for the arterial segment, the processor obtaining a first inflow flow rate for the arterial segment; the processor calculating a first outflow flow rate for the arterial segment according to the first inflow flow rate; the processor calculating the first flow field within the arterial segment according to the shape image, the first inflow rate, and the first outflow rate; Including, The processor determining the second flow field for the arterial segment using the shape image includes: the processor obtaining a second inflow flow rate for the arterial segment; the processor calculating a second outflow flow rate for the arterial segment according to the second inflow flow rate; the processor calculating the second flow field within the arterial segment according to the shape image, the second inflow rate, and the second outflow rate; The method of claim 1 , comprising:

Images