Coronary Blood Flow Modeling With FFR Sensitivity Analysis
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Solution Overview
Problem
Existing methods for assessing coronary artery disease, such as CCTA and diagnostic cardiac catheterization, fail to provide accurate functional significance of coronary lesions, leading to unnecessary invasive procedures and health care costs, while computational fluid dynamics (CFD) simulations are limited by uncertainties in data and geometry.
Innovation Solution
A system and method for creating a three-dimensional model of the patient's coronary vasculature, incorporating uncertain parameters and clinical variables, and calculating fractional flow reserve (FFR) with sensitivity analysis and confidence intervals, using non-invasive data to determine functional significance of lesions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If CCTA is used to image coronary arteries, then anatomic data is obtained noninvasively, but functional significance of lesions cannot be determined
Solution Approach 1:
The patent introduces computational fluid dynamics (CFD) simulations as an intermediary between CCTA anatomical data and functional assessment. The CFD model acts as a mediator that processes the anatomical information and translates it into functional predictions, including blood flow rates, pressure gradients, and fractional flow reserve estimates, thereby bridging the information gap without requiring additional invasive procedures
Solution Approach 2:
The patent replaces the mechanical/invasive FFR measurement system with a computational simulation system. Instead of physically measuring pressure gradients using catheter-based FFR, the system uses CFD algorithms to calculate flow characteristics and pressure distributions numerically, substituting a mechanical measurement approach with a computational model that derives functional data from anatomical images
2Measurement precision
If diagnostic cardiac catheterization is performed to assess functional significance, then FFR can be measured, but invasive procedures and health care costs increase
Solution Approach 1:
The patent creates a virtual copy of the patient's coronary anatomy through CFD simulation. By generating a computational model that replicates the coronary tree geometry, vessel properties, and flow characteristics, the system can assess functional significance without physically invading the patient's body. This virtual replica allows repeated measurements and scenario testing without exposing the patient to invasive risks
Solution Approach 2:
The patent substitutes the invasive mechanical FFR measurement system with a noninvasive computational simulation system. The CFD model calculates pressure gradients and flow rates through numerical solutions of fluid dynamics equations, replacing the need for physical catheter insertion and pressure transducer measurements, thereby eliminating procedure-related risks while maintaining assessment accuracy
3Ease of operation
If CFD simulations are used to model blood flow, then functional significance can be assessed noninvasively, but uncertainties in data and geometry limit accuracy
Solution Approach 1:
The patent systematically varies input parameters such as boundary conditions, material properties, and geometric dimensions within their uncertainty ranges to perform sensitivity analysis. By changing these parameters and observing the resulting variations in FFR predictions, the system identifies which parameters most influence model output and quantifies the impact of uncertainties on the final assessment
Solution Approach 2:
The patent incorporates feedback mechanisms through iterative model refinement and validation. The system compares simulation results against available clinical data and patient outcomes, using this feedback to adjust and improve the model. This iterative process allows the system to learn from actual patient responses and refine its predictions, thereby improving reliability over time
4Ease of manufacture
If FFR measurement is performed to determine lesion treatment necessity, then treatment decisions can be made, but unnecessary operations increase due to lack of functional data
Solution Approach 1:
The patent performs preliminary functional assessment using CFD simulations before committing to invasive treatment procedures. By pre-evaluating the functional significance of lesions through noninvasive computational modeling, the system identifies which lesions truly require intervention and which can be safely observed, preventing unnecessary treatments while ensuring that truly problematic lesions receive appropriate care
Data Source
AI summary
Embodiments include systems and methods for determining cardiovascular information for a patient. A method includes receiving patient-specific data regarding a geometry of the patient's vasculature; creating an anatomic model representing at least a portion of the patient's vasculature based on the patient-specific data; and creating a computational model of a blood flow characteristic based on the anatomic model. The method also includes identifying one or more of an uncertain parameter, an uncertain clinical variable, and an uncertain geometry; modifying a probability model based on one or more of the identified uncertain parameter, uncertain clinical variable, or uncertain geometry; determining a blood flow characteristic within the patient's vasculature based on the anatomic model and the computational model of the blood flow characteristic of the patient's vasculature; and calculating, based on the probability model and the determined blood flow characteristic, a sensitivity of the determined fractional flow reserve to one or more of the identified uncertain parameter, uncertain clinical variable, or uncertain geometry.