Non-invasive Fractional Flow Reserve Prediction via Computational Fluid Dynamics
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Solution Overview
Problem
Current methods for assessing coronary artery disease, such as coronary angiography, have limitations in evaluating the functional significance of intermediate coronary lesions due to high variability and lack of correlation with physiologic severity, necessitating complementary methods that combine coronary anatomy and physiology.
Innovation Solution
A non-invasive method for determining fractional flow reserve (FFR) using a monitoring device external to the luminal organ, which determines stenosis geometry and flow rate, and calculates FFR through equations that predict the degree of stenosis without empirical parameters, allowing for non-invasive prediction of functional lesion severity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional coronary angiography is used to assess coronary artery disease, then coronary anatomy can be visualized, but functional significance of intermediate lesions cannot be accurately evaluated due to high variability and lack of correlation with physiologic severity
Solution Approach 1:
The patent replaces the mechanical/invasive pressure wire system with a non-invasive computational fluid dynamics (CFD) model that uses image processing and numerical simulations to calculate FFR, eliminating the need for physical wire insertion while maintaining measurement accuracy
Solution Approach 2:
The patent introduces computational fluid dynamics simulations as an intermediary between anatomical imaging and physiological function assessment, using virtual pressure and flow calculations to bridge the gap between structure and function without direct invasive measurement
2Measurement precision
If pressure wire is inserted through the stenosis to measure FFR, then functional severity can be directly measured, but operational complexity and risk increase due to guidewire obstruction and signal shift
Solution Approach 1:
The patent substitutes the mechanical pressure wire measurement system with a non-invasive computational model that calculates FFR based on CFD simulations of pressure and flow fields, eliminating all mechanical intervention in the coronary vessels
Solution Approach 2:
The patent creates a virtual copy of the coronary anatomy from imaging data and performs measurements on this digital replica through CFD simulations, avoiding the need to physically insert wires into the actual vessels while obtaining identical FFR information
3Ease of operation
If pressure wire is placed near the stenosis to avoid obstruction, then FFR can be measured, but overestimation of FFR occurs reducing measurement accuracy
Solution Approach 1:
The patent replaces mechanical wire-based measurement with computational fluid dynamics that can accurately model pressure gradients and flow rates at the stenosis location without physical obstruction, eliminating the trade-off between wire placement feasibility and measurement accuracy
4Ease of operation
If non-invasive method based on hyperemic coronary blood flow and lesion geometry is used, then operational simplicity and cost are improved, but measurement precision deteriorates due to lack of direct pressure measurement
Solution Approach 1:
The patent replaces direct mechanical pressure measurement with computational fluid dynamics simulations that calculate pressure gradients and flow rates from anatomical geometry and boundary conditions, achieving non-invasive operation while maintaining measurement precision through physically-based modeling
Solution Approach 2:
The patent transforms the measurement approach by changing from direct pressure measurement to computational calculation of pressure gradients and flow rates based on CFD equations, enabling non-invasive operation while maintaining accuracy through rigorous physical modeling
Data Source
AI summary
Non-invasive systems and methods for determining fractional flow reserve. At least one method of determining fractional flow reserve within a luminal organ of the present disclosure comprising the steps of positioning a monitoring device external to a luminal organ and near a stenosis, the monitoring device capable of determining at least one characteristic of the stenosis, operating the monitoring device to determine the at least one characteristic of the stenosis, and determining fractional flow reserve at or near the stenosis based upon the at least one characteristic determined by the monitoring device.