3D Printed Coronary Models for Non-Invasive FFR Prediction
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Solution Overview
Problem
Current methods for evaluating coronary artery disease, such as invasive fractional flow reserve (FFR) and computational fluid dynamics (CFD), have limitations in assessing microcirculatory resistance, patient-specific ischemic thresholds, and do not consider time-varying local blood flow patterns or plaque effects, while CFD simulations are computationally prohibitive and rely on unvalidated assumptions.
Innovation Solution
3D printed coronary models generated from coronary CT angiography, using advanced 3D printing methods with flexible digital materials, allow for realistic tissue mechanics and fluid/solid interactions, enabling non-invasive measurement of hemodynamics and biomechanics through particle imaging velocimetry and strain sensors, and predicting FFR.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If invasive fractional flow reserve (FFR) is used to evaluate coronary artery disease, then diagnostic accuracy is improved, but patient morbidity and procedural complexity increase
Solution Approach 1:
The patent creates physical 3D printed copies of patient-specific coronary artery geometries based on CT angiography data. These printed models replicate the actual arterial structure including plaques and stenoses, allowing external observation and measurement without invasive procedures. The models serve as safe, reusable copies that preserve diagnostic information while eliminating the need for repeated invasive wire insertions.
Solution Approach 2:
The patent replaces the mechanical invasive pressure wire system with an optical measurement system. By using transparent or translucent 3D printed models, the system substitutes direct mechanical insertion with external optical imaging techniques to measure hemodynamic parameters like pressure drops and flow patterns, thereby eliminating procedural risks while maintaining measurement capability.
2Ease of operation
If computational fluid dynamics (CFD) is used to simulate coronary hemodynamics, then non-invasive assessment is achieved, but computational time and resource requirements increase
Solution Approach 1:
The patent employs inexpensive, rapidly manufacturable 3D printed models that can be produced in minutes to hours rather than requiring hours or days of computational simulation. The additive manufacturing process creates disposable or single-use physical models that provide immediate results, replacing the time-consuming iterative nature of CFD simulations with rapid physical prototyping and direct measurement.
Solution Approach 2:
The patent performs preliminary actions by creating physical models before actual measurement is needed. The 3D printing process pre-establishes the coronary geometry with embedded sensors and flow loops, so that when diagnostic measurement is required, the system is already prepared and can provide immediate results without requiring time-consuming computational setup and simulation during the diagnostic moment.
3Reliability
If advanced 3D printing methods with flexible digital materials are used to create realistic tissue mechanics, then biomechanical accuracy is improved, but manufacturing complexity increases
Solution Approach 1:
The patent uses composite material approaches in 3D printing, combining different materials with varying degrees of flexibility, transparency, and mechanical properties to replicate different tissue types. By integrating multiple materials during the printing process, the system achieves realistic biomechanical behavior of coronary tissues including the compliance of arterial walls and the properties of plaques, while the additive manufacturing process itself manages the complexity of combining these materials.
Solution Approach 2:
The patent applies local quality by varying material properties at different locations within the 3D printed model. Different regions of the coronary artery model use materials with specific mechanical properties matched to local tissue characteristics - such as stiffer materials for calcified plaque regions and more compliant materials for healthy arterial segments. This localized material differentiation achieves high biomechanical accuracy while the digital printing process automatically manages the complexity of spatially varying material composition.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The 3D printed models provide accurate, non-invasive assessment of coronary mechanics, accounting for fluid/solid interactions and microcirculation, predicting FFR, and evaluating hemodynamic features like wall shear stress and particle resonance time, offering predictive value for myocardial infarction risk and testing coronary interventions.
Implementation Method 1
By printing these models from transparent materials, the system enables the measurement of hemodynamics and biomechanics using particle imaging velocimetry (PIV) and TOMO-PIV
Implementation Method 2
The system provides models, which provide realistic tissue mechanics (from flexible digital material printing). The models can be used with flow loops with adjustable flow profiles (programmable pulsatile flow pump) and microcirculatory resistance
Implementation Method 3
The system can also enable additional biomechanics to be measured by incorporating flexible strain sensors directly into the 3D print model
Data Source
AI summary
The present disclosure describes a system that can enable the prediction of coronary flow without invasive medical procedure. The system can generate physical models that can provide an accurate assessment of coronary mechanics and enable realistic simulation of coronary procedures. The models can enable the hemodynamic measurement of flow through the model and the study of flow dynamics through the model and the biomechanics of the model.


