Development of a Physiologically Realistic, 3D-Printed, Configurable Coronary Artery Mock Circulatory Loop

Modern medical imaging techniques and numerical modeling have paved the way for less invasive diagnostic procedures for coronary artery disease. One of the most prominent applications is the estimation of fractional flow reserve through a coronary stenosis using a computed tomography scan. While these techniques are commonly used in clinical practice, the methods used for experimental validation vary widely, and thus the quality of the validation evidence included in regulatory evaluation also varies. To help address this, we are developing a standardized end-to-end validation dataset using a baseline coronary artery lumen geometry which is based on a survey of patient geometric parameters in the literature. As part of this study, we have developed a 3D-printed coronary artery test section using this geometry with configurable coronary artery branches and integrated it into a mock circulatory loop. This mock circulatory loop has optical access sufficient for laser-based flow measurement techniques like particle image velocimetry and particle tracking velocimetry. Herein we will present the current state of development of our experimental setup and present our development plan and expected challenges. Once completed, this validation dataset will be made available to the public via the FDA Office of Science and Engineering Laboratories (OSEL) Regulatory Science Tool Catalog.