Methodology for Hemodynamic Assessment of a Three-Dimensional Printed Patient-Specific Vascular Test Device

Abstract

Assessing hemodynamics in vasculature is important for the development of cardiovascular diagnostic parameters and evaluation of medical devices. Benchtop experiments are a safe and comprehensive preclinical method for testing new diagnostic endpoints and devices within a controlled environment. Recent advances in three-dimensional (3D) printing have enhanced benchtop tests by allowing generation of patient-specific and pathophysiologic conditions. We used 3D printing, coupled with image processing and computer-aided design (CAD), to develop a patient-specific vascular test device from clinical data. The proximal pulmonary artery (PA) tree including the main, left, and right pulmonary arteries, with a stenosis within the left PA was selected as a representative anatomy for developing the vascular test device. Three test devices representing clinically relevant stenosis severities, 90%, 80%, and 70% area stenosis, were evaluated at different cardiac outputs (COs). A mock circulatory loop (MCL) generating pathophysiologic pulmonary pressure and flow was used to evaluate the hemodynamics within the devices. The dimensionless pressure drop–velocity ratio characteristic curves for the three stenosis severities were obtained. At a fixed CO, the dimensionless pressure drop increased nonlinearly with an increase in (a) the velocity ratio for a fixed stenosis severity and (b) the stenosis severity at a specific velocity ratio. The dimensionless pressure drop observed in vivo was similar (within 1%) to that measured in moderate area stenosis of 70% because both flows were viscous dominated. The hemodynamics of the 3D printed test device can be used for evaluating diagnostic endpoints and medical devices in a preclinical setting under realistic conditions.