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

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.