Using Biodesign Methodology for the Development and Initial Validation of a Novel Fetal Shunt: The Vortex Shunt.

Abstract

Fetal lower urinary tract obstruction (LUTO) is a severe malformation that is associated with significant neonatal and pediatric morbidity and mortality risk. Existing fetal shunts aimed at bypassing the obstruction and improving neonatal survival have significant limitations, primarily shunt dislodgement. Repeat in-utero invasive shunt replacement procedures are associated with maternal, fetal, and obstetric risks, highlighting a clinical need for a novel fetal shunt with improved performance. We used a biodesign approach to develop and validate a novel fetal shunt, the Vortex shunt, which can potentially reduce dislodgement and improve both neonatal and maternal outcomes. In this review, we will discuss our approach to assessing the clinical need, the initial prototyping and benchtop testing, and animal feasibility studies of the Vortex shunt. We will also discuss existing challenges and opportunities for innovation in the fetal medicine and surgery space, and how biodesign methodology can inform novel instrument development in high-impact small market areas.