The Q-shunt: Prototype development of a medical device to treat fetal bladder outlet obstruction

About This Grant

Project Summary/Abstract Fetal lower urinary tract obstruction (LUTO) is a rare but life-threatening congenital condition that causes progressive renal damage, pulmonary hypoplasia, and high perinatal mortality. Vesicoamniotic shunting (VAS) offers a means of restoring bladder drainage and preserving fetal organ development, but current shunting devices are highly unreliable. Existing options are associated with dislodgement and mechanical malfunction in over 50% of cases, often necessitating repeat procedures that increase fetal and maternal risk. The Q-shunt is a novel, anatomically stable fetal shunting device designed to overcome the limitations of current technology. Its patented design includes a self-expanding nitinol anchor to prevent dislodgement and a bidirectional delivery system that allows for real-time placement adjustment—two innovations that address the root causes of VAS failure. Preliminary clinical experience with a proof-of-concept prototype demonstrated 93% proper placement, 100% device retention, 88% live birth rate, and 72% of cases had normal renal function at 2 years of age. Phase I SBIR funding will facilitate device refinement while maintaining the anchoring strength and maneuverability of the Q-shunt. This project will establish the feasibility of an optimized Q-shunt design through materials refinement, functional performance validation, and risk mitigation in preparation for clinical trials. The work will include: (1) selection and testing of biocompatible materials for optimal clinical performance; (2) performance validation through bench testing of flow rate, yield point, tensile strength, curl strength, and anchoring retention; (3) development of engineering specifications and regulatory-compliant design drawings; and (4) prototype assembly and final bench testing for compliance with predefined safety, usability, and performance benchmarks. A medical device manufacturing firm will be subcontracted for device miniaturization and mechanical optimization. The finalized prototype will be suitable for regulatory engagement and serve as the basis for a Phase II clinical safety trial. A validated Q-shunt prototype offers a safe, reliable, single-procedure solution for fetuses with LUTO, minimizing fetal and maternal risk and reducing overall healthcare costs. Projected revenues are $6.5M within five years based on 50% penetration among specialized antenatal care centers, targeting a ~$13M annual U.S. market. With bench-tested performance data and finalized engineering plans, the project will be positioned for Phase II SBIR funding, preclinical regulatory discussions, and strategic investor engagement.