SBIR Phase I: Transcatheter Tricuspid Valve Replacement using Physical Vapor Deposition Thin-Films

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be to provide a life-saving treatment option to patients suffering from a specific heart condition called tricuspid regurgitation (TR). In the US, 1.6 million patients need treatment for life-threatening TR, and no good medical, surgical, or transcatheter therapy exists. Current solutions lead to bleeding complications, damage to the circulatory system, or inability to deliver the device. This project will develop a novel device to address these constraints with a method that can be manufactured at scale, resulting in significant cost savings to the healthcare system and improved quality of life. This Small Business Innovation Research (SBIR) project will enable the development of a new transcatheter tricuspid valve replacement device and novel technology to produce 3D physical vapor deposition (PVD) nitinol thin-film leaflets. One of the main challenges in valve development is a design that can be compressed into a catheter successfully. The use of a thin film rather than the standard of pericardial tissue will significantly reduce the volume of the valve material, enabling a much smaller delivery catheter profile. This study addresses critical developmental objectives, such as manufacturing feasibility and thin film leaflet characteristics. The solution will be optimized for material fatigue life, valve characteristics, valve durability, and anchoring to validate it for medical use. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.