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

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力将是为患有一种名为三尖瓣返流(TR)的特殊心脏疾病的患者提供一种挽救生命的治疗选择。在美国，160万患者需要治疗危及生命的TR，而目前还没有好的内科、外科或经导管治疗方法。目前的解决方案会导致出血并发症、循环系统受损或无法交付设备。该项目将开发一种可规模化制造的新设备来解决这些限制，从而显著节省医疗保健系统的成本并提高生活质量。该小型企业创新研究(SBIR)项目将使新的经导管三尖瓣置换设备和新技术的开发成为可能，以生产3D物理气相沉积(PVD)镍钛醇薄膜小叶。瓣膜开发中的主要挑战之一是设计一种可以成功压缩到导管中的设计。使用薄膜而不是标准的心包组织将显著减少瓣膜材料的体积，从而实现更小的输送导管外形。这项研究解决了关键的发展目标，如制造可行性和薄膜小叶的特征。该解决方案将在材料疲劳寿命、阀门特性、阀门耐久性和锚定方面进行优化，以验证其医疗用途。该奖项反映了NSF的法定使命，并已通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.