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

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力将是为患有三尖瓣反流（TR）的特定心脏疾病的患者提供一种挽救生命的治疗选择。在美国，有160万患者需要治疗危及生命的TR，但没有好的医疗、手术或经导管治疗方法。目前的解决方案会导致出血并发症、循环系统受损或无法输送设备。该项目将开发一种新颖的设备，通过一种可以大规模制造的方法来解决这些限制，从而为医疗保健系统节省大量成本，提高生活质量。这项小型企业创新研究（SBIR）项目将开发一种新的经导管三尖瓣置换装置和新技术，以生产3D物理气相沉积（PVD）镍钛诺薄膜。瓣膜开发的主要挑战之一是能够成功地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，使输送导管轮廓更小。这项研究解决了关键的发展目标，如制造可行性和薄膜传单特性。该解决方案将针对材料疲劳寿命、阀门特性、阀门耐久性和锚定进行优化，以验证其用于医疗用途。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值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.