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

SBIR 第一阶段：使用物理气相沉积薄膜进行经导管三尖瓣置换术

• 批准号: 2031818
• 负责人: Daniel Anderson
• 金额: $ 25.6万
• 依托单位: NININGER MEDICAL, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-15 至 2022-05-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2031818&HistoricalAwards=false
• 关键词: SBIR; Phase; Transcatheter; Tricuspid; Valve

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.

这项小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力将为患有称为三尖瓣反流（TR）的特定心脏病的患者提供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，并且不存在良好的药物、手术或经导管治疗。目前的解决方案导致出血并发症、对循环系统的损伤或不能递送装置。该项目将开发一种新的设备来解决这些限制，并采用一种可以大规模生产的方法，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）项目将开发一种新的经导管三尖瓣置换设备和生产3D物理气相沉积（PVD）镍钛合金薄膜瓣叶的新技术。瓣膜开发中的主要挑战之一是可以成功压缩到导管中的设计。使用薄膜而不是标准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轮廓。本研究讨论了关键开发目标，如生产可行性和薄膜瓣叶特征。该解决方案将针对材料疲劳寿命、阀门特性、阀门耐久性和锚固进行优化，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。