SBIR Phase I: Novel Self-Closing, Transcatheter, Edge-to-Edge Repair Device to Percutaneously Treat Tricuspid Valve Regurgitation Using Jugular or Femoral Vein Access

该小型企业创新研究（SBIR）I期项目开发了一种新型医疗器械，可用于微创手术翻修和三尖瓣修复。美国有超过160万患者患有中度至重度三尖瓣反流（TR），到2028年市场规模将超过24亿美元。这种修复的患病率随着年龄的增长而增加，女性患TR的可能性是男性的4倍以上。目前尚无食品药品监督管理局（FDA）批准的用于TR治疗的经皮器械。由于与大手术相关的固有风险以及术后并发症导致严重TR患者的发病率和死亡率高达36.1%，因此很少进行孤立性TR手术。因此，目前只有大约8,000名美国中度至重度TR患者接受手术治疗。 该小型企业创新研究（SBIR）I期项目开发了一种新型经皮、基于导管的器械和手术，用于三尖瓣返流（TR）患者的三尖瓣翻修手术。三尖瓣是四种心脏瓣膜中最大的一种，由于其复杂的解剖结构（包括3个薄瓣叶和位置）而面临独特的挑战。使用传统股静脉入路难以进入瓣膜。本项目旨在提供一种新颖的、低切迹的经颈静脉的导管和植入装置。第一阶段的目标包括证明瓣膜瓣叶的抓取能力，使用模拟人体条件的台式模型确认设计，进一步设计、开发和确认动物模型，并在实验室环境中通过颈静脉进行经导管三尖瓣缘对缘修复术（t-TEER）。结果来自技术开发、台架测试。该奖项反映了NSF的法定使命，并被认为值得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来支持。

This Small Business Innovation Research (SBIR) Phase I project develops a novel medical device enabling minimally invasive surgical revision and repair of the tricuspid valve. More than 1.6 million patients in the U.S. suffer from moderate to severe tricuspid valve regurgitation (TR) resulting in a market-size exceeding $2.4 billion by 2028. The prevalence of this repair increases with age, with women over 4 times more likely to be affected with TR than men. There are no Food and Drug Administration (FDA)-approved percutaneous devices for TR treatment. Isolated TR surgery is rarely performed due to the inherent risks associated with major surgery with post-operative complications resulting in high morbidity and mortality rates of 36.1% among severe TR patients. Hence, only about 8,000 of all U.S. patients with moderate to severe TR currently receive surgical treatment. This Small Business Innovation Research (SBIR) Phase I project develops a novel, percutaneous, catheter-based device and procedure for surgically revising the tricuspid Valve in patients suffering from Tricuspid Regurgitation (TR). The tricuspid valve is the largest of the four heart valves presenting unique challenges due to its complex anatomy including 3 thin leaflets and location. The valve is difficult to access using traditional femoral vein access. This project aims to provide a novel, low-profile catheter and implant device via the jugular vein. The Phase I objectives include demonstrating the ability to grasp valve leaflets, validating the design using a benchtop model simulating human conditions, further designing, developing and validating an animal model, and performing a transcatheter tricuspid edge-to-edge repair (t-TEER) procedure via the jugular vein in a lab setting. The results from the technology development, bench testing. and preclinical models will further the system towards eventual human 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.