A Novel Polymeric Valve for Transcatheter Aortic Valve Replacement

用于经导管主动脉瓣置换的新型聚合物瓣膜

基本信息

批准号：
9344868
负责人：
DANNY BLUESTEIN
金额：
$ 11.47万
依托单位：
POLYNOVA CARDIOVASCULAR, INC
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-04-01 至 2019-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9344868
关键词：
3D Print Adverse event Anatomy Animals Aortic Valve Stenosis Berlin Biological Assay Bioprosthesis device Blood Blood Platelets Blood Vessels Calcified Cardiovascular system Chronic Clinical Clinical Research Collaborations Complication Computer Simulation Cyclic GMP Deposition Deterioration Devices Dissection Evaluation Extravasation Follow-Up Studies Generations Geometry Goals Grant Heart Heart Valve Prosthesis In Situ In Vitro Left Licensing Life Life Cycle Stages Liquid substance Measures Methodology Modeling Molds National Institute of Biomedical Imaging and Bioengineering Operative Surgical Procedures Outcome Pathway interactions Patient risk Patients Performance Phase Physiological Plant Roots Platelet Activation Polymers Population Predisposition Preparation Procedures Process Prosthesis Protocols documentation Publishing Risk Risk Factors Rupture Savings Serious Adverse Event Silicones Small Business Technology Transfer Research Stents Stress Stroke Structure Surgical Valves System Technology Testing Therapeutic Embolization Thick Thrombosis Tissues Translating United States National Institutes of Health Universities X-Ray Computed Tomography aortic valve aortic valve disorder aortic valve replacement base bone calcification commercialization crosslink design effective therapy experimental study follow-up hemodynamics high risk improved in vivo innovation left ventricular assist device mechanical properties migration minimally invasive new technology novel older patient patient population pressure programs prototype quantum replicator research and development simulation success valve replacement verification and validation

项目摘要

Project Summary: A Novel Polymeric Valve for Transcatheter Aortic Valve Replacement Minimally invasive transcatheter aortic valve replacement (TAVR) has emerged as an effective therapy for the unmet clinical need of inoperable patients with severe aortic stenosis (AS). Recent longitudinal follow-up studies of TAVR patients however indicate that this procedure and associated technology may result in serious adverse events. Current technology is based on tissue valves adapted to, but not specifically designed for TAVR. Those may sustain damage during crimping as well as deployment, are susceptible to ‘bone-like’ calcific deposition, and suffer from limited durability. Our group has developed a novel valve that is specifically designed to tackle the numerous challenges that a TAVR valve will meet during its life cycle, from crimping to deployment and long term performance in situ. It incorporates (i) novel polymer technology, xSIBS, which combines superior bio-stability together with excellent mechanical properties, and (ii) a novel design optimization methodology of the leaflets profile for enhanced hemodynamic, durability, and thromboresistance performance. Our broad objective is to develop a viable and durable TAVR valve that will propose a real alternative to existing bioprosthetic aortic valves, and allow a long-term solution adequate for broader segment of the population. This Phase I STTR project, in a collaboration between Stony Brook University and PolyNova Cardiovascular Inc, aims to shift our existing novel polymeric prosthetic heart valve to a TAVR application, providing proof-of-concept. This will be tested in four aims: Aim 1 analyses the hydrodynamic performance in silico both in standard as well as in patient- specific anatomy, quantify its thrombogenic potential, and compares it to a commercially available valve. Aim 2 tests the hydrodynamic performance in vitro, using standard and patient-specific anatomy, and evaluates damage to the polymer as a result of valve crimping. Aim 3 quantifies the thromboresistance profile of the valve via platelet activation under physiological flow conditions. Aim 4 evaluates the durability performance and calcification susceptibility under accelerated wear testing conditions. Successful accomplishment of the above aims will lead to a breakthrough in the treatment of aortic valve diseases, providing an affordable, long-term, minimally invasive solution, enhancing the life of a much broader patient population.

项目摘要：用于经导管主动脉瓣置换术的新型聚合物瓣膜微创经导管主动脉瓣置换术（TAVR）已成为一种有效的治疗方法最近的纵向随访研究未满足无法手术的严重主动脉瓣狭窄（AS）患者的临床需求。然而，TAVR 患者表示该手术和相关技术可能会导致严重的不良后果当前的技术是基于适应 TAVR 的组织瓣膜，但不是专门为这些事件设计的。在压接和展开过程中遭受损坏，容易受到“骨状”钙化沉积的影响，并遭受由于耐用性有限，我们的团队开发了一种新型阀门，专门用于解决众多问题。 TAVR 阀门在其生命周期中将遇到的挑战，从压接到部署以及长期性能它采用了 (i) 新型聚合物技术 xSIBS，它将卓越的生物稳定性与优异的机械性能，以及（ii）新颖的小叶轮廓设计优化方法，以增强血流动力学、耐久性和抗血栓性能。我们的总体目标是开发一种可行且耐用的 TAVR 瓣膜，为现有的 TAVR 瓣膜提供真正的替代品生物主动脉瓣膜，并提供适合更广泛人群的长期解决方案。 STTR 一期项目由石溪大学和 PolyNova 心血管公司合作，旨在将我们现有的新型聚合物人工心脏瓣膜转移到 TAVR 应用，这将提供概念验证。在四个目标中进行测试：目标 1 在计算机中分析标准和患者的流体动力学性能特定的解剖结构，量化其血栓形成潜力，并将其与市售的 Aim 2 测试进行比较。使用标准和患者特定的解剖结构进行体外流体动力学性能，并评估对目标 3 通过血小板量化瓣膜的抗血栓特性。目标 4 评估耐久性能和钙化。加速磨损测试条件下的敏感性。上述目标的成功实现将为主动脉瓣疾病的治疗带来突破，提供负担得起的、长期的、微创的解决方案，改善更广泛患者的生活人口。