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：经导管主动脉瓣更换的新型聚合物阀微创经导管主动脉瓣置换（TAVR）已成为一种有效的治疗疗法未满足的临床需要严重主动脉瓣狭窄患者（AS）。最近的纵向随访研究但是，TAVR患者表明此程序和相关技术可能会导致严重的逆境事件。当前的技术基于适合TAVR的组织阀，但不是专门设计的。那些可以在犯罪和部署期间维持损害，容易受到“骨状”钙化沉积的影响，并遭受痛苦从有限的耐用性。我们的小组开发了一个新颖的阀 TAVR阀在其生命周期中将面临的挑战，从犯罪到部署和长期性能原位。它结合了（i）新型聚合物技术，XSIBS，将卓越的生物稳定性与优秀的机械性能，以及（ii）提高小叶的新型设计优化方法论血液动力学，耐用性和血栓抗性性能。我们广泛的目标是开发一个可行耐用的TAVR阀，该阀将提出真正的替代品生物假体主动脉瓣，并允许长期解决方案足以适应更广泛的人群。这第一阶段的STTR项目，在Stony Brook University与Polynova Cardiescular Inc之间的合作中，旨在将我们现有的新型聚合假体心脏阀转移到TAVR应用，提供概念验证。这会在四个目标中进行测试：AIM 1分析了标准和患者中硅中的流体动力性能特定解剖结构，量化其血栓形成潜力，并将其与市售阀进行比较。 AIM 2测试使用标准和患者特异性解剖学的体外流体动力性能，并评估对聚合物是由于阀压接。 AIM 3量化了通过血小板的阀门的血栓抗性轮廓在物理流条件下激活。 AIM 4评估耐用性能和钙化在加速磨损测试条件下的敏感性。成功完成上述目标将导致主动脉瓣疾病治疗的突破，提供负担得起的长期，微创的解决方案，增强了更广泛的患者的寿命人口。