Beating-Heart Surgery for Heart Valve Replacement

心脏瓣膜置换术的心脏跳动手术

基本信息

批准号：
8132787
负责人：
Ivan Vesely
金额：
$ 107.7万
依托单位：
VALVEXCHANGE, INC.
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-08-19 至 2014-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8132787
关键词：
Acute Address Adolescent Adopted Age American Heart Association Animal Model Animals Anticoagulants Anticoagulation Aorta Apex of the Heart Arterial Fatty Streak Atherosclerosis Autopsy Benign Bioprosthesis device Businesses Bypass Capital Cardiac Cardiac Surgery procedures Cardiac conduction system Catheters Chest Chronic Communities Complex Data Data Reporting Development Devices Direct Costs Disease Distal Docking Elderly Engineering Ensure Excision Facilities and Administrative Costs Fibrosis Freedom Funding Future Generations Goals Healed Heart Heart Diseases Heart Valve Diseases Heart Valves Hemorrhage Hemostatic function Hour Hybrids Implant Implantation procedure Individual Intervention Joints Lead Letters Licensing Life Life Style Longevity Mainstreaming Marketing Mechanics Medical Metals Modeling Morbidity - disease rate Mullerian duct inhibiting substance Nervous System Trauma Operative Surgical Procedures Patients Perception Performance Phase Physicians Physiological Plant Roots Plug-in Positioning Attribute Price Procedures Process Prosthesis Pump Puncture procedure Quality of life Repeat Surgery Risk Running Rupture Safety Seeds Series Sheep Small Business Innovation Research Grant Solid Solutions Sports Stroke Surgeon Surgical Valves Surgical sutures System Techniques Technology Testing Therapeutic Time Tissues Trocars Ventricular Video Recording Waran Weaning animal tissue aortic valve base dacron design disease diagnosis experience flexibility healing heart valve replacement implantation improved innovation meetings minimally invasive nitinol novel novel therapeutic intervention older patient patient safety phase 2 study prototype repaired research clinical testing research study technology development tool valve replacement young adult

项目摘要

Each year, over 115,000 patients in the US need to have their diseased heart valves replaced with artificial devices. Although bioprosthetic valves are considered ideal, they wear out in about 15 years and are thus used primarily in the elderly who are not expected to outlive the valve. Younger patients receive mechanical valves that are more durable, but require chronic anticoagulation. This makes participation in most sports impossible and exposes the patient to increased risk for fatal bleeds and strokes. VXi is developing a two-part heart valve consisting of a permanent base and a plug-in exchangeable bioprosthetic tissue leaflet set. The VXi device is thus a lifetime bioprosthetic valve system that does not require anticoagulation. As the leaflet set begins to show signs of wear it can be exchanged rapidly, using a minimally invasive off-pump, beating heart procedure. Rapid, minimally invasive leaflet exchange significantly reduces the duration of redo surgery and eliminates the need for the technically demanding and potentially dangerous re-excision of the initial prosthetic valve. As the leaflet set is exchanged, the docking station remains in place, avoiding disruption of the aortic root and the nearby conduction system of the heart. VXi has successfully developed prototypes of its valves and demonstrated their exchangeability in a chronic animal model. In this Fast Track application, we propose to develop (i) the tools and techniques for minimally invasive, off-pump, beating-heart surgery for heart valve replacement, and (ii) a fully transapical implant of the initial docking station. The tools for valve implant and leaflet exchange evolve from our existing open surgery tool set. Access to the valve through the apex will be by way of a novel collapsible port technology pioneered by Dr. Gerard Guiraudon. Unlike conventional trocars, our introducer technology enables multiple tools to be inserted through a flexible cardiac port that enables a high degree of articulation, and rapid tool exchange. We propose to develop the transapical docking station, the port and the exchange tool technology and evaluate their function in a series of acute and chronic valve exchange experiments in the juvenile sheep model.

每年，美国有115,000多名患者需要将患病的心脏瓣膜替换为人造设备。尽管生物假体阀被认为是理想的，但它们在大约15年内磨损，因此主要用于不预计阀门的老年人。年轻的患者会收到更耐用但需要慢性抗凝的机械瓣膜。这使参加大多数运动的参与不可能，并使患者暴露于增加致命性出血和中风的风险。 VXI正在开发一个由永久底座和可插入式生物假体组织小叶集组成的两部分心脏阀。因此，VXI设备是不需要抗凝的寿命生物假体瓣膜系统。当传单套装开始显示磨损的迹象时，可以使用微创的脱泵，跳动的心脏手术来迅速交换。快速，微创的传单交换显着降低了重做手术的持续时间，并消除了对初始假体瓣膜的技术要求和潜在危险的重新分离的需求。当交换传单时，对接站仍留在原处，避免了主动脉根和附近心脏的传导系统的破坏。 VXI成功地开发了其阀门原型，并在慢性动物模型中证明了它们的交换性。在此快速应用中，我们建议（i）（i）为心脏瓣膜替代品的微创，脱水，跳动的手术的工具和技术，以及（ii）最初的对接站的完全跨行植入物。阀门植入物和传单交换的工具从我们现有的开放手术工具集演变。通过顶端进入阀门将通过Gerard Guiraudon博士开创的新型可折叠港口技术。与传统的套管器不同，我们的介绍器技术可以通过灵活的心脏端口插入多个工具，该端口可以高度发音和快速的工具交换。我们建议开发跨速对接站，端口和交换工具技术，并在少年绵羊模型中的一系列急性和慢性阀交换实验中评估它们的功能。