Beating-Heart Surgery for Heart Valve Replacement

描述(申请人提供)：在美国，每年有超过115,000名患者需要用人造装置替换他们患病的心脏瓣膜。尽管生物瓣膜被认为是理想的，但它们会在大约15年内磨损，因此主要用于那些预计不会比瓣膜活得更久的老年人。较年轻的患者接受更耐用的机械瓣膜，但需要长期抗凝。这使得患者不可能参加大多数运动，并增加了致命出血和中风的风险。VXI正在开发一种由两部分组成的心脏瓣膜，包括永久基座和可插入式可交换生物假体组织叶组。因此，VXi装置是一种终身生物瓣膜系统，不需要抗凝。当传单集开始显示磨损迹象时，可以使用微创的非体外循环心脏不停跳程序快速更换。快速、微创的瓣叶交换大大缩短了重做手术的时间，并消除了重新切除初始人工瓣膜的技术要求和潜在危险的需要。在交换传单时，对接站保持在原位，避免了主动脉根部和附近的心脏传导系统的中断。VXI已经成功地开发了其瓣膜的原型，并在慢性动物模型中展示了它们的可互换性。在这一Fast Track应用中，我们建议开发(I)用于心脏瓣膜置换术的微创、非体外循环、心脏不停跳手术的工具和技术，以及(Ii)初始对接站的完全经尖植入。瓣膜植入和瓣叶交换的工具是从我们现有的开放手术工具集发展而来的。通过顶端进入阀门的途径将是Gerard Guiraudon博士首创的新型可折叠端口技术。与传统的套管针不同，我们的导入器技术使多种工具能够通过灵活的心脏端口插入，从而实现高度的铰接性和快速的工具交换。我们建议开发经根尖对接站、端口和交换工具技术，并在幼年绵羊模型的一系列急慢性瓣膜交换实验中评价它们的作用。 与公共卫生相关：在过去的30年里，经导管瓣膜的发展一直是心脏瓣膜领域唯一的重大创新。这些装置减少了侵入性，但代价是增加了中风和其他程序并发症，并大大降低了瓣膜本身的耐用性。因此，我们的技术提供了最小侵入性瓣膜植入和瓣叶交换的最佳组合，并具有与现有外科瓣膜相同的长期耐用性。一旦被市场开发和采用，它将改善美国10万心脏瓣膜疾病患者中大多数人的生活质量，并减少与长期使用抗凝剂有关的昂贵的并发症治疗。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: The development of transcatheter valves has been the only major innovation in the heart valve field in the past 30 years. These devices provide the reduction in invasiveness, but at the price of increased strokes and other procedural complications, and much reduced durability of the valve itself. Our technology thus offers the best combination of least invasive valve implant and leaflet exchange, with the same long-term durability of established surgical valves. Once developed and adopted by the marketplace, it will improve the quality of life for the majority of the 100,000 patients suffering from heart valve disease in the U.S., and reduce the expensive treatment of complications related to long-term use of anticoagulants.