微小切口经导管“双皇冠”支架瓣膜二尖瓣位植入的实验研究

Nowadays, transcatheter heart stent valve implantation has been widely concerned and studied because of its minimal invasiveness, no need of cardiopulmonary bypass and so on. This technique has been treated as supplementary therapy or even the alternative therapy for heart valve replacement surgery. But there are still a lot of shortage such as high mortality rate and complication rate of this technique. Our research group has designed “Double-crown” stent valve with independent intellectual property rights during previous study. In addition, the effectiveness and feasibility of implantation in the mitral ring has been testified through animal experiment. This research aims to modify the stereostructure, material and to design an all new “Double-crown” stent valve which can apply to all conditions including native mitral valve implantation, “Valve-in-valve” implantation and “Valve-in-ring” implantation. This modified “Double-crown” stent valve will also be testified through animal experiment in order to confirm its feasibility and effectiveness. A sound technical system of transcatheter “Double-crown” stent valve implantation on mitral valve location will finally be established. This research achievement might play an important role in transcatheter heart stent valve implantation of minimally invasive valve surgery.

目前，经导管心脏瓣膜支架植入技术以其微创、非体外循环等优势而成为近年来的研究热点。该技术被认为是瓣膜置换术的补充甚至是一种有效的替代治疗。但是目前该技术仍存在诸多的问题，如较高的死亡率和并发症发生率。本项目组在前期研究工作中设计出具有自主知识产权的“双皇冠”支架瓣膜，并通过动物的体内及体外实验验证其在二尖瓣成形环内植入的有效性。本申请课题拟在前期研究基础上对“双皇冠”支架瓣膜的立体结构、选材、工艺等做进一步改进，设计出通用于自然二尖瓣、“瓣中瓣”、“环中瓣”的“双皇冠”支架瓣膜，并通过动物实验将该支架瓣膜植入到二尖瓣位，以此来探讨改良后的“双皇冠”支架瓣膜在二尖瓣位应用的可行性和有效性。最终建立一套完整的经导管“双皇冠”支架瓣膜在二尖瓣位的植入体系。该研究成果将有可能为微创瓣膜外科经导管瓣膜置换技术提供新的设计思路和研究方向。

经导管介入下治疗结构性心脏病，尤其是心脏瓣膜病是近年来心血管领域的重大突破。经导管介入下的瓣膜治疗凭借其微创、无需体外循环等优势，已逐步成为高危心脏患者的替代治疗手段。本项目组在前期研究工作中研制出具有自主知识产权的“双皇冠”支架瓣膜，并通过动物的体内外实验初步证实了其在”环中瓣“中应用的可行性和有效性。本项目在前期研究基础上，对”双皇冠“支架瓣膜做了进一步的改良，设计研发出新型“D”形二尖瓣支架瓣膜，该支架瓣膜具有独有的二尖瓣前叶夹设计，可有效的减少左室流出道梗阻现象，同时通过倒刺锚定结构、双侧支架结构以及左房侧伞边设计，有效的将支架固定于二尖瓣位，减少了瓣周漏的发生。该支架瓣膜适用于经导管自然二尖瓣置换（TMVR）、“瓣中瓣”和“环中瓣”等使用场景。在体外动态实验及体内动物实验中，我们观察到该支架瓣膜具有植入简便、径向支撑良好、瓣周漏发生率低、不阻挡左室流出道等优点。同时，本项目还对输送系统做进一步的优化，明确了最优的手术入路，最终初步建立了一套新型“D”型支架瓣膜在二尖瓣位植入的手术体系。