“衬裙”二尖瓣生物瓣膜的初步设计与体外耐久性实验  

Preliminary design and in vitro durability testing of“chimney”mitral bioprosthetic valve

作　　者：包璐日 宋来春 董锦程 陶凉 Bao Luri;Song Laichun;Dong Jincheng;Tao Liang(Wuhan Asia Heart Hospital affiliated to Wuhan University of Science and Technology,Wuhan 430022;Medical School of Wuhan University of Science and Technology,Hubei Wuhan 430062,China)

机构地区：[1]武汉科技大学附属武汉亚洲心脏病医院,武汉430022 [2]武汉科技大学医学部医学院,武汉430062

出　　处：《中国体外循环杂志》2024年第6期510-515,共6页Chinese Journal of Extracorporeal Circulation

基　　金：武汉市科技局2022年度知识创新专项项目(2022020801010577)。

摘　　要：目的通过设计一种新型的二尖瓣膜,为二尖瓣位人工瓣膜不匹配患者提供一个潜在的、更有价值的选择,并通过瓣膜耐久性实验初步评估该瓣膜的可行性及安全性。方法依据ISO5840标准中的人工瓣膜耐久性实验方法,通过VDT-3600I型心脏瓣膜疲劳试验机对该测试瓣膜进行300×10^(6)次循环,在每50×10^(6)、100×10^(6)、300×10^(6)次循环后取下测试瓣膜进行10倍放大率的疲劳后观察。结果TAO-4-001、TAO-4-002、TAO-4-0033枚瓣膜在50×10^(6)、100×10^(6)、300×10^(6)次循环后在10倍放大率观察下瓣膜无任何损伤,“衬裙”无明显拉伸变形,其变形范围在整个测试周期内是可以接受的。结论“衬裙”二尖瓣生物瓣膜在长期负载条件下的机械运动和响应表现稳定,性能特征一致,适合于长期稳定的临床应用。Objective To design a novel mitral valve that offers a potentially valuable alternative for patients with mitral prosthesis-patient mismatch(PPM)and to preliminarily assess the feasibility and safety of this valve through durability testing.Methods According to the durability testing methods specified in the ISO 5840 standard,the valve was tested on a VDT-3600I heart valve fatigue testing machine for 300×10^(6)cycles.Observations at 10x magnification were conducted on the test valve after 50 million,100 million,and 300 million cycles.Results TAO-4-001,TAO-4-002,and TAO-4-003 valves showed no damage at 10x magnification after 50×10^(6),100×10^(6),and 300×10^(6)cycles,respectively.The“chimney”showed no significant stretching deformation,and its deformation range was acceptable throughout the test cycle.Conclusion“Chimney”Mitral Bioprosthetic Valve demonstrated stable mechanical motion and consistent performance characteristics under long-term load conditions,indicating its suitability for sustained clinical application.

关 键 词：二尖瓣膜 人工瓣膜-患者不匹配 耐久性实验 体外性能实验 心脏外科 

分 类 号：R54[医药卫生—心血管疾病]