25#超微孔膨体聚四氟乙烯人工二尖瓣体外脉动流性能评价
25#超微孔膨体聚四氟乙烯人工二尖瓣体外脉动流性能评价Evaluation of 25# ultramicroporous expanded polytetrafluoroethylene mitral valve under pulsatile flow in vitro
作 者：梁勇 王武军 蔡开灿 李海波
Liang Yong, Wang Wu-jun, Cai Kai-can, Li Hai-bo（1.Department of Cardiothoracic Surgery, the 454 Hospital of Chinese PLA, Nanjing 210002, Jiangsu Province, China; 2Department of Cardiothoracic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou 510515, Guangdong Province, China）
机构地区：解放军第四五四医院胸心外科,江苏省南京市210002 南方医科大学附属南方医院胸心血管外科,广东省广州市510515
出 处：《中国组织工程研究与临床康复》 CAS CSCD 2008年第12卷第14期 2667-2670页,共4页
Journal of Clinical Rehabilitative Tissue Engineering Research
基 金：广东省科技计划项目（2002811703）
摘 要：背景：超微孔膨体聚四氟乙烯是新型血液相容性高分子材料,具有不降解、抗钙化功能,用其制作的人工柔性瓣叶心脏瓣膜理论上可有良好的抗血栓、抗钙化性能和流体力学特性。目的：对自行研制的四瓣叶、无支架、带腱索人工二尖瓣——25#超微孔膨体聚四氟乙烯人工二尖瓣（UPMV）进行体外脉动流检测。设计、时间及地点：体外对比实验,于2003-05/2005-02在南方医科大学南方医院胸心血管外科实验室及湘雅二院胸心血管外科实验室进行。材料：25#UPMV的制作材料选用超微孔膨体聚四氟乙烯片状材料,由W.L.GORE＆Associates,Inc.Medical Products Division制造。CL-III型人工机械心脏瓣膜为兰州飞供仪器总厂医疗器械制造厂制造。方法：25#UPMV组为6例自行缝制成的UPMV,安装直径为25mm;25#人工机械瓣组采用6例CL-III型人工机械心脏瓣膜,安装直径为25mm。主要观察指标：使用TH-1200型人工心脏瓣膜体外脉动流试验台对两组瓣膜进行检测,观察流量为2,3,4,5,6L/min时的平均跨瓣压差、开口面积和返流量。结果：①平均跨瓣压差：25#UPMV组在不同流量时均小于10mmHg,不同流量下25#UPMV组平均跨瓣压差均低于25#人工机械瓣组（P=0.000）。②有效开口面积：25#UPMV组在不同流量时均高于1.5cm2,流量为3,5,6L/min时,25#UPMV组有效开口面积大于25#人工机械瓣组（P〈0.01）。③返流百分比：25#UPMV组在不同流量时均小于10%,流量为2,3L/min时,25#UPMV组返流百分比低于25#人工机械瓣组（P〈0.01）。结论：25#UPMV在体外脉动流下的平均跨瓣压差、有效开口面积和返流百分比均符合国家标准,总体表现优于25#CL-III型人工机械心脏瓣膜。
BACKGROUND： Ultramicroporous expanded polytetrafluoroethylene mitral valve （UPMV） is a novel kind of high polymer materials that are compatible to the blood, rare to degrade and can resist calcification. Theoretically, the artificial flexible cardiac valve prepared by UPMV can be satisfactory in the resistance thrombosis, resistance calcification and hydrodynamics. OBJECTIVE： To test the pulsatile flow of 25# UPMV in vitro, which is a rnitral valve prosthesis with four valves and chordae tendineae, but absent to scaffolds. DESIGN, TIME AND SETTING： An in vitro controlled experiment was carried out in the Laboratory of Cardiothoracic Surgery, Nanfang Hospital, Southern Medical University and the Laboratory of Cardiothoracic Surgery, Xiangya Second Hospital between May 2003 and February 2005. MATERIALS： The 25# UPMV was manufactured by W.L.GORE ＆ Associates, Inc. Medical Products Division. CL-III type artificial cardiac valve was produced by Lanzhou Flight Control Instrument Factory. METHODS： The 25# UPMV group （6 cases） were treated with self-made tested UPMV, with the diameter of 25 mm; the 25# CL-III cardiac valve prosthesis （6 cases） were taken as controls, with the same diameter. MAIN OUTCOME MEASURES： TH-1200 H.V. Prosthesis Pulsatile Flow Tester was used to determine the mitral valve in two groups by observing the mean transvalvular pressure gradient, the effective valvular orifice and the regurgitant fraction at the stimulant cardiac output of 2, 3, 4, 5 and 6 L/min, respectively. RESULTS： （1）Mean transvalvular pressure gradient of 25# UPMV group under each stimulant cardiac output was all less than 10 mm Hg, which was lower than that of 25# cardiac valve prosthesis group （P =0.000）.（2）Effective valvular orifice of 25# UPMV group under each stimulant cardiac output was all more than 1.5 cm^2, and was larger than that of 25# cardiac valve prosthesis group at the cardiac output of 3, 5 and 6 L/min （P 〈 0.01）. （3） Regurgitant fraction of 25# UPMV group under each stimulant cardiac output was all less than 10%, and was greater than that of 25# cardiac valve prosthesis group at the cardiac output of 2 and 3 L/min （P 〈 0.01）. CONCLUSION： Mean transvalvular pressure gradient, effective valvular orifice and regurgitant fraction of 25# UPMV measure up to the criterion of China under pulsafile flow in vitro, and 25# UPMV, as a new artificial heart valve, is superior to 25# CL-Ⅲ heart valve prosthesis.
关 键 词：人工心脏瓣膜 二尖瓣 超微孔膨体聚四氟乙烯人工二尖瓣 脉动流实验 生物材料
分 类 号： R318 [医药、卫生 > 基础医学 > 医用一般科学]
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