介入瓣膜瓣中瓣模式下耐久性能测试及评价  

Durability test and evaluation of valve in valve-transcatheter heart valves in surgical bioprostheses

作　　者：刘丽[1] 万辰杰 王硕[1] 李崇崇 柯林楠[1] LIU Li;WAN Chen-jie;WANG Shuo;LI Chong-chong;KE Lin-nan(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《生物医学工程与临床》2022年第1期9-14,共6页Biomedical Engineering and Clinical Medicine

基　　金：国家重点研发计划基金资助项目(2016YFC1102304)。

摘　　要：目的随着之前植入外科人工生物心脏瓣膜患者瓣膜毁损的病例增加,介入瓣膜瓣中瓣越来越多地被用于临床。由于其临床应用时间不长,目前没有长期临床数据可以参考,故实验采用体外加速方法,对一种介入瓣膜瓣中瓣耐久性能进行测试及评价。方法将23 mm、27 mm、29 mm 3个规格(牛心包材质)介入瓣膜作为瓣中瓣分别安装在23 mm、27 mm、29 mm对应规格外科生物心脏瓣膜中,通过预扩达到相同的内径后进行体外加速疲劳耐久性能测试,每5 000万次对其脉动流性能进行测试。2.0亿次疲劳测试后,对瓣叶进行热力学分析、双光子共聚焦显微镜下观察瓣叶胶原纤维结构。结果经过2.0亿次耐久性能测试,介入瓣膜瓣中瓣平均跨瓣压差无显著变化[23 mm:1.92~1.98 kPa(14.4~14.9 mmHg);27 mm:0.92~1.64 kPa(6.9~12.3 mmHg);29 mm:0.72~1.02 kPa(5.4~7.4 mmHg)],有效瓣口面积基本一致(23 mm:1.45~1.66 cm^(2);27 mm:1.88~2.17 cm^(2);29 mm:2.24~2.54 cm^(2)),反流百分比减小(23 mm:7.2%~3.3%;27 mm:14.9%~3.3%;29 mm:14.7%~3.9%),脉动流性能满足YY/T 1449.3—2016标准的要求,具有良好的脉动流性能。瓣叶材料的热力学变性温度降低,从(105.4±0.9)℃变为(98.1±0.5)℃(P <0.05)。瓣叶材料中胶原纤维形状发生变化,由疲劳测试前卷曲的立体结构变为疲劳测试后波浪形线状结构。结论经过模拟临床使用5年(2.0亿次)体外疲劳测试后,虽然介入瓣膜瓣中瓣瓣叶材料发生蠕变,胶原蛋白纤维结构发生变化,热变性温度降低,但瓣膜整体仍具有良好的流体力学性能。Objective To test and evaluate peripheral endurance of valve in valve-transcatheter heart valves(ViV-THV),under the consideration that valve damage cases in patients with surgical artificial biological heart valve are increasing, and petals in intervention valve are increasingly used in clinical practice, of which clinical application is not long, and currently there is no long-term clinical data for reference. Methods The transcatheter heart valves with 23 mm, 27 mm and 29 mm(bovine) were respectively installed in surgical biological heart valves(23 mm, 27 mm and 29 mm). The durability test was carried out to evaluate durability properties of ViV-THV in vitro after predevelopment reaches the same inner diameter, and pulsatile-flow testing was carried out every 50 million times. After 200.0 million times of durability testing, thermodynamic analysis and the collagen fiber structure were observed through two-photon confocal microscope. Results After 200.0 million times of durability test, there was no significant change in mean pressure difference of ViV-THV[23 mm: 1.92 ~ 1.98 kPa(14.4-14.9 mmHg);27 mm: 0.92 ~ 1.64 kPa(6.9-12.3 mmHg);29 mm: 0.72 ~ 1.02 kPa(5.4-7.4 mmHg)], effective valve area was basically consistent(23 mm: 1.45-1.66 cm^(2);27 mm: 1.88-2.17 cm^(2);29 mm: 2.24-2.54 cm^(2)), and reflux percentage decreased(23 mm: 7.2 %-3.3 %;27 mm: 14.9 %-3.3 %;29 mm: 14.7 %-3.9 %). The pulsatile-flow testing performance complied with requirements of YY/T1449.3-2016 standard, which showed good pulsating flow performance. The thermodynamic denaturation temperature of valve leaf decreased from(105.4 ± 0.9) ℃ to(98.1 ± 0.5) ℃(P < 0.05). The shape of collagen fiber in valve material changed from curled stereoscopic structure to wavy linear structure before and after durability test.Conclusion It is demonstrated that after simulated 5 years(200.0 million times) in vitro durability-testing, although the material of the valve leaflet in the interventional valve has creep deformation, the structure of collagen fiber c

关 键 词：介入瓣膜瓣中瓣 耐久性能 脉动流实验 热变性温度 胶原纤维结构 

分 类 号：R318.08[医药卫生—生物医学工程]