介入瓣膜输送释放性能体外评价的初步研究  

Preliminary study of heart valve prostheses implanted by transcatheter technique:in vitro evaluation on delivery and deployment properties

作　　者：汤京龙[1] 王硕[1] 刘丽[1] 王迎[1] 尚汝瑶[1] 王健[1] 李守彦 潘轶 王春仁[1] 黄清泉[1] 

机构地区：[1]中国食品药品检定研究院,北京100050 [2]苏州心伴测试科技有限公司,苏州215123

出　　处：《药物分析杂志》2014年第9期1680-1683,共4页Chinese Journal of Pharmaceutical Analysis

基　　金：北京市科技计划课题:肺动脉介入瓣膜的临床前研究(Z131100002713018)

摘　　要：目的:采用一种新的血管模型对3种介入瓣输送释放性能进行体外评价,在此基础上就输送释放过程引入的风险进行初步分析。方法:将人工心脏瓣膜脉动流测试仪和硅胶动脉血管及主动脉瓣模型联合使用,模拟介入瓣经血管输送并释放到体内的手术过程,观察被测瓣膜能否成功完成输送和释放。结果:所有被测介入瓣及输送系统在输送释放性能上没有明显差异,均可顺利完成整个输送释放过程。结论:虽然经血管介入的手术过程会引入一些新的风险,但体外试验结果显示,在相应的风险分析、风险控制和风险管理下,国内外介入瓣的输送释放性能较好,没有出现输送释放失效的情况。Objective：To conduct the in vitro evaluation on the delivery and deployment properties of three heart valve prostheses implanted by transcatheter technique（ HVPTT） in a new mock silicone artery vessel and aortic valve model and analyze the risks induced by the delivery process. Methods：The pulsatile cardiac function simulator was used in combination with the mock silicone artery vessel and aortic valve model to simulate the operation process that the HVPTT was delivered and deployed in vivo via femoral arteries. The tested valve was observed for the accomplishment of delivery and deployment. Results：All of tested HVPTT could be delivered and deployed into the aortic valve position of the mock silicone artery vessel and aortic valve model with no obvious differences in the delivery and deployment properties. Conclusion：Although new risks would be involved during transcatheter valve implantation,the in vitro results showed a satisfactory quality in delivery and deployment properties of the foreign and domestic valves and there were no situations of failure in delivery and deployment under the corresponding risk analysis,control and management.

关 键 词：微创介入 生物瓣膜 介入瓣 主动脉瓣 血管模型 输送释放性能 体外评价 

分 类 号：R917[医药卫生—药物分析学]