文章摘要
经导管植入式人工心脏瓣膜体外脉动流性能研究
Study of Heart valve substitutes implanted by transcathetertechniques: pulsatile-flow testing in vitro
投稿时间:2020-07-20  修订日期:2020-12-25
DOI:
中文关键词: 经导管瓣膜  模拟植入测试;脉动流性能测试  瓣膜移位测试
英文关键词: Heart valve substitutes implanted by transcatheter techniques  simulated implantation testing, Pulsatile-flow testing  valve displacement testing
基金项目:国家重点研发计划2016YFC1102304全降解聚合物支架检测与评价体系的建立
作者单位邮编
刘丽 中国食品药品检定研究院 医疗器械检定所 北京 100050 100050
万辰杰 中国食品药品检定研究院 医疗器械检定所 北京 100050 
李崇崇 中国食品药品检定研究院 医疗器械检定所 北京 100050 
王硕 中国食品药品检定研究院 医疗器械检定所 北京 100050 
柯林楠 中国食品药品检定研究院 医疗器械检定所 北京 100050 
王春仁* 中国食品药品检定研究院 医疗器械检定所 北京 100050 100050
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中文摘要:
      目的:针对经导管植入式人工心脏瓣膜由于其特殊的植入方式和固定方式引入的新风险,设计体外脉动流测试,对经导管瓣膜临床使用过程中的风险进行评估。方法:选择自膨式经导管主动脉瓣膜,在脉动条件下,经模拟血管系统将瓣膜植入脉动流测试腔,在非圆型测试腔中测试返流百分比、跨瓣压差、有效瓣口面积参数,增大反向压力,测试瓣膜移位量。结果:测试瓣膜均可以顺利完成模拟植入试验,准确释放在主动脉瓣膜测试腔中。脉动流性能试验中,随着瓣膜尺寸的增大,返流百分比增大,瓣膜跨瓣压差减小,有效开口面积增大。在180 mmHg反向压力模下,测试瓣膜发生微小移位。结论:研究建立的经导管瓣膜体外脉动流测试方法,模拟了经导管瓣膜临床使用条件,对经导管瓣膜体外脉动流性能进行了更加全面的评价,可以作为经导管瓣膜临床前体外评价的参考。
英文摘要:
      Objective: A new method of pulsatile-flow testing was designed to evaluate the risk of transcatheter heart valve substitute due to its special implantation and fixation. Methods: Under pulsating condition, the valve was implanted into the aortic test chamber through the simulating vascular system. The parameters of the regurgitant fraction, the mean pressure difference and the effective orifice area were measured in the ellipsoid test chamber. The reverse pressure was increased and the valve displacement was measured. Results: All the tested valves could successfully complete the simulated implantation test, and accurately released into the aortic valve test chamber to complete the pulsatile-flow test. With the increase of valve size, the regurgitant fraction increased, the mean pressure difference decreased and the effective orifice area increased. Slight displacement of the test valves occurred at 180 mmHg reverse pressure. Conclusion: More experimental results of The pulsatile-flow testing are given. The pulsatile-flow testing was designed to evaluate the hydrodynamic performance of transcatheter heart valve substitute . It can be used as a reference for the evaluation of transcatheter heart valve in vitro.
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