带瓣膜二尖瓣支架的研制及体外经导管植入实验
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国家高科技研究发展计划(“863”计划)(2006AA02Z4D7).


Preparation of valved mitral stent and in vitro experimental implantation to mitral position through catheter
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Supported by National Hightech R&D Program (“863” program)(2006AA02Z4D7).

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    摘要:

    目的:研制可经导管植入的带瓣膜二尖瓣支架,并探索二尖瓣支架植入方法的可行性。方法:用超弹性镍钛记忆合金丝编织双盘状网状支架,中间有腰部连接,内置瓣膜环。将新鲜的羊心包给予0.6%戊二醛浸泡36 h后缝合在瓣膜环上,制成带瓣膜二尖瓣支架。取离体的山羊心脏及大血管标本,直视下穿刺房间隔,将输送鞘管从下腔静脉送到左心室,沿鞘管将带瓣膜二尖瓣支架送入左心室,打开左室面,回拉鞘管,确认左室面卡住瓣环口后,释放左房面,完成体外经导管植入实验。注水实验观察瓣膜启闭功能。结果:制备的带瓣膜二尖瓣支架可牢固地置于自体二尖瓣环位置,反复牵拉后未见支架脱入心腔,同时观察到原有二尖瓣瓣叶、腱索等均被夹在双盘状支架之间,瓣下结构无破坏。瓣膜启闭功能良好。结论:人工带瓣膜二尖瓣支架设计合理,可经导管安全释放,瓣膜功能良好。

    Abstract:

    Objective:To prepare valved mitral stent and to discuss the feasibility of transcatheter implantation of the valved mitral stent in vitro. Methods: We designed a selfexpandable stent made of superelastic NiTi shape memory alloy. The stent was composed of double disks with tubular linkage between them. A valvular ring made of nitinol wire was sutured on the tubular part. Fresh sheep pericardium was crosslinked with a 0.6% glutaraldehyde solution for 36 hours then sutured into a valvular ring; the latter was sutured onto the nitinol selfexpandable stent. Through a sheath across the interatrial septum positioned in the left ventricle of isolated sheep heart via vena cava, the device was delivered into the native mitral valve position. When the left ventricle disk was deployed, it was applied to the mitral annulus by pulling back the external sheath. The waist and the left atrial disk were deployed by pulling the sheath in the annulus and left atrium, respectively. Thus the whole device was deployed in the mitral native. Water was injected into the pulmonary veins and left ventricle to test competence of the prosthetic heart valves.Results: The prepared valved mitral stent could be stably positioned at the native valves. There was no stent migration when it was repeatedly pulled. The two disks sandwiched the native mitral valve with one disk lying in the left ventricle and the other one in the left atrium. The prosthetic heart valves showed satisfactory function without structure damage.Conclusion: This selfexpandable stent is well designed and can be safely implanted in the mitral valve position via transcatheter approach, and the function of the stent is satisfactory.

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  • 收稿日期:2007-08-05
  • 最后修改日期:2008-01-09
  • 录用日期:2008-01-09
  • 在线发布日期: 2008-01-31
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