真空热处理对钴铬合金瓣膜支架性能影响的研究
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上海翰凌医疗器械有限公司

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“十四五”国家重点研发计划( 2022YFC2409200)


Research on the Influence of Vacuum Heat Treatment on the Performance of Cobalt-Chromium Alloy Valve Stents
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Shanghai Healing Medical Devices Co., Ltd.

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    摘要:

    2010 年以来,随着中国首例经导管主动脉瓣膜置换手术(TAVR)在复旦大学附属中山医院心内科进行,心脏瓣膜介入领域迅速发展起来,目前已有多款介入瓣膜获得国家药品监督管理局批准上市。钴铬合金是球囊扩张式心脏瓣膜支架的主要原材料。该文从临床应用的角度出发,为提高钴铬合金瓣膜支架植入人体后在心脏收缩和舒张时的疲劳耐久性,探索钴铬合金瓣膜支架在不同真空热处理工艺条件下,抗拉强度、断裂延伸率、径向支撑力、回缩性能、硬度及微观组织等性能的变化趋势。实验结果表明,在真空热处理温度为 1000℃ 、保温时间为 20min 时,可以得到性能优异的钴铬合金瓣膜支架。该文旨在通过对支架真空热处理的评价和分析,为球囊扩张式钴铬合金瓣膜支架的发展与应用提供理论依据,并对未来介入瓣膜的研究提供参考。

    Abstract:

    Since 2010, with the first transcatheter aortic valve replacement (TAVR) in China performed in the Department of Cardiology, Zhongshan Hospital Affiliated to Fudan University, the field of heart valve intervention has developed rapidly, and a number of interventional valves have been approved by NMPA. Cobalt-chromium alloy is the main raw material of balloon-expandable valves stents. From the perspective of clinical application, in order to improve the fatigue durability of cobalt-chromium alloy valve stents after implantation in the human body during the contraction and relaxation of the heart, this study explores the changing trend of tensile strength, fracture elongation, radial support, retraction, hardness and microtissue under different vacuum heat treatment conditions. The experimental results show that the excellent performance of cobalt-chromium alloy valve stents can be obtained when the vacuum heat treatment temperature is 1000℃ and the holding time is 20minutes. This study aims to evaluate and analyze the vacuum heat treatment of stents, providing a theoretical basis for the development and application of balloon-expandable cobaltchromium alloy valves stents, and offering references for future research on interventional valves.

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孙福俊.真空热处理对钴铬合金瓣膜支架性能影响的研究[J].生物医学工程学进展,2025,46(4):423-428

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  • 收稿日期:2024-11-08
  • 最后修改日期:2024-12-26
  • 录用日期:2025-01-03
  • 在线发布日期: 2025-09-16
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