| 引用本文: | 张贵,杨宏韬,张万谦,刘爱华,张德元,高润霖,郑玉峰.生物可吸收Fe-N合金血管支架研究现状与展望[J].材料科学与工艺,2025,33(5):19-37.DOI:10.11951/j.issn.1005-0299.20240019. |
| ZHANG Gui,YANG Hongtao,ZHANG Wanqian,LIU Aihua,ZHANG Deyuan,GAO Runlin,ZHENG Yufeng.Research status and prospects of bioresorbable Fe-N alloy vascular scaffold[J].Materials Science and Technology,2025,33(5):19-37.DOI:10.11951/j.issn.1005-0299.20240019. |
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| 生物可吸收Fe-N合金血管支架研究现状与展望 |
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张贵1, 杨宏韬2,6, 张万谦1,3, 刘爱华4, 张德元1, 高润霖5, 郑玉峰2
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(1.元心科技(深圳)有限公司,深圳 518109; 2.北京大学 工学院 材料科学与工程系,北京 100871; 3.复旦大学 高分子科学系,上海 200438; 4.首都医科大学附属天坛医院 北京市神经外科研究所,北京 100070; 5.中国医学科学院 阜外医院冠心病中心,北京 100037; 6.北京航空航天大学 医学科学与工程学院,北京 100191)[HJ0.4mm]
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| 摘要: |
| 药物洗脱支架(Drug Eluting Stent, DES)的靶病变失败率(Target Lesion Failure, TLF)逐年上升,远期效果不佳。发展可吸收支架(Bioresorbable Scaffold, BRS)是解决上述问题的临床共识。在不添加任何有毒金属元素的前提下,Fe-N合金材料凭借其优异的综合力学性能脱颖而出,由Fe-N合金材料制成的铁基可吸收药物洗脱支架(Iron-Based Scaffold, IBS),不仅实现了超薄杆壁设计(壁厚薄至50 μm),且可在术后3~6个月内保持与钴铬合金DES相当的径向支撑强度,并在术后2~3年内逐渐降解而被人体吸收,有望降低DES支架植入带来的远期风险。本文以近20年的基础和转化医学研究为基础,详细探讨了铁基BRS支架研发过程,包括纯铁氮化技术、超薄杆壁BRS支架设计、药物涂层设计、生物相容性、体内降解行为、临床试验进展以及未来挑战等,旨在为临床医学应用提供参考,并期望为本领域的后续研究带来启示和借鉴。 |
| 关键词: 可降解金属 可吸收支架 铁基可吸收支架 支架设计 临床研究 研究进展 |
| DOI：10.11951/j.issn.1005-0299.20240019 |
| 分类号:TG14 |
| 文献标识码:A |
| 基金项目:北京新星计划项目(20220484167). |
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| Research status and prospects of bioresorbable Fe-N alloy vascular scaffold |
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ZHANG Gui1, YANG Hongtao2,6, ZHANG Wanqian1,3, LIU Aihua4, ZHANG Deyuan1, GAO Runlin5, ZHENG Yufeng2
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(1.Biotyx Medical (Shenzhen) Co., Ltd., Shenzhen 518109, China; 2.Department of Materials Science and Engineering, college of Engineering, Peking University, Beijing 100871, China; 3.Department of Polymer Science, Fudan University, Shanghai 200438, China; 4.Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China; 5.Coronary Heart Disease Center, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing 100037, China; 6.School of Engineering Medicine, Beihang University, Beijing 100191, China) [HJ0.3mm]
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| Abstract: |
| The target lesion failure (TLF) rate of drug eluting stents (DES) has been increasing over the years, resulting in suboptimal long-term outcomes. In response to these challenges, the development of bioresorbable scaffolds (BRS) has emerged as a prevailing clinical consensus. Fe-N alloy material stands out because of its excellent comprehensive mechanical properties without adding any toxic metal elements. The iron-based scaffold (IBS)made of Fe-N alloy material not only achievesan ultra-thin struts designs(≤50 μm),but also maintains the radial support strength comparable to that of the Co-Cr alloy DES within 3 to 6 months after implantation.IBS scaffold is gradually degraded and absorbed in vivo within 2 to 3 years after implantation, which is expected to mitigate the long-term risks associated with DES implantation. Based on nearly 20 years of basic and translational medical research, this article discusses in detail the research and development process of iron-based BRS, including the pure iron nitriding technology, the design of ultra-thin strut BRS scaffold, drug coating methodologies, biocompatibility, in vivo degradation profiles, clinical trial results and future challenges. This study aims to provide a reference for clinical medical applications and inspire and guide future research in this field. |
| Key words: biodegradable metals bioresorbable scaffold iron-based absorbable scaffold stent design clinical trial research status |
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