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在过去的20年间,随着对可降解金属研究的不断深入,从合金成分设计到熔炼制造加工,从毛细管到支架激光加工和药物涂覆等相关技术不断成熟。可降解金属支架也从一个概念发展为实际产品,并形成3个材料体系分支:可降解镁合金支架已经开展了大量的动物实验和临床实验,结果显示其良好的表现和临床安全性,Biotronik公司生产的可降解镁合金产品Magmaris在2016年获得CE认证;可降解铁合金支架目前处在动物实验阶段,注氮铁合金支架具有优异的力学性能,动物实验结果显示注氮铁支架具有良好的生物相容性;可降解锌合金支架近几年才得到人们的关注,目前的体内动物实验研究结果显示,纯Zn丝在小鼠体内具有良好的降解性能和生物相容性,暂未见体内支架研究报道。本文在综合评述可降解金属支架材料的研究现状基础上,展望了可降解金属支架在性能优化、药物洗脱和智能化方面的未来发展趋势。
Over the past 20 years, with the deepening of research on degradable metals, technologies ranging from alloy composition design to smelting manufacturing and processing from capillaries to stents laser processing and drug coating continue to mature. Biodegradable metal stents have also evolved from one concept into practical products and formed three material system branches: Degradable Magnesium Alloy Stents A large number of animal and clinical trials have been conducted and the results show good performance and clinical safety. Biotronik The Magmaris biodegradable magnesium alloy product obtained the CE certification in 2016; the biodegradable ferroalloy stent is currently in the experimental stage of animals; the ferro-nitrided alloy stent has excellent mechanical properties; animal experiments show that the stent has good biocompatibility In recent years, animal experiments have shown that pure Zn wire has good degradation performance and biocompatibility in mice, and no reports of in vivo stent studies yet have been reported . Based on the review of the research status of biodegradable metal scaffolds, the future development trends of biodegradable metal scaffolds in terms of performance optimization, drug elution and intelligence are prospected.