摘要
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。
During the last two decades, a great amount of researches have been focused on biodegradable metals. Technologies from alloy design to melting, manufacturing and processing, from microtube to stent laser processing and drug eluting coating have been improved and optimized continuously.Biodegradable metallic stent has evolved from a concept to a real product and generated three branches of material system. A large amount of animal tests and clinical tests have been carried out to investigate biodegradable magnesium stents. Results of clinical study have indicated that the magnesium stent is feasible, with favourable safety and performance outcomes. More importantly, Biotronik won CE Mark for Magmaris bioresorbable stent in 2016. Researches of biodegradable iron stents are still in the stage of animal tests. The nitrided iron stent possesses excellent mechanical properties. Results showed a good long-term biocompatibility of nitrided iron stent in rabbit and porcine model. Biodegradable zinc stent has only been introduced in recent years. Only a few in vivo studies have been reported with zinc wires implanted in rats. Results showed a good degradation behavior and biocompatibility of zinc wires. In this paper, the current research status of biodegradable metallic stents is reviewed, and the future research and development in mechanical property optimization, drug eluting and intelligence is proposed.
出处
《金属学报》
SCIE
EI
CAS
CSCD
北大核心
2017年第10期1227-1237,共11页
Acta Metallurgica Sinica
基金
国家重点研发计划项目No.2016YFC1102402
国家自然科学基金重点项目No.51431002~~
关键词
可降解金属支架
镁合金
铁合金
锌合金
生物相容性
体内实验
降解机制
biodegradable metallic stent, magnesium alloy, iron alloy, zinc alloy, biocompatibility,in vivo, degradation mechanism