血管支架用可降解金屬研究進(jìn)展

血管支架用可降解金屬研究進(jìn)展Research progress in biodegradable metals for stent application

在過(guò)去的20年間，隨著對(duì)可降解金屬研究的不斷深入，從合金成分設(shè)計(jì)到熔煉制造加工，從毛細(xì)管到支架激光加工和藥物涂覆等相關(guān)技術(shù)不斷成熟。可降解金屬支架也從一個(gè)概念發(fā)展為實(shí)際的產(chǎn)品，并形成3個(gè)材料體系分支：可降解鎂合金支架已經(jīng)開(kāi)展了大量的動(dòng)物實(shí)驗(yàn)和臨床實(shí)驗(yàn)，結(jié)果顯示其良好的表現(xiàn)和臨床安全性，Biotronik公司生產(chǎn)的可降解鎂合金產(chǎn)品Magmaris在2016年獲得CE認(rèn)證；可降解鐵合金支架目前處在動(dòng)物實(shí)驗(yàn)階段，注氮鐵合金支架具有優(yōu)異的力學(xué)性能，動(dòng)物實(shí)驗(yàn)結(jié)果顯示注氮鐵支架具有良好的生物相容性；可降解鋅合金支架從近幾年才得到人們的關(guān)注，目前的體內(nèi)動(dòng)物實(shí)驗(yàn)研究結(jié)果顯示，純Zn絲在小鼠體內(nèi)具有良好的降解性能和生物相容性，暫未見(jiàn)體內(nèi)支架研究報(bào)道。本文在綜合評(píng)述可降解金屬支架材料的研究現(xiàn)狀基礎(chǔ)上，展望了可降解金屬支架在性能優(yōu)化、藥物洗脫和智能化方面的未來(lái)發(fā)展趨勢(shì)。

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 micro-tube 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.

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