Bio-Adaption between Magnesium Alloy Stent and the Blood Vessel: A Review.
Bio-Adaption between Magnesium Alloy Stent and the Blood Vessel: A Review.
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DOI：
10.1016/j.jmst.2015.12.018
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发表时间：
2016-09
影响因子：
10.9
通讯作者：
Zhu, Donghui
中科院分区：
文献类型：
--
作者：
Ma, Jun;Zhao, Nan;Betts, Lexxus;Zhu, Donghui
可生物降解镁合金支架是最有前途的下一代生物可吸收支架。本文综述了近几十年来可降解镁合金支架的体外研究、动物试验和临床试验的进展。这些令人兴奋的发现使我们提出了植入后镁合金支架与局部组织微环境之间的“生物适应性”概念的重要性。支架血管的愈合反应一般可分为三个相互重叠的阶段：炎症、肉芽形成和重塑。一旦植入血管中，镁合金支架的理想生物适应性需要是时间和空间/尺寸的合理函数。首先，在最初的四个月内，预计机械支撑的退化非常缓慢，以便为受伤的血管提供足够的机械支撑。尽管在植入后的前4个月内支架病变中是否必须提供完全机械支持仍然是不确定的，但它肯定是安全性设计参数和监管评价的基准，因为没有足够的人体体内数据，特别是愈合/重塑阶段的血管壁机械性能。第二，一旦镁合金支架降解，空隙空间将被再生的血管组织填充。镁合金支架的降解应100%完成，无残留物，降解产物（例如，离子和氢）将有助于血管的组织重建。针对这一目标，一些未来的研究前景进行了讨论。
Biodegradable magnesium (Mg) alloy stents are the most promising next generation of bio-absorbable stents. In this article, we summarized the progresses on the in vitro studies, animal testing and clinical trials of biodegradable Mg alloy stents in the past decades. These exciting findings led us to propose the importance of the concept “bio-adaption” between the Mg alloy stent and the local tissue microenvironment after implantation. The healing responses of stented blood vessel can be generally described in three overlapping phases: inflammation, granulation and remodeling. The ideal bio-adaption of the Mg alloy stent, once implanted into the blood vessel, needs to be a reasonable function of the time and the space/dimension. First, a very slow degeneration of mechanical support is expected in the initial four months in order to provide sufficient mechanical support to the injured vessels. Although it is still arguable whether full mechanical support in stented lesions is mandatory during the first four months after implantation, it would certainly be a safety design parameter and a benchmark for regulatory evaluations based on the fact that there is insufficient human in vivo data available, especially the vessel wall mechanical properties during the healing/remodeling phase. Second, once the Mg alloy stent being degraded, the void space will be filled by the regenerated blood vessel tissues. The degradation of the Mg alloy stent should be 100% completed with no residues, and the degradation products (e.g., ions and hydrogen) will be helpful for the tissue reconstruction of the blood vessel. Toward this target, some future research perspectives are also discussed.
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