Evaluating the Platelet Activation Related to the Degradation of Biomaterials by Scheme of Molecular Markers

Sheng Ye, Hong Wang, Fenghua Zhao, T. Yuan, Jie Liang, Yujiang Fan, Xing‐dong Zhang
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Abstract

The evaluation of platelet activation of medical devices using in cardiovascular system is very meaningful. Currently, it is mainly based on the ISO10993-4 international standard. However, the methods given in the standard are originally designed for non-degradable materials, the applicability, the operability, and the convenience to degradable materials of the methods needs to be carefully studied. In this study, the platelet activation by 3 typical degradable materials (collagen, polylactic acid and hydroxyapatite) were evaluated by three widely used molecular markers CD62P, CD63, CD40L and the three molecular markers PF4, β-TG and TXB2 mentioned in the ISO10993-4 standard. The variations of the six markers in a simulated degradation process of the degradable materials were compared. It was found that the degree of platelet activation changed with the degradation and was strongly relative with the surface physicochemical properties. For example, when the surface roughness and contact angle of the materials change, the degree of platelet activation also changes. These six platelet activation molecular markers can to be the promising key for the assessing of platelet function in degradable medical devices which is instructive for the quality control and the development of new degradable medical devices.
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应用分子标记技术评价血小板活化与生物材料降解的关系
评价用于心血管系统的医疗器械的血小板活化情况具有十分重要的意义。目前主要依据的是ISO10993-4国际标准。然而,标准中给出的方法最初是针对不可降解材料设计的,方法的适用性、可操作性以及对可降解材料的便利性需要仔细研究。本研究采用三种常用的分子标记CD62P、CD63、CD40L以及ISO10993-4标准中提到的PF4、β-TG和TXB2三种分子标记,评价了3种典型的可降解材料(胶原蛋白、聚乳酸和羟基磷灰石)对血小板的活化作用。比较了六种标记物在可降解材料模拟降解过程中的变化。结果表明,血小板活化程度随降解程度的变化而变化,且与表面理化性质密切相关。例如,当材料的表面粗糙度和接触角发生变化时,血小板的活化程度也会发生变化。这6种血小板活化分子标记物有望成为可降解医疗器械中血小板功能评价的关键,对可降解医疗器械的质量控制和新型可降解医疗器械的开发具有指导意义。
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