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| 一个冠脉支架系统的血液相容性评价 |
| Blood compatibility evaluation of a coronary stent system |
| 投稿时间：2019-10-12 修订日期：2020-07-16 |
| DOI： |
| 中文关键词: 冠脉支架系统 血液相容性评价 体外凝血 颈静脉短期血栓形成 支架原位植入 溶血 |
| 英文关键词: coronary stent system, blood compatibility evaluation, in vitro coagulation test , short-term jugular thrombosis, coronary stent in situ implantation,hemolysis |
| 基金项目: |
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| 中文摘要: |
| 背景：作为与循环血液直接接触的医疗器械，冠脉支架系统的血液相容性检测非常重要。目的：通过对一个冠脉支架系统的血液相容性进行全面检测来介绍所用的血液相容性试验方法。方法：以已经上市的金属药物洗脱支架为产品对照进行体外凝血试验、体内比格犬颈静脉短期血栓形成试验，不用产品对照进行体内家猪冠脉支架原位植入法以及直接光学法溶血试验，对一个聚乳酸基全降解雷帕霉素洗脱冠脉支架系统的血液相容性进行全面检测。结果：供试输送系统、支架的凝血及输送系统的短期血栓形成与产品对照无明显差异，供试冠脉支架的血栓形成及溶血性能、输送系统的溶血性能均可被接受。结论：供试冠脉支架系统的血液相容性可被接受。 |
| 英文摘要: |
| BACKGROUND: As a medical device that is in direct contact with circulating blood, the blood compatibility test of the coronary stent system is very important. OBJECTIVE： The blood compatibility test method used is introduced by comprehensively testing the blood compatibility of a coronary stent system.METHODS: The in vitro coagulation test and the short-term thrombosis test of the jugular vein in the beagle dogs were carried out with the metal drug-eluting stents already on the market as the product control, and the in-situ implantation of the coronary stent in vivo and the direct optical hemolysis test were performed without the product control. A comprehensive test of the blood compatibility of a polylactic acid-based fully degradable rapamycin-eluting coronary stent system was performed. RESULTS: The short-term thrombus formation of the test delivery system, the coagulation property of stent and delivery system were not significantly different from the product control. The thrombosis and hemolysis properties of the coronary stent and the hemolysis performance of the delivery system were acceptable. CONCLUSION: The blood compatibility of the coronary stent system can be accepted. |
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