本项目围绕锌合金作为血管支架材料存在的“室温老化”和“加工软化”的问题,与美方研究团队合作,开展了血管支架用可降解锌合金的强韧化设计与制备、支架用锌合金微管精密加工及性能调控、锌合金血管支架的结构优化设计与精密制造工艺开发,锌合金血管支架表面细胞选择性生长、促内皮化的功能涂层研究、锌合金支架动物体内研究等一系列工作。通过项目实施,成功攻克了上述难题,实现了锌合金血管支架产品原型在大动物(猪)冠脉血管内有效支撑时间9 个月以上,初始径向支撑力大于1.2N/mm,1 个月内完成内皮化,2 年左右时间内完成降解,研究成果达到了国内领先、国际先进水平。目前已经建立起具有我国自主知识产权的新一代全降解锌合金血管支架产品的技术体系,拥有从高强韧可降解锌合金材料、支架用微细管材精密加工技术、支架的结构设计、支架的功能涂层等系列核心技术专利群,为锌合金血管支架的未来临床转化奠定了基础,对创建中国可降解锌合金血管支架品牌具有重要的意义。通过本项目的实施,加强了中美双方项目团队的合作交流,提升了我国在可降解金属技术领域的影响力。培养了包括1 名国家优青在内的科研人才数名。
Focusing on the problems of "room temperature aging" and "work softening" of zinc alloy as vascular stent materials, this project cooperating with the American research team has carried out a series of research work including the strengthening and toughening design and preparation of degradable zinc alloys for vascular stent, the precision processing and performance regulation of zinc alloy microtubules for stent, the structural optimization design and precision manufacturing process development of zinc alloy vascular stent, the functional coating for selective growth of cells and promoting endothelialization, and the in vivo study of zinc alloy stents. Through the implementation of the project, the above problems have been successfully overcome, and the prototype of zinc alloy vascular stent has been effective ly supported in the coronary arteries of large animals (pigs) for more than 9 months. The initial radial support force is greater than 1.2N/mm. Endothelialization is completed within one month, and degradation is completed within about 2 years, the research achievements of the project reaching the international advanced level. At present, the technical system of a new generation of fully biodegradable zinc alloy vascular stent products with independent intellectual property rights has been established. It has a series of core technology patents from high strength and toughness degradable zinc alloy materials, precision processing technology of micro tubes, structural design of stents, functional coating, etc., laying a foundation for the future clinical transformation of zinc alloy vascular stents. It is of great significance to create a brand of degradable zinc alloy vascular stent in China. The implementation of this project has strengthened the cooperation between the project teams of China and the United States, and enhanced China's influence in the field of degradable metal technology. This project has trained several scientific research talents including one Chinese Outstanding Young Scholar.