【摘要】 通过临床动物实验评价金属注射成型(MIM)制备的新型血管支架的可行性与安全性。采用粉末注射成型技术制备血管支架,大幅提高材料利用率;研究MIM过程中碳杂质含量变化对316L不锈钢力学性能与耐腐蚀性能的影响;同时开展MIM血管支架的体外毒性测试与动物实验以评价支架的安全性。结果表明,316L不锈钢的性能对碳含量变化极为敏感,在MIM制备过程中应该对碳含量波动实施精准控制。所有MIM血管支架都成功植入狗的主动脉血管,MIM 316L不锈钢支架未出现明显毒性,能够稳定维持支架形状及结构,快速实现内皮化过程,呈长期植入通畅性。采用MIM技术制备的新型血管支架具备合适的结构、物理以及化学稳定性和生物相容性,在临床实践中具有广阔应用前景。更多还原

【Abstract】 This study aimed to evaluate the feasibility and safety of a novel stent manufactured by metal injection molding(MIM) in clinical practice through animal experiments. Vessel stents were prepared using powder injection molding technology to considerably improve material utilization. The influence of MIM carbon impurity variation on the mechanical properties and corrosion resistance of 316L stainless steel was studied. In vitro cytotoxicity and animal transplantation tests were also carried out to evaluate the safety of MIM stents. The results showed that the performance of 316L stainless steel was very sensitive to the carbon content. Carbon fluctuations should be precisely controlled during MIM. All MIM stents were successfully implanted into the aortas of the dogs, and the MIM 316L stents had no significant cytotoxicity. The novel intravascular stent manufactured using MIM can maintain a stable form and structure with fast endothelialization of the luminal surface of the stent and ensure long-term patency in an animal model. The novel intravascular stent manufactured using MIM demonstrates favorable structural, physical, and chemical stability, as well as biocompatibility, offering promising application in clinical practice.更多还原