不同清洗剂和清洗工艺对主动脉覆膜支架微粒的影响

The Effect of Different Detengents and Cleaning Processes on the Aortic Stent-graft Particle

对用于微创伤介入术的主动脉覆膜支架,生产过程中的清洁对其满足相关技术要求有着重要意义。主动脉覆膜支架由覆膜材料、金属材料和缝合线构成。缝合覆膜支架的过程中,缝合线通过与覆膜材料以及金属支架摩擦掉下微粒,则覆膜支架的清洗以及清洗过程中微粒的控制显得尤为重要。覆膜支架的清洗需要选择针对性的清洁剂。由于注射用水对脏污没有去污能力,所以清洗覆膜支架的首道清洗剂选用碱性或者酸性的清洗剂去除覆膜支架表面的脏污;末道清洗剂用注射用水,以便溶解上一步的清洗剂,使覆膜支架化学生物性能合格。清洗过程中去除微粒的效果主要与清洗时间、清洗剂容量和单次清洗数量等工艺控制有关。清洗时间主要根据覆膜支架的组成材料和微粒清洗要求确定;清洗剂容量则至少需满足浸没单次清洗覆膜支架数量;单次清洗数量由技术要求和生产效率等因素确定。

For the aortic stent-graft used to minimally invasive interventional therapy,the cleaning process during the production is very critical to assure the product to meet the technical specification and requirements.Stent-graft consists of graft,suture and metallic material.The particle will be often produced by the friction between the graft and the metallic stent when stitching the stent-graft,so the cleaning process during the production is very important.Firstly,selection of detergents will have a decisive effect on the cleaning process.Since water for injection has not detergency to the dirt,the detergent of the first cleaning process to the stent-graft should select alkali or acid detergent to clean dirt on the stent-graft.The detergent of the last cleaning process should use water for injection to dissolve the detergent residues of previous process.By the cleaning process,the chemical and biological properties of stent-graft will meet the requirements.Secondly,the cleaning duration time,the volume of the detergent and the amount per cleaning process are the key control points of cleaning process.The cleaning time is decided by the particle cleaning requirements and material of stent-graft.The volume of detergent need submerge the stent-graft at least,while the amount per cleaning process should be based on production efficiency and particle removal requirement.