血管内导管、导丝和输送系统润滑涂层的审评思考

Evaluation of Lubrication Coatings for Intravascular Catheters,Wires,and Delivery System

润滑涂层广泛用于减少介入器械与血管之间的摩擦、改善介入器械表面生物相容性,同时也带来了涂层稳定性问题及相关风险。该文从器械描述、性能验证、技术要求等方面对涂层相关内容进行阐述,以期将涂层带来的风险降至可接受水平。

Lubrication coating is widely used to reduce the friction between the interventional devices and the blood vessels,improves the surface biocompatibility of the interventional device,and also brings the coating stability problems and related risks.This paper describes the coating-related content from the equipment description,performance verification,technical requirements,etc.,to reduce the risk of the coating to an acceptable level.