介入式心室辅助装置导管泵的制造技术及其研究问题概述  

Overview of the Manufacturing Technology and Research Issues of Percutaneous Ventricular Assist Devices Catheter Pump

作　　者：王冬阳 WANG Dong-yang(Shanghai Phigine Medical Technology Co.,Ltd.,Shanghai 200120)

机构地区：[1]上海焕擎医疗科技有限公司,上海200120

出　　处：《中国医疗器械信息》2025年第5期58-61,共4页China Medical Device Information

摘　　要：介入式心室辅助装置作为结构性心脏病治疗领域的重要有效治疗手段,在我国的发展和应用都起步较晚,但是近年来发展迅速。截止2024年8月,我国已经有4款植入式心室辅助装置获得国家药品监督管理局批准上市,已有8款介入式心室辅助装置正在临床试验研究阶段。由于介入式心室辅助装置的导管泵是在微创手术过程中经皮介入人体的动脉血管内,直至输送到心室内后再启动电机高速运转为患者提供所需的心脏功能辅助,所以其体积需要更小、转速需要更高、器械的组成部件也更精密才能保证器械的有效、安全和可靠。针对该类医疗器械的开发制造,国内外的相关研究较为欠缺。文章从导管泵设计阶段的材料选择入手,如医用不锈钢材料、镍铬合金材料和特种高分子材料并强调其独特的性能,详细地讨论导管泵在开发制造过程中需要的关键制造技术,这其中有3D打印、计算机数控精密加工、高温氧化、表面改性、激光焊接、胶水灌封、胶水粘接、微机电系统等,以及它们需要研究和解决哪些主要问题以实现该医疗器械的产品开发和高质量的生产制造。为我国高危经皮冠脉介入术或心力衰竭患者提供更加安全和有效的治疗手段,为相关领域的进一步研究提供参考。Percutaneous ventricular assist devices(pVADs)are an important effective treatment method in the field of structural heart disease,and their development and application in China have started lately,but have developed rapidly in recent years.By August 2024,four implantable left ventricular assist devices have been approved by the NMPA for marketing in China,and eight percutaneous ventricular assist devices are currently under clinical trial research.Since the catheter pump of the percutaneous ventricular assist device is introduced into the human body through a minimally invasive surgical,via the skin and into the arterial vessels,and then transported to the ventricles of the heart,operating at high speed to provide necessary cardiac function assistance to the patient after starting operation.Its size needs to be smaller,the rotation speed needs to be super higher,and the components of the device need to be more precise to ensure the effectiveness,safety,and reliability.There is less research on the development and manufacture of this medical devices.The paper starts from the material selection in the design stage of the catheter pump,such as medical stainless steel materials,nickel-chromium alloy materials,and special high molecular materials,and emphasizes their unique properties.It discusses detailly these key manufacturing technologies required for the development and manufacture of the catheter pump,including 3D printing,CNC precision machining,high-temperature oxidation,surface modification,laser welding,glue potting,glue bonding,MEMS,etc.,and the main problems that need to be studied and solved to achieve the product development and high-quality manufacturing of this medical device.This paper provides reference for the further research in this field and provides safer and more effective treatment methods for high-risk PCI(percutaneous coronary intervention)or heart failure patients in China.

关 键 词：介入式心室辅助 导管泵 制造技术 

分 类 号：R318.1[医药卫生—生物医学工程]