纺织学报 ›› 2024, Vol. 45 ›› Issue (08): 234-240.doi: 10.13475/j.fzxb.20230806202

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国内体外膜肺氧合技术研究进展

席立锋1, 马丕波1, 贾伟2, 王佳冕2, 张红斌2, 彭小权2, 夏风林1, 蒋高明1()   

  1. 1.江南大学 针织技术教育部工程研究中心, 江苏 无锡 214122
    2.深圳国家高性能医疗器械创新中心, 广东 深圳 518100
  • 收稿日期:2023-08-29 修回日期:2024-04-25 出版日期:2024-08-15 发布日期:2024-08-21
  • 通讯作者: 蒋高明(1962—),男,教授,博士。主要研究方向为智能化纺织装备技术。E-mail:jgm@jiangnan.edu.cn
  • 作者简介:席立锋(1994—),男,博士生。主要研究方向为针织装备数字化技术和针织产品开发。
  • 基金资助:
    深圳市科技重大专项课题(202327D238);中央高校基本科研业务费专项资金资助、江苏省研究生科研与实践创新计划项目(KYCX24_2547)

Research progress of extracorporeal membrane oxygenation technology in China

XI Lifeng1, MA Pibo1, JIA Wei2, WANG Jiamian2, ZHANG Hongbin2, PENG Xiaoquan2, XIA Fenglin1, JIANG Gaoming1()   

  1. 1. Engineering Research Center for Knitting Technology, Ministry of Education, Jiangnan University, Wuxi, Jiangsu 214122, China
    2. National Innovation Center for Advanced Medical Devices, Shenzhen, Guangdong 518100, China
  • Received:2023-08-29 Revised:2024-04-25 Published:2024-08-15 Online:2024-08-21

摘要:

体外膜肺氧合技术用于对重症心肺功能衰竭患者提供持续的体外血液氧合以维持患者生命。为加速促进体外膜肺氧合技术的国产化进程,从氧合器的工作原理出发综述了国内体外膜肺氧合技术中氧合膜、离心泵、控制系统等关键技术的研究进展;针对氧合器卡脖子难题,主要介绍了氧合膜材料、制备方法的技术难题。结合3M样品的编织组织分析得出了聚甲基戊烯(PMP)中空纤维的膜织物样品幅宽、密度等关键参数,验证了PMP膜织物的编织组织为编链/衬纬组织,指出了氧合器技术的国产化需从PMP中空纤维制备的工艺优化和开发专用编织设备展开。最后提出未来体外膜肺氧合技术的发展需要多学科的技术交叉合作,实现从国产化向国际领先的技术转变。

关键词: 体外膜肺氧合技术, 氧合器, 聚甲基戊烯中空纤维, 编织技术

Abstract:

Significance Extracorporeal Membrane Oxygenation (ECMO) is an extracorporeal life support method. Since the outbreak of COVID-19, ECMO has achieved remarkable clinical results despite the high cost of consumables. On the other hand, the shortage of ECMO equipment and technical reserves in China becomes increasingly prominent, making it urgent to breakthrough the core technology for domestic ECMO production.In March 2021, the national "Fourteenth Five-Year Plan and 2035 Vision and Goals Outline" was released, calling for breakthroughs in extracorporeal membrane oxygenation machine and other core technologies, and the innovation research and development of domestic ECMO technology has been upgraded to the height of the national strategy since then. As part of the national effort, this paper reviews the research progress of ECMO in China and and tries to point out the future research directions.

Progress The working principle of ECMO extracorporeal membrane pulmonary oxygenation device was introduced in this review, and the centrifugal pump, control system, and oxygenator have been highlighted as the three key technologies for ECMO development. The progress of domestic research on the current technical difficulties was reviewed. Since the national policy was put forward, various medical research organizations have joined forces and overcome many key technologies of ECMO. The centrifugal pump in ECMO has been successively developed in China. The preparation technology of PMP (polymethylpentene)has been broken through, and the control system of ECMO equipment has been developed with the help of domestic leading aerospace technology. Since 2023, three ECMO products have been released domestically. The centrifugal pump product has a pump body speed of 7 000 r/min, which is better than that of 3M's 5 000 r/min; the maximum flow rate can reach 8 L/min, which is on a par with the performance of 3M's products. The porosity of domestic PMP membrane material can reach 60%, and the strength is more than 60 cN, which is the same as that of 3M products. Aiming at the development of manufacturing technology of PMP membrane, the organizational structure of 3M samples were studied and analyzed, and it was learnt that the structure of PMP membrane is warp knitting with pillar stitches. Through the trial experiment on the machine, it was found that the technical difficulties of the PMP membrane manufacturing process were mainly the selection of equipment and the control of weaving tension.

Conclusion and Prospect Through the study of ECMO key technologies, it was found that the focus of breakthrough oxygenator technology should be driven by the policy of frequent outbreaks and localization of ECMO technology, and PMP membrane preparation based on warp knitting technology is one of the important challenges in China for the future. It was found that the focus of breakthrough oxygenator technology should be the cross-fertilization of multidisciplinary collaborations. It is necessary to continuously optimize the physical properties of PMP membrane according to the requirements of knitting equipment, and it is necessary to develop special knitting equipment according to the mechanical properties of the PMP membrane to realize the complete localization of ECMO technology. In the future, the focus of ECMO technology development should be shifted from localized technology to international leading technology. Scientific researchers from various fields, such as textile technology, membrane technology, clinical medicine, and electromechanical engineering should work together to overcome the technological difficulties in different fields. The working efficiency of the ECMO equipment should be further optimized and improved in order to make advancement in the oxygenated membrane technology, and to promote the development of China's high-end medical equipment.

Key words: extracorporeal membrane oxygenation technology, oxygenation equipment, polymethylpentene hollow fiber membrane, braiding technology

中图分类号: 

  • TS186.1

图1

ECMO体外膜肺氧合设备工作示意图"

表1

国产和进口泵头参数"

类型 预充量/
mL
转速/
(r·min-1)
最大流量/
(L·min-1)
轴承座 离心泵
类型
迈柯唯 32 0~5 000 10 单轴承 径向泵
理诺法 57 0~3 500 8 单轴承 径向泵
索林 17 0~10 000 8 单轴承 对角泵
国产产品 16 0~7 000 8 单轴承 对角泵

图2

PMP中空纤维截面和氧合原理图"

图3

PMP中空纤维的TIPS法制备"

表2

国内PMP中空纤维与3M产品的技术指标比较结果"

产品开
发单位
外径/
μm
内径/
μm
致密层
厚度/μm
孔隙率/
%
完全泡
点/MPa
拉伸强
力/cN
3M公司 380±30 200±50 0.4 61 >0.4 >60
清华大学 580±30 350±50 60~70 >0.4 110~115
南京工
业大学
400±30 200±30 ≥ 55 ≥ 70
深圳国家高性能医疗器械创新中心 400±30 200±30 60 ≥60

图4

PMP中空纤维编织结构图"

图5

PMP中空纤维上机试织图"

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