Department of Biomedical Engineering, Kindai University, 930 Nishimitani, Kinokawa-City, Wakayama, 649-6493, Japan.
J Artif Organs. 2024 Mar;27(1):1-6. doi: 10.1007/s10047-023-01389-w. Epub 2023 Mar 14.
Hollow fiber membrane is incorporated into an extracorporeal membrane oxygenator (ECMO), and the function of the membrane determines the ECMO's functions, such as gas transfer rate, biocompatibility, and durability. In Japan, the membrane oxygenator to assist circulation and ventilation is approved for ECMO support. However, in all cases, the maximum use period has been only 6 h, and so-called 'off-label use' is common for ECMO support of severely ill COVID-19 patients. Under these circumstances, the HLS SET Advanced (Getinge Group Japan K.K.) was approved in 2020 for the first time in Japan as a membrane oxygenator with a two-week period of use. Following this membrane oxygenator, it is necessary to establish a domestic ECMO system that is approved for long-term use and suitable for supporting patients. Looking back on the evolution of ECMO so far, Japanese researchers and manufacturers have also contributed to the developments of ECMO globally. Currently, excellent membrane oxygenators and systems have been marketed by Japanese manufacturers and some of them are globally acclaimed, but in fact, most of the ECMO membranes are not made in Japan. Fortunately, Japan has led the world in the fields of membrane separation technology and hollow fiber membrane production. In the wake of this pandemic, from the perspective of medical and economic security, the practical use of purely domestic hollow fiber membranes and membrane oxygenators for long-term ECMO is imperative in anticipation of the next pandemic.
中空纤维膜被纳入体外膜肺氧合(ECMO)中,膜的功能决定了 ECMO 的功能,例如气体传输率、生物相容性和耐用性。在日本,用于辅助循环和通气的膜氧合器已被批准用于 ECMO 支持。然而,在所有情况下,最长使用期限仅为 6 小时,因此对于 COVID-19 重症患者的 ECMO 支持,通常采用所谓的“超适应证使用”。在这种情况下,HLS SET Advanced(Getinge Group Japan K.K.)于 2020 年在日本首次获得批准,作为一种可使用两周的膜氧合器。在此膜氧合器之后,有必要建立一种经过批准可长期使用且适合支持患者的国内 ECMO 系统。回顾迄今为止的 ECMO 发展历程,日本的研究人员和制造商也为全球的 ECMO 发展做出了贡献。目前,日本制造商已经推出了优秀的膜氧合器和系统,其中一些在全球范围内广受好评,但实际上,大多数 ECMO 膜并非在日本制造。幸运的是,日本在膜分离技术和中空纤维膜生产领域处于世界领先地位。在这场大流行之后,从医疗和经济安全的角度来看,为了应对下一次大流行,迫切需要在长期 ECMO 中实际使用纯国产的中空纤维膜和膜氧合器。