世界原创，宁波第一！宁波诺丁汉大学参与研发的国家级创新器械获批上市

▋“这是一次产学研用精诚合作迎来的突破性成果，为无液氦磁共振（MRI）临床应用铺平了道路，为移动、可旋转MRI的研发奠定了基础。”宁波诺丁汉大学医学影像中心主任王成波博士说。

不久前，宁波诺丁汉大学参与的科技部重点研发计划项目“1.5T无液氦低温超导磁体技术研发”取得转化成果——其磁共振成像系统已获批三类创新医疗器械注册证，产品可上市销售。这是世界原创产品，也是宁波市历史上获得批准的第一个国家级三类创新医疗器械。

创新医疗器械是具有我国自主知识产权，技术上属于国内首创、国际领先，具有显著临床应用价值的医疗器械。自2014年第一个创新器械批准至今，全国仅有150个产品获批上市，门槛极高。

该产品由宁波诺丁汉大学、鑫高益医疗设备股份有限公司、中国科学院大学宁波华美医院（宁波市第二医院）等单位共同研发。

据介绍，作为磁共振超导磁体的理想冷冻气体，液氦在MRI的用量占了全球氦气供应的25-30%。然而自然界中氦资源含量极微，全球氦资源中国仅有0.2%。近年来，全球各大科研机构和磁共振生产厂家都在探索研发少液氦乃至无液氦超导MRI系统。

此次获批上市的新型“磁共振成像系统”主要创新点正是采用了无液氦超导磁体技术，该超导磁体采用制冷机直接传导冷却。与常规使用液氦对磁体中的超导线圈进行冷却的超导磁共振产品相比，该产品具有生产使用成本更低、磁体结构简化、磁体重量降低等优势。中国科学院大学宁波华美医院将率先进行临床应用。

“由于液氦的存在，传统的磁共振扫描只能以卧姿进行。因为MRI一旦发生移动旋转，极易引发液氦气化爆炸、磁体失超。”王成波博士介绍，无液氦冷却技术壁垒的突破，为接下来的技术路线——多姿态扫描磁共振检查技术方案奠定了坚实基础。团队正在全力研发一套1.5T可旋转双姿态（卧姿或站姿）无液氦MRI系统。

中国科学院大学宁波华美医院放射学郑建军主任医师表示，站立姿态下的MRI检查在前沿脑科学、血流灌注、脊柱及关节成像等领域的临床研究上有突出的意义。此外，新型冠状病毒肺炎主要攻击肺部，这台可旋转MRI与超极化惰性气体成像技术的结合，也将为肺部疾病的诊断、预后及功能评估提供全新的理念和研究视野。

目前，宁波诺丁汉大学、鑫高益医疗设备股份有限公司、中国科学院大学宁波华美医院还在共同研发可移动部署MRI系统。得益于无液氦MRI磁场可轻易开启或关闭、不需要失超管、无爆炸危险等优势，无液氦MRI可以在狭小或封闭的环境中安装、使用和运输，也可用于舰载、车载等场合中，这将大幅助推未来移动医疗的发展。

Innovative cryogen-free MRI co-developed by UNNC approved for listing on market

Recently, it was reported that the 1.5T cryogen-free clinical Magnetic Resonance Imaging (MRI) scanner co-developed by the University of Nottingham Ningbo China (UNNC) was awarded the national Innovative Medical Device registration certificate from National Medical Product Administration and was granted for listing on market. “This is a breakthrough medical equipment emerged from the close cooperation among industry, academia and research in the MRI field ” said Dr Chengbo Wang, the director of MRI Research Centre at UNNC. This innovative MRI scanner is bearing fruit from the research project funded by the Ministry of Science and Technology of the People’s Republic of China “Development of 1.5T cryogen-free superconducting magnets” collaborated among UNNC, Xingaoyi Medical Equipment Co. Ltd and Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No.2 Hospital).

Innovative Medical Devices are internationally recognized leading medical devices with intellectual property rights in China and have significant clinical applications. Since the first Innovative Medical Device was approved in 2014, only 150 others have been granted in China due to an extremely high threshold. The MRI scanner is classified as a Class III Innovative Medical Device which requires strict regulatory controls as they involve devices that are important to health or sustaining life.

Professor Richard Bowtell, Director of the Sir Peter Mansfield Imaging Centre at the University of Nottingham in the UK and a past President of the European Society of Magnetic Resonance in Medicine and Biology, stated that these were exciting developments made at UNNC. “Compared with conventional liquid-helium-cooled magnets, this innovative cryogen-free MRI system has a number of advantages, including reduced production and service costs, simplified cooling and decreased weight,” he said. He went on to say that this breakthrough in cryogen-free MRI technology will be one of the optimal solutions to dealing with the global shortage in helium resources.

As the ideal refrigerated gas for superconducting MRI magnets, liquid helium used in MRI’s accounts for 25-30% of the global helium supply. However, the quantity of helium found in nature is minute and China’s global helium resource amounts to only 0.2%. The use of cryogen-free MRI’s has thus become increasingly important.

Dr Chengbo Wang stated, “Due to the presence of liquid helium, traditional MRI scans can only be performed in a reclining position. Once the MRI begins to rotate, it is very easy for the magnets to overrun which could potentially lead to the liquid helium turning into gas and igniting an explosion.” According to Dr Chengbo Wang, the breakthrough in cryogen-free cooling systems has also laid a solid foundation for the technological advances in multi-pose MRI scanning techniques. The team is currently developing a 1.5T rotatable dual-gesture (reclining or standing) cryogen-free MRI scanner.

Jianjun Zheng, Chief Radiology at Hwa Mei Hospital, stated that the MRI in standing posture has outstanding significance in the fields of neuroscience, blood perfusion, spine and joint imaging in clinic. In addition, the combination of the rotatable MRI and hyperpolarized noble gas imaging technology will provide new insights and perspectives on the diagnosis and evaluation of respiratory diseases such as Covid-19. The Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No.2 Hospital) will take the lead in the MRI’s clinical application.

At present, UNNC, Xingaoyi Medical Equipment Co. Ltd and Hwa Mei Hospital, are jointly developing a mobile version of the MRI scanner. Since the cryogen-free MRI can be installed, used, and transported in small or enclosed spaces, this will be an important step in the development of mobile medical treatments in the future.

图文来源 | Lily Su，Liam Morgan，王成波

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