Research on Radiofrequency Thermogenic Testing of Medical Devices

doi:10.16153/j.1002-7777.2021.03.012

Chinese Pharmaceutical Affairs ›› 2021, Vol. 35 ›› Issue (3) : 323-328. DOI: 10.16153/j.1002-7777.2021.03.012

Zhang Zhenghui¹, Ma Chunbao¹, Hu Tianzhou², Shi Haifeng², Chen Jianmei², Li yong², Wen Liyin³, Tang Jinglong³

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Abstract

Objective: To find the position of the maximum temperature rise of the cylindrical metallic implant due to radio frequency (RF) heating in the magnetic resonance environment. Method: Through experimental design, two metal rods of 316L stainless steel and nickel-chromium alloy from 5 to 21 cm were tested in 3T NMR (MR) environment. The temperature rise of metal rods of different sizes and the temperature rise at different positions of the same size metal rod were compared. Result: Experiments had shown that when the size of the metal rod was half the wavelength, that is, when it was 13 cm in a 3T MR environment, the maximum temperature rise effect would be produced at both ends of the sample. Conclusion: For cylindrical metal implants, a simplified approach to RF thermogenesis studies of cylindrical implants is provided because the maximum temperature rise generated by RF thermogenesis occurs at the two ends of the implant.

Key words

magnetic resonance； radiofrequency heating； metal implants； coronary stents； interventional therapy

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Zhang Zhenghui, Hu Tianzhou, Wen Liyin, Ma Chunbao, Shi Haifeng, Chen Jianmei, Li yong, Tang Jinglong. Research on Radiofrequency Thermogenic Testing of Medical Devices[J]. Chinese Pharmaceutical Affairs, 2021, 35(3): 323-328 https://doi.org/10.16153/j.1002-7777.2021.03.012

References

[1] 李澍,郝烨,王权,等.有源植入医疗器械核磁共振成像安全性评价方法研究[J].中国药事,2019,33(10):1109-1115.
[2] 田建广,刘买利,夏照帆,等.磁共振成像的安全性 [J].波谱学杂志,2000,(6):505-511.
[3] 李大鹏,王传兵,邹月芬,等.符合最新标准牌号的金属植入物MRI扫描安全性研究[J].生物医学工程与临床,2015,19(5):460-463.
[4] 陈克敏,潘自来,姚侃敏,等.磁共振检查以及体内植入物的安全性[J].中国医学计算机成像杂志,2014,20(5):430-434.
[5] U.S.Food and Drug Administration.Guidance for Industry and Food and Drug Administration Staff:Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance(MR)Environment for Multi-Configuration Passive Medical Devices[EB/OL].(2016-03-22)[2020-12-14].https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/assessmentradiofrequency-induced-heating-magnetic-resonancemr-environment-multi-configuration.
[6] ISO/TS 10974-2018 Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active ImplantableMedical Device[S].2018.
[7] Zhang X,He B.Imaging Electric Properties of Human Brain Tissues by B1 mapping:A Simulation Study[J].J Phys C Series,2010,224(1):012077.
[8] 曾雁冰,周宇佳,黄绮华.MR射频能量特定吸收率在女性盆腔不同组织中分布规律的研究[J].中国医学物理学杂志,2012,29(5):3632-3637.
[9] 李铖铃,邬小玫.MRI射频场环境下植入物佩戴者的安全性研究[J].中国医疗器械杂志,2020,44(2):101-107.
[10] ASTM F2182-19 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment[S].2019.
[11] Saeedi M,Thomas A,Shellock FG.Evaluation of MRI Issues at 3-Tesla for a Transcatheter Aortic Valve Replacement(TAVR)Bioprosthesis[J].Magnetic Resonance Imaging,2015,33:497-501.
[12] Moghtader D,Crawack HJ,Shellock FG.Assessment of MRI Issues for a New Cerebral Spinal Fluid Shunt,Gravity Assisted Valve(GAV)[J].Magnetic Resonance Imaging,2017,44:8-14.
[13] Kraai TL,Loch RB,Shellock FG.Assessment of MRI Issues for Steel Sutures Used for Microtia Reconstruction[J].J Plast Reconstr Aes,2018,71:1469-1475.
[14] Kozlov M,Horner M,Kainz W,et al.Effect of Incident Field Magnitude and Phase Distribution on RF Induced Heating Due to Hip Implants[C]//IEEE.2018 40th Annual International Conference of the IEEE Engineering in Medicine and Biology Society(EMBC).Hawaii,2018:1360-1363.
[15] 金永君,艾延宝.核磁共振技术及应用[J].物理与工程,2002,(1):47-48,50.
[16] 嵇鸣,叶春涛,苗华栋,等.心脏支架患者1.5T MRI 检查的安全性分析[J].实用放射学杂志,2008,24(12):1688-1690.
[17] 梁婧,傅叶叶,钟慧颖,等.国产封堵器植入后行3.0T 磁共振检查的安全性及对影像的影响[J].中国医学影像技术,2016,32(7):1115-1118.