Wooldridge J, Arduino A, Zilberti L, Zanovello U, Chiampi M, Clementi V, Bottauscio O
National Physical Laboratory, Hampton Road, Teddington, Middlesex, TW11 0LW, United Kingdom.
Istituto Nazionale di Ricerca Metrologica, Str. delle Cacce, 91, I-10135 Torino TO, Italy.
Phys Med Biol. 2021 Dec 23;66(24). doi: 10.1088/1361-6560/ac3eab.
Patients with implanted orthopaedic devices represent a growing number of subjects undergoing magnetic resonance imaging (MRI) scans each year. MRI safety labelling is required for all implants under the EU Medical Device Regulations to ensure regulatory compliance, with each device assessed through standardised testing procedures. In this paper, we employ parametric studies to assess a range of clinically relevant factors that cause tissue heating, performing simulations with both radiofrequency (RF) and gradient coil (GC) switching fields, the latter of which is often overlooked in the literature. A series of 'worst-case' scenarios for both types of excitation field is discussed. In the case of GC fields, large volume implants and large plate areas with the field orientated perpendicular to the plane cause the highest heating levels, along with sequences with high rates of field switching. Implant heating from RF fields is driven primarily from the 'antenna effect', with thin, linear implants of resonant length resulting in the highest temperature rises. In this work, we show that simplifications may be made to the field sequence and in some cases the device geometry without significantly compromising the accuracy of the simulation results, enabling the possibility for generic estimates of the implant heating for orthopaedic device manufacturers and opportunities to simplify the safety compliance process.
每年,植入骨科器械的患者接受磁共振成像(MRI)扫描的人数不断增加。根据欧盟医疗器械法规,所有植入物都需要进行MRI安全标记,以确保符合法规要求,每种器械都要通过标准化测试程序进行评估。在本文中,我们采用参数研究来评估一系列导致组织发热的临床相关因素,同时使用射频(RF)和梯度线圈(GC)切换场进行模拟,而后者在文献中常常被忽视。本文讨论了两种类型激发场的一系列“最坏情况”场景。对于GC场,大体积植入物以及场垂直于平面的大平板区域,再加上场切换速率高的序列,会导致最高的加热水平。RF场引起的植入物发热主要由“天线效应”驱动,谐振长度的细线性植入物会导致最高的温度升高。在这项工作中,我们表明,可以对场序列进行简化,在某些情况下还可以对器械几何形状进行简化,而不会显著影响模拟结果的准确性,这使得骨科器械制造商能够对植入物发热进行通用估计,并有可能简化安全合规流程。