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医疗器械梯度感应加热相关的 MRI 安全性测试的贡献。

A contribution to MRI safety testing related to gradient-induced heating of medical devices.

机构信息

Istituto Nazionale di Ricerca Metrologica (INRIM), Torino, Italy.

出版信息

Magn Reson Med. 2022 Aug;88(2):930-944. doi: 10.1002/mrm.29235. Epub 2022 Mar 28.

Abstract

PURPOSE

To theoretically investigate the feasibility of a novel procedure for testing the MRI gradient-induced heating of medical devices and translating the results into clinical practice.

METHODS

The concept of index of stress is introduced by decoupling the time waveform characteristics of the gradient field signals from the field spatial distribution within an MRI scanner. This index is also extended to consider the anisotropy of complex bulky metallic implants. Merits and drawbacks of the proposed index of stress are investigated through virtual experiments. In particular, the values of the index of stress evaluated for realistic orthopedic implants placed within an ASTM phantom are compared with accurate heating simulations performed with 2 anatomic body models (a man and a woman) implanted through a virtual surgery procedure.

RESULTS

The manipulation of the proposed index of stress allows to identify regions within the MRI bore where the implant could affect the safety of the examinations. Furthermore, the conducted analysis shows that the power dissipated into the implant by the induced eddy currents is a dosimetric quantity that estimates well the maximum temperature increase in the tissues surrounding the implant.

CONCLUSION

The results support the adoption of an anisotropic index of stress to regulate the gradient-induced heating of geometrically complex implants. They also pave the way for a laboratory characterization of the implants based on electrical measurements, rather than on thermal measurements. The next step will be to set up a standardized experimental procedure to evaluate the index of stress associated with an implant.

摘要

目的

从理论上探讨一种新的测试医疗设备在 MRI 梯度致热方面的可行性,并将结果转化为临床实践。

方法

通过将梯度场信号的时间波形特征与 MRI 扫描仪内的场空间分布解耦,引入应力指数的概念。该指数还扩展到考虑复杂大块金属植入物的各向异性。通过虚拟实验研究了所提出的应力指数的优点和缺点。特别是,将放置在 ASTM 体模内的现实骨科植入物的应力指数值与通过虚拟手术程序植入的 2 个解剖体模型(男性和女性)进行的精确加热模拟进行了比较。

结果

对所提出的应力指数的操作可以识别 MRI 磁体腔内可能影响检查安全性的区域。此外,所进行的分析表明,感应涡流在植入物中耗散的功率是一种剂量学量,它很好地估计了植入物周围组织的最大温升。

结论

结果支持采用各向异性的应力指数来调节几何形状复杂的植入物的梯度致热。它们还为基于电测量而不是热测量对植入物进行实验室特性描述铺平了道路。下一步将是建立一个标准化的实验程序来评估与植入物相关的应力指数。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9585/9314691/90cc685a8971/MRM-88-930-g007.jpg

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