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开发一种用于测量医疗器械磁扭矩的数字仪器,以促进 ASTM F2213 标准的应用。

Development of an Apparatus for Digital Measurement of Magnetically Induced Torque on Medical Implants to Facilitate the Application of the ASTM F2213 Standard.

出版信息

IEEE Trans Biomed Eng. 2019 Dec;66(12):3420-3425. doi: 10.1109/TBME.2019.2905236. Epub 2019 Mar 15.

DOI:10.1109/TBME.2019.2905236
PMID:30892195
Abstract

OBJECTIVE

The ASTM F2213 standard describes the measurement of the magnetically induced torques by means of a torsional spring method. As this method is highly complex, it has rarely ever been employed. The purpose was to develop an easy-to-handle measuring setup for the reproducible, fast, and precise measurement of magnetically induced torques, following ASTM F2213, at a static magnetic field (B) of 1.5 and 3 T.

METHODS

An magnetic resonance (MR)-save measuring platform was developed according to the ASTM F2213 standard and combined with a precision balance. The evaluation was performed with ten test objects, e.g., a steel screw (length 60 mm) and a neurostimulator, at 1.5 and 3 T. The torque was measured at 10° increments as the test object was rotated relative to B.

RESULTS

The measurement setup allows fast and reproducible measurements. The maximum magnetically induced torque measured was 397 ± 2 N·mm for the steel screw and 63 ± 1 N·mm for the neurostimulator. The maximum torque on a test object is insensitive to B if the magnetization of the object has reached saturation.

CONCLUSION

Ferromagnetic implants may exhibit strong magnetically induced torques during MRI examination. For analyzing these magnetically induced torques, we developed a digital measuring device that allows simplified and accelerated application of the ASTM F2213 standard test method.

SIGNIFICANCE

In a B, ferromagnetic implants may exert considerable torques on the surrounding tissue. These forces may affect the functionality of the implant and inflict severe injuries on a patient.

摘要

目的

ASTM F2213 标准描述了通过扭转弹簧法测量磁感应扭矩的方法。由于该方法非常复杂,因此很少使用。目的是开发一种易于操作的测量装置,以根据 ASTM F2213 标准在 1.5 和 3 T 的静态磁场 (B) 下对磁感应扭矩进行可重复、快速和精确的测量。

方法

根据 ASTM F2213 标准开发了一种磁共振 (MR) 保存测量平台,并与精密天平相结合。使用十个测试物体(例如,长度为 60 毫米的钢螺钉和神经刺激器)在 1.5 和 3 T 下进行了评估。当测试物体相对于 B 旋转时,以 10°的增量测量扭矩。

结果

测量装置允许快速和可重复的测量。钢螺钉的最大磁感应扭矩为 397 ± 2 N·mm,神经刺激器的最大磁感应扭矩为 63 ± 1 N·mm。如果物体的磁化已达到饱和,则测试物体上的最大扭矩对 B 不敏感。

结论

铁磁植入物在 MRI 检查期间可能会产生强烈的磁感应扭矩。为了分析这些磁感应扭矩,我们开发了一种数字测量装置,该装置简化并加速了 ASTM F2213 标准测试方法的应用。

意义

在 B 中,铁磁植入物可能会对周围组织施加相当大的扭矩。这些力可能会影响植入物的功能,并对患者造成严重伤害。

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引用本文的文献

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Measurement of Magnetically Induced Torque on Lightweight Medical Devices in the Magnetic Resonance Environment for ASTM F2213.在 ASTM F2213 磁共振环境下测量轻质医疗设备的磁转矩
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2
MRI following scoliosis surgery? An analysis of implant heating, displacement, torque, and susceptibility artifacts.脊柱侧弯手术后的磁共振成像?植入物加热、移位、扭矩及磁化率伪影分析。
Eur Radiol. 2021 Jun;31(6):4298-4307. doi: 10.1007/s00330-020-07546-6. Epub 2020 Dec 4.