A Web-based searchable system to confirm magnetic resonance compatibility of implantable medical devices in Japan: a preliminary study

2017 ◽  
Vol 10 (3) ◽  
pp. 340-348 ◽  
Author(s):  
Yasuhiro Fujiwara ◽  
Hitoshi Fujioka ◽  
Tomoko Watanabe ◽  
Maiko Sekiguchi ◽  
Ryuji Murakami
Keyword(s):  
Magnetic Resonance ◽  
Medical Devices ◽  
Implantable Medical Devices ◽  
Web Based ◽  
Preliminary Study

Novel test field diversity method for demonstrating magnetic resonance imaging safety of active implantable medical devices

2020 ◽  
Vol 65 (7) ◽  
pp. 075004
Author(s):  
Aiping Yao ◽  
Earl Zastrow ◽  
Esra Neufeld ◽  
Maria Cabanes-Sempere ◽  
Theodoros Samaras ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Medical Devices ◽  
Test Field ◽  
Resonance Imaging ◽  
Implantable Medical Devices ◽  
Magnetic Resonance Imaging Safety

An automated computational tool to study MRI safety of implanted passive cardiovascular medical devices

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Baretta ◽  
R Bursi ◽  
A Palazzin ◽  
L Emili
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
In Silico ◽  
Test Method ◽  
Rf Heating ◽  
Implantable Medical Devices ◽  
Web Based ◽  
Computer Aided ◽  
Simulation Results ◽  
Rf Energy

Abstract Introduction The absorption of radiofrequency (RF) energy during an MRI procedure may cause tissue heating in the vicinity of an implanted device, such as a stent or a stented valve, potentially causing patient harm. Computational modeling and simulation (M&S) can be used by medical device manufacturers to assess the RF-induced heating of implanted devices during an MRI scan and identify worst-case configurations within a given line of implants. However, despite the use of in-silico tools, a standard for in-silico testing of such problematic is still missing; The tool here proposed is a web-based application that automates the set-up and solution of RF-heating analysis, in line with existing standards for in-vitro testing. Methods The presented tool is part of a commercial web-based platform. The tool was developed in collaboration with the market leader of computer-aided engineering software and as part of a Research Collaboration Agreement with the American regulatory body. Commercial software was used to compute RF energy absorption and thermal heating of implantable medical devices replicating the directives of the ASTM F2182–11a Standard Test Method. The model is integrated in an automated workflow. Each simulation submitted by the user is sent to the cloud infrastructure for solution. Simulation results are stored in a database for later retrieval and report generation. Results The tool consists of a web-interface where the user can: i) upload the medical device computer-aided design (CAD) or select a simplified geometry from a library; ii) define the material properties of the device; ii) specify the desired input parameters specific to an MRI exposure scenario. Specifically, it is possible to study the device exposure: i) at different field frequencies (i.e., 64 MHz and 128 MHz); ii) at different powers (i.e., 2, 4 and 10 W/kg Whole body Specific Absorption Rate - SAR); iii) at different field polarizations (i.e., two circular and two linear); and iv) for different exposure time (i.e., form 240 s to 900 s). The presented tool allows the users to view and export results for each simulation, including electromagnetic fields, local SAR, and the temperature rise over time. Finally, the simulation results are summarized in an automatically generated report that follows regulatory guidance on M&S reporting. Conclusion The presented web-based M&S tool allows users to perform the thermal safety assessment of implantable medical devices during an MRI procedure following established good simulation practices. Minimal training or background in computer modeling is required to use the tool. Specific potential applications of the tool include RF-heating assessment of cardiovascular devices (e.g., stents, stented valves, stent retrievers). The proposed platform promotes the broader adoption of digital evidence in preclinical trials for RF safety analysis, supporting the device submission process and pre-market regulatory evaluation. Stent safety simulation result interface Funding Acknowledgement Type of funding source: None

MRI-visible polymer based on poly(methyl methacrylate) for imaging applications

RSC Advances ◽  
2016 ◽  
Vol 6 (7) ◽  
pp. 5754-5760 ◽  
Author(s):  
Mira Younis ◽  
Vincent Darcos ◽  
Cédric Paniagua ◽  
Pauline Ronjat ◽  
Laurent Lemaire ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Methyl Methacrylate ◽  
Contrast Agents ◽  
Medical Devices ◽  
Resonance Imaging ◽  
Implantable Medical Devices ◽  
Poly Methyl Methacrylate ◽  
Magnetic Resonance Imaging Mri

Macromolecular contrast agents are very attractive to afford efficient magnetic resonance imaging (MRI) visualization of implantable medical devices.

Magnetic resonance conditionality of abandoned leads from active implantable medical devices at 1.5 T

2021 ◽  
Author(s):  
Yu Wang ◽  
Ran Guo ◽  
Wei Hu ◽  
Jianfeng Zheng ◽  
Qingyan Wang ◽  
...  
Keyword(s):  
Magnetic Resonance ◽  
Medical Devices ◽  
Implantable Medical Devices

Highly sensitive magnetic resonance compatible temperature measurement system

2020 ◽  
pp. 66-71
Author(s):  
Dmitry S. Semenov ◽  
Ekaterina S. Akhmad ◽  
Vasily A. Yatseev ◽  
Yurij A. Vasilev ◽  
Kristina A. Sergunova ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Optical Fibers ◽  
Medical Devices ◽  
Measurement System ◽  
Radiation Thermometry ◽  
Calibration Method ◽  
Resonance Imaging ◽  
Implantable Medical Device ◽  
Implantable Medical Devices

One of the steps in determining the compliance of an implantable medical device with the safety requirements in magnetic resonance imaging (MRI) is the experimental assessment of its heating over the course of the study. However, the application of traditional methods, such as thermocouple measurements or radiation thermometry, is difficult in connection with the conditions of high magnetic fields. A spectrometric system is proposed for measuring temperature in a magnetic resonance imaging cabinet with sensitivity of 0.01 °C and error of 0.1 % in the range of 10–50 °C. Temperature sensors are Fabry–Perot interferometers formed by flat ends of optical fibers located at a distance of about tens of micrometers. A design of the sensor and a calibration method are described. A design of the sensor and a calibration method are described. The system was tested in the process of two passive implants heating in 1,5 T MRI. As a result, compliance with the accepted recommendations for assessing the heating of implantable medical devices in MRI was demonstrated, and the temperature rise value was obtained that was comparable to the manufacturer’s tests of this product according to ASTM F 2182. The presented measurement system can be used to assess the MR-compatibility of implantable medical devices, to develop scanning protocols for patients with metal structures, as well as to confirm or refine mathematical models of heat transfer.

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