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The radio frequency (RF)-induced heating is a major concern when patients with medical devices are placed inside a magnetic resonance imaging (MRI) system. In this article, numerical studies are applied to investigate the potentials of using insulated materials to reduce the RF heating for external fixation devices. It is found that by changing the dielectric constant of the insulation material, the RF-induced heating at the tips of devices can be altered. This study indicates a potential technique of developing external fixation device with low MRI RF heating. [ABSTRACT FROM AUTHOR]

This paper describes a novel simulator to perform electromagnetic compatibility (EMC) tests for active implantable medical devices (AIMDs) with electromagnetic fields emitted by security systems. The security system simulator was developed in response to over 100 incident reports over 17 years related to the interference of AIMD's with security systems and the lack of a standardized test method. The simulator was evaluated regarding field homogeneity, signal distortion, and maximum magnetic field strength levels. Small three-axis probes and a three-axis scanning system were designed to determine the spatial and temporal characteristics of the fields emitted by 12 different types of walk through metal detectors (WTMDs). Tests were performed on four implanted pacemakers with a saline phantom and correlated to a newly developed test method performed "in air" (without the phantom). Comparison of the simulator thresholds with tests per- formed in real WTMDs showed that the simulator is able to mimic the pacemaker interference. The interference thresholds found in the simulator indicate that pulsed magnetic fields are more likely to cause interference in pacemakers than sinusoidal fields. The security system simulator will help biomedical engineers, manufacturers of medical devices, and manufacturers of security systems to identify incompatible combinations of WTMDs and AIMDs early in the development stage. [ABSTRACT FROM AUTHOR]

This article presents a cascaded heterogeneous equivalent network for the evaluation of radiofrequency (RF) induced safety hazards on electrically long active implantable medical devices (AIMDs) exposed to magnetic resonance imaging systems. AIMDs in a highly heterogeneous human body are represented by cascaded transmission line models consisting of segments with different values of effective wavenumbers and characteristic impedances. Two terminations, implantable pulse generator (IPG), and lead-tip are modeled as lumped elements. Methods to extract values for lead-tip impedance, IPG impedance, wavenumber, and characteristic impedance of the AIMDs are proposed and validated through numerical simulations and experimental investigations. Based on these values, one can build up a unique AIMD model along each implanted trajectory inside human body models. The developed models can be used to accurately evaluate the RF-induced voltage and heating for each implantation scenario. [ABSTRACT FROM AUTHOR]

Background: The magnetic resonance imaging (MRI) radio frequency (RF) field induced heating on external fixation devices can be very high in the vicinity of device screws. Such induced RF heating is related to device constructs, device placements, as well as the device insertion depth into human subjects. In this study, computational modeling is performed to determine factors associated with such induced heating. Methods: Numerical modeling, based on the finite-difference time-domain (FDTD) method, is used to evaluate the temperature rises near external device screw tips inside the ASTM phantom for both 1.5-T and 3-T MRI systems. The modeling approach consists of 1) the development of RF coils for 1.5-T and 3-T, 2) the electromagnetic simulations of energy deposition near the screw tips of external fixation devices, and 3) the thermal simulations of temperature rises near the tips of these devices. Results: It is found that changing insertion depth and screw spacing could largely affect the heating of these devices. In 1.5-T MRI system, smaller insertion depth and larger pin spacing will lead to higher temperature rise. However, for 3-T MRI system, the relation is not very clear when insertion depth is larger than 5 cm or when pin spacing became larger than 20 cm. The effect of connection bar material on device heating is also studied and the heating mechanism of the device is analysed. Conclusions: Numerical simulation is used to study RF heating for external fixation devices in both 1.5-T and 3-T MRI coils. Typically, shallower insertion depth and larger pin spacing with conductive bar lead to higher RF heating. The heating mechanism is explained using induced current along the device and power decay inside ASTM phantom. [ABSTRACT FROM AUTHOR]

Purpose. To characterize and quantify the induced radiofrequency (RF) electric (E)-fields and B1+rms fields in patients undergoing magnetic resonance (MR) examinations; to provide guidance on aspects of RF heating risks for patients with and without implants; and to discuss some strengths and limitations of safety assessments in current ISO, IEC, and ASTM standards to determine the RF heating risks for patients with and without implants. Methods. Induced E-fields and B1+rms fields during 1.5 T and 3 T MR examinations were numerically estimated for high-resolution patient models of the Virtual Population exposed to ten two-port birdcage RF coils from head to feet imaging landmarks over the full polarization space, as well as in surrogate ASTM phantoms. Results. Worst-case B1+rms exposure greater than 3.5 μT (1.5 T) and 2 μT (3 T) must be considered for all MR examinations at the Normal Operating Mode limit. Representative induced E-field and specific absorption rate distributions under different clinical scenarios allow quick estimation of clinical factors of high and reduced exposure. B1 shimming can cause +6 dB enhancements to E-fields along implant trajectories. The distribution and magnitude of induced E-fields in the ASTM phantom differ from clinical exposures and are not always conservative for typical implant locations. Conclusions. Field distributions in patient models are condensed, visualized for quick estimation of risks, and compared to those induced in the ASTM phantom. Induced E-fields in patient models can significantly exceed those in the surrogate ASTM phantom in some cases. In the recent 19ε2 revision of the ASTM F2182 standard, the major shortcomings of previous versions have been addressed by requiring that the relationship between ASTM test conditions and in vivo tangential E-fields be established, e.g. numerically. With this requirement, the principal methods defined in the ASTM standard for passive implants are reconciled with those of the ISO 10974 standard for active implantable medical devices. [ABSTRACT FROM AUTHOR]

In this article, an electric (E) field generator is developed to generate uniform and high-strength E-fields at multiple frequencies. The system can be used to assess the radio frequency (RF) hazards of implantable medical devices (IMDs) in magnetic resonance imaging (MRI) environments. The novel system consists of three parts: 1) a signal generating and amplifying block; 2) a four-channel feeding network; and 3) a rectangular resonator box. Mixed modes are utilized to generate locally uniform E-fields inside the rectangular resonator at both 64 and 128 MHz. RF-induced heating for two passive IMD families are evaluated using both numerical and experimental methods inside the E-field generator. These results are compared with those obtained from standard American Society of Testing and Materials (ASTM) phantom testing. The results show that the novel E-field generator is capable of evaluating RF-induced heating for passive IMDs similar to that of the ASTM phantom. Furthermore, it integrates both 1.5- and 3-T RF-induced heating tests in a single system. It is much simpler compared to the ASTM test method which needs the RF coil as a source. Consequently, this small and efficient E-field generator can be used as an alternative system for RF-induced heating tests of passive IMDs in the MRI environment. [ABSTRACT FROM AUTHOR]

In this article, we discuss the model validation for active implantable medical devices (AIMDs) used for safety evaluations under magnetic resonance imaging (MRI) radio frequency (RF) coil emission. A mathematical derivation is presented to provide the guidance on selecting meaningful pathways for the model validation. Suggested validation pathways from current ISO 10974 are used as examples. It is shown that these standard pathways are: 1) inefficient since validations from several pathways are theoretically redundant and 2) incomplete or false since significantly different AIMD models can have identical validation outputs. Based on the developed guidance, two sets of pathways are proposed. It is demonstrated that for efficient and correct model validation, the electric-field distributions along validation pathways should be orthogonal to each other or at least has low correlations between each other. These guidelines can be implemented for future AIMD model validations in ISO10974. [ABSTRACT FROM AUTHOR]

In this paper, an absorbing radio frequency shield (ARFS) is developed to reduce the radio frequency (RF)-induced heating for active implantable medical device (AIMD) during magnetic resonance imaging (MRI). Using the ARFS, the strength of the incident electric field within the shielded region is significantly decreased, and subsequently the induced temperature rises near the tip of AIMD. Both numerical and experimental studies show that the proposed design of ARFS can effectively reduce the temperature rise induced by an AIMD and can mitigate the MRI RF heating risks for patients with AIMDs. [ABSTRACT FROM AUTHOR]

In this paper, a full-wave simulation-based method is proposed to determine the optimal tissue-simulating medium for magnetic resonance imaging radio-frequency safety assessment for patients with active implantable medical devices (AIMDs). Compared to the standard medium, the proposed tissue-simulating medium is optimized for each AIMD lead path in human bodies. The reciprocity-based transfer function model is used as a criterion for optimizing the medium parameters. Numerical investigations and validations are performed for a neurostimulator to demonstrate the method. [ABSTRACT FROM AUTHOR]

This paper presents a novel approach to minimize the radio frequency (RF)-induced heating from external fixation devices under magnetic resonance imaging (MRI) procedure. With proper placement and selection of absorption material, one can alter the electromagnetic field and current distributions around and/or on medical devices so that the MRI RF field-induced heating can be reduced. The absorption-material-based RF heating reduction schemes are analyzed and validated. Numerical and experimental studies are conducted to illustrate the potentials of reducing the RF heating for external fixation devices. A design strategy based on response surface methodology is presented for material selection, and it is shown that absorption materials can significantly reduce the RF heating effects from 645 to 172 W/kg in terms of 1-g spatial-averaged SAR for the device under this investigation. [ABSTRACT FROM AUTHOR]

This paper presents a magnetic-field system and the method developed for testing the immunity of the active implantable medical devices to continuous-wave magnetic fields in the frequency range up to 1 MHz. The system is able to produce magnetic fields of 150 A/rn for frequencies up to 100 kHz and strengths decreasing as 1/f between 100 kHz and 1 MHz, with uniformity of the field within ±2.5% in the volume for tests. To simulate human tissue, the medical device, together with its leads, is placed on a plastic grid in a saline tank that is introduced in the magnetic field of the induction coil. This paper offers an alternative for the injection voltage methods provided in the actual standards for assessing the protection of the implantable medical devices from the effects of the magnetic fields up to 1 MHz. This paper presents the equipment and signals used, the test procedure, and results from the preliminary tests performed at the Food and Drug Administration-Center for Devices and Radiological Health on implantable pacemakers and neurostirnulators. The new system and test method are useful for the EMC research on the implantable medical devices. [ABSTRACT FROM AUTHOR]

In the original article , a declaration of financial interest is missing. The declaration is given as follows: [ABSTRACT FROM AUTHOR]

In the original article , a declaration of financial interest is missing. The declaration is given as follows: [ABSTRACT FROM AUTHOR]