Simplified modeling of implanted medical devices with metallic filamentary closed loops exposed to low or medium frequency magnetic fields.

BACKGROUND AND OBJECTIVES: Electric currents are induced in implanted medical devices with metallic filamentary closed loops (e.g., fixation grids, stents) when exposed to time varying magnetic fields, as those generated during certain diagnostic and therapeutic biomedical treatments. A simplified methodology to efficiently compute these currents, to estimate the altered electromagnetic field distribution in the biological tissues and to assess the consequent biological effects is proposed for low or medium frequency fields. METHODS: The proposed methodology is based on decoupling the handling of the filamentary wire and the anatomical body. To do this, a circuital solution is adopted to study the metallic filamentary implant and this solution is inserted in the electromagnetic field solution involving the biological tissues. The Joule losses computed in the implant are then used as a forcing term for the thermal problem defined by the bioheat Pennes' equation. The methodology is validated against a model problem, where a reference solution is available. RESULTS: The proposed simplified methodology is proved to be in good agreement with solutions provided by alternative approaches. In particular, errors in the amplitude of the currents induced in the wires result to be always lower than 3%. After the validation, the methodology is applied to check the interactions between the magnetic field generated by different biomedical devices and a skull grid, which represents a complex filamentary wire implant. CONCLUSIONS: The proposed simplified methodology, suitable to be applied to closed loop wires in the low to intermediate frequency range, is found to be sufficiently accurate and easy to apply in realistic exposure scenarios. This modeling tool allows analyzing different types of small implants, from coronary and biliary duct stents to orthopedic grids, under a variety of exposure scenarios.

Computational dosimetry in MRI in presence of hip, knee or shoulder implants: do we need accurate surgery models?

Objective.To quantify the effects of different levels of realism in the description of the anatomy around hip, knee or shoulder implants when simulating, numerically, radiofrequency and gradient-induced heating in magnetic resonance imaging. This quantification is needed to define how precise the digital human model modified with the implant should be to get realistic dosimetric assessments.Approach. The analysis is based on a large number of numerical simulations where four 'levels of realism' have been adopted in modelling human bodies carrying orthopaedic implants.Main results. Results show that the quantification of the heating due to switched gradient fields does not strictly require a detailed local anatomical description when preparing the digital human model carrying an implant. In this case, a simple overlapping of the implant CAD with the body anatomy is sufficient to provide a quite good and conservative estimation of the heating. On the contrary, the evaluation of the electromagnetic field distribution and heating caused by the radiofrequency field requires an accurate description of the tissues around the prosthesis.Significance. The results of this paper provide hints for selecting the 'level of realism' in the definition of the anatomical models with embedded passive implants when performing simulations that should reproduce, as closely as possible, thein vivoscenarios of patients carrying orthopaedic implants.

Heating of metallic biliary stents during magnetic hyperthermia of patients with pancreatic ductal adenocarcinoma: an in silico study.

OBJECTIVE: To investigate the eddy current heating that occurs in metallic biliary stents during magnetic hyperthermia treatments and to assess whether these implants should continue to be an exclusion criterion for potential patients. METHODS: Computer simulations were run on stent heating during the hyperthermia treatment of local pancreatic tumors (5-15 mT fields at 300 kHz for 30 min), considering factors such as wire diameter, type of stent alloy, and field orientation. Maxwell's equations were solved numerically in a bile duct model, including the secondary field produced by the stents. The heat exchange problem was solved through a modified version of the Pennes' bioheat equation assuming a temperature dependency of blood perfusion and metabolic heat. RESULTS: The choice of alloy has a large impact on the stent heating, preferring those having a lower electrical conductivity. Only for low field intensities (5 mT) and for some of the bile duct tissue layers the produced heating can be considered safe. The orientation of the applied field with respect to the stent wires can give rise to the onset of regions with different heating levels depending on the shape that the stent has finally adopted according to the body's posture. Bile helps to partially dissipate the heat that is generated in the lumen of the bile duct, but not at a sufficient rate. CONCLUSION: The safety of patients with pancreatic cancer wearing metallic biliary stents during magnetic hyperthermia treatments cannot be fully assured under the most common treatment parameters.

Classification Scheme of Heating Risk during MRI Scans on Patients with Orthopaedic Prostheses.

Due to the large variety of possible clinical scenarios, a reliable heating-risk assessment is not straightforward when patients with arthroplasty undergo MRI scans. This paper proposes a simple procedure to estimate the thermal effects induced in patients with hip, knee, or shoulder arthroplasty during MRI exams. The most representative clinical scenarios were identified by a preliminary frequency analysis, based on clinical service databases, collecting MRI exams of 11,658 implant carrier patients. The thermal effects produced by radiofrequency and switching gradient fields were investigated through 588 numerical simulations performed on an ASTM-like phantom, considering four prostheses, two static field values, seven MR sequences, and seven regions of imaging. The risk assessment was inspired by standards for radiofrequency fields and by scientific studies for gradient fields. Three risk tiers were defined for the radiofrequency, in terms of whole-body and local SAR averages, and for GC fields, in terms of temperature elevation. Only 50 out of 588 scenarios require some caution to be managed. Results showed that the whole-body SAR is not a self-reliant safety parameter for patients with metallic implants. The proposed numerical procedure can be easily extended to any other scenario, including the use of detailed anatomical models.

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

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.

In silico assessment of collateral eddy current heating in biocompatible implants subjected to magnetic hyperthermia treatments.

Purpose: Bearing partially or fully metallic passive implants represents an exclusion criterion for patients undergoing a magnetic hyperthermia procedure, but there are no specific studies backing this restrictive decision. This work assesses how the secondary magnetic field generated at the surface of two common types of prostheses affects the safety and efficiency of magnetic hyperthermia treatments of localized tumors. The paper also proposes the combination of a multi-criteria decision analysis and a graphical representation of calculated data as an initial screening during the preclinical risk assessment for each patient.Materials and methods: Heating of a hip joint and a dental implant during the treatment of prostate, colorectal and head and neck tumors have been assessed considering different external field conditions and exposure times. The Maxwell equations including the secondary field produced by metallic prostheses have been solved numerically in a discretized computable human model. The heat exchange problem has been solved through a modified version of the Pennes' bioheat equation assuming a temperature dependency of blood perfusion and metabolic heat, i.e. thermorregulation. The degree of risk has been assessed using a risk index with parameters coming from custom graphs plotting the specific absorption rate (SAR) vs temperature increase, and coefficients derived from a multi-criteria decision analysis performed following the MACBETH approach.Results: The comparison of two common biomaterials for passive implants - Ti6Al4V and CoCrMo - shows that both specific absorption rate (SAR) and local temperature increase are found to be higher for the hip prosthesis made by Ti6Al4V despite its lower electrical and thermal conductivity. By tracking the time evolution of temperature upon field application, it has been established that there is a 30 s delay between the time point for which the thermal equilibrium is reached at prostheses and tissues. Likewise, damage may appear in those tissues adjacent to the prostheses at initial stages of treatment, since recommended thermal thresholds are soon surpassed for higher field intensities. However, it has also been found that under some operational conditions the typical safety rule of staying below or attain a maximum temperature increase or SAR value is met.Conclusion: The current exclusion criterion for implant-bearing patients in magnetic hyperthermia should be revised, since it may be too restrictive for a range of the typical field conditions used. Systematic in silico treatment planning using the proposed methodology after a well-focused diagnostic procedure can aid the clinical staff to find the appropriate limits for a safe treatment window.

Heating of hip joint implants in MRI: The combined effect of RF and switched-gradient fields.

PURPOSE: To investigate how the simultaneous exposure to gradient and RF fields affects the temperature rise in patients with a metallic hip prosthesis during an MRI session. METHODS: In silico analysis was performed with an anatomically realistic human model with CoCrMo hip implant in 12 imaging positions. The analysis was performed at 1.5 T and 3 T, considering four clinical sequences: turbo spin-echo, EPI, gradient-echo, and true fast imaging sequence with steady precession. The exposure to gradient and RF fields was evaluated separately and superposed, by adopting an ad hoc computational algorithm. Temperature increase within the body, rather than specific absorption rate, was used as a safety metric. RESULTS: With the exception of gradient-echo, all investigated sequences produced temperature increases higher than 1 K after 360 seconds, at least for one body position. In general, RF-induced heating dominates the turbo spin-echo sequence, whereas gradient-induced heating prevails with EPI; the situation with fast imaging sequence with steady precession is more diversified. The RF effects are enhanced when the implant is within the RF coil, whereas the effects of gradient fields are maximized if the prosthesis is outside the imaging region. Cases for which temperature-increase thresholds were exceeded were identified, together with the corresponding amount of tissue mass involved and the exposure time needed to reach these limits. CONCLUSION: The analysis confirms that risky situations may occur when a patient carrying a hip implant undergoes an MRI exam and that, in some cases, the gradient field heating may be significant. In general, exclusion criteria only based on whole-body specific absorption rate may not be sufficient to ensure patients' safety.

In silico evaluation of the thermal stress induced by MRI switched gradient fields in patients with metallic hip implant.

This work focuses on the in silico evaluation of the energy deposed by MRI switched gradient fields in bulk metallic implants and the consequent temperature increase in the surrounding tissues. An original computational strategy, based on the subdivision of the gradient coil switching sequences into sub-signals and on the time-harmonic electromagnetic field solution, allows to realistically simulate the evolution of the phenomena produced by the gradient coils fed according to any MRI sequence. Then, Pennes' bioheat equation is solved through a Douglas-Gunn time split scheme to compute the time-dependent temperature increase. The procedure is validated by comparison with laboratory results, using a component of a realistic hip implant embedded within a phantom, obtaining an agreement on the temperature increase better than 5%, lower than the overall measurement uncertainty. The heating generated inside the body of a patient with a unilateral hip implant when undergoing an Echo-Planar Imaging (EPI) MRI sequence is evaluated and the role of the parameters affecting the thermal results (body position, coil performing the frequency encoding, effects of thermoregulation) is discussed. The results show that the gradient coils can generate local increases of temperature up to some kelvin when acting without radiofrequency excitation. Hence, their contribution in general should not be disregarded when evaluating patients' safety.

Dynamic Simulation of a Fe-Ga Energy Harvester Prototype Through a Preisach-Type Hysteresis Model.

This paper presents the modeling of an Fe-Ga energy harvester prototype, within a large range of values of operating parameters (mechanical preload, amplitude and frequency of dynamic load, electric load resistance). The simulations, based on a hysteretic Preisach-type model, employ a voltage-driven finite element formulation using the fixed-point technique, to handle the material nonlinearities. Due to the magneto-mechanical characteristics of Fe-Ga, a preliminary tuning must be performed for each preload to individualize the fixed point constant, to ensure a good convergence of the method. This paper demonstrates how this approach leads to good results for the Fe-Ga prototype. The relative discrepancies between experimental and computational values of the output power remain lower than 5% in the entire range of operating parameters considered.

CSI-EPT in Presence of RF-Shield for MR-Coils.

Contrast source inversion electric properties tomography (CSI-EPT) is a recently developed technique for the electric properties tomography that recovers the electric properties distribution starting from measurements performed by magnetic resonance imaging scanners. This method is an optimal control approach based on the contrast source inversion technique, which distinguishes itself from other electric properties tomography techniques for its capability to recover also the local specific absorption rate distribution, essential for online dosimetry. Up to now, CSI-EPT has only been described in terms of integral equations, limiting its applicability to homogeneous unbounded background. In order to extend the method to the presence of a shield in the domain-as in the recurring case of shielded radio frequency coils-a more general formulation of CSI-EPT, based on a functional viewpoint, is introduced here. Two different implementations of CSI-EPT are proposed for a 2-D transverse magnetic model problem, one dealing with an unbounded domain and one considering the presence of a perfectly conductive shield. The two implementations are applied on the same virtual measurements obtained by numerically simulating a shielded radio frequency coil. The results are compared in terms of both electric properties recovery and local specific absorption rate estimate, in order to investigate the requirement of an accurate modeling of the underlying physical problem.

Assessment of exposure to MRI motion-induced fields based on the International Commission on Non-Ionizing Radiation Protection (ICNIRP) guidelines.

PURPOSE: The goal of this study was to conduct an exposure assessment for workers moving through the stray stationary field of common MRI scanners, performed according to the recent International Commission on Non-Ionizing Radiation Protection (ICNIRP) Guidelines, which aim at avoiding annoying sensory effects. THEORY AND METHODS: The analysis was performed through numerical simulations, using a high-resolution anatomical model that moved along realistic trajectories in proximity to a tubular and open MRI scanner. Both dosimetric indexes indicated by ICNIRP (maximum variation of the magnetic flux density vector and exposure index for the motion-induced electric field) were computed for three statures of the human model. RESULTS: A total of 51 exposure situations were analyzed. None of them exceeded the limit for the maximum variation of the magnetic flux density, whereas some critical cases were found when computing the induced electric field. In the latter case, the exposure indexes computed via Fourier transform and through an equivalent filter result to be consistent. CONCLUSION: The results suggest the adoption of some simple precautionary rules, useful when sensory effects experienced by an operator could reflect upon the patient's safety. Moreover, some open issues regarding the quantification of motion-induced fields are highlighted, putting in evidence the need for clarification at standardization level. Magn Reson Med 76:1291-1300, 2016. © 2015 Wiley Periodicals, Inc.

Numerical prediction of temperature elevation induced around metallic hip prostheses by traditional, split, and uniplanar gradient coils.

PURPOSE: The paper presents a computational study for the estimation of the temperature elevation occurring in a human subject carrying metallic hip prostheses when exposed to the magnetic field produced by gradient coils. METHODS: The simulations are performed through validated numerical codes, which solve the electromagnetic and thermal equations applied to a high-resolution anatomical human model. Three different sets of gradient coils (traditional, split and uniplanar) are considered to evaluate the maximum steady-state temperature elevation in the human body. This result is then rescaled to take into account the waveform of the signal, the duty-cycle and the duration of the scan. RESULTS: Several exposure situations obtained by changing the patient's position are analyzed, finding temperature elevations on the order of some degrees. CONCLUSION: The results are of possible concern and provide evidence of the need for further specific investigations aimed at assuring the safety of potential patients carrying metallic hip implants. Magn Reson Med 74:272-279, 2015. © 2014 Wiley Periodicals, Inc.

Parametric analysis of transient skin heating induced by terahertz radiation.

This paper investigates the effect of relevant physical parameters on transient temperature elevation induced in human tissues by electromagnetic waves in the terahertz (THz) band. The problem is defined by assuming a plane wave, which, during a limited time interval, normally impinges on the surface of a 3-layer model of the human body, causing a thermal transient. The electromagnetic equations are solved analytically, while the thermal ones are handled according to the finite element method. A parametric analysis is performed with the aim of identifying the contribution of each parameter, showing that the properties of the first skin layer (except blood flow) play a major role in the computation of the maximum temperature rise for the considered exposure situation. Final results, obtained by combining all relevant parameters together, show that the deviation from the reference solution of the maximum temperature elevation in skin is included in the coverage intervals from -30% to +10% at 0.1 THz and from -33% to +18% at 1 THz (with 95% confidence level). These data allow bounding the possible temperature increase against the spread of tissue properties that could be reasonably used for dosimetric simulations.

A numerical survey of motion-induced electric fields experienced by MRI operators.

This paper deals with the electric field generated inside the bodies of people moving in proximity to magnetic resonance scanners. Different types of scanners (tubular and open) and various kinds of movements (translation, rotation, and revolution) are analyzed, considering the homogeneous human model proposed in some technical Standards. The computations are performed through the Boundary Element Method, adopting a reference frame attached to the body, which significantly reduces the computational burden. The induced electric fields are evaluated in terms of both spatial distributions and local time evolutions. The possibility of limiting the study to the head without affecting the accuracy of the results is also investigated. Finally, a first attempt to quantify the transient effect of charge separation is proposed.

A procedure to estimate the electric field induced in human body exposed to unknown magnetic sources.

The paper proposes and discusses a boundary element procedure able to predict the distribution of the electric field induced in a human body exposed to a low-frequency magnetic field produced by unknown sources. As a first step, the magnetic field on the body surface is reconstructed starting from the magnetic field values detected on a closed surface enclosing the sources. Then, the solution of a boundary value problem provides the electric field distribution inside the human model. The procedure is tested and validated by considering different non-uniform magnetic field distributions generated by a Helmholtz coil system as well as different locations of the human model.

Influence of probe size on the measurement accuracy of non-uniform ELF magnetic fields.

The accuracy of extremely low frequency (ELF) magnetic field measurements can be sensitively varied by the meter probe size when the spatial distribution of the magnetic flux density is highly non-uniform, e.g. if the measurement point is close to the field source. The deviation between measured and actual field varies from point to point depending on the probe dimension and on the source configuration, once the other measurement conditions are fixed. The analysis of this effect is developed through a two-dimensional numerical model that enables the evaluation of the actual field value and of the corresponding probe indication. The error distribution, i.e. the deviation between actual and measured value, is computed for magnetic fields generated by industrial three-phase systems under both balanced and unbalanced supply conditions. The analysis shows how, for a given source, the error depends not simply on the distance from the source in relation to the probe size, but on its spatial distribution, which is complex and cannot be a priori predicted without using a computational tool such as the one proposed.