Alessandro Arduino1, Umberto Zanovello1, Luca Zilberti1, Mario Chiampi1, and Oriano Bottauscio1
1INRiM, Torino, Italy
Synopsis
MRI safety for
patients carrying metallic implants, whose prevalence grows continuously, has
become a matter of concern, so that risk assessment for passive implanted
medical devices is important for both radiologists and implant manufacturers. A
wide analysis of parameters influencing the thermal effects of Gradient Coil
fields is here performed. Results show that it seems possible to identify some
general rules related to this cause of heating, also in view of future
standardized approaches.
Introduction
MRI safety
for patients carrying metallic implants, whose prevalence grows continuously, has
become a matter of concern. A clear definition of the risk assessment for passive
implanted medical devices, ranging from orthopaedic components up to small
surgical implants, is important for both radiologists and implant manufacturers.
For such a purpose, an European project
within the framework of the metrology community (EURAMET) is currently on-going
to define measurement/computation procedures to demonstrate compliance with MRI
safety regulations1.
This paper
focuses on thermal effects of Gradient Coil (GC) fields, which have received
attention in recent scientific literature2,3,4,5,6. The eddy currents
induced by the switching GC fields inside the metallic implant heat it up increasing
the surrounding tissues temperature through diffusion. Since the GC heating mechanism
involves many factors, like the implant shape, size and physical properties,
the MRI magnetic field spatial distribution and the MRI sequence characteristics,
a wide parametric analysis under simplifying assumptions is needed to
discriminate influencing factors.Methods
The temperature
increase is estimated by numerical simulations, based on a computational tool that
integrates the computation of eddy currents and power deposition in the metal with
the thermal diffusion towards surrounding tissues. This computational scheme,
previously validated against laboratory experiments7, is suitable to
take into account the time waveforms of most used MRI sequences.
Because of
the large variability of metallic implants, a simplified shape is adopted in
the analysis. Spheres with radii from 5 mm to 50 mm and spheroids with radii of
20 mm and 40 mm and longitudinal semi-axis varying from 5 mm to 120 mm are
considered. With reference to the implant alloys, the electrical conductivity is
varied from 0.1 MS/m up to 1.5 MS/m.
The
implant models are surrounded by homogenous phantoms, whose thermal properties correspond
to muscle or bone in the IT’IS database8 or a suitable gel (thermal
conductivity 0.5 W/(m∙K),
heat capacity 3700 J/(kg∙K),
density 1100 kg/m3).
By
adopting the simplified standardized approach of ISO_TS_109749, a
continuous, symmetrical, trapezoidal GC signal is used, whose rising time ts
varies from 0.2 ms to 1 ms. The trapezium flat top, with duration
ranging from 0 to 3 ms, is set to the realistic value of 30 mT/m. The analysis
is performed applying a uniform magnetic flux density of 3 mT, verifiable value
within tubular scanners in positions where the implant can be realistically
located.Results
More than 150 simulations are performed, by
combining the parameters variability. In all simulations, the GC is continuously
supplied for 1800 s. The maximum local power density, the total power, and the
maximum temperature rise after 300 s and 1800 s are recorded. The results have
a quadratic dependence with respect to the gradient intensity.
The effect of the implant shape is sketched in
Fig. 1 for different GC signals, electric conductivity of 1 MS/m and a phantom having
muscle properties. The spheroid axis is oriented along the magnetic field
direction.
In an elongated implant, the B-field direction
affects the power deposition, as sketched in Fig. 2, where the field is
oriented along the spheroid axis, the perpendicular direction or an
intermediate axis.
The influence of the sequence parameters is
summarized in Fig. 3. In Fig. 4, the role of the electrical conductivity of the
implant metal is investigated.
Finally, the correlation between the
temperature increase and the ratio between the total power and the external
surface of the implant is shown in Fig. 5.Discussion
The implant size strongly affects the
heating: assuming a given value of the gradient amplitude, a minimum sphere size
can be determined under which the heating effects can be disregarded. Precisely,
for the considered amplitude, the heating, after 1800 s, is always lower than
1 K for spheres with radius smaller than 15 mm (Fig. 1).
In case of elongated implants, the power is
lower when the field is directed along the main axis, whereas it is higher if
the field is along the transversal direction (Fig. 2).
At the
increase of the sequence rising time, power and temperature always reduce, whereas the dependence on the flat duration
is non-monotonic (Fig. 3).
The
increase of the electrical conductivity determines an increase of the
dissipated power and the maximum temperature up to a given size. When skin
effect plays a significant role, the behavior is no longer monotonic (Fig. 4).
Fig. 5 shows a
linear dependence of the maximum temperature with respect to the ratio between
the total power and the external surface, which holds independently of the considered parameters values, especially for
the longest duration.
The
maximum variation between maximum temperature increase considering muscle and
gel phantom is lower than 10 %. Higher variation (up to 50 %) are found when
using the properties of bone.Conclusion
The parametric analysis gives some useful hints
about the parameters that mostly affect the heating of implants due to GC
fields. It seems possible to identify some general rules, also in view of a
standardized approach. A future extensive work will be focused on the application
of these rules to realistic implants in order to clarify on the reliability of
a possible standardized approach.Acknowledgements
The results here presented have been developed
in the framework of the 17IND01 MIMAS Project. This project has received
funding from the EMPIR Programme, co-financed by the Participating States and
from the European Union’s Horizon 2020 Research and Innovation Programme.References
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- IEC 60601-2-33: Particular requirements for
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