Md Zahidul Islam1, Ran Guo1, Mir Khadiza Akter1, Jianfeng Zheng1, Hongbae Jeong2, Ananda Kumar2, and Ji Chen1
1Dept. of Electrical and Computer Engineering, University of Houston, Houston, TX, United States, 2CDRH, U.S. Food and Drug Administration, Silver Spring, MD, United States
Synopsis
Keywords: Safety, Safety
Motivation: RF-induced heating for the partially-in and partially-out (PIPO) medical implants is the primary concern for patient’s safety under MRI.
Goal(s): Winding the external portion of the PIPO medical electrodes is proposed to reduce the RF heating under 1.5T MRI.
Approach: One commercial PIPO medical electrode and an insulated solid wire were used to demonstrate this concept. RF heating is measured inside the ASTM phantom under a 1.5T RF birdcage coil and evaluated from the in-vivo simulations using the transfer function (TF) approach.
Results: The results showed a significant reduction of RF heating in the commercial lead and simplified wire.
Impact: The proposed method can
reduce RF-induced heating significantly, mitigating the risk of tissue damage
and improving the quality of care for patients with partially-in and
partially-out (PIPO) medical devices under 1.5T MRI.
Introduction
Magnetic Resonance
Imaging (MRI) is a non-invasive medical imaging technology that employs strong static
and radio frequency (RF) magnetic fields to produce detailed images of internal
body structures. However, due to antenna effects during MRI scans of patients
with partially implanted medical devices, RF-induced heating is the primary safety
concern[1]–[3]. To avoid this safety concern, we
proposed a strategy involving winding the external portion of the partially-in
and partially-out (PIPO) medical electrodes [4], [5].Methods
Experiment: A
technique of lead trajectory modification is proposed by winding the external
portion of the PIPO devices outside the human body. The RF heating is evaluated
using the transfer function approach following the methodology described in the
ISO TS 10974:2018 [6]. Commercially available temporary cardiac pacing wires
and general-purpose insulated solid wires of 60 cm in length were used in this study.
During MRI scans, these devices are disconnected from the external pacing
devices and terminated as open circuits.
Thus, it is possible to make any trajectory modification for the outer
portion under MRI. An illustration of the winding of the outer portion and
transfer function measurement for modified trajectories is shown in Fig 1. The
PIPO devices were placed partially inside the gel (conductivity 0.47 S/m) under
a 1.5T RF birdcage coil (MITS 1.5, Zürich MedTech, Switzerland) to measure the
RF-induced heating inside the ASTM phantom. Trajectories used for device model scaling
and validation are shown in Fig 2. Fiber optical probes were used to record
temperatures at the tip of the PIPO devices. The transfer function was
measured, scaled, and validated inside the ASTM phantom for 10 mm diameter
winding and straight configurations with 10 cm insertions depth, and the scaled
TF is shown in Fig 3.
Simulation: A
Duke model (34yrs, BMI 21.6) [7] was used for the numerical simulations using
the full-wave electromagnetic simulation platform SEMCAD X (version 14.8.6.1)
based on the Finite Difference Time Domain method. In total, 112 clinically
relevant lead trajectories were developed for each device by varying the
original 16 trajectories +2 or -2 mm in the x, y, and z-directions, as shown in
Fig 4. Then, the RF heating was evaluated for 75 imaging landmarks (-200 mm to
1650 mm; see Fig 4(b)) using three RF transmit body coil sizes in diameter (D)
and length (L) in mm (D700, L500; D700, L600; D600, L600) to estimate the
effectiveness of our study in mitigating the RF-induced heating.Results and Discussion
The results of numerical
modeling, simulations, and experimental studies are in Figures 3 and 5 below. With the winding of the
external portion of PIPO electrodes, we can see up to a 9-fold reduction of the RF
heating from the measured results inside the ASTM phantom shown in Fig 5(a). The
in-vivo RF heating results from the simulations for the devices with winding
and original straight trajectories as a function of imaging landmarks are shown
in Fig 5(b). Each landmark contains 672 heating data points, including all
clinically relevant trajectories and variations of RF coil sizes. The amount of
RF heating mitigation by winding the external portion of the devices resulted
in over a 10-fold reduction for the temporary cardiac pacing wire and a 3-fold
reduction for the solid wire connected to the ventricles and atrium. The wound portion
of the PIPO device behaves as a lumped element rather than a long receiving
“antenna” in this condition (i.e., winding diameter:10 mm), so that the induced
energy on the entire PIPO system is reduced. Hence, the RF-induced heating
contributed by the wound section of PIPO becomes much lower than that from the
original straight lead configurations inside the ASTM phantom and human body
models. Conclusion
The RF-induced heating
for the PIPO devices is evaluated using the transfer function approach. The
results show that winding the external portion of a PIPO system can result in up
to a 10-fold RF heating reduction compared to the straight configuration of the
device lead. Thus, this approach can reduce RF heating significantly, mitigating
the risk of tissue damage from RF-induced heating and improving the quality of
care for patients with PIPO medical devices under 1.5T MRI. However, the
heating profile can be different for different devices and applications. Thus,
safety studies and specific protocols are necessary for patients with PIPO
medical devices undergoing MRI.Disclaimer
The mention of commercial
products, their sources, or their use in connection with material reported
herein is not to be construed as either an actual or suggested endorsement of
such products by the Department of Health and Human Services.Acknowledgements
No acknowledgement found.References
- J.
Liu, J. Zheng, Q. Wang, W. Kainz, and J. Chen, “A Transmission Line Model for
the Evaluation of MRI RF-Induced Fields on Active Implantable Medical
Devices,” IEEE Trans Microw Theory Tech, vol. 66, no. 9, pp. 4271–4281,
Sep. 2018, doi: 10.1109/TMTT.2018.2851975.
- R.
Guo, J. Zheng, and J. Chen, “MRI RF-Induced Heating in Heterogeneous Human
Body with Implantable Medical Device,” in High-Resolution Neuroimaging -
Basic Physical Principles and Clinical Applications, InTech, 2018. doi:
10.5772/intechopen.71384.
- S.
Feng, R. Qiang, W. Kainz, and J. Chen, “A technique to evaluate MRI-induced
electric fields at the ends of practical implanted lead,” IEEE Trans Microw
Theory Tech, vol. 63, no. 1, pp. 305–313, Jan. 2015, doi:
10.1109/TMTT.2014.2376523.
- R.
Guo, M. Z. Islam, W. Kainz, and J. Chen, “MRI‐Induced RF Heating
Considerations for Devices and Accessories that are Partially in and Partially
Out of the Human Body,” in The Application of Heat in Oncology, Wiley,
2023, pp. 533–543. doi: 10.1002/9781119799627.ch32.
- M.
Z. Islam, W. Hu, R. Guo, and J. Chen, “Factors Affecting the RF-Induced
Heating for the Electrodes Partially Inserted Inside Human Body at 1.5T MRI,”
in 2023 IEEE International Symposium on Antennas and Propagation and
USNC-URSI Radio Science Meeting (USNC-URSI), IEEE, Jul. 2023, pp. 789–790.
doi: 10.1109/USNC-URSI52151.2023.10238180.
- ISO/TS
10974:2018, “Assessment of the safety of magnetic resonance imaging for
patients with an active implantable medical device”.
- A.
Christ et al., “The Virtual Family - Development of surface-based
anatomical models of two adults and two children for dosimetric simulations,” Phys
Med Biol, vol. 55, no. 2, 2010, doi: 10.1088/0031-9155/55/2/N01.