Berk Silemek1, Oktay Algin1,2, Cagdas Oto3, and Ergin Atalar1,4
1UMRAM, Bilkent University, Ankara, Turkey, 2Department of Radiology, Atatürk Education and Research Hospital, Ankara, Turkey, 3Faculty of Veterinary Medicine, Ankara University, Ankara, Turkey, 4Electrical and Electronics Engineering, Bilkent University, Ankara, Turkey
Synopsis
RF tissue heating of the Active Medical
Implantable Devices (AIMD) is a well-known problem. However, due to the complex
structure of the body, in vivo testing of the AIMDs’ heating under MRI cannot
be verified with phantoms completely. Acute in vivo experiments damage the
tissue and body’s thermoregulation response changes which can affect the
measurements and investigation of the problems. Here, we propose a Temperature
Sensor Implant setup to eliminate hyperacute effects of the surgery and enable
real-time temperature monitoring of the tip of the implant during MRI examinationPurpose
The purpose of this study is to develop a
circuit that can be placed inside a deep brain stimulator (DBS) and enable
real-time temperature monitoring of tip of the implant during MRI examination,
and show temperature increase during MRI examination a few days after
implantation eliminating hyperacute effects of the surgery.
Introduction
RF tissue
heating of metallic implants is a well-known problem shown with many phantom
experiments
1,2. It is well-known that the amount of temperature rise
depends on both electrical and thermal properties of the body of interest. In vivo
experiments are needed to accurately predict the temperature rise because the tissue
properties cannot be simulated even with complex phantoms. In limited number of
in-vivo studies3 RF heating tests were performed with placing
temperature probes into the tissue with surgery. Unfortunately, both electrical
and thermal tissue properties change acutely. Additionally, traumatic hyperacute
symptoms can disturb the perfusion system which can mislead the temperature
measurements while location sensitive temperature probe measurements can also lapse
the localized RF heating of the electrode and tissue. Here, we demonstrate an
in vivo study of RF heating of an Active Implantable Medical Device (AIMD) with
enhanced version of Temperature Sensor implant (TSI) which we proposed earlier
4
having very similar electrical properties with commercial AIMDs but measures
its own temperature allowing a closer approach to subacute surgery effects to
the RF tissue heating problem.
Methods
The enhanced version of TSI proposed earlier is used
for the experiment. Unlike the early prototype, the case is changed to a circular
shape of 5x4x1cm titanium alloy covered with Polydimethylsiloxane. 1.5cm2
of surface is left uncovered for tissue connection. Furthermore, additional
functionalities are added to the implant circuit illustrated in Figure 1 such
as capability of measuring the electrode impedance and case temperature upon request.
In addition to an Android phone connection, real-time communication software
with TSI is implemented using a BLED112 dongle (Bluegiga Technologies Inc.) It
collects the Bluetooth data inside the MRI room and sends it to an external
computer via USB connection. The real-time implant monitoring with a computer
software interface (Figure 2) under MRI scan eliminates memory size limitation.
TSI was tested with
a sheep experiment. The implant was inserted into the sheep following 1 hour
medical surgery. The case was placed near the neck of the animal. Under the
skin, the lead was sent straight toward to the top of skull. With assistance of
prior MR images, the electrode was sent to interior of the brain (see Figure 3).
After surgery, a rapid MRI heating test implemented with a Siemens 3T TrimTrio
scanner. Then, for partially eliminating surgery’s traumatic effect on tissue,
the animal was kept alive for 3 days and RF heating experiment was repeated.
Maximum possible power was given by scanner for 10 min continuously. The tip temperature
was monitored in real-time. Furthermore, the case temperature and the electrode
impedance recorded as reference.
Results
In Figure 4a, tip temperature of rapid RF heating
experiment, immediately after surgery, is shown. Note that the glitches at data are due to
thermistor filtering. The temperature measurements for this result were
post-processed with a median filter. Maximum of 2
oC difference due
to local RF heating was observed at the tip. Case temperature remained almost
the same. The electrode impedance was approximately 1.7kΩ having 100Ω
difference at maximum temperature. However, tissue impedance was the same when
temperature is back to its reference. In the 3
rd day experiment,
animal scars due to the surgery were healed partially. Maximum of 3
oC
temperature change at the tip was observed as it is shown in Figure 4b.
However, after tip temperature saturated at its maximum around 40
oC,
case temperature gradually increased up to 40
oC while tip temperature
slightly decreased as RF proceeds. Electrode impedance behavior was not changed
compared with previous experiment. Lastly, no tissue damage due to the RF
heating observed on post experiment MRI images.
Discussion and Conclusion
In this study, RF heating was demonstrated with TSI in
vivo. Although it is only one animal experiment, electrode heating can be easily
observed in contrast to other techniques, because the localized heating was
measured at the most possible heating source. Additionally, the tissue property
and perfusion change due to the hyperacute surgery were tried to be reduced. Future
studies should consider longer tissue recovery time, and more heating tests
must be performed to confirm the animal’s physiological response to the heating.
Acknowledgements
This study has been granted by SANTEZ (0204STZ2013-1).
References
1.Nyenhuis, John A. et al. MRI and implanted medical devices: basic interactions with an emphasis on
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3.Luechinger, Roger, et al. In vivo heating of pacemaker leads during magnetic resonance imaging. European Heart Journal.2005;26(4):376-383.
4.Silemek B,Acikel V, Atalar E. Temperature Sensor Implant for Analysis of RF Safety of Active Implantable Medical Devices under MRI. Proc. Intl. Soc. Mag. Reson. Med. 23 (2015).