Objective: A research study combining numerical simulation and animal-model experiments has been performed to assess the ability of simulation to accurately calculate temperatures within living tissue during the recharge of a neuromodulation system (Restore Ultra device, Medtronic Neuromodulation, Minneapolis, MN, USA).
Materials and methods: The experiments were carried out on a sheep with the neuromodulation implant set to depths of 0.6 cm and 2.1 cm. Temperatures were recorded on the surfaces of the implant and on the sheep skin. Finite element simulations were carried out to determine the degree to which the simulations and experiments match. Additional calculations were performed for an intermediate implant depth.
Results: It was found that there was excellent agreement between the simulations and the animal model for both depths.
Conclusion: It is shown that numerical simulation using the Pennes bioheat equation is capable of predicting temperature increases within living tissues when implanted heat-generating devices are in use. The device used in the present study does not give rise to temperatures which cause concern of thermal injury or safety. The study was performed for aligned antenna and implant.
Keywords: Bio heating; chronic pain; implant; neurostimulation; safety.
© 2015 International Neuromodulation Society.