Thermal safety considerations for implantable micro-coil design.

Abstract

Micro magnetic stimulation of the brain via implantable micro-coils is a promising novel technology for neuromodulation. Careful consideration of the thermodynamic profile of such devices is necessary for effective and safe designs.Objective.We seek to quantify the thermal profile of bent wire micro-coils in order to understand and mitigate thermal impacts of micro-coil stimulation.Approach. In this study, we use fine wire thermocouples and COMSOL finite element modeling to examine the profile of the thermal gradients generated near bent wire micro-coils submerged in a water bath during stimulation. We tested a range of stimulation parameters previously reported in the literature such as voltage amplitude, stimulus frequency, stimulus repetition rate and coil wire materials.Main results. We found temperature increases ranging from <1 °C to 8.4 °C depending upon the stimulation parameters tested and coil wire materials used. Numerical modeling of the thermodynamics identified hot spots of the highest temperatures along the micro-coil contributing to the thermal gradients and demonstrated that these thermal gradients can be mitigated by the choice of wire conductor material and construction geometry.Significance. ISO standard 14708-1 designates a thermal safety limit of 2 °C temperature increase for active implantable medical devices. By switching the coil wire material from platinum/iridium to gold, our study achieved a 5-6-fold decrease in the thermal impact of coil stimulation. The thermal gradients generated from the gold wire coil were measured below the 2 °C safety limit for all stimulation parameters tested.