Abstract
Neural electrodes are widely used in brain-computer interfaces and neuroprosthesis for the treatment of various neurological disorders. However, as components that come into direct contact with neural tissue, implanted neural electrodes could cause mechanical damage during surgical insertions or while inside the brain. Thus, accurately and timely assessing this damage was vital for chronic implantation, which posed a significant challenge. This study aimed to evaluate the biomechanical effects and clinical application risks of a polyimide-based ultrathin flexible intracortical microelectrode through the finite element method (FEM). It analyzed the electrode-brain biomechanical effects during the electrode's insertion process and under steady-state acceleration with the electrode inside the brain. Furthermore, the study examined the impact of factors including implantation depth (ranging from 5 to 5000 μm), cortical thickness (0.5 mm, 2.5 mm, and 4.5 mm), step displacement (from 1 to 5 μm) during insertion, and acceleration direction (vertical and horizontal) on the electrode's biomechanical effects. The primary findings showed that the 98th percentile Von Mises Strain (ε(98)) and Von Mises Stress (σ(98)) in the region of interest (ROI) decreased dual-exponentially with increasing implantation depth and increased linearly with larger step displacements. Compared to the Von Mises strain threshold of 14.65%, as proposed by Sahoo et al., indicating a 50% risk of diffuse axonal injury (DAI), it was recommended to limit the initial step displacement during insertion to 1 μm, increasing to 5 μm at deeper locations (over 500 μm) to balance safety and efficiency. Additionally, it was found that cortical thickness had a negligible impact during insertion and while experiencing steady-state acceleration in vivo, with the three fitted curves almost coinciding when cortical thicknesses were 0.5 mm, 2.5 mm, and 4.5 mm. The flexible electrode exhibited excellent mechanical performance under steady-state acceleration in vivo, with ε(98) being less than 0.3% and σ(98) being less than 50 Pa, although it was more sensitive to horizontal acceleration. Thus, it could be concluded that during long-duration accelerations from transportation modes such as elevators and high-speed trains, the electrode's mechanical effects on brain tissue could be neglected, demonstrating long-term mechanical stability. This research was significant for guiding surgical insertion and clinical applications of flexible electrodes.