For cochlear implants (CI) a final position of the electrode array (EA) along the inner wall of the spirally shaped cochlea is considered to be beneficial because it results in a closer proximity to the auditory nerve fibers. A shape memory effect (SME) could facilitate such shift of the EA toward the cochlear inner wall, but its implementation remains to be solved. The current study presents an EA prototype featuring the SME with minute adjustments of the material properties of Nitinol, a shape memory alloy, in combination with a suitable cooling strategy to prevent premature curling. Ten samples were successfully inserted by a CI surgeon into an artificial cochlear model submerged into a temperature-controllable water bath to simulate temporary hypothermia of the inner ear (31°C). Gentle insertions were possible, with an average insertion speed of 0.81 ± 0.14 mm/s. After recovery of body temperature, the desired position shift toward the modiolus was observed in all trials. Angular insertion depth increased by approximately 81.8° ± 23.4°. We demonstrate for the first time that using the body temperature responsive SME for perimodiolar EA positioning is feasible and does not impede a gentle surgical insertion.
Keywords: austenite finish temperature; modiolus hugging electrode; nickel titanium alloy; nitinol; shape memory alloy; smart material; transformation temperature range.
© 2022 The Authors. Journal of Biomedical Materials Research Part B: Applied Biomaterials published by Wiley Periodicals LLC.