Abstract
PURPOSE: Automated insertion of electrode arrays (EA) in cochlear implant surgery is presumed to be less traumatic than manual insertions, but no tool is widely available in the operating room. We sought (1) to design and create a simple tool able to automate the EA insertion process; and (2) to perform preliminary evaluations of the designed prototype. METHODS: A first prototype of a tool with maximum simplicity was designed and fabricated to take advantage of hydraulic actuation. The prototype facilitates automated forward motion using a syringe connected to an infusion pump. Initial prototype evaluation included: (1) testing of forward motion at different velocities (2) EA insertion trials into an artificial cochlear model with force recordings, and (3) evaluation of device handling, fixation and positioning using cadaver head specimens and a surgical retractor. Alignment of the tool was explored with CT imaging. RESULTS: In this initial phase, the prototype demonstrated easy assembly and ability to respond to hydraulic actuation driven by an infusion pump at different velocities. EA insertions at an ultra-slow velocity of 0.03 mm/s revealed smooth force profiles with mean maximum force of 0.060 N ± 0.007 N. Device positioning with an appropriate insertion axis into the cochlea was deemed feasible and easy to achieve. CONCLUSIONS: Initial testing of our hydraulic insertion tool did not reveal any serious complications that contradict the initially defined design specifications. Further meticulous testing is needed to determine the safety of the device, its reliability and clinical applicability.