Abstract
PurposeAutomated 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.MethodsA 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.ResultsIn 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.ConclusionsInitial 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.
Highlights
A cochlear implant (CI) is a neuroprosthesis containing an electrode array (EA), which is implanted or introduced into the human inner ear to electrically stimulate the auditory nerve for auditory rehabilitation of patients with severe to profound sensorineural hearing loss
Prevention of intracochlear trauma became a dominant topic in cochlear implantation surgery since the 1990s
Reliable prevention of intracochlear trauma remains a clinical challenge, as the damage resulting from the EA insertion process is influenced by multiple, interdependent factors that are difficult to control
Summary
A cochlear implant (CI) is a neuroprosthesis containing an electrode array (EA), which is implanted or introduced into the human inner ear (cochlea) to electrically stimulate the auditory nerve for auditory rehabilitation of patients with severe to profound sensorineural hearing loss. Inserting the “foreign body” into the intracochlear biological environment may cause injuries to the delicate. Motivated by these findings, prevention of intracochlear trauma became a dominant topic in cochlear implantation surgery since the 1990s. In order to reduce intracochlear trauma and improve hearing outcomes, Lehnhardt introduced the concept of the “soft surgery technique” already in 1993 [8]. Reliable prevention of intracochlear trauma remains a clinical challenge, as the damage resulting from the EA insertion process is influenced by multiple, interdependent factors that are difficult to control. Their direct effect on trauma and functional
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