This work presents the design of a novel compliant steerable tip (CST) instrument to facilitate transcanal (or totally) endoscopic ear surgery (TEES). The evolution of the instrument's design is shown, where prototypes were evaluated by surgeons and their feedback was used to inform the design changes for the next prototype iteration. The final prototype enables the surgeon to articulate the compliant tip to achieve the desired bending curvature while automatically locking in place and providing dissection and suction capabilities. Pre-clinical validation testing was performed in goat and human cadaver models by two surgeons who successfully removed an allograft from the middle ear. Time and the number of blockages while suctioning saline in both cadaver models were measured and compared with current instruments used during TEES. The CST took significantly less time to suction saline within a flooded middle ear compared to the Panetti suction dissector (PSD) for atticus and underwent less blockages than the PSD for atticus, ear drum and sinus tympani instruments, Wilcoxon Method p < .05. Our study demonstrates the development and successful clinical evaluation of a minimally invasive surgical instrument designed to facilitate endoscopic approaches to the ear.
Keywords: Endoscopy; design iteration; device innovation; notched tube compliant wrist; user study.