Abstract

The aim of this work is to design, fabricate and experimentally validate a miniature steerable digital endoscope that can provide comprehensive, high-resolution imaging of the middle ear using a trans-nasal approach. The motivation for this work comes from the high incidence of middle ear diseases, and the current reliance on invasive surgery to diagnose and survey these diseases which typically consists of the eardrum being lifted surgically to directly visualize the middle ear using a trans-canal approach. To enable less-invasive diagnosis and surveillance of middle ear disease, we propose an endoscope that is small enough to pass into the middle ear through the Eustachian tube, with a steerable tip that carries a 1 Megapixel image sensor and fiber-optic illumination to provide high-resolution visualization of critical middle ear structures. The proposed endoscope would enable physicians to diagnose middle ear disease using a non-surgical trans-nasal approach instead, enabling such procedures to be performed in an office setting and greatly reducing invasiveness for the patient. In this work, the computational design of the steerable tip based on computed tomography models of real human middle ear anatomy is presented, and these results informed the fabrication of a clinical-scale steerable endoscope prototype. The prototype was used in a pilot study in three cadaveric temporal bone specimens, where high-quality middle ear visualization was achieved as determined by an unbiased cohort of otolaryngologists. This is the first paper to demonstrate cadaveric validation of a digital, steerable, clinical-scale endoscope for middle ear disease diagnosis, and the experimental results illustrate that the endoscope enables the visualization of critical middle ear structures (such as the epitympanum or sinus tympani) that were seldom or never visualized in prior published trans-Eustachian tube endoscopy feasibility studies.