Design of a Surgical Device for Office-Based Myringotomy and Grommet Insertion for Patients With Otitis Media With Effusion

Abstract

Otitis media with effusion (OME) is a very common ear disease occurring in adults and children alike when the middle ear is infected or the eustachian tube becomes dysfunctional, resulting in accumulation of fluid in the middle ear space. When medication as the first treatment fails, a grommet is commonly surgically inserted on the tympanic membrane (TM) of the patient to discharge the fluid. In this paper, a novel “all-in-one” device allowing office-based grommet insertion in an awake patient with OME is proposed, designed, fabricated, and tested. It utilizes a highly integrated structure encompassing key components of a mechanical system, a sensing system and a motion control system, all are synergized to enable the surgery to be completed in a short time automatically, precisely, effectively, and safely. The experimental results obtained with the device working on a mock membrane with characteristics representative of the TM are duly furnished, showing a success rate of up to 98%.