Novel Design and Validation of a Micro Instrument in an Ear Grommet Insertion Device

An automated surgical device, the ventilator tube applicator (VTA), enables a grommet insertion surgery for patients with otitis media with effusion (OME) to be completed in a short time automatically and precisely, eliminating the use of general anesthesia (GA) typically required in such procedure. However, its current design limits the usefulness of the device as it is restricted by the properties of the tympanic membrane (TM), such as angle, thickness, and strength. Therefore, a novel design was conceptualized and the insertion control algorithm was improved to overcome the current challenges of the VTA. This innovative cover-cutter instrument design allows three-dimensional (3D) motion on an oblique surface using a single axis actuator. Experimental results on mock membranes showed great improvements in terms of robustness and success rate. The new design allowed the procedure to be performed on wider range of TM angles and hence increased the effectiveness of VTA. Grommet insertion force was reduced by an average of 66%, and the overall peak force reduced by an average of 14%. Finite element (FE) analysis on a cadaveric TM model further validated the usefulness of the cover-cutter instrument, and showed some interesting insights in the grommet insertion process.