Shape‐Memory Stapes Prosthesis for Otosclerosis Surgery

Abstract

The aim of this study was to determine the efficacy of a shape-memory alloy, Nitinol, as a component of an improved stapes prosthesis. Prospective laboratory and clinical study to develop a Nitinol stapes prosthesis. Various diameters of Nitinol wire and temperature transition variants were analyzed with regard to ease of deformation, response to heating, and strength. The size and geometry of the closed hook was determined by measurement of 50 incus cadaver bones. Several heat sources for activating the shape memory were evaluated, including electrocautery, lasers, and warm water. Trial surgeries were then performed on human temporal bones in the laboratory. The closure characteristics of the Nitinol loop were studied. Magnetic resonance imaging (MRI) testing at 1.5 Tesla was performed to determine safety during MRI studies. Preliminary human subject trials were then instituted. In all cases, a low heat condition was ample to activate the shape memory characteristics of the hook and return it to a closed position after it had been opened. Laser power was generally set well below the power needed for removing bone. The Nitinol loop closed snugly around the incus with application to the top of the hook with a low temperature laser setting. Almost any heat source was effective. MRI testing at 1.5 Tesla showed no movement of the prosthesis. Preliminary results in human subjects showed excellent air-bone closure. The Nitinol loop holds uniform contact around the incus. The Nitinol piston greatly simplifies the stapedectomy procedure by taking the need for a hand operated instrument out of the surgeon's hands. Because of the nature of the Nitinol wire, it can never over-crimp. All these characteristics make the prosthesis advantageous for otosclerosis surgery.