OBJECTIVES: The aim of this study was to determine the efficacy of a shape-memory alloy, @entity5648 , as a component of an improved stapes prosthesis. STUDY DESIGN: Prospective laboratory and clinical study to develop a @entity5648 stapes prosthesis. METHODS: Various diameters of @entity5648 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 @entity1 temporal bones in the laboratory. The closure characteristics of the @entity5648 loop were studied. Magnetic resonance imaging (MRI) testing at 1.5 Tesla was performed to determine safety during MRI studies. Preliminary @entity1 subject trials were then instituted. RESULTS: In all cases, a @entity258 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 @entity5648 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 @entity1 subjects showed excellent air-bone closure. The @entity5648 loop holds uniform contact around the incus. CONCLUSIONS: The @entity5648 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 @entity5648 wire, it can never over-crimp. All these characteristics make the prosthesis advantageous for @entity8719 surgery.

Shape-memory stapes prosthesis for XXXX surgery.

@entity1 :: ('9606', 'Species') :: ['human'] @entity258 :: ('MESH:D009800', 'Disease') :: ['low heat condition'] @entity8719 :: ('MESH:D010040', 'Disease') :: ['otosclerosis'] @entity5648 :: ('MESH:C013616', 'Chemical') :: ['Nitinol']
@entity8719 :: (MESH:D010040,Disease) :: ['otosclerosis']
