Titanium bridge modification for type 2 thyroplasty to improve device mechanical & safety performance

Abstract

ObjectiveTitanium bridges are used to separate the thyroid ala during type 2 thyroplasty for adductor spasmodic dysphonia. Revision surgeries have adventitiously indicated that bridge wing failure occurs in the area of the medial hole in some cases. This study investigated the rate and cause of device malfunctions and developed an improved device. MethodsWe conducted a questionnaire survey to determine the number of surgeries performed in Japan up to the end of 2014, and to obtain information about revision cases. In addition, damage analyses were performed on the fracture surfaces of recovered titanium bridges through use of scanning electron microscopy (SEM). ResultsBetween 2002 and 2014, titanium bridges were used in 385 patients. Revision surgery was performed in 19 cases. Revision surgeries revealed that in 11 cases breakage occurred in the wings of the device in the region of the medial hole. However, such fractures were not associated with any signs of recurrence or any adverse events. SEM analyses of fracture surfaces confirmed that fatigue fractures were caused by repeated bending stress in the area of the medial hole. Based on these results, the shape of the hole was changed from round to oval and the wing thickness was increased to prevent breakage. ConclusionsThe wings of titanium bridges may break without any associated signs, symptoms or tissue damage. Based on the malfunctions detected and analyses of the devices recovered following malfunction, changes to the specification were made for commercial development of the titanium bridge.