Titanium bridge modification for type 2 thyroplasty to improve device mechanical & safety performance
Titanium bridge modification for type 2 thyroplasty to improve device mechanical & safety performance
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用于 2 型甲状成形术的钛桥改良以改善装置机械性能
DOI：
10.1016/j.anl.2021.10.011
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发表时间：
2022
影响因子：
1.7
通讯作者：
Fukushima Masanori
中科院分区：
文献类型：
--
作者：
Sanuki Tetsuji;Nishimura Tsutomu;Aburada Takako;Fukushima Masanori
钛桥用于在2型甲状腺成形术治疗内收肌痉挛性发音困难期间分离甲状腺翼。翻修手术意外表明，在某些情况下，桥翼失效发生在内侧孔区域。本研究调查的速度和设备故障的原因，并开发了一种改进的device.MethodsWe进行了问卷调查，以确定在日本进行手术的数量，到2014年底，并获得有关修订的情况下的信息。此外，通过使用扫描电子显微镜（SEM）对恢复的钛桥的断裂表面进行损伤分析。结果在2002年至2014年期间，385例患者使用钛桥。19例进行了翻修手术。翻修手术显示，在11例病例中，内侧孔区域的器械翼发生断裂。然而，这种骨折与任何复发迹象或任何不良事件无关。断裂表面的SEM分析证实，疲劳断裂是由内侧孔区域的反复弯曲应力引起的。根据这些结果，孔的形状从圆形变成椭圆形，翼厚度增加，以防止breaks.ConclusionsThe翼钛桥可能会打破没有任何相关的迹象，症状或组织损伤。根据检测到的故障和故障后恢复的器械分析，对钛桥的商业开发质量标准进行了变更。
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.