Webb R L, Clark G M, Shepherd R K, Franz B K, Pyman B C
Department of Otolaryngology, University of Melbourne, Victoria, Australia.
Am J Otol. 1988 Jan;9(1):8-13.
Studies have been undertaken to confirm the biologic safety of the Cochlear Corporation multi-electrode intracochlear implant. The materials used are biocompatible. The electrode array is flexible: it can be inserted with minimal or no trauma, providing the insertion is stopped when resistance is first felt. An atraumatic insertion is facilitated if a good view is obtained along the scala tympani of the basal turn of the cochlea by drilling through the crista fenestrae. The passage of the electrode around the cochlea can be facilitated if the electrode is rotated during insertion (clockwise for the left and anticlockwise for the right cochlea). The electrode can be explanted and another one reinserted with minimal or no trauma. A seal established around the electrode after an implantation period of 2 weeks can prevent infection extending from the middle to the inner ear. The electrical stimulus parameters produced by the Nucleus receiver-stimulator cause no loss of spiral ganglion cells or corrosion of the platinum band electrodes. Long-term stimulation has been carried out for up to 8 years in patients without affecting their clinical performance.
已开展多项研究以证实科利耳公司多电极人工耳蜗的生物安全性。所使用的材料具有生物相容性。电极阵列具有柔韧性：插入时创伤极小或无创伤，前提是首次感觉到阻力时即停止插入。如果通过钻穿圆窗嵴，能沿耳蜗底转的鼓阶获得良好视野，则有助于实现无创伤插入。如果在插入过程中旋转电极（左耳顺时针，右耳逆时针），电极环绕耳蜗的过程会更顺利。电极可以取出，再插入另一根电极，创伤极小或无创伤。植入2周后在电极周围形成的密封可防止感染从中耳蔓延至内耳。Nucleus接收器刺激器产生的电刺激参数不会导致螺旋神经节细胞损失或铂带电极腐蚀。已对患者进行了长达8年的长期刺激，且未影响其临床表现。
