Robotic middle ear access for cochlear implantation: First in man
Robotic middle ear access for cochlear implantation: First in man
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DOI：
10.1371/journal.pone.0220543
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发表时间：
2019-08-02
期刊：
影响因子：
3.7
通讯作者：
Weber, Stefan
中科院分区：
文献类型：
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作者：
Caversaccio, Marco;Wimmer, Wilhelm;Weber, Stefan
为了证明机器人中耳入路在临床环境中的可行性，本临床试验纳入了9例患有重度至极重度听力损失且需要人工耳蜗植入的成人患者。根据术前获取的计算机断层扫描图像数据，计划了一个通往鼓膜腔并瞄准圆窗的锁孔通道，并通过机器人钻孔至面神经窝的水平。进行术中成像，以确认钻孔轨迹与相关解剖结构的距离足够。机器人继续向圆窗钻孔。耳蜗通路由外科医生手动创建。电极阵列通过锁孔隧道插入显微镜监督下，通过鼓膜瓣。所有患者均成功植入人工耳蜗。在9/9例患者中，计划并执行机器人钻孔至面神经隐窝水平。出于安全性原因，3例患者的手术恢复为传统方法。与基线测量值相比，未观察到面神经功能的变化。机器人锁孔入路人工耳蜗植入术是可行的。需要进一步改进工作流程的复杂性、手术持续时间和可用性（包括安全性评估），以便更广泛地采用该手术。
To demonstrate the feasibility of robotic middle ear access in a clinical setting, nine adult patients with severe-to-profound hearing loss indicated for cochlear implantation were included in this clinical trial. A keyhole access tunnel to the tympanic cavity and targeting the round window was planned based on preoperatively acquired computed tomography image data and robotically drilled to the level of the facial recess. Intraoperative imaging was performed to confirm sufficient distance of the drilling trajectory to relevant anatomy. Robotic drilling continued toward the round window. The cochlear access was manually created by the surgeon. Electrode arrays were inserted through the keyhole tunnel under microscopic supervision via a tympanomeatal flap. All patients were successfully implanted with a cochlear implant. In 9 of 9 patients the robotic drilling was planned and performed to the level of the facial recess. In 3 patients, the procedure was reverted to a conventional approach for safety reasons. No change in facial nerve function compared to baseline measurements was observed. Robotic keyhole access for cochlear implantation is feasible. Further improvements to workflow complexity, duration of surgery, and usability including safety assessments are required to enable wider adoption of the procedure.