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机器人辅助与手动耳蜗植入电极阵列插入的比较分析。

Comparative Analysis of Robotics-Assisted and Manual Insertions of Cochlear Implant Electrode Arrays.

机构信息

Department of Otolaryngology-Head and Neck Surgery, University of Iowa.

iotaMotion, Inc., Iowa City, Iowa.

出版信息

Otol Neurotol. 2022 Dec 1;43(10):1155-1161. doi: 10.1097/MAO.0000000000003707. Epub 2022 Oct 6.

Abstract

HYPOTHESIS

Robotics-assisted cochlear implant (CI) insertions will result in reduced intracochlear trauma when compared with manual, across multiple users.

BACKGROUND

Whether intracochlear trauma and translocations are two factors that may contribute to significant variability in CI outcomes remains to be seen. To address this issue, we have developed a robotics-assisted insertion system designed to aid the surgeon in inserting electrode arrays with consistent speeds and reduced variability. This study evaluated the effect of robotics-assisted insertions on the intracochlear trauma as compared with manual insertions in cadaveric cochleae in a simulated operative environment.

METHODS

Twelve neurotologists performed bilateral electrode insertions into cochleae of full cadaveric heads using both the robotics-assisted system and manual hand insertion. Lateral wall electrodes from three different manufacturers (n = 24) were used and randomized between surgeons. Insertion angle of the electrode and trauma scoring were evaluated using high-resolution three-dimensional x-ray microscopy and compared between robotics-assisted and manual insertions.

RESULTS

Three-dimensional x-ray microscopy provided excellent resolution to characterize the in situ trauma and insertion angle. Robotics-assisted insertions significantly decreased insertional intracochlear trauma as measured by reduced trauma scores compared with manual insertions (average: 1.3 versus 2.2, device versus manual, respectively; p < 0.05). There was no significant difference between insertion angles observed for manual and robotics-assisted techniques (311 ± 131° versus 307 ± 96°, device versus manual, respectively).

CONCLUSIONS

Robotics-assisted insertion systems enable standardized electrode insertions across individual surgeons and experience levels. Clinical trials are necessary to investigate whether insertion techniques that reduce insertional variability and the likelihood of intracochlear trauma also improve CI auditory outcomes.

摘要

假设

与手动相比,在多个使用者中,机器人辅助的人工耳蜗植入(CI)插入将减少耳蜗内的创伤。

背景

耳蜗内创伤和移位是否是导致 CI 结果显著差异的两个因素仍有待观察。为了解决这个问题,我们开发了一种机器人辅助插入系统,旨在帮助外科医生以一致的速度和降低的可变性插入电极阵列。这项研究在模拟手术环境中评估了机器人辅助插入与手动插入相比对尸体耳蜗内创伤的影响。

方法

12 名神经耳科医生使用机器人辅助系统和手动插入双侧电极到全尸头的耳蜗中。使用了来自三个不同制造商的侧墙电极(n = 24),并在外科医生之间随机分配。使用高分辨率三维 X 射线显微镜评估电极插入角度和创伤评分,并在机器人辅助和手动插入之间进行比较。

结果

三维 X 射线显微镜提供了极好的分辨率,能够对原位创伤和插入角度进行特征描述。与手动插入相比,机器人辅助插入显著降低了插入性耳蜗内创伤,表现为创伤评分降低(平均:1.3 与 2.2,分别为器械与手动)(p < 0.05)。手动和机器人辅助技术观察到的插入角度之间没有显著差异(分别为 311 ± 131°与 307 ± 96°)。

结论

机器人辅助插入系统能够实现个体外科医生和经验水平之间的标准化电极插入。需要进行临床试验,以研究是否降低插入可变性和耳蜗内创伤可能性的插入技术也能改善 CI 听觉结果。

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