PurposeThe significance of atraumatic electrode array (EA) insertion in cochlear implant (CI) surgery is widely acknowledged, with consensus that forces due to EA insertion are directly correlated with insertion trauma. Unfortunately, the manual perception of these forces through haptic feedback is inherently limited, and techniques for in vivo force measurements to monitor the insertion are not yet available. Addressing this gap, we developed of a force-sensitive insertion tool capable of capturing real-time insertion forces during standard CI surgery.MethodsThis paper describes the tool and its pioneering application in a clinical setting and reports initial findings from an ongoing clinical study. Data and experiences from five patients have been evaluated so far, including force profiles of four patients.ResultsThe initial intraoperative experiences are promising, with successful integration into the conventional workflow. Feasibility of in vivo insertion force measurement and practicability of the tool’s intraoperative use could be demonstrated. The recorded in vivo insertion forces show the expected rise with increasing insertion depth. Forces at the end of insertion range from 17.2 mN to 43.6 mN, while maximal peak forces were observed in the range from 44.8 mN to 102.4 mN.ConclusionWe hypothesize that this novel method holds the potential to assist surgeons in monitoring the insertion forces and, thus, minimizing insertion trauma and ensuring better preservation of residual hearing. Future data recording with this tool can form the basis of ongoing research into the causes of insertion trauma, paving the way for new and improved prevention strategies.

中文翻译：

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首次临床实施人工耳蜗植入手术中的插入力测量

目的无创伤电极阵列 (EA) 插入在人工耳蜗植入 (CI) 手术中的重要性已得到广泛认可，一致认为 EA 插入产生的力与插入创伤直接相关。不幸的是，通过触觉反馈对这些力的手动感知本质上是有限的，并且技术体内目前尚无法通过力测量来监测插入情况。为了解决这一差距，我们开发了一种力敏感插入工具，能够在标准 CI 手术期间捕获实时插入力。方法本文描述了该工具及其在临床环境中的开创性应用，并报告了正在进行的临床研究的初步结果。到目前为止，已经对五名患者的数据和经验进行了评估，其中包括四名患者的受力情况。结果最初的术中体验非常有希望，成功地融入了传统工作流程。可行性体内可以证明插入力测量和工具术中使用的实用性。所记录的体内插入力显示出随着插入深度的增加而预期的增加。插入结束时的力范围为 17.2 mN 至 43.6 mN，而观察到的最大峰值力范围为 44.8 mN 至 102.4 mN。结论我们假设这种新方法有可能帮助外科医生监测插入力，因此，最大限度地减少插入创伤并确保更好地保留残余听力。未来使用该工具记录的数据可以构成正在进行的插入创伤原因研究的基础，为新的和改进的预防策略铺平道路。