Riojas Katherine E, Tran Emily T, Freeman Michael H, Noble Jack H, Webster Robert J, Labadie Robert F
Department of Mechanical Engineering, Vanderbilt University, Nashville, TN 37212.
Department of Mechanical Engineering, The University of Tulsa, Tulsa, OK 74104.
J Med Device. 2021 Sep 1;15(3):031001. doi: 10.1115/1.4050203. Epub 2021 Apr 2.
The objective of this paper is to describe the development of a minimally invasive cochlear implant surgery (MICIS) electrode array insertion tool concept to enable clinical translation. First, analysis of the geometric parameters of potential MICIS patients (N = 97) was performed to inform tool design, inform MICIS phantom model design, and provide further insight into MICIS candidacy. Design changes were made to the insertion tool based on clinical requirements and parameter analysis results. A MICIS phantom testing model was built to evaluate insertion force profiles in a clinically realistic manner, and the new tool design was evaluated in the model and in cadavers to test clinical viability. Finally, after regulatory approval, the tool was used for the first time in a clinical case. Results of this work included first, in the parameter analysis, approximately 20% of the population was not considered viable MICIS candidates. Additionally, one 3D printed tool could accommodate all viable candidates with polyimide sheath length adjustments accounting for interpatient variation. The insertion tool design was miniaturized out of clinical necessity and a disassembly method, necessary for removal around the cochlear implant, was developed and tested. Phantom model testing revealed that the force profile of the insertion tool was similar to that of traditional forceps insertion. Cadaver testing demonstrated that all clinical requirements (including complete disassembly) were achieved with the tool, and the new tool enabled 15% deeper insertions compared to the forceps approach. Finally, and most importantly, the tool helped achieve a full insertion in its first MICIS clinical case. In conclusion, the new insertion tool provides a clinically viable solution to one of the most difficult aspects of MICIS.
本文的目的是描述一种微创人工耳蜗植入手术（MICIS）电极阵列插入工具概念的发展，以实现临床转化。首先，对潜在的MICIS患者（N = 97）的几何参数进行分析，为工具设计提供信息，为MICIS体模模型设计提供信息，并进一步深入了解MICIS的候选资格。根据临床要求和参数分析结果对插入工具进行了设计更改。建立了一个MICIS体模测试模型，以临床现实的方式评估插入力曲线，并在该模型和尸体中对新的工具设计进行评估，以测试临床可行性。最后，在获得监管批准后，该工具首次用于临床病例。这项工作的结果包括，首先，在参数分析中，约20%的人群不被认为是可行的MICIS候选者。此外，一个3D打印工具可以通过调整聚酰亚胺护套长度来适应所有可行的候选者，以考虑患者之间的差异。出于临床需要，插入工具的设计被小型化，并开发和测试了一种用于在人工耳蜗周围进行拆卸的必要拆卸方法。体模模型测试表明，插入工具的力曲线与传统镊子插入的力曲线相似。尸体测试表明，该工具满足了所有临床要求（包括完全拆卸），并且与镊子方法相比，新工具能够多插入15%的深度。最后，也是最重要的，该工具在其首例MICIS临床病例中帮助实现了完全插入。总之，新的插入工具为MICIS最困难的方面之一提供了一种临床可行的解决方案。
