Assessing the manufacturable 32-channel cochlear electrode array: evaluation results for clinical trials

IF 3 4区医学 Q3 ENGINEERING, BIOMEDICAL

Biomedical Microdevices Pub Date : 2023-10-23 DOI:10.1007/s10544-023-00681-z

Gwangjin Choi, Yoonhee Ha, Doo-Hee Kim, Soowon Shin, Junewoo Hyun, Sangwoo Kim, Seung-Ha Oh, Kyou-Sik Min

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Abstract

Reliability evaluation results of a manufacturable 32-channel cochlear electrode array are reported in this paper. Applying automated laser micro-machining process and a layer-by-layer silicone deposition scheme, authors developed the manufacturing methods of the electrode array for fine patterning and mass production. The developed electrode array has been verified through the requirements specified by the ISO Standard 14708-7. And the insertion trauma of the electrode array has been evaluated based on human temporal bone studies. According to the specified requirements, the electrode array was assessed through elongation & insulation, flexural, and fatigue tests. In addition, Temporal bone study was performed using eight fresh-frozen cadaver temporal bones with the electrode arrays inserted via the round window. Following soaking in saline condition, the impedances between conducting wires of the electrode array were measured over 100 kΩ (the pass/fail criterion). After each required test, it was shown that the electrode array maintained the electrical continuity and insulation condition. The average insertion angle of the electrode array inside the scala tympani was 399.7°. The human temporal bone studies exhibited atraumatic insertion rate of 60.3% (grade 0 or 1). The reliability of the manufacturable electrode array is successfully verified in mechanical, electrical, and histological aspects. Following the completion of a 32-channel cochlear implant system, the performance and stability of the 32-channel electrode array will be evaluated in clinical trials.

Graphical abstract

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评估可制造的32通道耳蜗电极阵列：临床试验的评估结果。

本文报道了一种可制造的32通道耳蜗电极阵列的可靠性评估结果。作者应用自动激光微细加工工艺和逐层硅树脂沉积方案，开发了用于精细图案化和大规模生产的电极阵列的制造方法。开发的电极阵列已通过ISO标准14708-7规定的要求进行了验证。基于对人体颞骨的研究，对电极阵列的插入创伤进行了评估。根据规定的要求，通过伸长和绝缘、弯曲和疲劳测试对电极阵列进行评估。此外，还使用8具新鲜冷冻的尸体颞骨进行了颞骨研究，电极阵列通过圆窗插入。在盐水条件下浸泡后，测量电极阵列导线之间的阻抗超过100 kΩ（通过/失败标准）。在每次要求的测试之后，表明电极阵列保持了电连续性和绝缘条件。电极阵列在鼓阶内的平均插入角为399.7°。人类颞骨研究显示无损伤插入率为60.3%（0或1级）。可制造电极阵列的可靠性在机械、电气和组织学方面得到了成功验证。32通道耳蜗植入系统完成后，将在临床试验中评估32通道电极阵列的性能和稳定性。

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来源期刊

Biomedical Microdevices 工程技术-工程：生物医学

CiteScore

6.90

自引率

3.60%

发文量

审稿时长

6 months

期刊介绍： Biomedical Microdevices: BioMEMS and Biomedical Nanotechnology is an interdisciplinary periodical devoted to all aspects of research in the medical diagnostic and therapeutic applications of Micro-Electro-Mechanical Systems (BioMEMS) and nanotechnology for medicine and biology. General subjects of interest include the design, characterization, testing, modeling and clinical validation of microfabricated systems, and their integration on-chip and in larger functional units. The specific interests of the Journal include systems for neural stimulation and recording, bioseparation technologies such as nanofilters and electrophoretic equipment, miniaturized analytic and DNA identification systems, biosensors, and micro/nanotechnologies for cell and tissue research, tissue engineering, cell transplantation, and the controlled release of drugs and biological molecules. Contributions reporting on fundamental and applied investigations of the material science, biochemistry, and physics of biomedical microdevices and nanotechnology are encouraged. A non-exhaustive list of fields of interest includes: nanoparticle synthesis, characterization, and validation of therapeutic or imaging efficacy in animal models; biocompatibility; biochemical modification of microfabricated devices, with reference to non-specific protein adsorption, and the active immobilization and patterning of proteins on micro/nanofabricated surfaces; the dynamics of fluids in micro-and-nano-fabricated channels; the electromechanical and structural response of micro/nanofabricated systems; the interactions of microdevices with cells and tissues, including biocompatibility and biodegradation studies; variations in the characteristics of the systems as a function of the micro/nanofabrication parameters.