Objective. Micro-fabricated neural interfaces based on polyimide (PI) are achieving increasing importance in translational research. The ability to produce well-defined micro-structures with properties that include chemical inertness, mechanical flexibility and low water uptake are key advantages for these devices. Approach. This paper reports the development of the transverse intrafascicular multichannel electrode (TIME) used to deliver intraneural sensory feedback to an upper-limb amputee in combination with a sensorized hand prosthesis. A failure mode analysis on the explanted devices was performed after a first-in-human study limited to 30 d. Main results. About 90% of the stimulation contact sites of the TIMEs maintained electrical functionality and stability during the full implant period. However, optical analysis post-explantation revealed that 62.5% of the stimulation contacts showed signs of delamination at the metallization-PI interface. Such dam...

中文翻译：

---

柔性薄膜金属化刺激电极的稳定性：首次人体研究后的外植体分析和体内性能的改善。

目的。基于聚酰亚胺（PI）的微型神经接口在翻译研究中正变得越来越重要。这些设备具有产生具有化学惰性，机械柔韧性和低吸水率等特性的轮廓分明的微结构的能力。方法。本文报道了束状横肌内多通道电极（TIME）的发展，该电极用于将神经内感觉反馈与带感觉的手部假体相结合，传递至上肢截肢者。在首次人体研究限于30 d后，对植入的器械进行了失效模式分析。主要结果。在整个植入期间，约90％的TIME刺激接触部位保持电功能和稳定性。然而，植入后的光学分析表明，62.5％的刺激触点在金属化-PI界面处显示分层迹象。这样的水坝