Kilgore Kevin L, Peckham P Hunter, Keith Michael W, Montague Fred W, Hart Ronald L, Gazdik Martha M, Bryden Anne M, Snyder Scott A, Stage Thomas G
Department of Orthopaedics, MetroHealth Medical Center Cleveland, OH 44109, USA.
J Rehabil Res Dev. 2003 Nov-Dec;40(6):457-68. doi: 10.1682/jrrd.2003.11.0457.
Implanted neuroprosthetic systems have been successfully used to provide upper-limb function for over 16 years. A critical aspect of these implanted systems is the safety, stability, and-reliability of the stimulating electrodes and leads. These components are (1) the stimulating electrode itself, (2) the electrode lead, and (3) the lead-to-device connector. A failure in any of these components causes the direct loss of the capability to activate a muscle consistently, usually resulting in a decrement in the function provided by the neuroprosthesis. Our results indicate that the electrode, lead, and connector system are extremely durable. We analyzed 238 electrodes that have been implanted as part of an upper-limb neuroprosthesis. Each electrode had been implanted at least 3 years, with a maximum implantation time of over 16 years. Only three electrode-lead failures and one electrode infection occurred, for a survival rate of almost 99 percent. Electrode threshold measurements indicate that the electrode response is stable over time, with no evidence of electrode migration or continual encapsulation in any of the electrodes studied. These results have an impact on the design of implantable neuroprosthetic systems. The electrode-lead component of these systems should no longer be considered a weak technological link.
植入式神经假体系统已成功用于恢复上肢功能超过16年。这些植入系统的一个关键方面是刺激电极和导线的安全性、稳定性和可靠性。这些组件包括：（1）刺激电极本身；（2）电极导线；（3）导线与设备的连接器。这些组件中任何一个出现故障都会直接导致持续激活肌肉的能力丧失，通常会使神经假体提供的功能下降。我们的结果表明，电极、导线和连接器系统极其耐用。我们分析了作为上肢神经假体一部分植入的238个电极。每个电极植入时间至少3年，最长植入时间超过16年。仅发生了3次电极导线故障和1次电极感染，存活率近99%。电极阈值测量表明，电极反应随时间稳定，在所研究的任何电极中均无电极迁移或持续包裹的迹象。这些结果对植入式神经假体系统的设计有影响。这些系统的电极导线组件不应再被视为技术薄弱环节。
