Mechanical fatigue resistance of an implantable branched lead system for a distributed set of longitudinal intrafascicular electrodes.

Mechanical fatigue resistance of an implantable branched lead system for a distributed set of longitudinal intrafascicular electrodes.
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DOI:
10.1088/1741-2552/aa814d
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发表时间:
2017-12
影响因子:
4
通讯作者:
Jung R
Jung R
中科院分区:
工程技术2区
文献类型:
--
作者:
Pena AE;Kuntaegowdanahalli SS;Abbas JJ;Patrick J;Horch KW;Jung R

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已经开发出一种神经接口系统,该系统由植入式刺激器/记录器组成,该刺激器/记录器带有 15 根电极引线,该引线分为三束,每束 5 个单独的纵向束内电极。这项工作评估了分支引线和分布式电极系统在模拟植入人体上臂后观察到的预期应变分布的条件下的机械疲劳抗力。开发了定制测试设置和程序,以在引线和电极系统上的四个关键应力集中点施加线性或角应变。每次测试都是在高重复/低幅度范式下进行的,该范式旨在测试步行等活动期间手臂运动对导联的影响,或者在低重复/高幅度范式下进行评估,该范式旨在测试更剧烈的上臂活动的影响。这些测试是在供人类使用的植入式导线系统的代表性样品上进行的。这些样本的制作程序与人类使用的植入物生产过程中使用的程序相同。在测试程序之前和之后对所有测试样本进行电气和目视检查,以评估引线完整性。在施加重复应变之前和之后获得的测量结果表明,所有测试样本都保持了电气连续性,并且电阻抗仍然远低于预先指定的断裂检测阈值。在放大 10 倍的显微镜下进行目视检查,未发现应力集中点处的电线或硅胶护套有任何损坏迹象。这些结果表明,该植入式神经接口系统的分支引线具有足够的机械疲劳抗力,能够承受系统植入手臂时预期的应变分布。新颖的测试设置和范例可能有助于测试其他主导系统。
A neural interface system has been developed that consists of an implantable stimulator/recorder can with a 15-electrode lead that trifurcates into three bundles of five individual wire longitudinal intrafascicular electrodes. This work evaluated the mechanical fatigue resistance of the branched lead and distributed electrode system under conditions designed to mimic anticipated strain profiles that would be observed after implantation in the human upper arm. Custom test setups and procedures were developed to apply linear or angular strain at four critical stress riser points on the lead and electrode system. Each test was performed to evaluate fatigue under a high repetition/low amplitude paradigm designed to test the effects of arm movement on the leads during activities such as walking, or under a low repetition/high amplitude paradigm designed to test the effects of more strenuous upper arm activities. The tests were performed on representative samples of the implantable lead system for human use. The specimens were fabricated using procedures equivalent to those that will be used during production of human-use implants. Electrical and visual inspections of all test specimens were performed before and after the testing procedures to assess lead integrity. Measurements obtained before and after applying repetitive strain indicated that all test specimens retained electrical continuity and that electrical impedance remained well below pre-specified thresholds for detection of breakage. Visual inspection under a microscope at 10X magnification did not reveal any signs of damage to the wires or silicone sheathing at the stress riser points. These results demonstrate that the branched lead of this implantable neural interface system has sufficient mechanical fatigue resistance to withstand strain profiles anticipated when the system is implanted in an arm. The novel test setups and paradigms may be useful in testing other lead systems.
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