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设计并验证了一款完全可植入的、慢性的、闭环神经调节设备,该设备具有并发感应和刺激功能。

Design and validation of a fully implantable, chronic, closed-loop neuromodulation device with concurrent sensing and stimulation.

机构信息

Medtronic Neuromodulation, Minneapolis, MN 55432, USA.

出版信息

IEEE Trans Neural Syst Rehabil Eng. 2012 Jul;20(4):410-21. doi: 10.1109/TNSRE.2012.2183617. Epub 2012 Jan 23.

Abstract

Chronically implantable, closed-loop neuromodulation devices with concurrent sensing and stimulation hold promise for better understanding the nervous system and improving therapies for neurological disease. Concurrent sensing and stimulation are needed to maximize usable neural data, minimize time delays for closed-loop actuation, and investigate the instantaneous response to stimulation. Current systems lack concurrent sensing and stimulation primarily because of stimulation interference to neural signals of interest. While careful design of high performance amplifiers has proved useful to reduce disturbances in the system, stimulation continues to contaminate neural sensing due to biological effects like tissue-electrode impedance mismatch and constraints on stimulation parameters needed to deliver therapy. In this work we describe systematic methods to mitigate the effect of stimulation through a combination of sensing hardware, stimulation parameter selection, and classification algorithms that counter residual stimulation disturbances. To validate these methods we implemented and tested a completely implantable system for over one year in a large animal model of epilepsy. The system proved capable of measuring and detecting seizure activity in the hippocampus both during and after stimulation. Furthermore, we demonstrate an embedded algorithm that actuates neural modulation in response to seizure detection during stimulation, validating the capability to detect bioelectrical markers in the presence of therapy and titrate it appropriately. The capability to detect neural states in the presence of stimulation and optimally titrate therapy is a key innovation required for generalizing closed-loop neural systems for multiple disease states.

摘要

具有同时感测和刺激功能的慢性可植入闭环神经调节设备有望更好地了解神经系统并改善神经疾病的治疗方法。需要同时感测和刺激以最大限度地利用可用的神经数据,最小化闭环致动的时间延迟,并研究对刺激的即时反应。当前的系统缺乏同时感测和刺激功能,主要是因为刺激会干扰感兴趣的神经信号。虽然精心设计高性能放大器已被证明有助于减少系统中的干扰,但由于组织-电极阻抗失配和为提供治疗所需的刺激参数的限制等生物学效应,刺激仍然会污染神经感测。在这项工作中,我们描述了通过结合感测硬件、刺激参数选择和分类算法来减轻刺激影响的系统方法,这些算法可以对抗残留的刺激干扰。为了验证这些方法,我们在癫痫的大动物模型中实施并测试了一个完全可植入的系统超过一年。该系统被证明能够在刺激期间和之后测量和检测海马体中的癫痫发作活动。此外,我们展示了一种嵌入式算法,该算法可以在刺激期间响应癫痫检测来致动神经调节,验证了在存在治疗的情况下检测生物电标记并适当调整治疗的能力。在刺激存在的情况下检测神经状态并优化治疗滴定的能力是将闭环神经系统推广到多种疾病状态的关键创新。

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