Development and Implantation of a Minimally Invasive Wireless Subretinal Neurostimulator

Development and Implantation of a Minimally Invasive Wireless Subretinal Neurostimulator
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DOI:
10.1109/tbme.2009.2021401
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发表时间:
2009-10-01
影响因子:
4.6
通讯作者:
Rizzo, Joseph F.
Rizzo, Joseph F.
中科院分区:
工程技术2区
文献类型:
--
作者:
Shire, Douglas B.;Kelly, Shawn K.;Rizzo, Joseph F.

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一种无线操作的微创视网膜假体用于尤卡坦迷你猪模型的临床前慢性植入研究。植入物符合眼睛的外壁,并驱动带有溅射氧化铱电极的微制造聚酰亚胺刺激电极阵列。该阵列通过一种特殊设计的体外手术技术植入视网膜下空间,将假体的大部分固定在巩膜的外表面。所述植入装置是在宿主聚酰亚胺柔性电路上制造的。它由一个15通道刺激芯片、二次电源和数据接收线圈以及分立电源组件组成。除了参比/对电极和薄电极阵列外,完成的装置被封装在聚(二甲基硅氧烷)中。使用定制的射频发射电路和初级线圈进行了体外测试,以验证系统在生物盐水中的性能。刺激模式、脉冲强度、持续时间和频率通过定制软件和图形用户界面进行无线编程。视网膜植入物的无线操作已经在三只猪身上进行了七个多月的体外和体内验证,后者是通过使用隐形眼镜电极测量眼表面的刺激伪影。
A wirelessly operated, minimally invasive retinal prosthesis was developed for preclinical chronic implantation studies in Yucatan minipig models. The implant conforms to the outer wall of the eye and drives a microfabricated polyimide stimulating electrode array with sputtered iridium oxide electrodes. This array is implanted in the subretinal space using a specially designed ab externo surgical technique that fixes the bulk of the prosthesis to the outer surface of the sclera. The implanted device is fabricated on a host polyimide flexible circuit. It consists of a 15-channel stimulator chip, secondary power and data receiving coils, and discrete power supply components. The completed device is encapsulated in poly(dimethylsiloxane) except for the reference/counter electrode and the thin electrode array. In vitro testing was performed to verify the performance of the system in biological saline using a custom RF transmitter circuit and primary coils. Stimulation patterns as well as pulse strength, duration, and frequency were programmed wirelessly using custom software and a graphical user interface. Wireless operation of the retinal implant has been verified both in vitro and in vivo in three pigs for more than seven months, the latter by measuring stimulus artifacts on the eye surface using contact lens electrodes.