Center for Innovative Visual Rehabilitation, VA Boston Healthcare System, Boston, MA 02130, USA.
IEEE Trans Biomed Eng. 2011 Nov;58(11):3197-205. doi: 10.1109/TBME.2011.2165713. Epub 2011 Aug 22.
A miniaturized, hermetically encased, wirelessly operated retinal prosthesis has been developed for preclinical studies in the Yucatan minipig, and includes several design improvements over our previously reported device. The prosthesis attaches conformally to the outside of the eye and electrically drives a microfabricated thin-film polyimide array of sputtered iridium oxide film electrodes. This array is implanted into the subretinal space using a customized ab externo surgical technique. The implanted device includes a hermetic titanium case containing a 15-channel stimulator chip and discrete circuit components. Feedthroughs in the case connect the stimulator chip to secondary power and data receiving coils on the eye and to the electrode array under the retina. Long-term in vitro pulse testing of the electrodes projected a lifetime consistent with typical devices in industry. The final assembly was tested in vitro to verify wireless operation of the system in physiological saline using a custom RF transmitter and primary coils. Stimulation pulse strength, duration, and frequency were programmed wirelessly from a Peripheral Component Interconnect eXtensions for Instrumentation (PXI) computer. Operation of the retinal implant has been verified in two pigs for up to five and a half months by detecting stimulus artifacts generated by the implanted device.
一种微型、密封、无线操作的视网膜假体已被开发用于尤卡坦小型猪的临床前研究，并且相对于我们之前报道的设备，该假体具有多项设计改进。该假体与眼睛外部贴合，并通过微加工的薄膜聚酰亚胺阵列驱动溅射氧化铱薄膜电极进行电驱动。该阵列使用定制的外部手术技术植入到视网膜下空间。植入的设备包括一个密封的钛外壳，其中包含一个 15 通道刺激器芯片和离散的电路组件。外壳中的贯穿件将刺激器芯片连接到眼睛上的二次电源和数据接收线圈，以及连接到视网膜下的电极阵列。电极的长期体外脉冲测试预测了与典型工业设备一致的寿命。最终组件在体外进行了测试，使用定制的射频发射器和初级线圈，在生理盐水中验证了系统的无线操作。通过检测由植入设备产生的刺激伪影，已经在两只猪中验证了视网膜植入物长达五个半月的运行。
