Fully Implantable Eye Blink Motor Neuroprosthesis for Facial Nerve Paralysis

描述（由申请人提供）：这个项目的目标是创造一个完全植入式刺激装置，可以恢复单侧面神经麻痹患者的眨眼。该系统将记录完整眼的肌电图，以检测正常的眨眼，并刺激瘫痪眼的肌肉以产生同步眨眼。植入物将由一个薄薄的陶瓷包组成，放置在乳突附近的皮下，通过微创面部内窥镜将少量表面电极缝合到肌肉上。在第一阶段，该方法的可行性将通过使用经皮电极急性刺激面神经麻痹患者的眼肌来证明。这项研究将证实先前在人类受试者领域的动物工作，并确定适当的电极放置和刺激，以实现功能性和美容上可接受的闭眼。在第二阶段，将开发一个完全可植入的系统，用于有限的人体临床试验。这些设备的市场相对较小，每年的患者人数约为几千人。然而，对于慢性面瘫患者来说，恢复功能性眨眼将大大提高生活质量，并减少眼睛损伤、感染和视力丧失等并发症的可能性和成本。

DESCRIPTION (provided by applicant): The goal of this program is to create a totally implantable stimulator device that can restore eye blink in patients with unilateral facial nerve paralysis. The system will record EMG from the intact eye to detect normal blink and stimulate the muscle of the paralyzed eye to create a synchronous blink. The implant will consist of a thin, ceramic package placed subcutaneously near the mastoid with a small number of surface electrodes sutured to the muscles placed with minimally-invasive facial endoscopy. In Phase I, the feasibility of the approach will be demonstrated by acutely stimulating the eye muscles of patients with facial nerve paralysis using transcutaneous electrodes. This study will confirm previous animal work in the area for human subjects and identify proper electrode placement and stimulation for functional and cosmetically acceptable eye closure. In Phase II, a fully implantable system will be developed for use in limited clinical trials with human subjects. The market for these devices is relatively small with annual patient populations on the order of a few thousand per year. For patients with chronic facial paralysis, however, the restoration of functional eye blink will provide a profound improvement in quality of life, and a reduction in the likelihood and costs of complications such as eye damage, infections and vision loss.