BION Treatment of Neuromuscular Dysfunction

描述（由申请人提供）：理论上，广泛的感觉和运动功能障碍可以通过电刺激来治疗，以唤起类似于正常功能基础的神经活动模式。然而，这种刺激通常需要外科医生植入相对昂贵的大型设备，或者由训练有素的治疗师进行皮肤表面刺激。我们已经开发了一种新型的通用设备，可以向任意数量的神经和肌肉部位提供精确测量的刺激脉冲。这些无铅仿生神经元（BlONsTM）可以通过12号皮下注射针注射到所需的位置。它们通过射频遥测从单个外部磨损的传输线圈接收功率和数字命令信号。它们已广泛用于电诱导肌肉运动效果的临床前动物研究。1999年11月开始了治疗肩关节半脱位的临床试验，2000年6月开始了治疗膝关节骨关节炎的临床试验，迄今为止都取得了很好的效果。根据该BRP，我们将设计和制造BION1植入物和附属组件，用于在患者身上进行测试、编程和控制。我们将开发和测试一系列临床应用，以确定安全性和有效性，并进一步了解神经肌肉病理和治疗的机制。在最初的五年里，这些应用包括激活和加强中风和脑瘫患者的手部、肩部和脚踝的肌肉。目前BION1技术的增强正在开发中（由NIH单独资助），以提高功率效率和便携性，并结合功能电刺激（FES）的传感和反向遥测。在接下来的几年里，我们将扩大临床应用，为这些疾病中常见的多关节功能障碍提供更完整的康复，我们将结合先进的BION2技术，通过神经假肢控制提供瘫痪肢体的功能恢复。

DESCRIPTION (provided by applicant): In theory, a wide range of sensory and motor dysfunctions can be treated by electrical stimulation to evoke patterns of neural activity similar to those that underlie normal function. In practice, however, such stimulation typically has required relatively expensive and large devices implanted by a surgeon or skin surface stimulation applied by a trained therapist. We have developed a new class of generic devices that can deliver precisely metered stimulation pulses to an arbitrary number of nerve and muscle sites. These leadless BIOnic Neurons (BlONsTM) can be injected through a 12 gauge hypodermic needle into the desired locations. They receive their power and digital command signals by RF telemetry from a single, externally worn transmission coil. They have been used extensively in preclinical animal studies of the effects of electrically induced muscle exercise. A clinical trial for shoulder subluxation began in November, 1999, and a second for osteoarthritis of the knee began in June 2000, both with excellent results to date. Under this BRP, we will design and build BION1 implants and accessory components for testing, programming and controlling them in patients. We will develop and test a range of clinical applications to determine safety and efficacy and to understand further the mechanisms underlying neuromuscular pathology and treatment. In the first five years, these applications include activating and strengthening muscles in the hand, shoulder, and ankle in patients suffering from stroke and cerebral palsy. Enhancements of the current BION1 technology are under development (with separate NIH funding) to improve power efficiency and portability and to incorporate sensing and back-telemetry for functional electrical stimulation (FES). In subsequent years, we will expand the clinical applications to provide more complete rehabilitation of multijoint dysfunctions that commonly occur in these disorders and we will incorporate advanced BION2 technology to provide functional reanimation of paralyzed limbs using neural prosthetic control.