BION Treatment of Neuromuscular Dysfunction

描述（由申请人提供）：理论上，可以通过电刺激来治疗各种感觉和运动功能障碍，以唤起与正常功能基础相似的神经活动模式。 然而，在实践中，这种刺激通常需要由外科医生植入的相对昂贵且较大的装置或由受过训练的治疗师施加的皮肤表面刺激。我们已经开发了一类新的通用设备，可以向任意数量的神经和肌肉部位提供精确计量的刺激脉冲。这些无引线仿生神经元（BlONsTM）可以通过12号皮下注射针注射到所需的位置。它们通过RF遥测从单个外部佩戴的传输线圈接收功率和数字命令信号。它们已被广泛用于电诱导肌肉锻炼效果的临床前动物研究。1999年11月开始了肩关节半脱位的临床试验，2000年6月开始了第二次膝关节骨关节炎的临床试验，迄今为止都取得了很好的结果。根据本BRP，我们将设计和制造BION 1植入物和附件组件，用于在患者体内进行测试、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、肩部和脚踝肌肉。目前BION 1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，并将传感和反向遥测用于功能性电刺激（FES）。在随后的几年里，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，我们将采用先进的BION 2技术，使用神经假肢控制为瘫痪肢体提供功能性复活。

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.