Spinal Cord Stimulation to Restore Cough In Humans

描述（由申请人提供）：颈脊髓和胸脊髓损伤患者的大部分呼气肌麻痹，因此缺乏正常的咳嗽机制。因此，这些患者中的大多数患有清除气道分泌物的能力明显降低，这是导致他们发生复发性呼吸道感染和肺不张以及伴随的高发病率和死亡率的因素。由于大多数患者损伤水平以下的脊髓是完整的，因此支配呼气肌的脊髓和外周神经肌肉系统的运动神经元是完整的。因此，这些肌肉理论上可以被电激活以产生功能有效的咳嗽机制。最近的动物研究（在我们的实验室进行）表明，呼气肌的主要部分可以通过下胸脊髓刺激（SCS）激活。通过这种方法，SCS导致产生大的气道正压和正常咳嗽特征的峰值呼气流速。我们的假设是，当应用于脊髓损伤患者时，下胸部SCS也会导致全身呼气肌收缩并产生有效的咳嗽机制。我们计划将这项技术应用于脊髓损伤的患者，他们的呼气肌大部分瘫痪。更具体地说，我们将评估以下患者：a）高位颈髓损伤（C1- C4），因此依赖呼吸机; B）低位颈髓损伤（C4-C8）患者，其中大多数患者由于正常的膈肌功能而能够自主呼吸; c）胸髓损伤患者。NDI Medical LLC（Cleveland，俄亥俄州）呼气肌刺激器和NeuroControl Corp.（Cleveland，OH）电极将用于通过SCS激活呼气肌。呼气肌的功能性电刺激应能够通过独立的患者控制按需产生有效的咳嗽机制，并避免经常需要训练有素的人员持续存在的频繁患者抽吸的需要。这种方法将提高患者的生活质量，因为更好的感觉和分泌物去除的压力更小。此外，这种技术应该为脊髓损伤的患者提供更容易地清除其分泌物的能力，从而降低呼吸并发症的发生率以及相关的发病率和死亡率。

DESCRIPTION (provided by applicant): Patients with cervical and thoracic spinal cord injuries have paralysis of a major portion of their expiratory muscles and therefore, lack a normal cough mechanism. Consequently, most of these patients suffer from a markedly reduced ability to clear airway secretions, a factor which contributes to their development of recurrent respiratory tract infections and atelectasis and attendant high morbidity and mortality. Since the spinal cord below the level of injury is intact in most patients, the motoneurons of the spinal cord and peripheral neuromuscular system innervating the expiratory muscles are intact. These muscles, therefore, can theoretically be electrically activated to produce a functionally effective cough mechanism. Recent animal studies (performed in our laboratory) indicate that a major portion of the expiratory muscles can be activated by lower thoracic spinal cord stimulation (SCS). By this method, SCS results in the generation of large positive airway pressures and peak expiratory flow rates characteristic of a normal cough. It is our hypothesis that lower thoracic SCS, when applied in patients with spinal cord injury, will also result in generalized expiratory muscle contraction and produce an effective cough mechanism. We plan to apply this technique to patients with spinal cord injury who have paralysis of a major portion of their expiratory muscles. More specifically, we will evaluate patients with a) high cervical spinal cord injury (C1- C4) and consequently ventilator dependent, b) patients with low cervical spinal cord injury (C4-C8), most of whom are able to breathe spontaneously due to normal diaphragm function and, c) patients with thoracic spinal cord injury. The NDI Medical LLC (Cleveland, Ohio) expiratory muscle stimulator and NeuroControl Corp. (Cleveland, OH) electrodes will be employed to activate the expiratory muscles via SCS. Functional electrical stimulation of the expiratory muscles should be capable of producing an effective cough mechanism on demand via independent patient control and obviate the need for frequent patient suctioning which often requires the constant presence of trained personnel. This method will improve patient quality of life due to a greater sense of well being and less stressful method of secretion removal. Moreover, this technique should provide spinal cord injured patients the capacity to clear their secretions more readily and thereby reduce the incidence of respiratory complications and associated morbidity and mortality.