Spinal Cord Stimulation to Restore Cough In Humans

描述(申请人提供)：颈椎和胸部脊髓损伤患者的大部分呼气肌瘫痪，因此，缺乏正常的咳嗽机制。因此，这些患者中的大多数患者清除呼吸道分泌物的能力明显降低，这是导致他们反复发生呼吸道感染和肺不张的一个因素，并伴随着高发病率和死亡率。由于大多数患者损伤平面以下的脊髓是完整的，所以脊髓的运动神经元和支配呼气肌的周围神经肌肉系统也是完整的。因此，从理论上讲，这些肌肉可以通过电激活来产生有效的咳嗽机制。最近的动物研究(在我们实验室进行)表明，下胸段脊髓刺激(SCS)可以激活大部分呼气肌。通过这种方法，SCS导致产生大的正压和正常咳嗽的特征的最大呼气流速。我们的假设是，当下胸段SCS应用于脊髓损伤患者时，也会导致全身性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患者，他们的呼气肌大部分瘫痪。更具体地说，我们将评估a)高位颈髓损伤(C1-C4)并因此依赖呼吸机的患者，b)低位颈髓损伤(C4-C8)患者，他们中的大多数人由于横隔膜功能正常而能够自发呼吸，以及c)胸段脊髓损伤患者。NDI Medical LLC(俄亥俄州克利夫兰)呼气肌肉刺激器和NeuroControl Corp.(俄亥俄州克利夫兰)电极将用于通过SCS激活呼气肌。呼气肌的功能性电刺激应该能够通过独立的患者控制根据需要产生有效的咳嗽机制，并消除经常需要训练有素的人员经常在场的患者吸痰的需要。这种方法将提高患者的生活质量，因为有更多的幸福感和更少的压力的分泌物去除方法。此外，这项技术应该使脊髓损伤患者能够更容易地清除他们的分泌物，从而减少呼吸道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.