Electrical Stimulation of the Bilaterally Paralyzed Larynx Paced with Respiration

描述（由申请人提供）：双侧声带麻痹是一种严重的，往往危及生命的医疗条件。喉返神经的损伤使声带停止在接近闭合的位置。传统的外科治疗依赖于部分喉切除术来扩大气道，但牺牲了声音，使患者有误吸的风险。一个更生理的方法涉及功能性电刺激环杓后肌（PCA）在吸气时外展声带。本研究的目的是设想一种植入式喉起搏器系统，将重建与吸气同步的双侧声门开放。研究将首先在犬中进行，然后通过临床试验转化为人类。研究的最初重点将是发明传感器技术，使起搏器与每次吸气努力可靠地同步。一旦确定了最合适的刺激电极阵列，将在慢性犬模型中对植入式喉部起搏系统的安全性和有效性进行研究。在适应人体解剖结构后，将对喉起搏治疗的前瞻性I期临床试验与气管切开术和声带切开术在通气、声音和吞咽参数方面进行比较。这种新的，更动态的治疗方法可以恢复通过口腔的正常通气，而不会改变声音或吞咽，并使患者恢复积极的生活方式。

DESCRIPTION (provided by applicant): Bilateral vocal fold paralysis is a serious and often life-threatening medical condition. Injury to the recurrent laryngeal nerves arrests the vocal folds in a near-closed position. Conventional surgical therapies rely on partial laryngeal resection to enlarge the airway, but sacrifice voice and leave the patient at risk for aspiration. A more physiologic approach involves functional electrical stimulation of the posterior cricoarytenoid (PCA) muscle to abduct the vocal folds during inspiration. The goal of this research is to conceive an implantable laryngeal pacemaker system that will reestablish bilateral glottal opening in synchrony with inspiration. Studies will be performed initially in the canine, and then translated into the human through a clinical trial. The initial focus of the research will be to invent sensor technology that can reliably synchronize the pacemaker with each inspiratory effort. Once the most suitable stimulus electrode array has been identified, an investigation of the safety and efficacy of an implanted laryngeal pacing system will ensue in a chronic canine model. After adaptation to human anatomy, a prospective Phase I clinical trial of laryngeal pacing treatment will be compared to tracheotomy and cordotomy with respect to ventilation, voice and swallowing parameters. This new, more dynamic approach to treatment could restore normal ventilation through the mouth without alteration of voice or swallowing, and return the patient to a physically active lifestyle.