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疾病，通常危及生命。喉返神经的损伤使声带处于接近闭合的位置。传统的手术疗法依赖于喉部分切除来扩大呼吸道，但会牺牲嗓音，使患者面临吸入的风险。一种更生理学的方法是在吸气时通过功能性电刺激环踝后肌(PCA)来外展声带。这项研究的目标是构思一种植入性喉部起搏器系统，该系统将与灵感同步重建双侧声门开口。研究将首先在犬身上进行，然后通过临床试验转化为人类。这项研究的最初重点将是发明传感器技术，使起搏器与每一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，将在慢性犬模型中研究植入喉部起搏系统的安全性和有效性。在适应人体解剖学之后，喉部起搏治疗的预期I期临床试验将在通风、声音和吞咽参数方面与气管切开术和心电切开术进行比较。这种新的、更有活力的治疗方法可以在不改变声音或吞咽的情况下恢复正常的口腔呼吸，并使患者恢复体力活动的生活方式。

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.