Closed-loop laryngeal pacing for voice restoration

项目摘要和摘要最常见的神经源性发声障碍是单侧的 声带麻痹(UVFP)，这会显著降低生活质量。当前可用 手术治疗只能通过放置可吸收材料暂时改善嗓音 材料或涉及永久性的、侵入性的喉部改变，不能完全恢复声音 而且经常需要进行翻修手术。先进的外科手术手段有限。 由于需要专门的外科技术和手术，结果略好 增加了侵入性手术的风险。 功能性电刺激(FES)具有恢复动态声带的潜力 闭合(内收)，改善UVFP患者的嗓音和呼吸道保护结果 人口。喉部肌电(LEMG)研究表明，其中约85%的人 有慢性UVFP的人没有完全的VF失神经，打开了低强度的大门 用于恢复瘫痪的VFS的闭环式FES。多项研究确实表明， 具有联合运动神经支配的喉肌可以有效地刺激或“调搏”到 恢复动态室颤开放(外展)。然而，到目前为止，喉部起搏设备只有 刺激VF外展以促进呼吸，并仅使用预设的刺激模式 (开环控制)而不是感知和响应生理需求 个体(闭环控制)。在这里，我们描述了一种新型的闭环式喉部FES系统 用于复苏室颤闭合(内收)以治疗UVFP。拟议的系统建立在 用于植入设备和FES的成熟方法，但包括多个关键创新元素， 并将创造一种全新的医疗设备，专为瘫痪的VF的复苏而定制 支持嗓音和呼吸道保护的内收。

Project Summary and Abstract The most common neurogenic voice disorder is unilateral vocal fold paralysis (UVFP), which can substantially reduce quality of life. Current available surgical treatments offer only temporary improvement in voice through placement of resorbable materials or involve permanent, invasive alteration of the larynx that incompletely restores voice and often requires revision surgeries. There is limited access to advanced surgical procedures with moderately better outcomes due to the need for specialized surgical techniques and an increased risk of invasive procedures. Functional electrical stimulation (FES) has the potential to restore dynamic vocal fold (VF) closure (adduction), improving voice and airway protective outcomes for the UVFP patient population. Laryngeal electromyography (LEMG) studies have shown that about 85% of those with chronic UVFP do not have complete VF denervation, opening the door to low-intensity closed-loop FES to reanimate paralyzed VFs. Several studies have indeed shown that laryngeal muscles with synkinetic reinnervation can be effectively stimulated or “paced” to restore dynamic VF opening (abduction). However, laryngeal pacing devices to date have only stimulated VF abduction to facilitate breathing and have only used preset patterns of stimulation (open-loop control) rather than sensing and responding to the physiological needs of the individual (closed-loop control). Herein we describe a novel closed-loop laryngeal FES system for reanimation of VF closure (adduction) to treat UVFP. The proposed system builds upon proven approaches for implant devices and FES, yet includes multiple key innovative elements, and will create an entirely new medical device tailored for reanimation of paralyzed VF adduction to support voice and airway protection.