Closed-loop laryngeal pacing for voice restoration

用于声音恢复的闭环喉部起搏

• 批准号: 10761204
• 负责人: James T. Heaton
• 金额: $ 38.24万
• 依托单位: RIPPLE, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10761204
• 关键词: 3D Print; Affect; Algorithms; Animal Testing; Animals; Axon; Bilateral; Biocompatible Materials; Breathing; Canis familiaris; Cartilage; Chronic; Clinical Trials; Communication; Contralateral; Deglutition; Denervation; Development; Devices; Doctor of Medicine; Electrodes; Electromyography; Elements; Equilibrium; Feasibility Studies; Future; General Hospitals; Goals; Human; Human Engineering; Implant; Individual; Injections; Laryngeal muscle structure; Larynx; Lateral; Longevity; Massachusetts; Mechanics; Medial; Medical Device; Movement; Muscle; Muscular Atrophy; National Institute on Deafness and Other Communication Disorders; Neck; Operative Surgical Procedures; Outcome; Painless; Paralysed; Patient-Focused Outcomes; Patients; Pattern; Persons; Phase; Phonation; Physiological; Polymers; Positioning Attribute; Procedures; Quality of life; Rehabilitation therapy; Research; Risk; Second Look Surgery; Signal Transduction; Small Business Technology Transfer Research; Specimen; Structure; Surgeon; System; Techniques; Technology; Testing; Thyroarytenoid Muscle; Time; Training; United States; Voice; Voice Disorders; Work; Writing; adduct; animation; canine model; cricoarytenoideus; design; flexibility; functional electrical stimulation; implantable device; implantation; improved; innovation; nerve supply; neuromuscular stimulation; novel; patient population; pre-clinical; prototype; reinnervation; restoration; signal processing; software systems; vocal cord

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.

项目摘要和摘要最常见的神经源性语音障碍是单侧 声带瘫痪（UVFP），可以大大降低生活质量。当前可用 外科手术治疗仅通过放置可吸收来暂时改善语音 材料或涉及永久性的侵入性改变，该喉部不完全恢复语音 通常需要修订手术。获得高级手术程序的访问有限 由于需要专门的手术技术，因此取得了适度的结果和 增加了侵入性程序的风险。 功能电刺激（FES）具有恢复动态声折（VF）的潜力 闭合（内收），改善了UVFP患者的语音和气道保护结果 人口。喉肌电图（LEMG）研究表明，其中约有85％ 慢性UVFP没有完整的VF神经保护，打开了低强度的门 闭环FES重新瘫痪的VF。几项研究确实表明 可以有效地刺激或“节奏”到合成补充的喉肌肉肌肉 还原动态VF开放（绑架）。但是，迄今为止的喉起搏设备只有 刺激VF绑架以促进呼吸，只使用了刺激的预设模式 （开环控制）而不是敏感性并响应 个人（闭环控制）。本文我们描述了一种新型的闭环喉FES系统 为了使VF闭合（内收）的复活以治疗UVFP。提出的系统建立在 证明了植入设备和FES的方法，但包括多个关键创新元素， 并将创建一个全新的医疗设备 补充支持语音和气道保护。