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.

最常见的神经源性嗓音障碍是单侧的 声带麻痹（UVFP），这可以大大降低生活质量。当前可用 手术治疗通过放置可吸收的 材料或涉及永久性的，侵入性的喉改变，不完全恢复声音 并且经常需要翻修手术。高级外科手术的机会有限 由于需要专门的手术技术和 增加侵入性手术的风险。 功能性电刺激（FES）具有恢复动态声带（VF）的潜力 闭合（内收），改善UVFP患者的声音和气道保护结果 人口喉肌电图（LEMG）研究表明，大约85%的人 慢性UVFP没有完全的VF去神经支配，打开了低强度的大门。 闭环FES来恢复瘫痪的VF。几项研究确实表明， 具有联动神经再支配的喉肌可以被有效地刺激或“起搏”， 恢复动态VF开放（外展）。然而，迄今为止，喉起搏装置仅具有 刺激VF外展以促进呼吸，并且仅使用预设的刺激模式 （开环控制）而不是感知和响应的生理需求， 单独（闭环控制）。在这里，我们描述了一种新的闭环喉FES系统 用于VF闭合（内收）的复苏以治疗UVFP。拟议的系统建立在 植入器械和FES的成熟方法，还包括多个关键创新元素， 并将创造一种全新的医疗设备， 内收以支持声音和气道保护。