Development of a Patient-Specific Surgical Planning Tool for Type I Laryngoplasty

项目摘要 声音障碍使人衰弱，并可能导致严重的社会情绪后果，收入损失， 长期残疾。在发音困难的耳鼻喉科评价中，医源性病因（最常见的是 来自甲状腺切除术或颈椎前路椎间盘融合术）估计占单侧腰椎间盘突出症新病例的50%， 声带麻痹（UVFP）。UVFP对患者的症状负担显著， 估计100%的已识别病例发生发音困难，60%发生呼吸困难，75%发生吞咽困难， 在严重的情况下，可导致吸入性肺炎和死亡。治疗需要使 麻痹的声带重建声门闭合有几种模式可以实现关闭，包括： 射出增强然而，注射增强只能暂时缓解症状， 并且在超过一半的诊断为UVFP的患者中最终需要手术干预（弗朗西斯等人 al. 2016）。永久性框架手术仍然是患者的黄金标准， 自然恢复（通常6 - 12个月）。目前的建议特别侧重于框架手术， 其中I型喉成形术最为常见。这种手术的适应症远远超出了UVFP，包括越来越多的其他原因导致声门闭合不全的患者（例如，老视）。尽管这些患者受益于I型喉成形术，但手术技术和翻修率差异很大， 很大程度上依赖于数量和经验。不幸的是，这种变化产生不一致和不期望的临床结果。因此，非常需要一种临床工具来帮助外科医生进行术前规划并改善患者结果。为了满足这一需求，我们组建了一个由工程师、科学家和外科医生组成的多学科小组， I型喉成形术计划工具（PhonoSim）。可以设想的是，结合了外科手术器械的工具可以包括： 植入物，并捕获患者喉部解剖结构的个体特异性特征，可用于外科手术 计划优化I型喉成形术中使用的植入物的形状、大小和位置，以改善临床 结果。该提案利用了当前在显微成像、计算建模和 生物系统的高性能计算，以支持开发和验证 I型喉成形术手术计划工具。我们的初步工作集中在：1）开发一个 通用的计算方法，用于模拟涉及大变形的3D流体-结构相互作用，以及2）验证发声的计算模型，并首次对特定对象的振动特性进行建模。该提案的目标是对我们前期工作中开发的建模和验证方法进行实证测试，以产生用于未来人类研究的临床工具。的 在资助完成后交付的将是一种临床工具，将在未来的I/II期人体试验中进行严格测试。

Project Summary Voice disorders are debilitating and can lead to significant socioemotional consequences, loss of income, and long-term disability. Among otolaryngology evaluations for dysphonia, iatrogenic etiologies (most consequent from thyroidectomy or anterior cervical disc fusion surgery) account for an estimated 50% new cases of unilat- eral vocal fold paralysis (UVFP) annually. The symptomatic burden of UVFP on patients is significant with an estimated 100% of identified cases experiencing dysphonia, 60% dyspnea, and 75% dysphagia, which, in severe cases, can lead to aspiration pneumonia and death. Treatment requires medialization of the paralyzed vocal fold to reestablish glottal closure. Several modalities exist to achieve closure, including in- jection augmentation. However, injection augmentation is effective at only temporarily alleviating symptoms, and surgical intervention is ultimately necessary in more than half of patients diagnosed with UVFP (Francis et al. 2016). Permanent framework surgery remains the gold standard for patients that are beyond the period of spontaneous recovery (usually 6-12 months). The current proposal focuses specifically on framework surgery, of which type I laryngoplasty is most common. Indications for this procedure extend well beyond UVFP to include a growing population of patients with glottal insufficiency from other causes (e.g., presbyphonia). Although these patients benefit from type I laryngoplasty, surgical techniques and revision rates vary widely and are largely volume-dependent and experiential. Unfortunately, such variation produces inconsistent and undesirable clinical outcomes. Thus, there exists a significant need for a clinical tool to assist surgeons with pre-operative planning and to improve patient outcomes. To address this need, we have assembled a multidisciplinary group of engineers, scientists, and surgeons to work towards a patient-specific surgical planning tool for type I laryngoplasty (PhonoSim). It is envisioned that a tool that incorporates the surgical implant, and captures the individual-specific features of the patient’s laryngeal anatomy can be used in surgical planning to optimize the shape, size, and position of implants used in type I laryngoplasty to improve clinical outcomes. This proposal leverages current advances in microimaging, computational modeling, and high-performance computing of biological systems to support the development and validation of a surgical planning tool for type I laryngoplasty. Our preliminary work has focused on: 1) development of a versatile computational approach for the simulation of 3D fluid-structure interactions involving large deformations, and 2) validation of computational models of phonation and for the first time the modeling of subject-specific vibratory characteristics. The goal of this proposal is to empirically test the modeling and validation approaches developed in our preliminary work to produce a clinical tool to be used in future human studies. The deliverable upon grant completion will be a clinical tool to be rigorously tested in future phase I/II human trials.