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

开发针对 I 型喉成形术的患者特定手术计划工具

• 批准号: 9882979
• 负责人: Bernard Rousseau
• 金额: $ 45.77万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-12-20 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9882979
• 关键词: 3-Dimensional; Address; Air Movements; Anatomy; Anterior; Area; Aspiration Pneumonia; Biomechanics; Cervical; Cervical spine; Cessation of life; Characteristics; Clinical; Computer Models; Computer Simulation; Deglutition Disorders; Development; Diagnosis; Disease; Dysphonia; Dyspnea; Engineering; Etiology; Evaluation; Frequencies; Future; Goals; Gold; Grant; Growth; High Performance Computing; Human; Iatrogenesis; Implant; Incidence; Income; Individual; Injections; Investigation; Larynx; Lead; Left; Liquid substance; Location; Medial; Medicine; Modality; Modeling; Operative Surgical Procedures; Oryctolagus cuniculus; Otolaryngology; Outcome; Paralysed; Patient-Focused Outcomes; Patients; Phase; Phonation; Positioning Attribute; Procedures; Recovery; Research; Respiration Disorders; Risk; Science; Scientist; Shapes; Spine surgery; Structure; Surgeon; System; Techniques; Testing; Thyroid Gland; Thyroidectomy; Time; Tissues; United States; Validation; Variant; Voice Disorders; Work; base; biological systems; disability; experience; high resolution imaging; improved; in vivo; innovation; microCT; multidisciplinary; patient population; pre-clinical; reduce symptoms; simulation; surgery outcome; tool; vibration; vocal cord

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.

项目概要 声音障碍会使人衰弱，并可能导致严重的社会情感后果、收入损失和 在耳鼻喉科对发声困难、医源性病因（最常见的后果）进行的评估中。 甲状腺切除术或前路颈椎间盘融合手术）估计占单侧新发病例的 50% 每年都会发生一次声带麻痹（UVFP），UVFP 对患者的症状负担是显着的。 估计 100% 的已识别病例出现发声困难、60% 呼吸困难和 75% 吞咽困难， 在严重的情况下，可能导致吸入性肺炎和死亡。 麻痹的声带重建声门闭合有几种方法可以实现闭合，包括内-声门闭合。 然而，注射增强只能暂时缓解症状， 超过一半的 UVFP 患者最终需要手术干预（Francis 等，2017）。 al. 2016）。永久框架手术仍然是超过该时期的患者的黄金标准。 自然恢复（通常 6-12 个月）。目前的建议特别关注框架手术， 其中 I 型喉成形术最常见，该手术的适应症远远超出了 UVFP，包括越来越多的因其他原因（例如，老音症）而导致声门功能不全的患者，尽管这些患者受益于 I 型喉成形术、手术技术和翻修率。差异很大并且 不幸的是，这种变化会产生不一致且不良的临床结果，因此，迫切需要一种临床工具来协助外科医生进行术前计划并改善患者的治疗效果。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，致力于针对患者的特定手术 I 型喉成形术的规划工具 (PhonoSim) 预计是一种结合手术的工具。 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、尺寸和位置，以改善临床效果 该提案利用了显微成像、计算建模和技术方面的当前进展。 生物系统的高性能计算，以支持生物系统的开发和验证 I 型喉成形术的手术规划工具我们的前期工作重点是：1）开发一个 用于模拟涉及大变形的 3D 流体-结构相互作用的通用计算方法，以及 2）发声计算模型的验证以及首次对特定主题的振动特性进行建模该提案的目标是对建模进行实证测试。我们在前期工作中开发了验证方法，以生产用于未来人类研究的临床工具。 拨款完成后可交付的成果将是一种临床工具，将在未来的 I/II 期人体试验中接受严格测试。