In vivo evaluation of a CT-compatible retractor for image guided trans-oral surgery

用于图像引导经口腔手术的 CT 兼容牵开器的体内评估

• 批准号: 10704145
• 负责人: Ryan Joseph Halter
• 金额: $ 8.87万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10704145
• 关键词: 3D Print; Acceleration; Anatomy; Blood Vessels; Cadaver; Clinical; Clinical Research; Complex; Development; Devices; Distal; Elasticity; Ensure; Evaluation; Excision; Exhibits; Feasibility Studies; Feedback; Funding; Goals; Growth; Head; Head and Neck Cancer; Human; Image; Image-Guided Surgery; Imaging technology; Larynx; Lasers; Location; Magnetic Resonance Imaging; Malignant Neoplasms; Maps; Measurement; Metals; Microsurgery; Modeling; Modulus; Morbidity - disease rate; Morphologic artifacts; Nylons; Operative Surgical Procedures; Optics; Oral; Oral Surgical Procedures; Oral cavity; Oropharyngeal; Patient Schedules; Patients; Pharyngeal structure; Pilot Projects; Play; Polymers; Population; Preparation; Procedures; Process; Research; Risk; Robotics; Role; Safety; Scanning; Series; Sinus; Sterilization; Structure; Surgeon; System; Technology; Tensile Strength; Testing; Throat Cancer; Time; Tissues; Tongue; Translating; United States National Institutes of Health; Viral; Work; X-Ray Computed Tomography; cancer surgery; carbon fiber; cohort; design; efficacy evaluation; functional improvement; haptic feedback; image guided; imaging approach; improved; improved outcome; in vivo; in vivo evaluation; innovation; instrument; instrumentation; mechanical properties; metallicity; minimally invasive; multimodality; neurosurgery; novel; patient population; programs; recruit; robot assistance; safety assessment; skull base; standard of care; tool; tumor

PROJECT SUMMARY Cancers of the head and neck (oral cavity, pharynx, and larynx) are the 5th most common cancers worldwide. Trans-oral surgical approaches such as trans-oral robotic surgery (TORS) and trans-oral laser microsurgery (TLM) are effective, reducing complications and long-term treatment morbidity. One of the drawbacks of the trans-oral approach is the difficulty in intraoperatively assessing tumor extent and locating critical vascular structures, resulting in positive margins and risks of vascular complications. Image guidance and surgical navigation play a significant role in sinus, skull base, and neurosurgery, demonstrating improvement in the safety and efficacy of these procedures. There may be advantages to applying this technology to trans-oral surgery (TOS) for improved assessment of tumor depth and avoidance of vascular structures. Image guidance is currently not feasible for trans-oral surgery. The main reason is the significant intraoperative tissue deformation that occurs with the introduction of retractors needed to provide surgical access. This intraoperative deformation limits the ability to accurately register preoperative imaging to the intra-operative state. With the availability of intra-operative CT and MRI imaging at Dartmouth’s unique Center for Surgical Innovation, intra-operative imaging is feasible. However, current metallic instrumentation required for exposure and airway management during trans-oral surgery creates significant artifact on CT imaging. As part of an on-going NIH-funded R21 program (1R21CA246158-01A1), we have developed a novel 3D printed polymer retractor that enables us to acquire artifact free images of cadaver head during trans-oral surgery procedures and a surgical navigation framework to enable image-guided trans-oral robotic surgery. The work in this R21 is being performed on benchtop models and cadaver heads. Here in this R03, we are first proposing to prepare the retractor for in vivo deployment by evaluating the impact of sterilization on mechanical properties of the retractor and confirming system stability over the time-period of a typical TORS procedure. Secondly, we aim to deploy this retractor in a series of intraoperative trans-oral surgery procedures and compare the surgical working volume and function to that of standard metal retractor systems. The overarching goal of our efforts is to improve the safety and efficacy of trans-oral surgery and enable surgeons to perform surgery on more complex cases through the use of surgical navigation. Performing this in vivo evaluation in parallel with our R21 efforts to develop an image-guidance framework will accelerate our transition to in vivo evaluation of image-guided TORS. By the end of this program we expect to be prepared to evaluate a fully integrated surgical guidance system for use in trans-oral robotic surgery. Follow on in vivo human studies will be proposed to evaluate the efficacy of this framework in a clinical population of patients undergoing TORS.

项目摘要 头颈部癌症（口腔、咽和喉）是全球第五大常见癌症。 经口腔手术方法，如经口腔机器人手术（TORS）和经口腔激光显微手术 (TLM)有效，减少并发症和长期治疗发病率。的缺点之一 经口入路是术中评估肿瘤范围和定位关键血管的难点 结构，导致阳性边缘和血管并发症的风险。图像引导和手术 导航在鼻窦、颅底和神经外科中发挥重要作用，证明了安全性的提高 这些程序的有效性。将这项技术应用于经口腔手术可能会有优势 (TOS)用于改进肿瘤深度的评估和避免血管结构。图像引导 目前不适用于经口手术。主要原因是术中组织变形明显 这是在引入提供手术入口所需的牵开器时发生的。这种术中变形 限制了将术前成像精确配准到术中状态的能力。的可用性 在达特茅斯独特的外科创新中心进行术中CT和MRI成像， 成像是可行的。然而，目前暴露和气道管理所需的金属仪器 在经口腔手术期间，在CT成像上产生显著的伪影。作为正在进行的NIH资助的R21的一部分， 计划（1 R21 CA 246158 - 01 A1），我们开发了一种新型3D打印聚合物牵开器，使我们能够 在经口腔外科手术过程和外科手术导航期间获取尸体头部的无伪影图像 框架，以实现图像引导的经口腔机器人手术。本R21中的工作正在执行， 台式模型和尸头在本R 03中，我们首次提出准备体内牵开器 通过评价灭菌对牵开器机械性能的影响并确认 在典型TORS程序的时间段内的系统稳定性。其次，我们的目标是在一个 一系列术中经口手术程序，并比较手术工作量和功能， 标准金属牵开器系统。我们努力的首要目标是提高安全性和有效性， 使外科医生能够通过使用外科手术， 导航与我们的R21工作并行执行该体内评价，以开发图像引导 该框架将加速我们向图像引导TORS的体内评价的过渡。在节目结束时 我们希望能够评估一个完全集成的手术引导系统，用于经口腔机器人， 手术将提出后续的体内人体研究，以评估该框架在临床中的有效性。 接受TORS的患者人群。