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 头部和颈部的癌症（口腔，Pairynx和Larynx）是全球最常见的癌症。 跨口腔外科手术方法，例如跨口腔机器人手术（TOR）和反式激光显微外科手术 （TLM）有效，减少并发症和长期治疗。 跨路线是术中评估肿瘤程度并定位关键血管的差异 结构，导致阳性和血管并发症的风险。 导航在鼻窦，颅底和神经外科手术中起着重要作用，证明了安全性的改善 和这些程序的功效。 （TOS）用于图像指南。 目前不适合跨性手术。 这是在引入牵引器的引入中，需要提供手术术中 限制可准确注册到术中的能力。 达特茅斯独特的手术创新中心，手术室内部的术中CT和MRI成像 成像是可行的。 在跨性手术期间，作为正在进行的NIH资助的R21的一部分，在CT成像上产生了显着的伪像。 程序（1R21CA246158-01A1），我们开发了一个新颖的3D印刷聚合物牵开器，使我们能够 获取尸体的尸体免费图像的尸体头部头式手术手术程序和手术导航 实现图像引导的反式机器人手术的框架。 台式模型和尸体头。 通过评估灭菌对牵开器机械性能的影响和确认的部署 系统稳定性在典型TOR程序的时间周期内。 一系列术中跨口腔手术程序，并比较手术工作量和功能 总体目标逃离是提高安全性和功效 跨口腔手术并使外科医生能够对更复杂的病例进行手术 导航与我们的R21努力同时进行体内评估 框架将加速我们对图像引导的TOR的体内评估。 我们希望准备评估完全集成的手术指导系统，以用于跨跨机器人 将提出手术。 接受TOR的患者人数。