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

基本信息

批准号：
10575098
负责人：
Ryan Joseph Halter
金额：
$ 8.53万
依托单位：
DARTMOUTH COLLEGE
依托单位国家：
美国
项目类别：
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/10575098
关键词：
3D Print Anatomy Blood Vessels Cadaver Clinical Clinical Research Complex Development Devices Distal Ensure Evaluation Excision Exhibits Exploratory/Developmental Grant Feasibility Studies Feedback Funding Goals Growth Head Head Cancer 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 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 base cancer surgery carbon fiber cohort design efficacy evaluation functional outcomes 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

项目摘要

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.

项目概要头颈癌（口腔、咽和喉）是全球第五大常见癌症。经口腔手术方法，例如经口腔机器人手术 (TORS) 和经口腔激光显微手术 (TLM) 是有效的，可以减少并发症和长期治疗发病率。经口入路的难点在于术中评估肿瘤范围和定位关键血管结构，导致阳性切缘和血管并发症的风险。导航在鼻窦、颅底和神经外科手术中发挥着重要作用，证明了安全性的提高这些手术的效果和效果将该技术应用于经口腔手术可能有优势。 (TOS) 用于改进肿瘤深度评估并避免血管结构。目前经口手术不可行的主要原因是术中组织变形明显。这种术中变形是由于引入手术通道所需的牵开器而发生的。限制了将术前成像准确记录到术中状态的能力。在达特茅斯独特的外科创新中心进行术中 CT 和 MRI 成像然而，目前的暴露和气道管理需要金属仪器。作为正在进行的 NIH 资助的 R21 项目的一部分，经口手术期间会在 CT 成像上产生明显的伪影。计划 (1R21CA246158-01A1)，我们开发了一种新型 3D 打印聚合物牵开器，使我们能够在经口手术过程和手术导航过程中获取尸体头部的无伪影图像 R21 中的工作正在进行中，以实现图像引导的经口腔机器人手术。在这个 R03 中，我们首先建议为体内准备牵开器。通过评估灭菌对牵开器机械性能的影响并确认来部署其次，我们的目标是在典型的 TORS 手术期间部署该牵开器。系列术中经口手术程序，并比较手术工作量和功能我们努力的首要目标是提高安全性和有效性。经口腔手术，使外科医生能够通过使用外科手术对更复杂的病例进行手术在进行体内评估的同时，我们还致力于开发图像引导 R21。到本项目结束时，该框架将加速我们向图像引导 TORS 体内评估的过渡。我们希望准备好评估用于经口腔机器人的完全集成的手术引导系统将建议进行后续的体内人体研究，以评估该框架在临床中的功效。接受 TORS 的患者群体。