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

项目总结 头颈部(口腔、咽和喉癌)是全球第五大最常见的癌症。 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)是有效的，可减少并发症和长期治疗发病率。它的缺点之一就是 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，导致正利润率和血管并发症的风险。影像引导与外科手术 导航在鼻窦、颅底和神经外科中发挥着重要作用，显示出安全性的改善。 以及这些程序的有效性。将这项技术应用于经口腔外科手术可能会有好处。 (ToS)，用于改进对肿瘤深度的评估和避免血管结构。图像制导是 目前尚不适用于经口腔手术。主要原因是术中组织明显变形 随着提供手术通道所需的牵引器的引入，这种情况发生了。这一术中变形 限制了将术前影像准确配准到术中状态的能力。随着可用 达特茅斯独特的外科创新中心的术中CT和MRI成像 成像是可行的。然而，目前暴露和呼吸道管理所需的金属器械 在经口手术过程中，CT成像会产生明显的伪影。作为正在进行的NIH资助的R21的一部分 项目(1R21CA246158-01A1)，我们开发了一种新型的3D打印聚合物牵引器，使我们能够 在经口腔手术和手术导航过程中获取身体头部的无伪影图像 框架，以实现图像引导的跨口腔机器人手术。此R21中的工作是在 桌上模特和身体头像。在R03中，我们首先建议为活体准备牵引器 通过评估灭菌对牵引器机械性能的影响并确认 系统在典型TORS程序的时间段内的稳定性。其次，我们的目标是将该牵引器部署在 术中经口腔手术的一系列操作，并比较手术工作量和功能 标准金属牵引器系统。我们努力的首要目标是提高安全性和有效性 并使外科医生能够通过使用外科手术来对更复杂的病例进行手术 导航。在进行活体评估的同时，我们的R21努力开发了图像指南 框架将加速我们向图像引导的Tors的活体评估的过渡。到这个节目结束时 我们希望准备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。 做手术。后续的活体人体研究将建议在临床上评估该框架的有效性。 接受TORS手术的患者人数。

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.