Thayer School of Engineering, Dartmouth College, Hanover, NH, USA.
Section of Otolaryngology, Audiology, and Maxillofacial Surgery, Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
Ann Biomed Eng. 2024 Sep;52(9):2473-2484. doi: 10.1007/s10439-024-03536-7. Epub 2024 May 25.
This study aimed to develop and validate a Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)-compatible polymer oral retractor system to enable intraoperative image guidance for transoral robotic surgery (TORS). The retractor was designed based on standard-of-care metallic retractors and 3D (three-dimensional) printed with carbon fiber composite and nylon. The system was comprehensively evaluated in bench-top and cadaveric experiments in terms of its ability to enable intraoperative CT/MR images during TORS, functionality including surgical exposure and working volume, usability, compatibility with da Vinci surgical systems, feasibility for disinfection or sterilization, and robustness over an extended period of time. The polymer retractor system enabled the acquisition of high-resolution and artifact-free intraoperative CT/MR images during TORS. With an inter-incisive distance of 42.55 mm and a working volume of 200.09 cm, it provided surgical exposure comparable to standard-of-care metallic retractors. The system proved intuitive and compatible with da Vinci S, Xi, and Single Port systems, enabling successful mock surgical tasks performed by surgeons and residents. The retractor components could be effectively disinfected or sterilized for clinical use without significant compromise in material strength, with STERRAD considered the optimal method. Throughout a 2 h mock procedure, the retractor system showed minimal displacements (<1.5 mm) due to surrounding tissue deformation, with insignificant device deformation. The 3D-printed polymer retractor system successfully enabled artifact-free intraoperative CT/MR imaging in TORS for the first time and demonstrated feasibility for clinical use. This breakthrough opens the door to surgical navigation with intraoperative image guidance in TORS, offering the potential to significantly improve surgical outcomes and patients' quality of life.
本研究旨在开发和验证一种计算机断层扫描(CT)/磁共振成像(MRI)兼容的聚合物口腔牵开器系统,以实现经口机器人手术(TORS)的术中图像引导。该牵开器基于标准的金属牵开器设计,并使用碳纤维复合材料和尼龙进行 3D(三维)打印。该系统在台式和尸体实验中进行了全面评估,评估内容包括其在 TORS 过程中启用术中 CT/MR 图像的能力、手术暴露和工作容积等功能、可用性、与达芬奇手术系统的兼容性、用于消毒或灭菌的可行性,以及在较长时间内的稳定性。聚合物牵开器系统可在 TORS 过程中获取高分辨率且无伪影的术中 CT/MR 图像。其切牙间距离为 42.55mm,工作容积为 200.09cm,提供了与标准金属牵开器相当的手术暴露。该系统被证明直观且与达芬奇 S、Xi 和单端口系统兼容,使外科医生和住院医师能够成功完成模拟手术任务。牵开器组件可以有效地进行消毒或灭菌,以供临床使用,而不会对材料强度造成显著影响,其中 STERRAD 被认为是最佳方法。在 2 小时的模拟手术过程中,由于周围组织变形,牵开器系统仅出现了最小的位移(<1.5mm),且设备变形不明显。3D 打印聚合物牵开器系统首次成功地实现了 TORS 中无伪影的术中 CT/MR 成像,并证明了其临床应用的可行性。这一突破为 TORS 中的术中图像引导手术导航开辟了道路,有望显著改善手术结果和患者的生活质量。