Abstract
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 42.55mm and a working volume of 200.09cm3, 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 2h mock procedure, the retractor system showed minimal displacements (<1.5mm) 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.
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