Design and Evaluation of Novel Devices to Facilitate Long Bone Fracture Reconstruction

摘要

Intramedullary (IM) nailing is the standard of care for adult lower extremity long bone fracture stabilization. In IM nailing, obtaining the correct entry point for nail insertion has been identified as the most important technical aspect of the operationF. Upon accurate entry point selection and opening the intramedullary canal, intra-operative reduction is necessary to insert a long guide wire through the proximal and distal fragments to enable subsequent IM reaming and nail insertion. Despite widespread usage of IM nailing, significant surgical challenges arise in accurate entry point selection and obtaining adequate provisional reduction to allow conventional intramedullary guide wire insertion. Such challenges can significantly impede the surgical workflow, introduce surgical complications, requiring additional operative time and radiation exposure to both patients and medical staff, as well as elevating surgical frustration levels.;This thesis focuses on analyzing the IM nailing surgical process and the development and evaluation of two novel surgical tools, FAST, to facilitate entry point selection and FLEX FiRST wire, to aid long bone fracture reduction. FAST (Femoral Antegrade Starting Tool) is a surgical tool that enables maintenance of Kirschner (K) wire anteroposterior (AP) alignment when lateral images are acquired to obtain accurate K-wire positioning in the sagittal plane. FLEX FiRST (FLEXible Fracture Reduction Steerable Telescoping) Wire is a flexible endoscopic device whose insertion is guided by a proximal joy-stick like controller which enables navigation of the device tip through a malreduced fracture site under standard intra-operative fluoroscopy.;Ultimately, the design of these novel tools can address the lack of connectivity in utilizing sequential 2D fluoroscopic images to achieve 3D alignment and may facilitate the overall surgical workflow in IM nailing of femoral shaft fractures.