In this paper, we explore the feasibility of developing a novel flexible pedicle screw (FPS) for enhanced spinal fixation of osteoporotic vertebrae. Vital for spinal fracture treatment, pedicle screws have been around since the early 20th century and have undergone multiple iterations to enhance internal spinal fixation. However, spinal fixation treatments tend to be problematic for osteoporotic patients due to multiple inopportune variables. The inherent rigid nature of the pedicle screw, along with the forced linear trajectory of the screw path, frequently leads to the placement of these screws in highly osteoporotic regions of the bone. This results in eventual screw slippage and causing neurological and respiratory problems for the patient. To address this problem, we focus on developing a novel FPS that is structurally capable of safely bending to fit curved trajectories drilled by a steerable drilling robot and bypass highly osteoporotic regions of the vertebral body. Afterwards, we simulate its morphability capabilities using finite element analysis (FEA). We then additively manufacture the FPS using stainless steel (SS) 316L alloy through direct metal laser sintering (DMLS). Finally, the fabricated FPS is experimentally evaluated for its bending performance and compared with the FEA results for verification. Results demonstrate the feasibility of additive manufacturing of FPS using DMLS approach and agreement of the developed FEA with the experiments.

Towards reducing the failure rate of spinal fixation surgical procedures in osteoporotic patients, we propose a unique biomechanically-aware framework for the design of a novel concentric tube steerable drilling robot (CT-SDR). The proposed framework leverages a patient-specific finite element (FE) biomechanics model developed based on Quantitative Computed Tomography (QCT) scans of the patient's vertebra to calculate a biomechanically-optimal and feasible drilling and implantation trajectory. The FE output is then used as a design requirement for the design and evaluation of the CT-SDR. Providing a balance between the necessary flexibility to create curved optimal trajectories obtained by the FE module with the required strength to not buckle during drilling through a hard simulated bone material, we showed that the CT-SDR can reliably recreate this drilling trajectory with errors between 1.7-2.2%