SBIR Phase II: Design and Development of Minimally-Invasive Orthopedic Fracture Fixation

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project involves Intramedullary (IM) nailing technology which is widely used to treat long bone fractures. Problems such as poor healing, infection, implant breakage, and limited compatibility with the body can occur because traditional metal implants are rigid and may reduce the natural stress placed on bone. These difficulties are often greater in complex injuries and in individuals with fragile bones, where achieving stable fixation and healthy healing is more difficult. This project focuses on creating an IM nail that forms inside the body during surgery. The method is intended to provide greater flexibility and more natural load sharing, so the implant behaves in a way that is closer to living bone. By reducing unnecessary stress on healing tissue and supporting stronger biological integration, this approach aims to lower the risk of complications often seen with metal implants. The proposed technology may reduce repeat surgeries and lengthy rehabilitation, improving recovery while creating commercial value through broader surgical adoption. This Small Business Innovation Research (SBIR) Phase II project focuses on developing an innovative technology solution for orthopedic fractures of long bones. Intramedullary (IM) nails are commonly used but can cause issues like poor anatomical fit, infection risk, stress shielding, and difficulty with bones of varying size or shape, especially in complicated fractures. The proposed IM nail is a flexible two layered carbon braid reinforced and an ultra-thin polymer sleeve, that offers enhanced load-bearing capacity, anatomical adaptability, fatigue resistance, imaging clarity, and streamlined design to improve fracture management. In the current proposed project, we propose to validate a) highly targeted, custom-designed IM sleeve systems specific to anatomical location and fracture type; b) develop a radiopaque, in situ-curable injectable resin system, as well as a minimally invasive ultrasound device for the removal of cured resin; c) create an Artificial Intelligence-driven guidance tool to facilitate rapid selection of the appropriate implant size based on anatomical site and fracture classification; d) design and develop a first generation implant for human humerus fractures; and e) conduct Good Laboratory Practice (GLP) validation of both individual device components and the complete device, providing early safety data to inform advanced preclinical development, leading to 510K regulatory device approval. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.