SBIR Phase II: 4D scanner for image guided interventions

The broader impact/commercial potential of this project is the significant improvement of surgical accuracy, which will dramatically reduce surgical errors, improve outcomes and reduce healthcare costs. In spine surgery alone, there are more than 500,000 procedures every year in the US utilizing implants such as screws. In 4% to 11% of these surgeries, the implant placement is inaccurate. For the patient this translates into longer recoveries - from days to weeks - and in many cases into a second revision surgery. The patient is non-productive, unable to carry out their daily routines for weeks, while the healthcare system has to absorb the costs of the longer recovery as well as the revision surgeries. For both the healthcare and economic systems these are avoidable costs. The medical imaging technology being developed in this project has the potential to eliminate surgical inaccuracies across the $2.4B market of image guidance, improving clinical applications that range from orthopedic surgery to minimally invasive vascular interventions, to cancer diagnosis and treatments. This Small Business Innovation Research (SBIR) Phase 2 project will demonstrate a novel imaging modality, which provides near-real-time 3D live imaging - 4D - during surgery. This novel system will provide surgical imaging at a lower x-ray dose than fluoroscopy (current standard), with a geometry that allows concurrent imaging with surgery. This 4D technology has the potential to significantly reduce surgical inaccuracies, improve outcomes and reduce costs. Phase 1 successfully demonstrated the feasibility of the reconstruction algorithm used by the proposed imaging modality by showing its potential of higher surgical accuracy in a single spinal screw insertion. This Phase 2 project will I) prove the robustness of the reconstruction algorithm across a variety of use-cases, II) demonstrate the clinical usability of the 4D scanner, and III) confirm the clinical utility of the scanner. The clinical usability will be studied with an ergonomic model in a surgical setting. The clinical utility will be proven by building a system prototype and performing image quality and x-ray dose comparisons versus fluoroscopy and 3D in a realistic surgical setting. Preliminary results show that these objectives are achievable. This research is readying the technology for clinical research, regulatory clearance and commercialization.