NSF Award
1456352
The broader impact/commercial potential of this project is the significant improvement of<br/>surgical accuracy, which will dramatically reduce surgical errors, improve outcomes and<br/>reduce healthcare costs. In spine surgery alone, there are more than 500,000<br/>procedures every year in the US utilizing implants such as screws. In 4% to 11% of<br/>these surgeries, the implant placement is inaccurate. For the patient this translates into<br/>longer recoveries - from days to weeks - and in many cases into a second revision<br/>surgery. The patient is non-productive, unable to carry out their daily routines for weeks,<br/>while the healthcare system has to absorb the costs of the longer recovery as well as<br/>the revision surgeries. For both the healthcare and economic systems these are<br/>avoidable costs. The medical imaging technology being developed in this project has<br/>the potential to eliminate surgical inaccuracies across the $2.4B market of image<br/>guidance, improving clinical applications that range from orthopedic surgery to minimally<br/>invasive vascular interventions, to cancer diagnosis and treatments.<br/><br/>This Small Business Innovation Research (SBIR) Phase 2 project will demonstrate a<br/>novel imaging modality, which provides near-real-time 3D live imaging - 4D - during<br/>surgery. This novel system will provide surgical imaging at a lower x-ray dose than<br/>fluoroscopy (current standard), with a geometry that allows concurrent imaging with<br/>surgery. This 4D technology has the potential to significantly reduce surgical<br/>inaccuracies, improve outcomes and reduce costs. Phase 1 successfully demonstrated<br/>the feasibility of the reconstruction algorithm used by the proposed imaging modality by<br/>showing its potential of higher surgical accuracy in a single spinal screw insertion. This<br/>Phase 2 project will I) prove the robustness of the reconstruction algorithm across a<br/>variety of use-cases, II) demonstrate the clinical usability of the 4D scanner, and III)<br/>confirm the clinical utility of the scanner. The clinical usability will be studied with an<br/>ergonomic model in a surgical setting. The clinical utility will be proven by building a<br/>system prototype and performing image quality and x-ray dose comparisons versus<br/>fluoroscopy and 3D in a realistic surgical setting. Preliminary results show that these<br/>objectives are achievable. This research is readying the technology for clinical research,<br/>regulatory clearance and commercialization.
