SBIR Phase II: Safe, Portable, Non-ionizing Bone Imaging with an Ultrasound-based X-ray Replacement Device

This Small Business Innovation Research (SBIR) Phase II project addresses the clinical and market need for an X-ray replacement technology that is portable, low-cost, and safe. While X-ray is the current dominant modality for diagnostic imaging of bone anatomy, it possesses many limitations: emission of radiation, bulky, and expensive. In the Phase I project, we demonstrated feasibility of the technology with a handheld ultrasound prototype, which demonstrated 3D freehand bone imaging using an ex vivo whole pig lumbar spine model. Phase II research objectives include: 1) Design and build a preproduction ultrasound prototype; 2) Develop a model registration-based 3D bone imaging application and release a clinical software version with formal verification and validation testing; and 3) Prepare the device for clinical use with human subjects and experimentally validate in an ex vivo porcine lumbar spine model with physician testing. It is anticipated that this project will result in the demonstration of a new medical device with demonstrated efficacy for improved administration of spinal anesthesia via 3D portable real-time spinal bone imaging. The broader impact/commercial potential of this project is an X-ray replacement technology based on medical ultrasound, which addresses market segments including spinal anesthesia, orthopedic, and emergency medicine. Rivanna Medical is targeting the spinal anesthesia market first because of the compelling market and clinical need. Due to lack of availability of safe, portable, and inexpensive medical imaging for bone anatomy, these procedures currently exhibit high first-attempt failure rates. Failures result in poor patient outcomes and higher costs for health care providers. In this application, our lead device, the SpineFinder, would improve success rates via real-time guidance of spinal injections at the patient?s bedside. The societal impact of a safe, inexpensive, portable bone imaging products includes more successful procedures, better patient outcomes, and lower healthcare costs. Additionally, the public would benefit by an overall reduction in ionizing radiation exposure from X-ray and a subsequent reduction in cancers. The general scientific and technological understanding of acoustics will be enhanced through this project by a better understanding of ultrasound interactions with specular reflecting surfaces, such as bone.