SBIR Phase I: Safe, portable, non-ionizing bone imaging with an ultrasound-based x-ray replacement device

This Small Business Innovation Research (SBIR) Phase I project addresses the clinical need for an X-ray replacement technology that is portable, low-cost, and safe. X-ray is the dominant modality currently in use for diagnostic imaging of bone despite its many limitations: emission of radiation, bulky, and relatively expensive. The research objectives of this feasibility study include: 1) Design, integrate, and test a low-power consumption mechanically scanned ultrasound transducer; 2) Demonstrate a handheld ultrasound system with free-hand three-dimensional (3D) bone reconstruction in in vitro phantoms; and 3) Demonstrate a free-hand 3D bone imaging system in ex vivo whole porcine models. It is anticipated that the mechanically scanned ultrasound transducer will yield frame rates>15 frames/s and resolution<2.5 mm at imaging depths>10 cm. In vitro phantom experiments will be performed using a computer aided design model of the human spine. Error between 3D ultrasound reconstructions and the computer model is anticipated to be<2.5 mm. Finally, the proposed device is anticipated to yield>0.90 correlation to CT reconstructions of whole porcine spinal bones. Overall, this project is anticipated to demonstrate feasibility of a handheld 3D ultrasound-based bone imaging technology with high correlation to CT. The broader impact/commercial potential of this project includes safer, less expensive, and more accurate imaging of bone anatomy in medical imaging technology applications: spinal anesthesia, orthopedic, emergency medicine. In applications such as emergency care, the technology would enable patient-side imaging of bone anatomy, which is currently unavailable due to the bulkiness of X-ray machines. Additionally, the public would benefit by an overall reduction in ionizing radiation exposure from X-ray and a subsequent reduction in cancers. The estimated market potential for the proposed ultrasound-based bone imaging technology is estimated at approximately $580 M/yr in the United States. The primary target market for the technology is the lumbar spinal anesthesia market. Currently these procedures exhibit failure rates of 40% - 80% in the obese, which results in poor patient outcomes and higher costs for health care providers. 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.