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

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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.