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

这个小型企业创新研究（SBIR）第一阶段项目解决了便携式，低成本和安全的X射线替代技术的临床需求。X射线是目前用于骨诊断成像的主要模式，尽管其有许多局限性：辐射发射、体积庞大且相对昂贵。本可行性研究的研究目标包括：1）设计、集成和测试低功耗机械扫描超声换能器; 2）在体外模型中演示具有徒手三维（3D）骨重建功能的手持式超声系统; 3）在离体全猪模型中演示徒手3D骨成像系统。预计机械扫描超声换能器将在成像深度10 cm处产生15帧/s的帧速率和2.5 mm的分辨率。将使用计算机辅助设计的人体脊柱模型进行体外体模实验。3D超声重建和计算机模型之间的误差预计为2.5 mm。最后，预计所提出的设备产生0.90的相关性CT重建的整个猪脊柱骨。总体而言，该项目预计将证明手持式三维超声骨成像技术的可行性，该技术与CT高度相关。该项目的更广泛影响/商业潜力包括在医学成像技术应用中更安全、更便宜、更准确的骨解剖成像：脊髓麻醉、骨科、急诊医学。在紧急护理等应用中，该技术将使患者侧骨骼解剖成像成为可能，由于X光机的庞大，目前无法实现。此外，公众将受益于X射线电离辐射照射的总体减少，从而减少癌症。在美国，基于超声的骨成像技术的市场潜力估计约为5.8亿美元/年。该技术的主要目标市场是腰椎麻醉市场。目前，这些手术在肥胖者中显示出40% - 80%的失败率，这导致患者预后不良和医疗保健提供者的成本更高。通过该项目，将更好地了解超声波与镜面反射表面（如骨骼）的相互作用，从而增强对声学的一般科学和技术理解。

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.