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)第一阶段项目满足了临床对便携式、低成本和安全的X射线替代技术的需求。X射线仍是目前用于骨骼诊断成像的主要方式，尽管它有许多局限性：辐射、体积大和相对昂贵。这项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)展示手持超声系统，在体外体模中进行自由手三维(3D)骨重建；以及3)在体外全猪模型中展示自由手3D骨成像系统。预计机械扫描的超声换能器将产生15帧/S的帧速率和2.5毫米的分辨率，成像深度为10厘米。体外体模实验将使用计算机辅助设计的人体脊椎模型进行。三维超声重建结果与计算机模型之间的误差预计为2.5 mm。最后，提出的设备预计将产生0.90相关性的CT重建完整的猪脊柱。总体而言，该项目预计将展示一种与CT高度相关的基于手持3D超声的骨骼成像技术的可行性。该项目的更广泛的影响/商业潜力包括更安全、更便宜、更准确的骨解剖成像在医疗成像技术应用中的应用：脊柱麻醉、矫形外科、急救医学。在急救等应用中，这项技术将使患者侧的骨骼解剖成像成为可能，而目前由于X光机的体积太大，这一技术还无法实现。此外，公众将受益于X射线电离辐射暴露的总体减少和随后的癌症减少。拟议中的基于超声波的骨骼成像技术在美国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的失败率为40%-80%，这导致患者结局不佳，医疗保健提供者的成本更高。通过这个项目，通过更好地了解超声波与镜面反射表面(如骨骼)的相互作用，将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.