SBIR Phase II: 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）二期项目解决了临床和市场对便携式、低成本和安全的x射线替代技术的需求。虽然x射线是目前骨骼解剖诊断成像的主要方式，但它有许多局限性：辐射、体积大、价格昂贵。在一期项目中，我们用手持式超声样机演示了该技术的可行性，该样机使用离体全猪腰椎模型演示了3D徒手骨成像。第二阶段的研究目标包括：1)设计并构建试产超声样机；2)开发基于模型配准的三维骨成像应用，并发布临床软件版本，并进行正式验证和验证测试；3)准备该装置用于人类受试者的临床使用，并通过医生测试在离体猪腰椎模型中进行实验验证。预计该项目将导致一种新的医疗设备的演示，该设备通过3D便携式实时脊柱骨成像证明了改善脊髓麻醉管理的有效性。该项目的更广泛的影响/商业潜力是基于医学超声的x射线替代技术，其细分市场包括脊髓麻醉、骨科和急诊医学。由于迫切的市场需求和临床需求，Rivanna Medical首先瞄准了脊髓麻醉市场。由于缺乏安全、便携和廉价的骨解剖医学成像，这些手术目前表现出很高的首次尝试失败率。失败会导致患者预后不佳，并给医疗保健提供者带来更高的成本。在这个应用中，我们的先导设备SpineFinder将通过实时引导患者进行脊柱注射来提高成功率。年代的床边。安全、廉价、便携的骨成像产品的社会影响包括更成功的手术、更好的患者预后和更低的医疗成本。此外，公众将受益于x射线电离辐射暴露的全面减少以及随后癌症的减少。通过这个项目，通过更好地理解超声与镜面反射表面（如骨头）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 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.