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

该小型企业创新研究（SBIR）第二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和市场需求。虽然X射线是目前用于骨解剖结构的诊断成像的主要模式，但它具有许多局限性：辐射发射、体积大且昂贵。在第一阶段的项目中，我们用手持式超声原型证明了该技术的可行性，该原型使用离体全猪腰椎模型证明了3D徒手骨成像。第二阶段研究目标包括：1）设计和构建预生产超声原型; 2）开发基于模型配准的3D骨骼成像应用程序，并发布临床软件版本，并进行正式验证和确认测试;和3）准备该设备用于人类受试者的临床使用，并在离体猪腰椎模型中进行实验验证，并进行医生测试。预计该项目将证明一种新的医疗器械，其通过3D便携式实时脊柱骨成像改善脊髓麻醉管理的有效性。该项目更广泛的影响/商业潜力是基于医疗超声的X射线替代技术，该技术可解决包括脊髓麻醉，骨科和急诊医学在内的细分市场。Rivanna Medical首先瞄准脊髓麻醉市场，因为市场和临床需求令人信服。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较高的首次尝试失败率。失败会导致患者预后不良，并增加医疗保健提供者的成本。在这个应用中，我们的主要设备，Spineplastics，将提高成功率，通过实时指导脊柱注射在病人？s bedside.安全、廉价、便携式骨成像产品的社会影响包括更成功的手术、更好的患者结局和更低的医疗成本。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。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 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.