SBIR Phase I: Acoustoelastic Tissue Property Evaluation of Selected Tissue Region in Dynamic Ultrasound Images

该小型企业创新研究（SBIR）第一阶段项目旨在开发一种用于实际临床应用的新型软件技术，该技术可以评估动态超声图像，以准确解释软组织（如肌腱和韧带）的变化或病理。今天，放射科医生通过观察静态MRI或超声图像并考虑关键因素（厚度变化，形状不规则性，图像像素强度）来诊断大多数肌肉骨骼疾病，这些因素只能支持定性的主观评估。开发一种客观、定量、可靠的诊断软组织损伤和监测愈合的方法可以导致更准确的诊断，并减少不完全愈合组织的再损伤。所提出的新型视频图像分析软件将在肌腱和韧带被拉伸时从肌腱和韧带捕获超声视频信号，将定量和定性地评估受影响组织的机械和功能特性，然后将结果呈现在清晰，易于解释的彩色编码显示器中。该软件应用代表了非侵入性和客观肌肉骨骼组织表征的突破，预期结果将是成功的感兴趣区域跟踪和变形分析算法以及可以区分组织病理的产品，如肌腱撕裂和肌腱炎，这些组织病理难以使用当前方法识别。该项目更广泛的影响/商业潜力是，所提出的软件应用程序将大大改善通过标准超声方法获得的诊断。人们越来越需要低成本的方法来提供对拉伤和扭伤的客观诊断，这占每年1600万次肌肉骨骼治疗事件的38%。最近超声图像质量、便携性和降低的价格的改进创造了在广泛的临床应用中使用超声的机会。阻碍更广泛执行的主要限制因素是外地？我们需要一个用户友好的，客观的分析结果的方法;目前，需要训练有素的放射科医生来分析超声图像。所提出的软件，通过提供临床医生（非放射科医生）的工具来诊断软组织病理在护理点，并通过定期评估愈合组织来评估康复的进展，将是第一个市场，并将彻底改变该领域。通过低成本的临床医生改善护理，并可能提供高成本MRI的替代品，将使患者和社会受益。拟议的技术将在生物和非生物材料的低成本定量表征领域带来更多创新。

This Small Business Innovation Research (SBIR) Phase I project proposes to develop a novel software technology for practical clinical use that can evaluate dynamic ultrasound images to accurately interpret changes or pathologies in soft tissues, such as tendons and ligaments. Today, a radiologist diagnoses most musculoskeletal diseases by observing static MRI or ultrasound images and considering key factors (thickness change, shape irregularity, image pixel intensity), that can support only qualitative, subjective assessments. Developing an objective, quantitative, reliable method of diagnosing soft tissue injuries and monitoring healing can lead to more accurate diagnoses and reduce re-injury of incompletely healed tissues. The proposed novel video image analysis software will capture ultrasound video signals from tendons and ligaments while they are being stretched, will both quantitatively and qualitatively evaluate the mechanical and functional properties of the affected tissues, and will then present the results in a clear, easy-to-interpret, color-coded display. This software application represents a breakthrough in non-invasive and objective musculoskeletal tissue characterization, and the expected outcome will be a successful region of interest tracking and deformation analysis algorithm and a product that can differentiate between tissue pathologies, like tendon tears and tendonitis, that are difficult to identify using current methods. The broader impact/commercial potential of this project is that the proposed software application will greatly improve diagnoses obtained through standard ultrasound methods. There is a growing need for low-cost methods for providing objective diagnoses of strains and sprains, which account for 38% of the 16 million musculoskeletal treatment episodes annually, at the point of care. Recent improvements in ultrasound image quality, portability, and reduced price have created the opportunity to use ultrasound in a wide array of clinical applications. The major limitation blocking wider implementation is the field?s need for a user-friendly, objective method of analyzing results; currently, highly trained radiologists are needed to analyze ultrasound images. The proposed software, by providing clinicians (non-radiologists) with a tool both to diagnose soft tissue pathologies at the point of care, and to evaluate the progress of rehabilitation by periodically assessing the healing tissues, will be the first to market and will revolutionize the field. Enabling improved care by lower cost clinicians and potentially offering a substitute for high-cost MRI will benefit patients and society. The proposed technology will lead to additional innovations in the area of low-cost, quantitative characterization of biological and non-biological materials.