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

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.