The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project includes the reduction in severe patient morbidity and elimination of hundreds of millions of dollars of expenditures by the U.S. healthcare system each year on revision surgeries and unnecessary procedures associated with late detection of post-surgical blood clots. Surgeons have the ability to prevent these catastrophic events, but only if the onset of the clot can be detected in a timely manner. Currently, of the patients who form clots after the targeted surgeries, half will suffer from a surgical failure due to the shortcomings of current modalities. This technology gives clinicians the ability to non-invasively track changes in blood flow within critical vessels to enable intervention prior to any compromise in health and prevent a majority of these catastrophic incidents. Beyond significant decreases in patient suffering and morbidity, such interventions will have an enormous positive economic impact on the health care system. This technology can also substantially improve clinical understanding of the clotting process and possibly enable non-invasive therapeutic treatments for these patients who otherwise would receive surgery.
The proposed project offers significant intellectual and scientific merit associated with new methods of ultrasound flow analysis. The objective of this work is to develop a system that is able to collect a 3D volume of ultrasound data and automatically extract the blood flow data in the region of interest by detecting an implantable component. This novel approach to measuring vascular flow will be the first to enable detection of localized post-operative clot formation rather than detecting clot-related issues via delayed and indirect methods that leave patients at risk for surgical failures. This technique can allow for intervention earlier than all other available methods, thus improving patient outcomes and reducing hospital costs. Furthermore, this method enables automatic detection of critical changes in blood flow, eliminating the risk of human error. Lastly, dissemination of the technology developed in this proposal represents an important milestone towards the creation of simpler, more automated ultrasound systems that can place this non-invasive, non-ionizing modality in the hands of non-expert clinicians for use in a broader spectrum of medical applications.