SBIR Phase II: Automatic Vascular Flow Reconstruction with Adaptive Three-Dimensional Doppler Ultrasound

这一小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力包括减少严重患者发病率，消除美国医疗系统每年用于修订手术和与手术后血栓检测较晚相关的不必要程序的数亿美元支出。外科医生有能力预防这些灾难性的事件，但前提是血栓的发作能够被及时检测到。目前，在靶向手术后形成血栓的患者中，有一半将由于目前手术方式的缺点而遭受手术失败。这项技术使临床医生能够非侵入性地跟踪关键血管内的血流变化，以便在任何健康损害之前进行干预，并防止大多数此类灾难性事件。除了显著减少病人的痛苦和发病率外，这种干预措施还将对卫生保健系统产生巨大的积极经济影响。这项技术还可以显著提高临床对凝血过程的了解，并可能使这些患者能够进行非侵入性治疗，否则他们将接受手术。拟议的项目提供了与超声流量分析新方法相关的重大智力和科学价值。这项工作的目标是开发一种系统，该系统能够收集3D体积的超声数据，并通过检测可植入部件来自动提取感兴趣区域的血流数据。这种测量血管流量的新方法将是第一个能够检测到手术后局部凝块形成的方法，而不是通过延迟和间接的方法检测与凝块相关的问题，这些方法会使患者面临手术失败的风险。这项技术可以比所有其他可用的方法更早地进行干预，从而改善患者的预后并降低医院成本。此外，该方法能够自动检测血流的关键变化，消除了人为错误的风险。最后，这项提案中开发的技术的传播是朝着创建更简单、更自动化的超声系统的一个重要里程碑，该系统可以将这种非侵入性、非电离模式交到非专家临床医生手中，用于更广泛的医疗应用。

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.