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

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力包括减少重症患者的发病率和消除美国医疗保健系统每年在翻修手术和与术后血栓后期检测相关的不必要程序上的数亿美元支出。外科医生有能力预防这些灾难性的事件，但前提是血栓的发生能够被及时发现。目前，在有针对性的手术后形成血栓的患者中，有一半会因为目前的方式的缺点而导致手术失败。这项技术使临床医生能够无创地跟踪关键血管内血流的变化，以便在健康受到任何损害之前进行干预，并防止大多数这些灾难性事件。除了显著减少患者痛苦和发病率外，此类干预措施还将对卫生保健系统产生巨大的积极经济影响。这项技术还可以大大提高临床对凝血过程的认识，并可能为这些本来要接受手术的患者提供非侵入性治疗。提出的项目与超声流动分析的新方法有关，具有重要的智力和科学价值。这项工作的目标是开发一种系统，该系统能够收集三维超声数据，并通过检测可植入部件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首次能够检测局部术后血栓形成，而不是通过延迟和间接的方法检测血栓相关问题，从而使患者面临手术失败的风险。该技术可以比所有其他可用方法更早地进行干预，从而改善患者的治疗效果并降低医院费用。此外，这种方法可以自动检测血流的关键变化，消除人为错误的风险。最后，本提案中开发的技术的传播代表了一个重要的里程碑，朝着创建更简单、更自动化的超声系统迈出了一步，这些系统可以将这种非侵入性、非电离的方式置于非专业临床医生手中，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.