SBIR Phase II: High-speed Low-cost Spectral Domain Optical Coherence Tomography System for Intravascular Imaging Applications

该小型企业创新研究（SBIR）第二阶段项目拟开发一种用于血管内成像应用的840 nm光谱域光学相干断层扫描（OCT）系统。 该系统将被设计为提供等于或优于当前临床可用的图像，并且将具有更高的成像速度和更低的成本。 血管内光学相干断层扫描已准备好接受临床和商业增长，但仍然受到可用性和成本的限制。 提高系统速度和降低成本将加速血管内OCT的临床应用。第二阶段的研究将通过在猪动物模型中进行体内成像，使系统走向商业化。如果成功，该项目更广泛的影响/商业潜力将是一种新的成像工具，用于冠状动脉疾病（CAD）的识别和治疗。 CAD影响估计1600万美国人，并且是心脏病发作和中风的主要原因，2006年在美国分别造成超过631，000人和137，000人死亡。 血管内OCT提供了随时间推移的斑块评估、支架植入和支架监测的详细成像信息。 识别和治疗不稳定斑块和其他血管内疾病将降低CAD的发病率和死亡率。 数十亿美元用于CAD的成像和治疗。 具有增加的成像能力和有竞争力的成本的OCT系统将提供对当前技术水平的显著改进。

This Small Business Innovation Research (SBIR) Phase II project proposes to develop an 840 nm spectral domain optical coherence tomography (OCT) system for intravascular imaging applications. The system will be designed to provide images equal to or better than what is currently clinically available, and will have higher imaging speeds with lower cost. Intravascular OCT is poised for clinical acceptance and commercial growth, but is still limited by availability and cost. Increasing system speed and reducing cost will accelerate clinical use of intravascular-OCT. The Phase II research will move the system toward commercial readiness by including in vivo imaging in a porcine animal model.The broader impact/commercial potential of this project, if successful, will be the availability of a new imaging tool for the identification and treatment of coronary artery disease (CAD). CAD affects an estimated 16 million Americans and is the primary cause of heart attacks and strokes, which killed over 631,000 and 137,000 people, respectively, in the United States in 2006. Intravascular OCT provides detailed imaging information on plaque assessment, stent implantation, and stent monitoring over time. Identification and treatment of unstable plaques and other intravascular conditions will reduce the morbidity and mortality rate from CAD. Billions of dollars are spent on imaging and treatment of CAD. An OCT system with increased imaging capability and competitive cost will provide a significant improvement over the current state-of-the-art.