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

这一小型企业创新研究(SBIR)第二阶段项目建议开发840 nm光谱域光学相干层析成像(OCT)系统，用于血管内成像应用。该系统的设计将提供与目前临床可用的图像相同或更好的图像，并将以更低的成本获得更高的成像速度。血管内OCT有望获得临床接受和商业发展，但仍受到可获得性和成本的限制。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活体成像，将该系统推向商业就绪状态。如果该项目成功，该项目的更广泛的影响/商业潜力将是一种新的成像工具的可用性，用于识别和治疗冠状动脉疾病(CAD)。据估计，冠心病影响着1600万美国人，是心脏病发作和中风的主要原因，2006年在美国，心脏病发作和中风分别导致超过63.1万人和13.7万人死亡。血管内OCT可提供斑块评估、支架植入和一段时间内支架监测的详细影像信息。识别和治疗不稳定的斑块和其他血管内疾病将降低冠心病的发病率和死亡率。数十亿美元被花费在冠心病的成像和治疗上。具有更高成像能力和更具竞争力的成本的OCT系统将比目前最先进的水平提供显著的改进。

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.