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

小型企业创新研究(SBIR)第一阶段项目旨在证明，840 nm光谱域光学相干断层扫描(OCT)可以提供与当前扫描源OCT相同或更好的图像，并具有更高的成像速度和更低的成本。血管内OCT有望实现商业增长，但仍受到技术复杂性、可用性和成本的限制。这一阶段的SBIR提出了一个完整的原型系统，基于非常高的分辨率(0.02 nm/像素)光谱仪，能够以10微米的分辨率成像5 mm深的图像。设计了一种新型光纤探头，并制作了样机。原则数据的证明将从组织模型和废弃的动物组织中收集。在第一阶段成功完成之前，第二阶段项目将完成系统工程，降低系统成本，并以首次人体成像为目标。该项目更广泛的影响/商业潜力是提高血管内OCT(IV-OCT)的性能和可用性。血管内OCT为斑块评估、支架植入和随时间推移的支架监测提供详细的成像信息。识别和治疗不稳定斑块和其他血管内疾病可以降低冠状动脉疾病(CAD)的发病率和死亡率。冠心病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。据估计，血管内OCT的市场规模每年超过10亿美元，但目前只有一种商业上可用的IV-OCT系统。通过提高系统速度和降低成本，本项目将加速IV-OCT的临床应用。

This Small Business Innovation Research (SBIR) Phase I project seeks to demonstrate that 840 nm spectral domain optical coherence tomography (OCT) can provide images equal to or better than those currently available from swept source OCT, with the added advantages of higher imaging speeds and lower cost. Intravascular OCT is poised for commercial growth, but is still limited by technical complexity, availability, and cost. This Phase I SBIR proposes a complete prototype system based on a very high resolution (0.02 nm/pixel) spectrometer, capable of imaging 5 mm deep with a resolution of 10 microns. A novel fiber probe will be designed and prototyped. Proof of principle data will be collected from tissue phantoms and waste animal tissue. Pending successful completion of a Phase I, a Phase II project would complete system engineering, decrease system cost, and target first in-human imaging.The broader impact/commercial potential of this project is an increase in performance and availability of intravascular OCT (IV-OCT). Intravascular OCT provides detailed imaging information for plaque assessment, stent implantation, and stent monitoring over time. Identification and treatment of unstable plaques and other intravascular conditions can reduce the morbidity and mortality rate from coronary artery disease (CAD). CAD is the primary cause of heart attacks and strokes, which killed over 631,000 and 137,000 people, respectively, in the U.S in 2006. The market size for intravascular OCT is estimated at more than $1B annually, but there is currently only one commercially available IV-OCT system. By increasing system speed and reducing cost, this project will accelerate clinical use of IV-OCT.