Clinical System for Arterial Characterization

描述（由申请人提供）：已发表的研究表明，可见波长反射和荧光光谱法均是临床识别易损斑块（VP）的有前景的技术-易损斑块是一种易于破裂并产生动脉血栓的疾病。在正常的血管镜检查中，反射率已经可见，黄色脂质可以通过白色纤维帽弥散可见，这取决于其厚度，并形成VP的定性指示。通过定量光谱学识别VP的临床有用仪器的进展需要基于动脉的光纤侧视探针（SLP）。第2阶段计划的主要目标是通过建立在第1阶段组织探针光谱建模、开发的探针构造技术和获得的探针组织测量值的基础上来实现这一点。在II期项目中，将生产三种SLP设计，并在外周动脉中进行临床试验。数据将被简化以提供光谱分辨的漫反射和固有荧光。将比较并行Monte Carlo建模的结果、病理学结果和其他测量结果，以表征组织并识别具有薄纤维帽和显著脂质核心的病变-VP标志。我们期望将比色信息与固有荧光结合在一起将产生比单独使用更好的结果。

DESCRIPTION (provided by applicant): Published studies indicate that visible wavelength reflectance and fluorescence spectroscopy are each promising techniques for clinically recognizing vulnerable plaque (VP) - a condition prone to rupture and produce arterial thrombosis. Reflectance is already visually accessible in normal angioscopy, and yellow lipid may be seen diffusely through an otherwise white fibrous cap, depending on its thickness, and form a qualitative indication for VP. Progress toward a clinically useful instrument for recognizing VP by quantified spectroscopy requires an arterial, optical-fiber based side-looking probe (SLP). It is a primary goal of the Phase-2 program to accomplish this by building on the Phase-1 tissue-probe-spectroscopy modeling, probe construction techniques developed, and probe - tissue measurements obtained. In the Phase-2 program three SLP designs will be produced and clinically tested in peripheral arteries. The data will be reduced to provide spectrally resolved diffuse reflectance and intrinsic fluorescence. Comparison will be made to results from concurrent Monte Carlo modeling, results from pathology, and results from the measurements of others with respect to characterizing the tissue and recognizing lesions with thin fibrous caps with a significant lipid core - hallmarks of VP. We expect that bringing together the colorimetry information with intrinsic fluorescence will produce results better than either alone.