Abstract

We report on the design of a frequency domain optical coherence tomography (FD-OCT) system, fiber optic imaging catheter, and image processing algorithms for in vivo clinical use in the human coronary arteries. This technology represents the third generation of commercially-available OCT system developed at LightLab Imaging Inc. over the last ten years, enabling three-dimensional (3D) intravascular imaging at unprecedented speeds and resolutions for a commercial system. The FD-OCT engine is designed around an exclusively licensed micro-cavity swept laser that was co-developed with AXSUN Technologies Ltd. The laser's unique combination of high sweep rates, broad tuning ranges, and narrow linewidth enable imaging at 50,000 axial lines/s with an axial resolution of < 16 μm in tissue. The disposable 2.7 French (0.9 mm) imaging catheter provides a spot size of < 30 μm at a working distance of 2 mm. The catheter is rotated at 100 Hz and pulled back 50 mm at 20 mm/s to conduct a high-density spiral scan in 2.5 s. Image processing algorithms have been developed to provide clinically important measurements of vessel lumen dimensions, stent malapposition, and neointimal thickness. This system has been used in over 2000 procedures since August 2007 at over 40 clinical sites, providing cardiologists with an advanced tool for 3D assessment of the coronary arteries.

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