Extended Depth SDOCT Imaging

描述（由申请人提供）：在这个第二阶段的小企业创新研究申请中，Bioptigen, Inc.提议将一种深度成像光谱域光学相干断层扫描（DI-SDOCT）成像系统商业化，该成像系统结合了第一阶段验证的技术，可以克服传统的OCT深度限制，最大无伪影成像深度接近10毫米。该产品将实现高速、高分辨率的角膜、虹膜和晶状体囊的前后表面成像，这是迄今为止任何其他产品都无法实现的。围手术期OCT有一个成熟的市场，二期的成果将是一种OCT成像产品，它扩展了目前临床使用的技术的能力，并使全深度、高分辨率的OCT前房成像能够满足手术室的严格需求。复合体共轭去除（Complex Conjugate Removal， CCR）是第一阶段方案中的高风险元素，该方案通过抑制直流噪声、自相关项和复合体共轭伪影，将可用成像深度提高了一倍。该系统能够在4.4 mm（深度）x 6 mm（横向）成像范围内以< 5mm深度分辨率成像，并校正角膜折射，从而能够准确测量组织微观结构和病理。第二阶段提出的技术创新包括用于扩展深度成像的光谱仪和探头光学设计，以及通过梳状滤波器减少衰减，这些都在Bioptigen之前的开发经验范围内。与巴斯科姆帕尔默眼科研究所合作者的分包合同将首先在临床和术中环境中进行外部技术验证和人体试验。

DESCRIPTION (provided by applicant): In this Phase II Small Business Innovation Research application, Bioptigen, Inc. proposes to commercialize a deep imaging spectral domain optical coherence tomography (DI-SDOCT) imaging system that incorporates technology proven during the Phase I period to overcome traditional depth limits in OCT and has a maximum, artifact free imaging depth approaching 10 mm. This product will enable high-speed, high- resolution imaging of the cornea, iris, and anterior and posterior surfaces of the lens capsule that is unavailable in any other product to date. There is a proven market for perioperative OCT, and the outcome of this Phase II will be an OCT imaging product that extends the capabilities of current technology used in the clinic and enables full depth, high resolution anterior chamber imaging with OCT that can meet the exacting needs of the operating suite. Complex Conjugate Removal (CCR), the high risk element of the Phase I proposal, was successfully implemented, doubling the available imaging depth with suppression of DC noise, autocorrelation terms, and the complex conjugate artifact. This system is capable of imaging with <5 mm depth resolution over a 4.4 mm (depth) x 6 mm (lateral) imaging range with correction for refraction at the cornea, enabling accurate measurement of tissue microstructure and pathologies. Technical innovations proposed in the Phase II include spectrometer and probe optical design for extended depth imaging and falloff mitigation through a comb filter and are within the scope of Bioptigen's prior development experience. A subcontract with collaborators at the Bascom Palmer Eye Institute will enable external technology validation and human trials in first a clinical and then an intraoperative setting.