Extended Depth SDOCT Imaging

描述(由申请人提供)：在此第二阶段小型企业创新研究申请中，Bioptigen，Inc.提议将深度成像光谱域光学相干层析成像(DI-SDOCT)成像系统商业化，该成像系统结合了在第一阶段期间得到验证的技术，以克服OCT的传统深度限制，并且具有最大无伪影成像深度接近10毫米。这款产品将实现对角膜、虹膜以及晶状体囊前后表面的高速、高分辨率成像，这是任何其他产品迄今无法提供的。围手术期OCT有一个成熟的市场，这一第二阶段的结果将是OCT成像产品，它扩展了临床使用的现有技术的能力，并通过OCT实现全深度、高分辨率的前房成像，可以满足手术室的严格需求。成功地实施了复数共轭去除(CCR)，这是第一阶段提案中的高风险元素，通过抑制DC噪声、自相关项和复共轭伪影，使可用成像深度加倍。该系统能够在4.4 mm(深度)x 6 mm(横向)的成像范围内以&lt；5 mm的深度分辨率进行成像，并对角膜的折射进行校正，从而能够准确测量组织的微观结构和病理。在第二阶段中提出的技术创新包括光谱仪和探头光学设计，用于扩展深度成像和通过梳状过滤器减少衰减，属于Bioptigen以前的开发经验范围。与巴斯科姆·帕尔默眼科研究所的合作者签订的分包合同将使外部技术验证和人体试验能够首先在临床上进行，然后在手术中进行。

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.