Extended Depth SDOCT Imaging

描述（由申请人提供）：在此II期小企业创新研究申请中，Bioptigen，Inc.提出将深成像谱域光学相干断层扫描商业化（DI-SDOCT）成像系统，该系统采用了在第一阶段经过验证的技术，克服了OCT的传统深度限制，最大无伪影成像深度接近10 mm。该产品将实现角膜、虹膜、以及透镜囊的前表面和后表面，这在迄今为止的任何其它产品中是不可用的。围手术期OCT有一个成熟的市场，第二阶段的成果将是一个OCT成像产品，它扩展了临床中使用的现有技术的能力，并实现了OCT的全深度、高分辨率前房成像，可以满足手术室的严格需求。成功实施了第一阶段提案的高风险要素--复共轭消除（CCR），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）成像范围内以<5 mm的深度分辨率成像，并校正角膜处的屈光，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光谱仪和探头光学设计，用于扩展深度成像和通过梳状滤波器减轻衰减，并且在Bioptigen先前开发经验的范围内。与巴斯科姆帕尔默眼科研究所的合作者进行的一项研究将首先在临床上进行外部技术验证和人体试验，然后在术中进行。 公共卫生相关性：谱域光学相干断层扫描（SDOCT）是一种非侵入性的高分辨率光学成像方法，常用于眼科应用，以更好地了解或诊断疾病。目前还没有针对手术市场的SDOCT产品，但在手术过程中快速成像眼睛的能力可以大大改善手术结果并限制患者风险。该建议试图通过提供能够对角膜、虹膜和透镜的两个表面成像的装置来扩展SDOCT的实用性，该装置可以用于临床和手术室。该产品将提供比市场上任何商业SDOCT产品更长的成像深度范围。这可以极大地帮助研究其病理表现为结构大于传统SDOCT系统的最大深度范围的疾病。一个直接的应用将是在白内障或青光眼手术之前、期间和之后监测眼睛，以确保手术成功。

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. PUBLIC HEALTH RELEVANCE: Spectral Domain Optical Coherence Tomography (SDOCT) is a non-invasive, high resolution optical imaging method that is often used in ophthalmic applications to better understand or diagnose disease. There are currently no SDOCT products that target the surgical market, but the ability to rapidly image the eye during surgery could greatly improve the outcome of the surgery and limit patient risk. This proposal seeks to extend the utility of SDOCT by providing a device capable of imaging the cornea, iris, and both surfaces of the lens that can be used in the clinic and in the surgical suite. This product will provide a much longer imaging depth range than any commercial SDOCT product on the market. This could greatly aid in the research of diseases whose pathology manifests as structures larger than the maximum depth range of traditional SDOCT systems. An immediate application would be monitoring the eye before, during, and after cataract or glaucoma surgery to ensure the surgery is successful.