Robust Wide-Angle Spectral Domain OCT Arthroscope for Operative Imaging and Guida

描述（由申请人提供）：该I期小企业创新研究申请建议开发一种鲁棒的光谱域光学相干断层扫描（SDOCT）系统，适用于骨关节炎的联合诊断和治疗监测。骨关节炎在美国已达到流行病的程度。在发生不可逆变化之前难以诊断软骨退行性变是骨关节炎疾病改善治疗发展和评估的主要障碍。退行性变的最早迹象发生在关节面破裂之前，包括难以通过x线摄影、标准关节镜检查或常规磁共振成像（MRI）检测到的微结构变化。骨科医生每年为膝关节问题进行超过65万次关节镜检查，并在高达80%的患者中发现明显的软骨损伤。该应用的分包商Constance Chu教授表明，OCT可以在关节镜下以与低倍率组织学相当的分辨率对关节软骨进行无损成像，并且在实验室中发现的OCT可检测的变化表明，早期软骨对合成代谢生长因子不敏感的潜在可逆性在接受关节镜手术的早期退行性关节疾病患者中更为普遍。由于早期软骨细胞代谢不全与骨关节炎的发病机制有关，这些发现支持了OCT可以在临床上用于改善早期关节软骨退变的关节镜诊断的假设。本提案旨在开发关节镜OCT的新型临床技术，包括开发用于软骨表面亚表面可视化的新型刚性管镜技术，将OCT探头与用于清创的关节镜工具协同使用，以及组件的重新配置/小型化，以方便和频繁地对整个探头进行灭菌。

DESCRIPTION (provided by applicant): This Phase I Small Business Innovative Research application proposes to develop a robust spectral domain optical coherence tomography (SDOCT) system suitable for combined diagnosis and treatment monitoring of osteoarthritis. Osteoarthritis is reaching epidemic proportions in the United States. Difficulty in diagnosing cartilage degeneration prior to the development of irreversible changes is a major obstacle to development and evaluation of disease modifying treatments for osteoarthritis. The earliest signs of degeneration occur prior to breakdown of the articular surface and include microstructural changes that are difficult to detect by radiographs, standard arthroscopy, or conventional magnetic resonance imaging (MRI). Orthopaedic surgeons perform over 650,000 arthroscopies a year for knee problems and find visible cartilage damage in up to 80% of patients. Professor Constance Chu, a subcontractor on this application, has shown that OCT can be used arthroscopically to nondestructively image articular cartilage at resolutions comparable to low power histology, and that OCT detectable changes found in the laboratory to indicate potentially reversible early cartilage insensitivity to anabolic growth factors were more prevalent in patients undergoing arthroscopic surgery for conditions associated with early degenerative joint disease. Because early chondrocyte metabolic incompetence has been implicated in the pathogenesis of osteoarthritis, these findings support the hypothesis that OCT can be used clinically to improve arthroscopic diagnosis of early articular cartilage degeneration. This proposal aims to develop novel clinical technology for arthroscopic OCT by developing new rigid borescope technology for sub-surface visualization of cartilage surfaces, synergizing the OCT probe with arthroscopic tools used for debridement, and reconfiguration/miniaturization of components to permit easy and frequent sterilization of the entire probe.