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

描述(由申请人提供)：这项第一阶段的小型企业创新研究申请提出开发一种稳健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。骨性关节炎在美国正达到流行的程度。在发生不可逆转的变化之前难以诊断软骨退变，这是开发和评估骨关节炎疾病修正治疗的主要障碍。退变的最早迹象发生在关节表面破裂之前，包括很难通过X光片、标准关节镜或常规磁共振成像(MRI)发现的微结构变化。骨科医生每年为膝关节问题进行超过650,000次关节镜检查，发现高达80%的患者存在明显的软骨损伤。康斯坦斯·朱教授是这一应用的分包商，他已经证明，OCT可以在关节镜下以与低倍组织学相当的分辨率对关节软骨进行非破坏性成像，并且在实验室发现的表明早期软骨对合成生长因子潜在可逆的可检测变化在接受关节镜手术治疗早期退行性关节疾病的患者中更为普遍。由于早期软骨细胞代谢不足与骨关节炎的发病机制有关，这些发现支持OCT可用于临床提高关节镜下对早期关节软骨退行性变的诊断。这项建议旨在开发关节镜下OCT的新临床技术，开发用于软骨表面下可视化的新的硬性孔镜技术，将OCT探头与用于清创的关节镜工具协同使用，并对部件进行重新配置/微型化，以便于对整个探头进行方便和频繁的灭菌。

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.