Fluorescence lifetime imaging/spectroscopy system for robotic cancer surgery guid

描述（由申请人提供）：我们建议推进和临床评价多光谱时间分辨荧光光谱（ms-TRFS）诊断技术，将其作为增强广泛使用的市售da芬奇Surgical平台功能的工具。这是加州大学戴维斯分校与Intuitive Surgical之间的合作伙伴关系，该大学率先在术中使用ms-TRFS，Intuitive Surgical是微创机器人辅助手术的全球技术领导者。ms-TRFS技术将在机器人手术过程中提供生物化学和功能组织特征的无标记实时（~秒）测量。我们将在da芬奇仪器中集成一个光学端口，当耦合到ms-TRFS装置时，允许组织的点和成像光谱。ms-TRFS参数将为外科医生提供局部病理的快速临床评估，肿瘤边缘和其他相关组织的识别，以及机器人辅助手术期间活检的指导。该提案的初步临床目标是对接受经口腔机器人手术（TORS）的患者进行头颈癌的术中评估。不完全的手术切除与肿瘤复发密切相关，并且正常组织和异常组织之间的可见和可触知界面通常是微妙的。因此，准确地确定肿瘤和正常组织之间的边界是特别困难和关键的。我们在这种癌症的荧光寿命特征和临床兼容的TRFS技术方面都有丰富的经验。我们的初步临床数据表明，TRFS可以区分口腔中不同类型的组织，包括癌，拟议的工作建立在我们的基础上。拟定的研究策略包括两个步骤：第一步是加速平台的临床验证，该平台将通过临床可用的仪器（即Intuitive Surgical 5 French导引器）将ms-TRFS器械与da芬奇手术机器人集成。该仪器包括一个光纤端口，最初将用于提供各种组织类型的直接测量，包括头颈癌。这一步骤将允许快速生成来自不同组织类型的光学特征数据库，该数据库可用于确定ms-TRFS诊断潜力，并代表了行业合作伙伴的“去风险”步骤。第二个是开发一种更专业的仪器，包括一个端口，可以在机器人辅助手术过程中满足特定的诊断需求。这将满足我们的工业合作伙伴的长期研发计划目标和商业化战略。总之，拟议的研究解决了机器人辅助头颈外科手术中的两个关键挑战，即缺乏触觉反馈和无法在手术期间真实的时间内进行组织诊断;并且有可能提高外科医生在保留正常组织和功能的同时以低复发率进行完整手术切除的能力。虽然本申请的重点是TORS，但我们注意到所提出的技术可以广泛应用，因为da芬奇机器人用于一系列肿瘤手术，包括泌尿外科、结肠直肠癌、妇科和胸部癌症。

DESCRIPTION (provided by applicant): We propose to advance and clinically evaluate a multispectral Time-Resolved Fluorescence Spectroscopy (ms-TRFS) diagnostic technique as a tool for enhancing the functionality of the widely-used commercial da Vinci Surgical platform. This is a partnership between the University of California, Davis, which has pioneered intra-operative use of ms-TRFS and Intuitive Surgical, the global technology leader in minimally invasive robotic-assisted surgery. The ms-TRFS technique will provide label-free real-time (~secs) measures of biochemical and functional tissue features during robotic surgical procedures. We will integrate an optical port within the da Vinci instruments that when coupled to the ms-TRFS apparatus allows for both point- and imaging spectroscopy of tissue. The ms-TRFS parameters will provide surgeons with rapid clinical assessment of local pathologies, identification of tumor margins and other relevant tissues, and guidance of biopsy during robotic-assisted surgery. The initial clinical target of this proposal is intra-operative assessmen of head & neck cancer in patients undergoing TransOral Robotic Surgery (TORS). Incomplete surgical resection is strongly associated with tumor recurrence and the visible and palpable interface between normal and abnormal tissue is frequently subtle. As such it is particularly difficult and critical to accurately determine the boundary between tumor and normal tissue. We have extensive experience with both the fluorescence lifetime signatures of this cancer and clinically-compatible TRFS technology. The proposed work builds on our preliminary clinical data showing that TRFS can distinguish different types of tissues in the oral cavity including carcinoma. The proposed research strategy involves two steps: The first is to accelerate the clinical validation of a platform which will integrate the ms-TRFS device with the da Vinci Surgical Robot via a clinically available instrument, i.e. the Intuitive Surgical 5 French Introducer. This instrument includes a fiber optic port and will be initially used to provide direc measurements from various tissue types including cancer of the head & neck. This step will allow rapid generation of a database of optical features from different tissues types that can be used to determine the ms-TRFS diagnostic potential and represents a "derisking" step for the industry partner. The second is to develop a more specialized instrument including a port that can accommodate specific diagnostic needs during robot-assist surgical procedures. This will address our industrial partner's longer-term R&D programmatic goals and commercialization strategy. In summary, the proposed study addresses two critical challenges in robot-assisted head & neck surgery, i.e. the lack of tactile feedback and the inability to perform tissue diagnosis in real time during surgery; and has the potential to improve the surgeon's ability to perform complete surgical resection with low recurrence rates while preserving normal tissue and function. While the focus of this application is on TORS, we note the proposed technique can be broadly applied as the da Vinci Robot is used in a range of tumor surgeries including urologic, colorectal, gynecologic, and thoracic cancers.