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估多光谱时间分辨荧光光谱（ms-TRFS）诊断技术，作为增强广泛使用的商用达芬奇手术平台功能的工具。这是加州大学戴维斯分校（University of California, Davis）和Intuitive Surgical之间的合作。Intuitive Surgical是微创机器人辅助手术领域的全球技术领导者，在手术中率先使用了ms-TRFS。ms-TRFS技术将在机器人手术过程中提供无标签的实时（~secs）生化和功能组织特征测量。我们将在达芬奇仪器中集成一个光学端口，当与ms-TRFS设备耦合时，允许组织的点光谱和成像光谱。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，并指导机器人辅助手术期间的活检。本提案的初步临床目标是在接受经口机器人手术（TORS）的患者中进行头颈癌的术中评估。手术切除不完全与肿瘤复发密切相关，正常和异常组织之间可见和可触及的界面往往是微妙的。因此，准确确定肿瘤和正常组织之间的界限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。提出的研究策略包括两个步骤：首先是加速一个平台的临床验证，该平台将通过临床可用的仪器（即Intuitive Surgical 5 French Introducer）将ms-TRFS设备与达芬奇手术机器人集成在一起。该仪器包括一个光纤端口，最初将用于提供包括头颈部癌症在内的各种组织类型的直接测量。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，可用于确定ms-TRFS诊断潜力，对行业合作伙伴来说是一个“降低风险”的步骤。第二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适应特定的诊断需求。这将解决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，该研究解决了机器人辅助头颈部手术的两个关键挑战，即缺乏触觉反馈和无法在手术过程中进行实时组织诊断；并且有可能提高外科医生在保持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。虽然这项应用的重点是TORS，但我们注意到，该技术可以广泛应用，因为达芬奇机器人可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.