SBIR Phase I: Hybrid Mechanical-Optical Patient Tracking for Robotic Surgery

该项目的更广泛的影响/商业潜力将是创新一种新的患者跟踪系统，这将提高机器人手术在术中环境中的可用性。机器人手术在各种医疗程序中变得无处不在，数据继续显示临床结果有所改善。然而，可用性挑战阻碍了更广泛的采用。该项目将结合多种跟踪模式，包括机械和光学跟踪，以创建一种混合跟踪技术，允许每种模式的优势。这将优化患者的活动范围，同时最大限度地减少视线挑战。这种患者跟踪技术可以与现有的牙科种植手术机器人手术系统结合使用，这构成了一个重要的市场机会。植牙是牙齿替换的标准护理，美国的植牙市场价值超过10亿美元，每年增长近8%，全球每年植入的种植体超过1400万颗。这项技术不仅可以用来革新目前应用该系统的牙科种植手术，还可以在其他颅骨手术中创造潜在的机会，否则这些手术会受到侵入性、繁琐的跟踪技术的负担，阻碍手术中的可用性。这个小企业创新研究(SBIR)第一阶段项目将展示第一个结合机械和光学跟踪方法的混合患者跟踪设备的可行性。光学跟踪系统要求摄像机对外科领域中的几个跟踪标记具有直接的视线，这对外科医生和助手构成了巨大的挑战，他们必须小心避免遮挡摄像机的视场。机械跟踪系统限制了患者的活动范围，而且可能很笨重。该项目的成功将导致牙科种植手术机器人手术系统的开发，该系统包括：1)基于CT的术前规划软件；2)提供GPS系统等屏幕图形的视觉引导系统；3)监控患者位置的光学和机械混合跟踪系统；4)与外科医生同时抓住钻头以提供触觉反馈的机械臂，以约束外科医生匹配计划的截骨手术。该系统实现了微创、无瓣手术，结果表明，患者痛苦较少，手术速度更快。它被设计成易于使用，并无缝地集成到外科医生的工作流程中。

The broader impact/commercial potential of this project will be to innovate a novel patient tracking system, which will improve robotic surgery usability in an intra-operative environment. Robotic surgery is becoming ubiquitous across various medical procedures, and data continues to show improved clinical results. However, usability challenges impede broader adoption. This project will combine multiple tracking modalities, including mechanical and optical tracking, to create a hybrid tracking technology that allows for the advantages of each modality. This will optimize patient range of motion while minimizing line-of-sight challenges. This patient tracking technology can be used in conjunction with an existing robotic surgery system for dental implant procedures, which comprise a significant market opportunity. Dental implants are the standard of care for tooth replacement, and the dental implant market in the US is over $1 billion and growing nearly 8% per year with more than 14 million implants being placed annually worldwide. This technique can be used not only to revolutionize dental implant surgery, where the system is currently applied, but also to potentially create opportunities in other cranial procedures, which are otherwise burdened by invasive, cumbersome tracking technologies that impede intra-operative usability.This Small Business Innovation Research (SBIR) Phase I project will demonstrate the feasibility of the first hybrid patient tracking device that combines mechanical and optical tracking methods. Optical tracking systems require that cameras have direct line-of-sight to several tracked markers in the surgical field, which poses a significant challenge to the surgeon and assistants that have to carefully avoid blocking the camera's field-of-view. Mechanical tracking systems limit a patient's range of motion and can be bulky. The success of this project will lead to the development of a robotic surgery system for dental implant procedures that encompasses: 1) pre-operative CT-based planning software, 2) a visual guidance system that provides on-screen graphics like a GPS system, 3) a hybrid optical and mechanical tracking system that monitors the patient position, and 4) a robot arm that physically grasps the drill at the same time as the surgeon in order to provide haptic feedback, constraining the surgeon to match the planned osteotomy. This system enables minimally invasive, flapless surgery that is shown to result in less pain for the patient and faster surgery. It is designed to be easy to use and seamlessly integrate into the surgeon's workflow.