自主手术机器人行业研究报告

（2024年第16期总第48期） 2024年09月14日 自主手术机器人行业研究报告1 科创金融研究中心 朱雅姝刘碧波 【摘要】行业图谱研究是本中心科技成果转化研究的一项子课题，目标定位于清晰理解前沿科技成果的技术核心、科创企业的技术竞争力及科研工作者的研究进度，从而助力科技成果转化效率的提升。行业图谱研究将以系列形式展开，选取国家战略重点科技领域的商业应用场景逐一进行，时效性较强。 本报告为行业图谱研究之生物医学系列中的课题：自主手术机器人行业研究报告。自主手术机器人作为手术机器人领域的新兴方向，旨在通过集成先进的计算机视觉、感知、运动控制和人工智能技术，实现对手术过程中的环境感知、信息处理和任务执行，从而提高手术 的精确性、安全性和效率，减少对医生直接手动操作的依赖。近年来，自主手术机器人正处于技术进步、临床需求等因素驱动下快速发展阶段。自主手术机器人主要应用于简单重复，并且任务量很大的手术子任务，比如缝合等。自主手术机器人的关键技术涵盖感知系统、决策系统和执行系统，其中感知技术决定着该技术水平的核心竞争力。 在全球范围内，以美国北卡罗来纳大学威明顿分校等研究机构研发的STAR（Smart Tissue Anastomosis Robot）自主手术机器人系统为代表，正引领着自主手术机器人的快速发展。这些系统通过集成光学相机、近红外荧光成像等多源感知技术，以及基于深度学习的组织识别与跟踪算法，实现了对手术环境的实时感知；并采用基于规则或强化学习的智能规划算法，对缝合等关键手术步骤实现自主操控。目前，STAR系统在动物实验中展现出优于人工缝合的精确性和稳定性。根据自主化程度，自主手术机器人可分为6个等级。STAR机器人系统是目前自主化程度最高的自主化手术机器人系统，自主等级为3级，即有监督的自主性。该系统的自主化程度有望得到进一步的提升。 在国内，以北航和北邮为代表的研究团队在手术自主化领域有相应的研究和尝试，其中的感知系统主要是根据双目摄像头进行设计。尽管相关的研究已经发表，但是目前的自主化的手术任务，比如手术切口闭合、手术中组织表面血液移除，相较简单。同时，目前国内的研究只停留于实验室模型验证阶段，需要进一步的动物实验和临床实验验证。 自主手术机器人的发展仍面临诸多挑战：一是核心技术有待突破，尤其在感知、决策和执行层面的精准度和鲁棒性方面；二是标准规范 亟需建立，涵盖功能安全、伦理道德等方方面面；三是临床验证有待加强，需在实际手术环境下全面评估其安全性和有效性；四是法律法规和商业模式尚不明晰，影响产业化进程。基于上述原因，当下还没有成熟的自主手术机器人产品。 未来，随着人工智能、微纳制造等共性技术的进步，以及手术机器人专用芯片、精密传感器等关键元器件的国产化，自主手术机器人有望在精准度、微创化、智能化等方面取得重大突破，并逐步在泌尿、妇科、普外等临床科室实现常规应用，提升患者的诊疗质量。届时，还可融合5G、云计算等信息基础设施，建立基于自主手术机器人的智慧手术平台，积累构建手术知识图谱，反哺基础研究。 总之，在智能医疗的时代，自主手术机器人已成为推动手术机器人产业化的下一个风口，具有广阔的应用前景和巨大的市场潜力。面向未来，亟需政产学研用各方协同发力，攻克共性技术难题，优化法律法规环境，加速行业标准制定，构建基于自主手术机器人的智慧医疗生态系统，推动我国手术机器人技术实现弯道超车、引领全球。 ResearchReport September 14, 2024 Atlas of AutonomousSurgicalRobot2 ResearchCenter for Sci-Tech and Finance YashuZhu,BiboLiu Abstract: The creation of an Atlas of the Industry is a sub-project within our center'sresearch on the transformation of scientific and technological achievements.The objective is to gain a comprehensive understanding of the coretechnologies driving cutting-edge innovations, assess the technologicalcompetitiveness of leading enterprises, and track researchers' progress toenhancethe efficiency of technology transfer. This research will beconductedin a series, focusing on commercial applications in key nationalstrategic scientific and technological fields, with a strong emphasis ontimeliness. This report delves into the autonomous surgical robots industry withinbiomedical research. Autonomous surgical robots represent an emergingfield in surgical robotics aimed at enhancing surgery through advancedtechnologies such as computer vision, perception, motion control, and artificial intelligence. These innovations seek to improve surgical accuracy,safety,and efficiency while reducing the reliance on direct manualintervention by surgeons. Recent years have seen rapid advancements inautonomous surgical robots driven by technological progress and clinicaldemands. They are primarily used for straightforward, repetitive tasks suchas suturing. Globally, the STAR (Smart Tissue Anastomosis Robot) system, developedby the University of North Carolina at Wilmington and other institutions,stands at the forefront of this development. STAR integrates multiplesensingtechnologies,including optical cameras and near-infraredfluorescence imaging, coupled with deep-learning algorithms for tissuerecognition and tracking. It employs intelligent planning algorithms toautonomously perform critical surgical steps like suturing, demonstratingsuperior accuracy and stability compared to manual methods in animal trials.The STAR system currently operates at level 3 autonomy, indicatingsupervised autonomy, with expectations for further enhancements. In China, research teams from Beijing University of Aeronautics andAstronautics(BUAA)andBeijingUniversityofPostsandTelecommunications(BUPT)areexploringautonomoussurgicaltechnologies, primarily using binocular camera-based perception systems.Although initial research has shown promise, current applications in surgicaltasks like incision closure and tissue surface blood removal remain relativelybasic.Domestic efforts are still confined to laboratory validations,necessitating further validation through animal and clinical trials. The development of autonomous surgical robots faces several challenges:advancing core technologies, establishing standards encompassing safetyand ethics, validating clinical effectiveness under surgical conditions, andnavigating unclear legal frameworks and business models, which hinderindustrialization. For these reasons, there are no mature autonomous surgicalrobot products available today. Lookingforward,advancements in artificial intelligence,micro-nanomanufacturing,and localized components are expected to propelautonomous surgical robots towards greater precision, minimally invasivecapabilities, and intelligence. This evolution anticipates routine integrationinto clinical departments such as urology, gynecology,and general surgery,thereby enhancing patient care quality. Future prospects include integrating5G and cloud computing into an intelligent surgical platform based onautonomous robots, building a comprehensive surgical kno