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达芬奇手术机器人技术与专利分析

嘉峪检测网        2023-01-30 11:30

手术机器人是一种先进的医疗设备,借助微创伤手术及相关底层技术的发展而发明。手术机器人被用于在高于人类能力的微创伤手术领域中实现高于人类能力的对手术器械的精准操控。手术机器人通常由手术控制台、配备机械臂的手术车及视像系统组成。外科医生坐在手术控制台,观看由放置在患者体内腔镜传输的手术区域三维影像,并操控机械臂的移动,以及该机械臂附带的手术器械及腔镜。机械臂模拟人类的手臂,为外科医生提供一系列模拟人体手腕的动作,同时过滤人手本身的震颤。
 
机器人手术系统是集多项现代高科技手段于一体的综合体,其用途广泛,在临床上外科上有大量的应用。外科医生可以远离手术台操纵机器进行手术,完全不同于传统的手术概念,在世界微创外科领域是当之无愧的革命性外科手术工具。
 
经过数十年发展,手术机器人现在主要用于五个快速增长的主要外科领域,其中的骨科、介入手术机器人是及其重要的一个版块。
 

手术机器人市场概览

 
当前,随着人工智能、物联网等新科技的快速渗透,医疗健康正在与机器人全面融合,引领外科技术大变革。手术机器人行业迎来快速发展,赛道火热,备受资本青睐。
 
根据Frost & Sullivan的统计,2020 年全球机器人手术市场规模为 61 亿美元,预计从 2021 年到 2028 年将以 17.60% 的复合年增长率增长,到 2028 年将达到 222.7 亿美元(折合人民币约为1414亿元)。
 
我国手术机器人市场发展迅猛,根据Frost & Sullivan的统计,市场规模由2016年的人民币853.6百万元增至2020年的人民币2,934.5百万元,年复合增长率达36.2%,预计2030年中国手术机器人的市场规模将达至人民币58,425.9百万元,年复合增长率为34.9%。
 
手术机器人是将机器人技术应用在医疗领域,显然的,机器人手术是使用机器人系统完成的外科手术类型,机器人辅助手术的开发旨在克服现有的微创手术程序的局限性,并增强外科医生进行开放手术的能力。
 
手术机器人集成了医学、材料学、自动控制学、数字图像处理学、生物力学、机器人学等诸多学科为一体的新型交叉科学。一般情况下,从临床医学应用角度可将手术机器人主要分为腔镜手术机器人、骨科手术机器人、泛血管手术机器人、 经自然腔道手术机器人、经皮穿刺手术机器人。
 
下面两幅附图分别给出了各主要细分手术机器人的应用场景和市场规模情况,供各位读者参考。
 
 
 
 
 
笔者认为,随着时间发展,对于国内手术机器人市场而言,各大厂商会面临如下5个方面的竞争,分别为:
 
1.技术战,入局者众多,内卷严重,而且在技术上目前国外先进巨头具有一定优势,国内厂家只有通过技术上“高人一等”才能“脱颖而出”。
 
2.临床战,目前手术机器人虽然种类繁多,但是依然是医械法规强监管的产业,且市场受众面以大城市的大医院为主体,在如此众多的品牌上市过程中,临床资源就显得弥足珍贵。
 
3.融资战,手术机器人是一个多学科高度集中的产品,研发周期长,临床要求高,各方面人力资源也紧张稀缺,必然需要高额的投入,这些都需要大量的资本投入,因此手术机器人的玩法从资本市场来讲其实就是“谁的资本强谁成功率大”。
 
4.营销战,随着国内、国外厂商的产品逐步上市,需要“卖出去”,也需要市场各群体的认同,更需要占据市场率,因此在众多同类型同适应症的手术机器人中“卖得好”才是各大厂商的终极目标,才是“长久之计”。
 
5.专利战,专利对于手术机器人而言十分重要,当然也是技术层面的演化,更是各大手术机器人厂商市场角力的重要武器,甚至是“终极核武”,规避设计风险、占据市场率都需要专利的辅助,达芬奇在腔镜机器人领域“叱咤风云”恰恰是得益于专利。
 
达芬奇 初探
 
达芬奇(da Vinci)手术机器人由美国直观医疗公司制造生产。美国直观医疗公司创立于1995年,总部设在美国加州,是开发革命性微创手术仪器和技术的先驱。
 
1999年,第一台达芬奇手术机器人面世。2000年,达芬奇手术机器人正式成为第一个受FDA批准用于临床手术的机器人辅助腹腔镜手术系统。
 
系统主要由三部分组成:医生操控台、床旁机械臂系统以及影像处理平台。主刀医生坐在控制台前控制器械和镜头;床旁机械臂系统是达芬奇手术机器人的操作部分,它放置在患者身旁为器械和镜头提供支撑,并实现医生的操作;影像处理系统,为患者身边的手术团队提供图像信息。
 
20 多年来,达芬奇平台开创了手术室的新功能,改变了微创手术领域。通过超过 500 万次手术,Intuitive已成为手术机器人领域公认的领导者。
 
 
 
 
达芬奇手术机器人拥有三维高清视野,头发丝大小的血管在医生眼里也能清晰可见;达芬奇手术机器人的器械拥有可转腕的关节,比人手更加的小巧灵活;同时医生的手部动作可以准确无延时地重现在患者体内的器械上。
 
达芬奇机器人手术和开放手术或传统腹腔镜手术相比具有以下潜在优势:
 
更小创伤:极大减轻患者的疼痛。
 
更加精准:出血更少,并发症更少,感染风险降低。
 
更快恢复:住院时间更短,更快恢复正常生活,提高生活质量。减少误工费用和陪床费用。
 

 
专利分析
 
对于达芬奇机器人相关专利,其申请人主要聚集于Intuitive Surgical公司。笔者针对Intuitive Surgical所涉及的专利情况,进行了检索,其结果进行如下展示:
 
专利概览
 
下图给出Intuitive Surgical公司专利的申请和公开情况。可以清晰得知,可以清晰得知,其专利申请和授权情况主要集中于2005年后。出现这种情况的出现也和达芬奇机器人的更新换代有着密切关系,结合下文中所提及的技术脉络,也进一步预示其初始专利已陆陆续续到期或即将到期,这也给部分机器人赛道入场者提供了部分机会和技术借鉴。
 
 

 
下面两幅图给出了达芬奇手术机器人专利布局情况,可以非常明确得到达芬奇手术机器人的专利地域布局情况,其专利申请目标国主要聚集于美国、欧洲、中国等区域性中心国家或地区,同样的,以2011年为界限,可以明确得知第一、二代达芬奇手术机器人和第三代达芬奇手术机器人的专利地域布局情况。
 

 
下图给出了Intuitive Surgical公司的技术生命周期情况。
 

 
下图给出了Intuitive Surgical公司相关专利合作和布局的情况,可以非常清晰的看出,与各个医疗器械大厂一样,作为手术机器人龙头公司,Intuitive Surgical也与众多企业和科研院所展开的合作研究。
 
 

 
下图给出了Intuitive Surgical公司相关专利的专利地图情况,从该专利地图可以很明了的得到Intuitive Surgical公司相关专利的技术分支情况。
 
 

 
 
技术脉络
 
达芬奇系列手术机器人共经历的四代进化。
 
达芬奇机器人1996年推出了第一代,2006年推出的第二代机器人机械手臂活动范围更大了,允许医生在不离开控制台的情况下进行多图观察。
 
2009年在第二代机器人的基础上增加了双控制台、模拟控制器、术中荧光显影技术等功能,进而推出了第三代达芬奇Si系统。
 
第四代达芬奇Xi系统在2014年推出,灵活度、精准度、成像清晰度等方面有了质的提高,公司在2014年下半年还开发了远程观察和指导系统。
 
图片来源:Intuitive Surgical公司官网,Intuitive Surgical公司公告,中金公司研究部
 
 
重要专利解析
 
从上文的技术脉络可以得知,对于达芬奇手术机器人而言,其总共经历的四次技术迭代,笔者对这四代达芬奇手术机器人和配套器械的相关专利根据类别分别进行了整理和剖析,这里笔者从众多专利中选择了若干进行了解析,相关相关结果如下:
 
第一代 达芬奇手术系统
公开/公告号 US5797900A 申请日 1997/5/16
发明名称 Wrist mechanism for surgical instrument for performing minimally invasive surgery with enhanced dexterity and sensitivity
解决的技术问题 In accordance with the above objects of the invention applicants describe a compact articulated surgical instrument suitable for endoscopic surgery. The instrument has two opposed pivoting jaws and a pivoting wrist member. The instrument is capable of providing force reflection with high'sensitivity. The instrument is adapted to be coupled via a servomechanism to a master control operated by a surgeon.
技术方案 An articulated surgical instrument for enhancing the performance of minimally invasive surgical procedures. The instrument has a high degree of dexterity, low friction, low inertia and good force reflection. A unique cable and pulley drive system operates to reduce friction and enhance force reflection. A unique wrist mechanism operates to enhance surgical dexterity compared to standard laparoscopic instruments. The system is optimized to reduce the number of actuators required and thus produce a fully functional articulated surgical instrument of minimum size.
相关附图
 
公开/公告号 US6905491B1 申请日 1997/5/16
发明名称 Apparatus for performing minimally invasive cardiac procedures with a robotic arm that has a passive joint and system which can decouple the robotic arm from the input device
解决的技术问题 There have been attempts to perform CABG procedures without opening the chest cavity. Minimally invasive procedures are conducted by inserting surgical instruments and an endoscope through small incision in the skin of the patient. Manipulating such instruments can be awkward, particularly when suturing a graft to a artery. It has been found that a high level of dexterity is required to accurately control the instruments. Additionally, human hands typically have at least a minimal amount of tremor. The tremor further increases the difficulty of performing minimal invasive cardiac procedures. It would be desirable to provide a system for effectively performing minimally invasive coronary artery bypass graft procedures..
技术方案 A system for performing minimally invasive cardiac procedures. The system includes a pair of surgical instruments that are coupled to a pair of robotic arms. The instruments have end effectors that can be manipulated to hold and suture tissue. The robotic arms are coupled to a pair of master handles by a controller. The handles can be moved by the surgeon to produce a corresponding movement of the end effectors. The movement of the handles is scaled so that the end effectors have a corresponding movement that is different, typically smaller, than the movement performed by the hands of the surgeon. The scale factor is adjustable so that the surgeon can control the resolution of the end effector movement. The movement of the end effector can be controlled by an input button, so that the end effector only moves when the button is depressed by the surgeon. The input button allows the surgeon to adjust the position of the handles without moving the end effector, so that the handles can be moved to a more comfortable position. The robotic arm may contain a passive joint that provides an additional degree of freedom. Additionally, the system may include a disconnect input device that decouples the arm from an input device such as the handles.
相关附图
 
 
 
第二代 达芬奇S手术系统
 
公开/公告号 US6783524B2 申请日 2002/4/18
发明名称 Robotic surgical tool with ultrasound cauterizing and cutting instrument
解决的技术问题 Surgical ultrasound instruments are generally capable of treating tissue with use of frictional heat produced by ultrasonic vibrations. For example, the heat may be use to cut and/or cauterize tissue. With many currently available instruments, tissue may first be grasped by an ultrasound surgical device and then ultrasound energy may be delivered to the tissue to cut, cauterize or the like. Ultrasound instruments provide advantages over other cutting and cauterizing systems, such as reduced collateral tissue damage, reduced risk of unwanted burns, and the like. Currently, however, ultrasound instruments for use with a robotic surgical system are not available.
技术方案 A surgical instrument for enhancing robotic surgery generally includes an elongate shaft with an ultrasound probe, an end effector at the distal end of the shaft, and a base at the proximal end of the shaft. The end effector includes an ultrasound probe tip and the surgical instrument is generally configured for convenient positioning of the probe tip within a surgical site by a robotic surgical system. Ultrasound energy delivered by the probe tip may be used to cut, cauterize, or achieve various other desired effects on tissue at a surgical site. In various embodiments, the end effector also includes a gripper, for gripping tissue in cooperation with the ultrasound probe tip. The base is generally configured to removably couple the surgical instrument to a robotic surgical system and to transmit forces from the surgical system to the end effector, through the elongate shaft. A method for enhancing robotic surgery generally includes coupling the surgical instrument to a robotic surgical system, positioning the probe tip in contact with tissue at a surgical site, and delivering ultrasound energy to the tissue.
相关附图  
 
公开/公告号 US8100133B2 申请日 2006/6/28
发明名称 Indicator for tool state and communication in multi-arm robotic telesurgery and method of use
解决的技术问题 While the new telesurgical systems, devices and methods have proven highly effective and advantageous, still further improvements would be desirable. In general, it would be desirable to provide improved robotic and/or surgical devices, systems and methods, particularly for performing telesurgical procedures. It may also be desirable to provide improved techniques for communication among the members of a telesurgical team, and for interfacing with the telesurgical apparatus so as to more fully take advantage of the capabilities of telesurgery to provide enhanced patient outcomes with improved efficiencies. It may be particularly beneficial to avoid unnecessary interruptions and distractions of a surgeon or other system operator, and to avoid delays and/or mistakes in the coordinated activities of a telesurgical team.
技术方案 Medical and/or robotic devices, systems and methods can provide an indicator associated with each manipulator assembly of a multi-arm telerobotic or telesurgical system. The exemplary indicator comprises a multi-color light emitting diode (LED) mounted to a manipulator moving an associated surgical instrument, allowing the indicator to display any of a wide variety of signals. The invention may provide an additional user interface to facilitate communications between the telesurgical system and/or members of a telesurgical team.
相关附图  
 
第三代 达芬奇Si手术系统
 
公开/公告号 US8545515B2 申请日 2009/11/13
发明名称 Curved cannula surgical system
解决的技术问题 To further reduce patient trauma and to retain the benefits of robotic surgical systems, surgeons have begun to carry out a surgical procedure to investigate or treat a patient's condition through a single incision through the skin. In some instances, such “single port access” surgeries have been performed with manual instruments or with existing surgical robotic systems. What is desired, therefore, are improved equipment and methods that enable surgeons to more effectively perform single port access surgeries, as compared with the use of existing equipment and methods. It is also desired to be able to easily modify existing robotic surgical systems that are typically used for multiple incision (multi-port) surgeries to perform such single port access surgeries.
技术方案 A robotic surgical system is configured with rigid, curved cannulas that extend through the same opening into a patient's body. Surgical instruments with passively flexible shafts extend through the curved cannulas. The cannulas are oriented to direct the instruments towards a surgical site. Various port features that support the curved cannulas within the single opening are disclosed. Cannula support fixtures that support the cannulas during insertion into the single opening and mounting to robotic manipulators are disclosed. A teleoperation control system that moves the curved cannulas and their associated instruments in a manner that allows a surgeon to experience intuitive control is disclosed.
相关附图  

 

公开/公告号 CN104799890B 申请日 2010/11/10
发明名称 弯曲套管和机器人操纵器
解决的技术问题 为了进一步减少病人创伤并且保留机器人手术系统的益处,外科医生已经开始执行通过经皮肤的单个切口来研究或处理病人状况的手术程序。在一些情况下,这样的“单端口入路(port access)”手术已经采用手动器械或采用现有机器人手术系统执行。因此,期望的是改进的设备和方法,与使用现有的设备和方法相比,其能够使外科医生更有效地进行单端口入路手术。还期望的是能够容易地修改一般用于执行这种单端口入路手术的多切口(多端口)手术的现有机器人手术系统。
技术方案 一种机器人手术系统配置有(多个)刚性的弯曲套管(416a),这些套管延伸穿过同一个开口进入病人体内。具有(多个)被动柔性轴(506)的手术器械(500)延伸穿过这些弯曲套管。这些套管被定向为朝手术部位引导器械。公开了一种远程操作控制系统,该系统以一种允许外科医生体验直观控制的方式移动这些弯曲套管及其相关联的器械。这些柔性轴器械被控制为就好像沿着一条虚拟的直线插入和抽出轴线进行延伸。公开了在该单个开口内支撑弯曲套管的各种端口构件(1402)。公开了在插入到该单个开口以及安装至机器人操纵器上的过程中支撑这些套管的(多个)套管支撑固定件(1902)。
相关附图  
 
第四代 达芬奇Xi手术系统
公开/公告号 US9358074B2 申请日 2013/5/31
发明名称 Multi-port surgical robotic system architecture
解决的技术问题 A robotic surgery system includes an orienting platform, a support linkage movably supporting the orienting platform, a plurality of surgical instrument manipulators, and a plurality of set-up linkages. Each of the manipulators includes an instrument holder and is operable to rotate the instrument holder around a remote center of manipulation (RC). At least one of the manipulators includes a reorientation mechanism that when actuated moves the attached manipulator through a motion that maintains the associated RC in a fixed position.
技术方案 While the new telesurgical systems and devices have proven highly effective and advantageous, still further improvements are desirable. In general, improved minimally invasive robotic surgery systems are desirable. It would be particularly beneficial if these improved technologies enhanced the efficiency and ease of use of robotic surgical systems. For example, it would be particularly beneficial to increase maneuverability, improve space utilization in an operating room, provide a faster and easier set-up, inhibit collisions between robotic devices during use, and/or reduce the mechanical complexity and size of these new surgical systems.
相关附图  
 
 
公开/公告号 CN105050531B 申请日 2014/3/13
发明名称 具有操控界面的外科患者侧手推车
解决的技术问题 移动远程操作的外科系统的患者侧手推车中的一个考虑是患者侧手推车可由使用者容易移动。由于其重量、大小和全部构造,可期望提供患者侧手推车以传动装置以帮助使用者移动患者侧手推车。这样的传动装置可基于来自使用者的输入而被控制,以相对容易的方式移动患者侧手推车。进一步,可期望提供患者侧手推车以控制机构,以驱动和移动不是复杂的而是相对容易使用的患者侧手推车。
技术方案 用于远程操作的外科系统的患者侧手推车包括至少一个保持外科器械的操纵器部分和操控界面。操控界面可包括至少一个传感器,其被安置以感测使用者施加的以移动手推车的旋转力、向前力、向后力。操控界面可进一步包括连接机构,以可移除地连接操控界面与患者侧手推车。至少一个传感器可被放置以当操控界面处于与患者侧手推车的连接状态时与患者侧手推车的驱动控制系统信号连通。
相关附图  
 
 
达芬奇机器人配套器械
公开/公告号 US6394998B1 申请日 1999/9/17
发明名称 Surgical tools for use in minimally invasive telesurgical applications
解决的技术问题 There are many disadvantages relating to current minimally invasive surgical (MIS) technology. For example, existing MIS instruments deny the surgeon the flexibility of tool placement found in open surgery. Most current laparoscopic tools have rigid shafts, so that it can be difficult to approach the worksite through the small incision. Additionally, the length and construction of many endoscopic instruments reduces the surgeon's ability to feel forces exerted by tissues and organs on the end effector of the associated tool. The lack of dexterity and sensitivity of endoscopic tools is a major impediment to the expansion of minimally invasive surgery.
技术方案 This invention provides surgical tools or instruments for use in minimally invasive telesurgical applications. The instruments typically include a base whereby the instrument is removably mountable on a robotically controlled articulated arm. An elongate shaft extends from the base. A working end of the shaft is disposed at an end of the shaft remote from the base. A wrist member is pivotally mounted on the working end. At least one end effector element mounting formation is pivotally mounted on an opposed end of the wrist member. A plurality of elongate elements, e.g., cables, extend from the end effector element mounting formation and the wrist member to cause selective angular displacement of the wrist member and end effector mounting formation in response to selective pulling of the elongate elements.
相关附图  
 
对于达芬奇机器人相关专利,其申请人主要聚集于Intuitive Surgical,目前相关数量已达1.2W余件,剔除同族影响,需重点关注的专利也达4500余件,笔者开展了学术研究,对于这4500余件专利逐个逐篇的进行了细读,形成了部分如下学术成果,工作模式与思路可供相关专利工作者参考:
 
1)从这4500余件专利中梳理出了每一代腔镜机器人(含单孔)以及相关配套器械专利,也梳理了其经自然腔道机器人相关专利,准确的形成了对应的专利列表。
 
2)从这4500余件专利中梳理出了达芬奇手术机器人核心技术专利,准确的形成了达芬奇手术机器人的完整的技术分支和技术脉络以及对应的专利。
 
3)梳理出了达芬奇手术机器人值得关注的过期专利,切实的总结了达芬奇哪些技术处于专利失效状态。
 
4)梳理出了达芬奇手术机器人在我国布局的核心专利,逐个逐篇各个角度进行分析解读,梳理出了目前具有较高法律风险的专利。
 
5)分析了达芬奇手术机器人专利常青战略,剖析了今后一段时间手术机器人厂家的潜在专利法律风险。
 
客观来讲,Intuitive Surgical知识产权工作相当完善,不愧为专利领域的标杆厂家,自然而然地,可形成的学术成果也较为丰富,以第四代Xi分析为例,笔者形成的分析文案就达7522页(含专利文本)。
 
小结
 
作为最成功的手术机器人,达芬奇医生只需要通过操作机械臂来完成手术,还能过滤掉手术者操作过程中手部的颤动,再加上高倍数的3D高清视野,令正常组织和肿瘤间的界限更清晰,能最大程度避免手术过程中对周围正常组织的损伤,确实在医疗器械领域开辟了一个崭新的时代。
 
诚如领域内人士共同认识的那样,手术机器人逐渐赢得市场追捧,站上了智能精细化发展、医保政策利好的快车道,随着达芬奇手术机器人核心专利的逐步过期,全球以及国内各大手术机器人厂商也必会将达芬奇机器人作为重要的标杆和对照,联动产学研医生多方力量,不断创新,推动中国手术机器人行业更智能化、精准化、微创化的发展,相关知识产权问题也必将会成为各大手术机器人厂商的研究重点课题,后续相关产品的的研发和专利事务值得持续关注。
 

 
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来源:医械知识产权