产品导读
最初，达芬奇机器人系统是由SRI（一个非营利性研究机构）开发的，后来在1985年得到了美国陆军（ DARPA（国防高级研究计划局）的资金支持，目的是在战场前沿附近的高级医疗设施与外科医生相距甚远时，对受伤士兵进行远程手术。
随后，NASA也加入了该项目，进而发展成为一个更加雄心勃勃的计划，即让地球上的外科医生在太空中进行手术。十年后，由于当时的技术条件限制，该计划被认为无法实现而被终止。
曾在该项目工作的斯坦福大学的一批工程师决定创办一家初创公司，将项目方向调整为更现实的目标——实施机器人辅助腹腔镜手术。1995年，直观外科公司成立，并收购了SRI的专利组合。随后，该公司通过实施积极的市场控制策略发展起来，收购了该领域内的其他重要公司，比如Computer Motion。
1999年，达芬奇机器人首次在欧洲上市，并随着时间不断改进：2003年引入了用于持有内窥镜的第四臂。2006年，推出了S版本，提供了真正的三维视野和改善的工作体积。2009年，达芬奇Si版本增加了第二个主控台，允许两名外科医生协同工作。最后，自2014年4月起可用的Xi版本设计更为紧凑，提高了工作体积，并且四臂中的任何一臂都能连接内窥镜相机，还具备了未来与直观外科公司专有的荧光成像系统配合使用的潜力。2024年3月15日,直观外科对外宣布下一代多臂机器人系统达芬奇5获得美国食品药品监督管理局(FDA)510(k)许可。
达芬奇系统的不同版本之间存在一些差异，本文主要以目前国内主流使用和各大国产厂家对标的达芬奇前4代产品为研究对象，笔者通过深入研究达芬奇机器人产品细节和详细检索分析重点专利而对达芬奇手术机器人技术进行细致剖析，形成此文。
系统主要部分
尽管其名称普遍，但实际上达芬奇系统并非传统想象中的那样的机器人，而是一种主从式遥操作器。
本质上，它由三个主要组件组成：一个集成了四条独立臂的从站、一个供主控用的控制台，带有两条可由外科医生流畅操作的独立臂，以及一个包含电源、计算机、3D图像处理器和单极电切电路的控制单元。终端执行器工具安装在四条从臂中的三条上，其中大多数依赖于广泛申请了专利的技术，以Endowrist®品牌进行交易。第二主控控制台作为可选配置（Si®版本），从而允许双外科医生四手操作程序。
下图 达芬奇系统总体结构。从动操作器（1）、主控控制台（2）、控制单元（3）。可选地，第二个主控台（4）允许双外科医生四手操作。
从动设计
从动部分是一个庞大的结构，由四条臂组成。每条单一臂的运动学主要使用串联连杆，并依赖于远程运动中心(RCM)的概念。一个用于设定每条臂的RCM点的被动近端部分，由四个关节构成。第一个关节是棱柱形的，允许调整高度。随后是三个平面回转关节，属于SCARA类型，便于进行被动操作。棱柱关节采用电动驱动，而其他关节仅包含刹车，并配有一个按钮，在设置过程中释放刹车。
下图展示了达芬奇系统的最初4个自由度(DoF)。电动驱动的棱柱关节J1允许根据患者身高调整臂的高度。关节J2、J3、J4形成一个SCARA被动臂，并配有强力刹车，一旦臂正确就位即可锁定它们。
系统底座庞大且足够重，一旦滚轮刹车接合，整个系统即固定不动，因此无需机械固定在手术台上。系统已实现电动化，以便协助可能没有足够力量来设置系统的护士。
驱动臂
这些臂的结构可以细分为两个子单元：具有3个主动自由度(DoF)的操纵臂和末端执行器工具，根据所使用的工具，该工具还具有3个额外的DoF主动驱动功能以及一个可选的抓握功能。
操纵主动臂是长期研究的结果，结合了串联连杆与平行四边形并联结构，用于RCM。
下图展示了达芬奇系统的主要结构。旋转驱动关节J4、J5共享同一轴Pa，而被动关节J6、J7的旋转复制J5的角运动到工具支架。因此，J5的作用就像位于RCM点一样。J8是一个棱柱关节，确保在RCM点为中心的平移。棱柱关节J8由多个堆叠的滑块通过缆绳和滑轮驱动。最终，达芬奇®系统主体由三个主动关节组成：工具轴向平移以及围绕患者进入点RCM的两个正交旋转。
起初，RCM是围绕刚性连杆构建的，但为了使每条臂更轻便、更紧凑，已经发展成由缆绳驱动的远程运动控制。
下图展示了达芬奇系统的RCM机制细节。被动关节J6通过电机驱动关节J5的缆绳（粉色）拉动。进而，J6移动连杆j67并通过缆绳（黄色）将其运动传递给J7滑轮，该滑轮连接到工具支架。这一机制使得J7能够获得与J5相同的角运动量，同时保持驱动器远离患者。整个系统如同一个角度保守的平行四边形（绿色虚线所示）。
下图展示了达芬奇臂内部的RCM机制。位于柱上的棱镜滑块和臂内的缆绳及滑轮（确保RCM运动）清晰可见。
末端执行器
这些构成了遥操作器系统的末端部分，可能是整个达芬奇系统对手术最富有想象力的贡献。它们也代表了直观外科公司专利组合中最重要的部分，拥有超过200项相关专利。
EndoWrist®包括一系列具有不同机制的器械。我们的目标仅限于对钳子进行运动学分析，这是机械上最复杂且在经口机器人手术中最重要的一项。
EndoWrist®钳子设计用于让运动系统在体内工作。这个巧妙而又复杂的概念提供了传统器械无法达到的非凡灵活性。三个自由度加上钳子开合动作，均由腱索驱动机构操作。
EndoWrist®器械有8mm和5mm输出直径两种规格，总长度为57cm，可用长度可达38cm。8mm的器械配备有万向节，而5mm的则具有更复杂的关节结构，由四个串联关节组成。
下图展示了EndoWrist®器械的内部设计。5mm的器械由于口咽腔空间有限，因此在经口机器人手术中最为常用。
这四个“脊椎”关节尖端结构允许减小关节直径，代价是增加了长度：头尾向Φ和平行侧向θ旋转各自解耦为两个交替旋转阶段，分别为Φ1、θ1、Φ2、θ2。缆绳和滑轮被用来控制关节角度和抓取功能（钳子开合）。系统采用主动肌-拮抗肌配对控制方案，因此每个自由度需要两根驱动缆绳。因此，为了驱动头尾向和平行侧向旋转及钳子，总共需要6根缆绳。这些缆绳的路径在器械轴内，设有间隔器以避免缆绳冲突和由此产生的摩擦。第四个自由度是轴向旋转Ψ，直接在驱动盒内部操作。四个卷筒各自对应一个自由度，而张紧滑轮确保缆绳张力恒定，否则会因环境温度、磨损和重复灭菌而降低。
每个卷筒本身在EndoWrist®器械固定到操纵臂时，机械连接到旋转鼓。另一组缆绳为这些鼓提供运动，从而驱动钳子的4个自由度。
从运动学上看，这种配置属于串联类型，允许在非常有限的末端执行器占用空间下进行大范围的运动。钳子的全角度Φ和θ为±90°，而Ψ允许全360°轴向旋转，提供了非常舒适的可达性。负载能力大致相当于开放手术中常见的水平，尽管关于这一点没有准确的信息。
5mm关节器械的缺点在于其双平面脊椎连续关节的曲率半径较大，因此比万向节8mm器械需要更多空间来使其弯曲。
鉴于其复杂且因此成本高昂的制造过程以及EndoWrist®架构的相对脆弱性，制造商在这些矛盾要求之间做出了妥协。系统销售时指定使用5次或10次具体次数取决于器械后废弃。这在医疗器械史上引入了一个新概念：中等消耗品器械。控制盒中内置了一个带有热敏电阻的电子芯片，记录每次灭菌，然后破坏识别码，迫使用户在达到最大循环次数后丢弃器械。
内窥镜
这些由两个霍普金斯类型的内窥镜并排组成，带有光源通道集成在一个管内。每个内窥镜与另一个相距6mm，以满足立体视觉所需的真正视网膜差异。有两种外径可供选择：8.5mm和12mm。通常只有第一种类型用于耳鼻喉-头颈外科手术。
下图展示了达芬奇立体内窥镜。
专利分析
专利概览
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。
技术脉络
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
第一代 达芬奇手术系统
公开/公告号 | US5797900A | 申请日 | 1997-05-16 |
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. | ||
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公开/公告号 | US6905491B1 | 申请日 | 1997-05-16 | |
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. | |||
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第二代 达芬奇S手术系统
公开/公告号 | US6783524B2 | 申请日 | 2002-04-18 |
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. | ||
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公开/公告号 | US8100133B2 | 申请日 | 2006-06-28 |
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. | ||
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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. | ||
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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)。 | ||
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第四代 达芬奇Xi手术系统
公开/公告号 | US9358074B2 | 申请日 | 2013-05-31 |
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. | ||
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公开/公告号 | CN105050531B | 申请日 | 2014-03-13 |
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。 | ||
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达芬奇机器人配套器械
公开/公告号 | US6394998B1 | 申请日 | 1999-09-17 |
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 | |||
专利事务值得关注
随着外科手术医疗器械技术领域的竞争日益加剧，专利事务已经成为企业不可或缺的一部分。做好自身的专利布局，不仅可以保护企业的创新成果，还可以为企业在市场竞争中提供有力的法律支持。
首先，企业需要注重专利的申请和保护。在研发过程中，一旦有新的技术突破或创新点，就应及时申请专利，确保自身的技术成果得到法律保护。同时，企业还需要对已有的专利进行定期维护和管理，确保其有效性和稳定性。
其次，企业需要建立完善的专利预警机制。通过定期检索和分析相关领域的专利信息，企业可以及时了解技术发展趋势和竞争对手的动态，从而避免可能的专利侵权风险。一旦发现存在侵权风险，企业应迅速采取措施进行应对，如寻求专利许可、进行技术改进或调整市场策略等。
此外，企业还需要做好应对专利战的准备。在竞争激烈的市场环境中，专利战可能随时爆发。因此，企业需要提前制定应对策略，如建立专门的法务团队、储备充足的资金用于可能的专利诉讼等。同时，企业还可以通过与合作伙伴建立专利联盟、参与行业标准制定等方式来增强自身的专利实力和市场影响力。
在手术机器人这一赛道上，专利事务的复杂性和专业性要求极高，因此，寻找专注、高水平且聚焦此领域的专业人士和团队显得尤为重要。这样的团队不仅具备深厚的法律和技术背景，还能准确理解并把握手术机器人技术的核心要点和市场动态。他们的专业知识和经验将为企业带来准确、高效、高质且低成本的专利事务服务，助力企业在激烈的市场竞争中脱颖而出。有需要欢迎扫描下方二维码添加医疗IP君取得联系。
作者简介
医疗IP君，知识产权学者。深耕医疗器械领域。
END
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