The da Vinci Surgical System

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The da Vinci Surgical System Mahdi Azizian, May Liu, Iman Khalaji, Jonathan Sorger, Daniel Oh and Simon Daimios Intuitive Surgical, Sunnyvale, CA, United States

ABSTRACT The da Vinci Surgical System is a platform for robot-assisted minimally invasive surgery. This chapter provides an overview of the design of the da Vinci System, as well as several of its key subsystems for vision, tissue manipulation, anatomical access, and operator technology training. Clinical adoption of the system to-date is described briefly, and we leave the reader with some thoughts on possible future development directions. Handbook of Robotic and Image-Guided Surgery. DOI: https://doi.org/10.1016/B978-0-12-814245-5.00003-7 © 2020 Elsevier Inc. All rights reserved.

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3.1

Handbook of Robotic and Image-Guided Surgery

Introduction

Surgery is fundamentally a balance of extirpating diseased tissue while simultaneously preserving or reconstructing physiological function. The greatest obstacle to this goal is that disease often occurs deep within the body cavity. To access these deep recesses in traditional surgery, a large incision through the abdominal or chest wall was historically required, which included disrupting multiple layers of muscle, fascia, and bone. For deeper areas of interest, even larger incisions were needed to avoid operating through deep, dark holes with poor visualization. These large incisions resulted in complex operations that, while effective, came at a significant cost to the patient. A large amount of tissue trauma resulted in delayed functional recovery, increased pain, and a longer time to rehabilitate. The evolution of surgical technology has evolved toward reaching these spaces with less tissue damage and impact on the surrounding healthy tissue. The development of laparoscopic technology in the 1970s allowed surgeons for the first time to visualize deep within the abdomen and pelvis. With further advances in video camera technology, true minimally invasive surgery evolved, first with Semm’s novel approaches to gynecologic procedures in the 1970s and subsequent endoscopic appendectomy in the early 1980s. After this, the first laparoscopic cholecystectomies were performed by Erich Mu¨he and Phillipe Mouret in the mid-1980s [1]. The ability to use laparoscopic technology while insufflating CO2 into the abdomen dramatically improved visualization and exposure. In the chest, this same technology was used for video-assisted thoracic surgery, but CO2 was not necessary as the lung could be isolated and collapsed out of the way by the anesthesiologist. Laparoscopic surgery was a true revolution, but after decades of adoption the limitations of the technology hindered further adoption in complex cases. One of the primary limitations of laparoscopic surgery has been the fixed fulcrum of the trocar that is inserted through the body wall combined with straight instruments. This limits the surgeon’s ability to work in certain angles and makes suturing extremely difficult. Moreover, the video remained two-dimensional (2D) and the flat view with limited angles of entry made laparoscopic surgical approaches and visualization very different from that of traditional open surgery. Nevertheless, the original premise of balancing extirpation of diseased tissue while preserving function could be better realized with smaller incisions and less tissue trauma. The advent of the da Vinci robotic platform provided a novel, alternative minimally invasive platform that addressed several of the shortcomings of laparoscopic surgery. The EndoWrist design of the instrumentation allowed for improved manipulation of the end effectors such that the surgeon could reproduce the movements of open surgery and eliminated the use of straight instruments working through a fixed fulcrum. The use of high-definition three-dimensional (3D) video allowed surgeons to see tissue similar to an open operation, and also magnified the tissue. The ability of the da Vinci system to scale motion and filter physiologic tremor greatly enhanced the surgeon’s precision during fine dissection or suturing. All of these advances brought about a third revolution in surgery and ushered in a new world of minimally invasive surgery.

3.2

The intuitive surgical timeline

The founding of Intuitive was the convergence of two evolutionary trends. The first was laparoscopic surgery, which finally allowed minimally invasive procedures to be performed reliably and safely. However, the limitations of this technology became apparent by the 1990s and stifled further innovation and adoption, as laparoscopic surgery was particularly difficult in confined spaces such as the pelvis or thoracic cavity, where the restricted angulation of the instruments was problematic. The second trend was the development of telepresence surgery, whereby the surgeon could control master manipulators to effect actions at an end of an instrument. This technology was incubating at Stanford Research Institute (SRI; Menlo Park, CA, USA) in the 1990s, and was a culmination of over a decade of research in this area. Much of the research had been sponsored by the Defense Advanced Research Programs Agency, which originally envisioned that this technology would allow military surgeons to remotely operate on injured soldiers on the front lines of a battlefield. The vision of Intuitive’s founders, namely to combine these two concepts—minimally invasive surgery with telepresence technology—allowed for the next revolution in surgery. Intuitive Surgical was founded in 1995 by John Freund, Frederick Moll, and Rob Younge. The company licensed telepresence surgical technology from SRI as well as key technologies from IBM and MIT and began developing what would ultimately become the da Vinci Surgical System. The distinguishing features of this system included the reproduction of open surgery in a minimally invasive platform using 3D video, 7-degrees of freedom from wristed instruments that fit through small trocars identical to laparoscopy, natural eye hand alignment, smooth movements with tremor filtration, and motion scaling. The first da Vinci System was set up for clinical trials in Belgium in 1997. Early marketing and sales of the system were focused outside of the United States, until the company received US Food and

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Drug Administration (FDA) clearance for the da Vinci System in 2000. This first FDA clearance was for applications in general surgery; however, additional indications for thoracoscopic (chest) and radical prostatectomy procedures followed 1 year later. During this early period, Intuitive Surgical faced competition from a company called Computer Motion, Inc., which made the Zeus surgical system. The Zeus system was based on an early product called AESOP, a voice-controlled endoscope manipulator that was the first robotic device used in assisting surgery to receive FDA approval. Zeus was launched in 1997, the same year that da Vinci was launched in Europe. Initially, the Zeus was preferred by general laparoscopic surgeons, while the da Vinci was adopted by open surgeons who did not perform laparoscopic surgery. Zeus was smaller, had a lower price point, but was less capable. Initially, Computer Motion and Intuitive targeted different procedures, but by 1999, Computer Motion began to move toward similar applications as the da Vinci. Competition and filing of several lawsuits between the two companies ultimately led to a merger between Intuitive Surgical and Computer Motion in 2003. Shortly afterward, the Zeus system was phased out in favor of the da Vinci System. Some of the key events of Intuitive Surgical’s early history are indicated in a company timeline in Fig. 3.1. Further details on the founding of the company are retold in Ref. [2]. In its second decade, Intuitive Surgical developed and launched a series of products to extend and evolve the da Vinci platform. New clinical indications were added as the technology was refined and as surgeons of different specialties adopted da Vinci surgery. Six models of the system have been launched globally to-date, as illustrated in Fig. 3.2. The development of the da Vinci system was the first robot-assisted technology that allowed surgeons to go one step further than laparoscopy through the integration of teleoperation technology that placed a computerized control system between the surgeon and the surgical field. Section 3.3 describes the basic principles of operation and key design refinements in recent embodiments of the system. Subsequent sections elaborate on the platform subsystems and how these take advantage of the computerized control system that is central to the architecture of da Vinci systems.

3.3

Basic principles and design of the da Vinci Surgical System

The da Vinci system comprises three distinct subsystems: (1) the patient-side cart; (2) the surgeon console; and (3) the vision cart. These subsystems comprise a consistent design of each generation of da Vinci systems that have been manufactured to-date, as shown in Fig. 3.2. In the operating room, the surgeon is seated at the surgeon console with the high-resolution stereo viewer to provide 3D vision. The console is typically positioned a few feet away from the operating table where the patient is located, and from there the surgeon controls the movement of the surgical instruments and the camera. The patient-side cart is comprised of four patient-side manipulators or arms, each of which is docked to the trocars placed in the abdominal or thoracic wall of the patient’s body. Unlike the laparoscopic approach—which connects the surgeon to the surgical field mechanically—the da Vinci operates using the principle of teleoperation. The da Vinci trocars have a remote center feature that keeps the fulcrum of the trocar centered in the wall of the body to minimize torque or excessive trauma of the surrounding tissue. This feature is especially important in the chest whereby the remote center keeps the trocar from rubbing on the surrounding ribs. The idea of “teleoperation” or “telemanipulation” has been described in science fiction writing since the 1940s [3] and it has since been deployed to space exploration, deep sea exploration, hazardous material handling, ordinance

3. The da Vinci Surgical System

FIGURE 3.1 Timeline of selected company milestones.

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FIGURE 3.2 Six models of the da Vinci Surgical System. Reproduced with permission from r 2018 Intuitive Surgical, Inc. Used with permission.

disposal, and a variety of other applications where the operator is required to be located separate from where the end effectors are working. A brief history of the evolution of telerobotics in surgery is provided in Ref. [2]. In the context of the da Vinci system, this approach relies on an electronic connection between the surgeon’s “master interface” and the surgical instruments that are driven by “slave manipulators.” A computerized control system acts as an intermediary in this master slave architecture, and is a key component of the system. The master slave architecture of the da Vinci system is illustrated in Fig. 3.3. The patient-side manipulators or arms are mounted to the patient-side cart via a setup structure, which is discussed in detail later. Each manipulator may support a stereo endoscopic camera or a surgical instrument, such as a grasper, a scissor, or a needle driver. The patient manipulators are covered with a sterile drape, and all of the trocars, camera, and instruments are sterile. The surgeon sits at the console in a nonsterile environment. The computerized control system extends the surgeon’s “presence”—their sensory awareness and control—into the surgical field by transmitting video images from the endoscopic camera to the stereo viewer of the console, and transmitting the surgeon’s hand motions— measured by the master interfaces—to the slave manipulators. Since this is an electronic link, the software of the control system can modify the signals, so as to filter out the surgeon’s normal physiological tremor, or to scale down their motions for enhanced precision (Fig. 3.4). The control system can incorporate additional imaging technology that may augment the surgeon’s view of the anatomy. In the future, this could provide navigation and guidance information; or it may help the surgeon to better anticipate critical task steps. This ability to enhance the surgeon’s capabilities is a key advantage of this type of system and

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FIGURE 3.4 The surgeon console blends visualization and instrument control into an intuitive and immersive user interface. r2018 Intuitive Surgical, Inc. Used with permission.

is an aspect that is explored later in this chapter. Currently, the surgeon may stream a second video source or imaging feed into the console’s TilePro feature so that it may be viewed adjacent to the endoscopic view of the surgical field. Future developments may allow different types of imaging to be fully integrated into the endoscopic video view. The four original product pillars of the da Vinci system included four key specifications. First and foremost, the system had to be reliable and failsafe in order to be feasible as a surgical device used on patients; second, the system was to provide the user with intuitive control of the instruments; third, the instrument tips were to have 6-degrees-offreedom dexterity as well as a functional gripper. The fourth pillar was to provide the surgeon with compelling 3D visualization of the anatomy. By transposing the surgeon’s eyes and hands into the patient in a reliable and effective way, these product pillars supported the ultimate goal to provide the surgeon with several key benefits of open surgery that had been lost in the laparoscopic approach, while maintaining minimal invasiveness. Subsequent generations of da Vinci system have extended these original product pillars to improve ease of use for the patient care team. Since the system does not function autonomously, a coordinated team is needed in order to perform surgery, including a bedside assistant, a surgical technologist, and a circulating nurse. The components of this team are no different than in traditional surgery, but there are new interactions and workflows. Several members of this team will interact with the da Vinci system and its components during the multiple phases of a surgery, which include: preparing the system for use, sterilely draping the robotic arms, roll-up (positioning the patient cart next to the patient bed), deployment (adjusting the angles of the robotic arms to ensure clearance between the arms and the patient), docking (securing the connection between the robotic arms and the patient), removing and inserting instruments during the

3. The da Vinci Surgical System

FIGURE 3.3 At the heart of the da Vinci system is a master slave teleoperation architecture, with the surgeon console containing two master interfaces that are used to control slave manipulators that are part of the patient-side cart. Reproduced with permission from r 2018 Intuitive Surgical, Inc. Used with permission.

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FIGURE 3.5 Comparison of the da Vinci Si and Xi setup structures. Reproduced with permission from r 2018 Intuitive Surgical, Inc. Used with permission.

operation, undocking, undraping, and cleaning, stowing the robotic arms to minimize space required for storage, and reprocessing of instruments and accessories. Apart from handling these specific tasks, the number of individuals in the operating room is not necessarily more than that required for traditional laparoscopic surgery. Distinct from prior generations, the latest da Vinci Xi system uses a gantry system or boom to position the instrument manipulators directly over the operating table (Fig. 3.5). This gantry makes the position of the cart base largely independent from the orientation of the surgical workspace, thereby allowing the operating room staff more ease and flexibility when positioning the base of the cart at the bedside, as they now have fine control of the instrument cluster position and orientation overhead. This is in contrast with the older da Vinci Si patient-side cart, where the reachable workspace is highly dependent on the orientation of the cart since the instrument manipulators are directly connected to the cart base. With the Si system, the team is required to anticipate a good location of the cart with respect to the patient, based on the requirements of the surgery, so as to avoid possible interruptions of the surgery for repositioning. This is just one example of a design solution that has been motivated by the need for ease of use and workflow efficiency. The da Vinci Xi system is the current flagship platform of Intuitive. It enables optimized, focused-quadrant surgery, such as for procedures like colorectal resections, pulmonary lobectomy, ventral hernia repair, and partial nephrectomy, among others. It features more flexible port placement and state-of-the-art 3D digital optics with a fully integrated endoscope and increases operational efficiencies by means of setup technology that uses voice and laser guidance and a sterile drape design that simplifies surgery prep. To provide a lower-cost solution to meet the needs of global customers who want a choice in price points, while offering access to some of the key innovations developed for the da Vinci Xi system, in 2017, Intuitive Surgical released the da Vinci X Surgical System. With the da Vinci X, the instrument manipulators are similar to those of the Xi but are fixed to the patient cart similar to the Si, without a gantry. The da Vinci X system uses the same vision cart and surgeon console found on the da Vinci Xi system, thus enabling customers the option of adding advanced capabilities, and providing an upgrade pathway, should they choose to do so as their practice and needs grow. While the mechatronic arms are the most iconic part of the da Vinci System, building and running a robot-assisted surgery program requires an ecosystem of products and services. This ecosystem starts with a range of robotic systems that address different clinical needs and price points, as well as a family of dozens of different instruments and accessories. It is important that an integrated ecosystem allows for a seamless user experience for both the surgeon and the hospital, as opposed to having different manufacturers responsible for different components of an operation. These include advanced instruments such as staplers and vessel sealers, as well as endoscopic stereo-imaging systems that include Firefly near-infrared imaging technology. The majority of da Vinci systems are connected to a network infrastructure that allows Intuitive Surgical to perform predictive maintenance, minimize downtime, as well as to share analytic insights with customers. A global team of field service specialists provides rapid round-the-clock support for customer systems. Experienced surgeons teach dozens of different advanced courses to their peers in the use of da Vinci technology. Well over a thousand da Vinci Skills Simulators are in use, along with hundreds of real-time training consoles that support intraoperative, collaborative learning (dual console configuration). We discuss several of these aspects of the ecosystem in subsequent sections (Fig. 3.6).

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3. The da Vinci Surgical System

FIGURE 3.6 The Intuitive Surgical ecosystem. Reproduced with permission from r 2018 Intuitive Surgical, Inc. Used with permission.

3.4

Visualization

The da Vinci surgical system was among the first commercial products to use stereoscopic endoscopes to guide softtissue surgery. Until recently, such endoscopes have captured and displayed white-light images that show only the visible surfaces of organs. This section introduces several advanced imaging technologies that can provide information that may not be directly visible in white-light images. For more detailed information see Ref. [4].

3.4.1

Fluorescence imaging

Near-infrared fluorescence imaging (Firefly) is a recent innovation that augments visualization during da Vinci surgical procedures. The components of this system include a fluorescent agent, a corresponding excitation light source, and a detector as shown in Fig. 3.7. Regulatory clearance is required for agents with demonstrated clinical utility and safety. The first agent to be widely used intraoperatively during robot-assisted surgical procedures is indocyanine green (ICG). Following injection into the bloodstream, ICG rapidly binds to plasma proteins in the blood. The near-infrared signal that is detected by the imaging sensor in the endoscope is used to highlight the white-light image with false color that provides the surgeon with an augmented view of the tissue, thereby giving the surgeon the ability to see vasculature and tissue perfusion (Fig. 3.8). This property has been valuable for assessing bowel or stomach viability during reconstruction, so that the connection or anastomosis is created at a well-perfused level [5]. Another application of ICG is for defining segmental planes during lung resection. After the arteries feeding the segment are divided, ICG is injected into the circulation, and the segment of lung to be resected will remain dark due to a perfusion deficit. The surgeon can then divide the lung along this defined border. After binding to blood proteins, ICG is metabolized by the liver and subsequently secreted into bile. This pathway for ICG excretion accounts for the rapid decrease in apparent brightness of ICG fluorescence in the vasculature after administration in patients with healthy liver function. However, the accumulation of ICG in bile enables surgeons to use ICG imaging to visualize the bile duct structures as bile is excreted from the liver [6]. In biliary surgery, such as cholecystectomy (removal of the gallbladder), inadvertent injury to the common bile duct is a major concern. The use of Firefly technology has enabled surgeons to help distinguish the anatomy in difficult, inflamed tissue. In general, the biliary structures become visible about 45 minutes following intravenous administration of ICG so the timing is important based on whether the purpose is to examine vascular perfusion or biliary excretion. The excitation and emission wavelengths of ICG are in the near-infrared region of the light spectrum, and as adipose and fascia tissue are somewhat

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FIGURE 3.7 Overview of the da Vinci Firefly imaging feature. A laser light source is used to excite the fluorophore (at wavelengths around 800 nm) and the emitted light is captured by the image sensors on the endoscope. Reproduced with permission from r 2018 Intuitive Surgical, Inc. Used with permission.

FIGURE 3.8 Vessel identification in FireFly fluorescence imaging mode (view of the renal hilum) during da Vinci partial nephrectomy. A whitelight view is shown on the left and the fluorescent view on the right. Reproduced with permission from r 2018 Intuitive Surgical, Inc. Used with permission.

transparent at these wavelengths, it is possible to see the ICG fluorescence through a modest thickness of intervening tissue. Researchers continue to explore other uses of ICG and its application to conditions suited to robot-assisted surgery. An example of this is ongoing research to explore the use of ICG to image lymphatic system drainage and to localize lymph nodes in order to reduce the invasiveness of node harvesting during cancer surgery [7]. In addition, many academic groups and small companies have brought forward novel imaging agents that fluoresce in the nearinfrared wavelength region. A host of such agents are being developed to image cancer margins using a variety of targeting techniques such as novel cell receptors [8], antigens [9], pH differences [10], the enhanced permeability and retention effect [11], and even scorpion venom, whose mechanism of action is currently unknown [12]. Others are being developed to image sensitive structures that surgeons wish to avoid during resections, such as nerves and ureters. For a review of fluorescent imaging agents currently under development, see Ref. [13].

3.4.2

Tomographic imaging

Tomographic imaging takes cross-sectional images of an object using penetrating waves such as X-rays (e.g., computed tomography, CT), gamma-rays (e.g., single-photon emission CT), radio-frequency waves (e.g., magnetic resonance imaging), mechanical waves (e.g., ultrasound), etc. These tomographic sectional images can provide information deep in the surface of tissue, as opposed to reflective images captured by endoscopes or bare eye vision. Viewing a series of tomographic sections allows one to gain 3D information about the anatomy of interest. Robot-assisted surgery for soft tissue has mostly focused on reflective imaging that allows the user to see only the visible surface of organs. Tomographic imaging is routinely used by surgeons prior to the operation to visualize deep

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3. The da Vinci Surgical System FIGURE 3.9 (Left) Overlay of renal arteries from a rendered CT angiogram over grayscale endoscopic images, (right) overlay of ultrasound images on endoscopic images of the liver. CT, Computed tomography. Reproduced with permission from r 2018 Intuitive Surgical, Inc. Used with permission.

tissue structures such as solid tumors and vasculature, and help plan the conduct of the operation. The ability to use intraoperative tomographic imaging that is integrated into the robotic platform may increase the efficiency and accuracy of the surgeon [14,15]. It is also possible that such augmented imaging would reduce complications by avoiding critical structures and reducing the risk of positive cancer margins with improved awareness of the tumor borders and any involved lymph nodes [14,15]. Tomographic images will need to be acquired preoperatively and need to be aligned (registered) to intraoperative patient coordinates—this is particularly challenging within soft-tissue structures, due to complex tissue deformations [14]. Intraoperative imaging modalities such as ultrasound are often used to acquire live images during surgery. The da Vinci system currently supports feeds from auxiliary video streams into the surgical display (TilePro), thus allowing third-party image and video sources to be viewed adjacent to live endoscopic video. Although the TilePro feature can be used to display tomographic images intraoperatively, the lack of automated alignment between the endoscopic view and the tomographic view makes it challenging to use real time during surgery. Numerous research efforts have attempted to solve the hand eye coordination problem in order to make more effective use of tomographic imaging modalities with the da Vinci system [16]. Fig. 3.9 shows examples of augmented reality images that combine endoscopic and tomographic images.

3.5

Tissue interaction

As part of the Intuitive ecosystem, a variety of instruments has been developed for the da Vinci system in order to facilitate tissue manipulation in various types of surgical procedures. Most of these instruments have an articulated wrist mechanism to allow for dexterous and intuitive tissue interaction, following the surgeon’s wrist articulation while controlling motion from the master interfaces of the surgical console. EndoWrist is the trade name for these articulated instruments, which include various types of scissors, forceps, needle drivers, retractors, monopolar and bipolar energy instruments, stabilizers, staplers, and vessel sealers. Only Intuitive instruments are compatible with the da Vinci system, in keeping with the goal of maintaining a uniform user experience in an integrated ecosystem. Due to the complexity and stress of reprocessing between operations, the instruments have a defined number of lives before they need to be replaced; some instruments, such as the vessel sealer, are single use only. In this section, we review two advanced instruments: the robotic stapler and vessel sealer.

3.5.1

Stapler

The EndoWrist Stapler is an articulated surgical stapling device for the da Vinci Si, Xi, and X systems and is used for resection, transection, or creation of anastomoses in general, thoracic, gynecologic, and urologic surgery. These surgical staplers utilize a disposable cartridge that places multiple staggered rows of staples and then transects the tissue between the staple rows with a knife blade. The stapler instrument can be reloaded multiple times with stapler reloads during a

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FIGURE 3.10 The da Vinci Xi EndoWrist Stapler. Reproduced with permission from r 2018 Intuitive Surgical, Inc. Used with permission.

procedure. Distinct from traditional hand-held endoscopic staplers, the robotic EndoWrist stapler allows surgeons to control the positioning and firing of the intended structure, rather than relying on a bedside assistant to do this manually. The EndoWrist stapler has two opposing jaws and 6 degrees of freedom: roll, pitch, yaw, grip, “clamp,” and “fire” (Fig. 3.10). Roll, pitch, yaw, and grip are used to position the upper and lower jaws of the instrument relative to the target tissue and are controlled in the same manner as other EndoWrist instruments, via master manipulators on the surgeon console. The term “clamp” is the same motion as grip, but uses a different mechanism to provide significantly higher grip force. The EndoWrist staplers incorporate software that can determine if there is excessive tissue thickness between the jaws to ensure that the staple line is fired only when the tissue is the appropriate thickness for the selected load. This technology is called SmartClamp on the older generation of stapler, and SmartFire on the newer generation. The term “fire” describes the combined action of implantation of staples and transection (translating blade) of the target tissue. Both functions are activated and controlled by the foot pedals at the surgeon console. One jaw of the instrument houses the staple reload, and the other jaw contains features which “form” the staples such that they remain implanted in the tissue. The EndoWrist stapler comes in three lengths: 30, 45, and 60 mm. The 30 and 45 mm are available with a curved tip design on the anvil which eases passing the anvil of the stapler around fragile vessels in small spaces (Fig. 3.10). The EndoWrist stapler cartridges come in different colors that signify different heights of the staples for different tissue thicknesses: gray (2.0 mm), white (2.5 mm), blue (3.5 mm), green (4.3 mm), and black (4.6 mm).

3.5.2

Vessel sealer

The da Vinci Vessel Sealer Extend is a single-use advanced bipolar cautery instrument with an EndoWrist that can seal and cut vessels up to 7 mm in diameter (Fig. 3.11). By applying precise pressure and controlled energy delivery between the jaws, soft-tissue proteins denature within the range of 60 C 90 C, causing the inside wall of the vessel to melt and fuse together. The energy delivery is controlled based on tissue impedance measurements during sealing to maintain temperature within a range that results in sealing, rather than charring or burning. Once sealed, the vessel can be transected by firing a mechanical knife that moves along the length of the instrument jaws, in a slot through the center of the electrodes. The tip of the Vessel Sealer Extend has a blunt end to allow for atraumatic dissection of tissue planes. The flat jaws can be also used for holding tissue, and it can be used for driving a needle during simple suturing. The jaws and wrist of the instrument are controlled using the surgeon console like the other EndoWrist instruments. The energy application and cut function are controlled using the foot pedals on the console.

3.5.3

Integrated table motion

During surgery, it is sometimes necessary to adjust the patient’s position for optimization of exposure. With the da Vinci system docked to the patient, this normally would require all of the instruments to be removed, the system

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FIGURE 3.12 Integrated operating table motion with the da Vinci Xi Surgical System. Reproduced with permission from r 2018 Intuitive Surgical, Inc. Used with permission.

undocked, and then the OR table can be adjusted. The integrated table motion feature of the da Vinci Xi system allows the system to communicate with TRUMPF Medical’s advanced operating table—the TruSystem 7000dV (TRUMPF Medezin Systeme, Saalfeld, Germany) (Fig. 3.12). With this feature, surgical teams can reposition the operating table while performing a procedure, while the robotic arms remain docked and the surgeon maintains control of the instruments. This is accomplished through computer-controlled, coordinated motion between the da Vinci system and the table. The table and the surgical system are synchronized, so that the surgical system adjusts the gantry and instrument arms to maintain the pose of instruments and endoscope relative to the patient’s anatomy while the table moves up and down, side to side, or tilting the upper body up or down. The integrated table motion feature improves efficiency in the operating room while offering an additional way of managing surgical access, exposure, and reach—essentially by employing gravity as a fourth “invisible instrument.” This is typically useful in surgery on the colon and rectum.

3. The da Vinci Surgical System

FIGURE 3.11 da Vinci Vessel Sealer Extend instrument. Reproduced with permission from r 2018 Intuitive Surgical, Inc. Used with permission.

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This feature can be used to: G G

G

Optimally position the table so that gravity exposes anatomy during multiquadrant procedures; Maximize reach and access to target anatomy, thus enabling surgeons to interact with tissue at an ideal working angle; and Reposition the table during the procedure to enhance the anesthesiologist’s care of the patient. Several key functions make this feature safe and effective:

G

G

G G G

Port following—the arms and gantry seamlessly follow the ports to leverage the da Vinci Xi system’s full range of motion. Center of motion—combines table Trendelenberg and Slide to move the patient around a virtual pivot point; maximizes the range of motion. Remote center monitoring—redundant software checks ensure cannulas and arms move in unison for added safety. Intuitive instrument control—surgeon maintains control from the surgeon console while the table is moving. Table tracking—actively rotates the da Vinci Xi camera and instruments to maintain a consistent orientation to anatomy during table movement.

3.6

Surgical access

The da Vinci system provides multiple ports of surgical access through small incisions in the patient’s body. This reduces the morbidity of the procedure, when compared to open surgery where large incisions are required to provide access [17]. However, there is increasing interest in further reducing invasiveness by using only a single incision or by accessing the body via natural orifices (NOTES: natural orifice transluminal endoscopic surgery). NOTES is considered the ultimate example of minimally invasive surgery since the surgical tools are introduced through the mouth, anus, or vagina and there is no skin incision made. As an example, Fig. 3.13 shows incisions required for open, multiport and single-port laparoscopic cholecystectomy (gallbladder removal) procedures.

3.6.1

da Vinci SP system

The latest iteration of the da Vinci system is a departure from the previous platforms, and is called the da Vinci SP, for single port. With this system three multijoint articulating instruments and an articulating camera pass through a single 2.5 cm diameter cannula. This design allows all instruments to enter a single long parallel axis, as opposed to the older single-site technology on the multiport systems (Fig. 3.14). As distinct from the EndoWrist design of the other da Vinci platforms, SP instruments have two joints to allow for expansion of the instruments once they have entered the body cavity. In addition, the articulating 3D high-definition camera is a first for the da Vinci platform, and allows the camera to position itself optimally for greater depth of field. This will make the da Vinci SP system particularly suitable for procedures that require natural orifice access, such as transoral, transrectal, and transvaginal procedures, or for operating in small spaces. It is currently approved in the United States for transabdominal urological procedures as of August 2018.

FIGURE 3.13 (Left) Open surgery with 5 8 in. of incision, (middle) multiport laparoscopic surgery with four small incisions and (right) single-site or single-port surgery with only one incision.

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3. The da Vinci Surgical System FIGURE 3.14 (A) da Vinci Si Single-Site system: (left) patient-side cart setup with three arms and curved cannulas used with two flexible instruments, (right) illustration of master manipulator associations with Single-Site instruments. (B) The da Vinci SP system, single-port cannula, three articulated instruments and camera shown. Reproduced with permission from r 2018 Intuitive Surgical, Inc. Used with permission.

The use of the da Vinci SP system is very similar to the multiport da Vinci Xi system, but there are some differences. The surgeon console appears very similar to the preexisting console with the addition of one foot pedal to allow more versatile camera control. The various uses of the camera and the ability to articulate it are the biggest differences between SP and the Xi. The use of the instrumentation is similar, but again there are some differences, particularly with regard to using the second joint which is distinct from the Xi. There is dedicated instrumentation for the SP, much of which is similar to that for the Xi. Given that the da Vinci SP system only recently received FDA 510(k) clearance in the United States for limited applications in 2018, it will be exciting to follow the different applications surgeons will develop in the near future with this totally different approach to surgical robotics.

3.7

Technology training

Training and continuing education for the surgeon and surgical staff remain crucial for successful use of the da Vinci system. The computer-assisted nature of the da Vinci system creates unique opportunities to deliver enhanced training experiences. Since the central computing system mediates all of the user commands and system outputs, one application of this information stream [18] is to measure and evaluate how the user is operating the system during training sessions [19 21]. It is possible that such approaches could eventually be used for intraoperative feedback to the users during surgical procedures to augment the decision-making capabilities of the surgeon. Another application of the information stream is to replace the endoscopic video feed with a virtual reality feed to the surgeon console during training; indeed the dynamics and controls of the entire patient-side cart can be computationally simulated and fed back to the surgeon console. Intuitive Surgical’s da Vinci Skills Simulator (Fig. 3.15) does just that, and it enables the surgeon to practice using the console without the accessories and support staff. The opportunities for virtual reality simulation in minimally invasive surgical training in general, and da Vinci training in particular [22 25], have been extensively documented, and include quantitative metrics, unlimited diversity of training and surgical scenarios, and the future potential for patient-specific procedure rehearsal [26 28].

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FIGURE 3.15 The da Vinci Skills Simulator, shown mounted on the surgeon console (left). Examples of digital training content available on the Skills Simulator (right). The upper right image demonstrates a needle targeting exercise (courtesy of Mimic Technologies, Inc., Seattle, WA, USA). The lower right image demonstrates a simulated hysterectomy procedure (courtesy of 3D Systems, Inc., Rock Hill, SC, USA). Reproduced with permission from r 2018 Intuitive Surgical, Inc. Used with permission.

The newest generation of robotic surgery simulation is known as SimNow. A key new feature of this platform is network connectivity of the simulator such that the progress of all the surgeons using it can be tracked for utilization and skills progression. This allows training programs to gain further insight into their residents and fellows training on the da Vinci platform, and to customize the curriculum based on the individual needs of the learning surgeon. Another key feature of SimNow is integration of both skills simulation as well as guided procedure simulation in a subscriptionbased platform, such that new content will be continuously pushed into the simulators remotely as they become available. da Vinci systems can be accessed by Intuitive Surgical via a secure network connection to facilitate preventative maintenance and customer service technical support. Network connectivity can also be used to support remote mentoring of surgeons who may be either mentees or newly trained robotic surgeons. The remote mentoring technology supports two-way audio communication and a 2D endoscopic view for the mentoring surgeon [29,30]. The platform also allows the mentoring surgeon to “draw” or telestrate on the mentee surgeon’s console screen. This technology allows for a surgeon who has completed training and in-person proctoring, to get additional advice or support from a mentor as he or she transitions into fully independent surgical practice on the da Vinci system. It is important that the development of training tools be driven by educational needs, rather than technological novelty. As robot-assisted surgery gains broader adoption, the types of learners and their needs grow as well. Thoughtful attention to different learners’ needs when developing training content and training technologies will ensure that impactful and efficient learning is available to all da Vinci users.

3.8

Clinical adoption

Intuitive Surgical’s current product lines focus on five surgical specialties: gynecologic surgery, urologic surgery, general surgery, cardiothoracic surgery, and head and neck surgery. Specific clearances vary across regulatory bodies worldwide and across the various models of da Vinci systems. In the United States, the da Vinci system is classified by the FDA as a Class II device, and as such, clearances are made for a specific set of indications. At the time of writing, these clearances include indications for urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures (specifically for the da Vinci Si system only: transoral otolaryngology surgical

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3.8.1

Procedure trends

In 2017, total US procedure volume was approximately 875,000, of which approximately a third was in urology, a third in gynecology, and a third in general surgery. The remaining procedures were in other specialties such as thoracic surgery or head and neck surgery. Most procedures outside of the United States were in urology. The fastest growing segment of robotic surgery currently is in general surgery, with enthusiastic adoption by surgeons for hernia repair and colorectal procedures. Procedure trends between 2000 and 2017 are illustrated in Fig. 3.16.

3.8.2

Publications

As public agencies seek to understand the impact of new technologies on healthcare outcomes and costs, peer-reviewed clinical publications and evidence-based medicine have become increasingly important. There are currently over 14,000 PubMed-indexed publications across multiple surgical specialties related to the clinical uses of the da Vinci system, the vast majority of which were researched and written independent of Intuitive Surgical. Fig. 3.17 shows publications by surgical specialty from 1998 to 2015. Contrary to some criticism that there is a lack of clinical evidence for the efficacy of robotic surgery, the peer-reviewed literature is both deep and compelling across many clinical applications of robotics. FIGURE 3.16 Worldwide da Vinci procedure growth from 2000 through 2017.

FIGURE 3.17 Publications on da Vinci technology from 1998 to 2015 by surgical specialty.

3. The da Vinci Surgical System

procedures restricted to benign and malignant tumors classified as T1 and T2 and for benign base of tongue resection procedures), general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for both adult and pediatric use except for transoral otolaryngology surgical procedures.

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Handbook of Robotic and Image-Guided Surgery

Conclusion and future opportunities

At Intuitive Surgical, we are keenly focused on continuing to enhance the value of our product and service ecosystem for our customers by striving to make surgery more effective, less invasive, and easier on surgeons, patients, and their families. This chapter has described the da Vinci system as a platform technology that we can leverage to further enhance surgeon perception, tissue manipulation, and minimally invasive access to diseased tissue. In the area of visualization, two major trends of research and development may shape the future of image guidance in robot-assisted surgery: (1) improvements in visualization techniques mainly driven by the gaming industry. In a recent survey of robotic urology surgeons, 87% felt that there is a role for augmented reality as a navigational tool in robot-assisted surgery [31]; and (2) advances in molecular imaging are likely to find more use in robot-assisted surgery with the advent of molecular markers specific to various tissue types and pathologies [32]. In the area of tissue interaction, mechanical manipulation of soft tissue using instruments such as scissors, forceps, and scalpels has been practiced for centuries and is still in use in operating rooms. The first use of electrosurgery at the Brigham and Women’s Hospital (Boston, Massachusetts) dates back to 1926. Development of advanced energy instruments that use electric currents, ultrasonic vibrations, lasers for cutting, tissue fusion and welding, etc. has been a major trend in the past few decades and we anticipate further advancements in energy instruments that are more efficient and precise. Robotic platforms will enable greater dexterity and control of these instruments. Haptic feedback or forcesensing instrumentation is another area of focus for the future, and it is anticipated that this will accelerate learning among inexperienced surgeons. In terms of minimally invasive access to tissue, five major areas of future development in surgical access can be identified as: (1) further miniaturization of surgical instruments, (2) increased use of endoluminal or percutaneous access driven by advances in snake robot-assisted technologies, (3) swallowable robots [33], (4) targeted therapy with magnetic guidance [34], and (5) noninvasive access via focal therapy [35]. Computer- and robot-assisted systems transform our ability to measure, compare, assess, and inform the performance of surgery. This has never before been possible at the scale that it is now enabled by digital surgery platforms, such as da Vinci. This creates tremendous opportunities for applying data science and analytics to model and objectively assess the practice of surgery, in order that we may further enhance clinical outcomes, safety, and operational efficiencies, while reducing complexity and variability by shortening surgeon and team learning curves. Surgical task automation is currently the subject of scientific research and is likely to be a topic of debate as regulatory challenges are realized. At Intuitive, the aim of using artificial intelligence or machine learning is to augment the surgeon’s capabilities, not replace them. This may include gradual introduction of guidance and warning features that will require the system to have some knowledge of the surgical task, similar to early aspects of autonomy in automobiles, where the first steps were recognition of road markings, obstacles, cars, and pedestrians. The future is bright for robot-assisted surgery and the introduction of several robotic surgery companies legitimizes the vision first undertaken by Intuitive over two decades ago. Multidisciplinary cross-fertilization has clearly been a key component of the development of our field to-date and will become increasingly important as new capabilities are realized and new applications are explored. This collaboration between clinical scientists, surgeons, academic researchers, industry engineers, regulatory groups, and many others will help to transition novel ideas into technologies that will ultimately benefit patients and their families in remarkable new ways.

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