Future of robotic surgery in urology

Transcription

1 Robotics and Laparoscopy Future of robotic surgery in urology Jens J. Rassweiler*, Riccardo Autorino, Jan Klein, Alex Mottrie, Ali Serdar Goezen*, Jens-Uwe Stolzenburg, Koon H. Rha**, Marc Schurr, Jihad Kaouk, Vipul Patel, Prokar Dasgupta and Evangelos Liatsikos *Department of Urology, SLK-Kliniken Heilbronn, University of Heidelberg, Heidelberg, Germany, Department of Urology, CWRU School of Medicine, Cleveland, OH, USA, Department of Urology, Medical School, University of Ulm, Ulm, Germany, Department of Urology, OLV Clinic, Aalst, Belgium, Department of Urology, Medical School, University of Leipzig, Leipzig, Germany, **Department of Urology, Yonsei University, Seoul, Korea, IHCI-Institute, Steinbeis University Berlin, T ubingen, Germany, Global Robotics Institute, Florida Hospital Celebration Health, Orlando, FL, USA, King s College London, Guy s Hospital, London, UK and Department of Urology, University of Patras, Patras, Greece Objectives To provide a comprehensive overview of the current status of the field of robotic systems for urological surgery and discuss future perspectives. Materials and Methods A non-systematic literature review was performed using PubMed/Medline search electronic engines. Existing patents for robotic devices were researched using the Google search engine. Findings were also critically analysed taking into account the personal experience of the authors. Results The relevant patents for the first generation of the da Vinci platform will expire in New robotic systems are coming onto the stage. These can be classified according to type of console, arrangement of robotic arms, handles and instruments, and other specific features (haptic feedback, eyetracking). The Telelap ALF-X robot uses an open console with eye-tracking, laparoscopy-like handles with haptic feedback, and arms mounted on separate carts; first clinical trials with this system were reported in The Medtronic robot provides an open console using three-dimensional highdefinition video technology and three arms. The Avatera robot features a closed console with microscope-like oculars, four arms arranged on one cart, and 5-mm instruments with six degrees of freedom. The REVO-I consists of an open console and a four-arm arrangement on one cart; the first experiments with this system were published in Medicaroid uses a semi-open console and three robot arms attached to the operating table. Clinical trials of the SP platform using the da Vinci Xi for console-based single-port surgery were reported in The SPORT robot has been tested in animal experiments for single-port surgery. The SurgiBot represents a bedside solution for single-port surgery providing flexible tube-guided instruments. The Avicenna Roboflex has been developed for robotic flexible ureteroscopy, with promising early clinical results. Conclusions Several console-based robots for laparoscopic multi- and single-port surgery are expected to come to market within the next 5 years. Future developments in the field of robotic surgery are likely to focus on the specific features of robotic arms, instruments, console, and video technology. The high technical standards of four da Vinci generations have set a high bar for upcoming devices. Ultimately, the implementation of these upcoming systems will depend on their clinical applicability and costs. How these technical developments will facilitate surgery and whether their use will translate into better outcomes for our patients remains to be determined. Keywords laparoscopy, patents, robotics, single-port surgery, video technology Introduction Several milestones have marked the successful introduction and implementation of Intuitive Surgical robotic systems in the field of laparoscopic surgery [1,2]. In 1999, the company started first studies in cardiac surgery, in parallel to their competitor Computer Motion [3,4]. Robot-assisted laparoscopic radical prostatectomy was pioneered in 2001, and Intuitive Surgical acquired Computer Motion in 2004 [5 10]. After successful US Food and Drug Administration (FDA) regulatory approvals, four generations of the da Vinci system have been introduced over the last 17 years [10 15]. In 2016, installations of da Vinci have risen by 21% to >2500 units worldwide, and robotic procedures leaped by 25% to BJU Int 2017; 120: wileyonlinelibrary.com BJU International 2017 BJU International doi: /bju Published by John Wiley & Sons Ltd.

2 Robotic surgery in urology > , mainly performed in urology, gynaecology and visceral surgery [16]. Intuitive Surgical currently owns >1500 patents (Appendix 1). Several manufacturers are developing alternative robotic systems (Figs 1 8); however, because of issues related to patenting, in particular, their clinical applications remain limited [17 22]. Nevertheless, the landscape of robotic surgery is expected to witness significant changes as new technologies might soon become available. The aim of the present study was to provide a comprehensive overview of the current status of robotic systems for urological surgery with a special emphasis on the development of novel devices and their potential future clinical applicability. Materials and Methods A comprehensive literature review was performed using the PubMed/Medline electronic search engine. The following search terms were used: robotic surgical device (n = 665), new surgical robots (n = 186), tele-presence surgery (n = 112), robotic surgery AND urology (n = 2564), robotic single port surgery (n = 821), ZEUS robotic (n = 111), Da Vinci XI (n = 102). Existing patents for robotic surgical devices were searched for using the Google search engine ( Appendices 1 and 2). Retrieved patents were classified according to their relevance in terms of clinical applicability. Robotic master slave systems consist of a console unit and a patient cart at bedside [1,15]. To faciliate illustration and comparison of the different systems, we considered the following main technical features (Figs 2 8): (1) type of Fig. 1 Artemis: first experimentally used device for laparoscopic telesurgery with open console and three robotic arms. The surgeon (G. Buess) used polarizing glasses for three-dimensional vision (note: double image on central screen). console (open vs closed with in-line view); (2) arrangement of robotic arms (single arms attached to the table, single arms on cart, multiple arms on a single cart); (3) camera control (voice control, eye-tracking, hand-controlled); (4) special features (haptics, lightweight arms, versatile use of camera); and (5) purpose built platforms for robotic single-port surgery. Historical Developments of Robotic Systems in Urology Table 1 summarizes the main historical developments of robotic technology in urological surgery. Early Years Artemis In 1996, Buess and Schurr successfully performed a telesurgical laparoscopic porcine cholecystectomy with the ARTEMIS system, designed with an open console and three single arms. The surgeon used polarizing glasses for threedimensional (3D) video-endoscopy (Fig. 1). Patents for this system were registered in 1997 and 2002, but, despite promising experimental trials in abdominal and cardiac surgery, it was never used during a clinical case [23 25]. All existing patents have expired (Appendix 1). Zeus Computer Motion Inc. (USA) developed the voice-controlled camera arm AESOP, together with the ZEUS system, enabling even long-distance manipulation. Production and development of ZEUS and AESOP were stopped when Intuitive Surgical acquired Computer Motion in The ZEUS system was designed with a control unit and two single arms plus the voice-controlled camera arm AESOP mounted to the operating table (Fig. 6A). The surgeon sat at an open console on a high-backed chair with armrests, controlling the instrument with chopsticklike handles (Fig. 3A). The instruments provided only 4 degrees of freedom (df). A two-dimensional (2D) or 3D video system was used for visualization of the operating field. All relevant patents for this system were registered in 1999 (Appendix 1 and Table 1), and a Conformite Europeene (CE) mark and FDA approval were received in 1999 for cardiovascular surgery [4]. The most impressive demonstration of this system was the transatlantic laparoscopic cholecystectomy performed by Marescaux et al. [26]. There were only few human urological applications of the ZEUS system, such as pelvic lymph node dissection and pyeloplasty [27,28]. BJU International 2017 BJU International 823

3 Rassweiler et al. Fig. 2 Technical modifications of closed consoles with in-line view and integrated monitors for three-dimensional (3D) vision. (A) da Vinci 2000: closed console providing in-line 3D vision and Endowrist TM technology applicable for three robotic arms. (B) da Vinci Si: concept of closed double-console for training and assistance. (C) Avatera: closed console with integrated seat and 3D high-definition video system using microscope-like technology with two adaptable oculars. (D) Medicaroid: closed console with a microscope-like ocular an in-line view; however for 3D vision polarized glasses are necessary. A B C D Fig. 3 Technical modifications of open consoles with external monitor for three-dimensional (3D) vision. (A) Zeus: open console with integrated seat and monitor. Optional 3D vision via mounted helmet. Second monitor displays the arrangement of robotic arms during transatlantic surgery. (B) MiroSurge: open console with auto-stereoscopic monitor and handles with force feedback. (C) Telelap Alf X: console with 3D monitor requiring polarizing glasses with eye-tracking. (D) REVO-I: open console with two handles, foot pedals and 3D high-definition monitor. A B C D 824 BJU International 2017 BJU International

4 Robotic surgery in urology Fig. 4 Comparison of handles used for manipulation of robotic instruments. (A) Da Vinci 2000: two loop-like handles to provide open and closing of instrument tips by thumb and index finger. Other degrees of freedom provided by movement of the wrist. Forearm and elbow is supported by an armrest. The system is integrated in the console. (B) MiroSurge: look-like handles to provide open and closing of instrument tips. Other degrees of freedom provided by wrist movements (manufactured by Force Dimension, Nyon, Switzerland). No specific support necessary as it is used in an openconsole setting. (C) Sport: same technology as with MiroSurge (Force Dimension, Nyon, Switzerland) in an open console setting. (D) Telelap Alf X: laparoscopy-like handles to control instruments with 4 6 degrees of freedom providing haptic feedback. A B C D Da Vinci Series Da Vinci 2000 and da Vinci S A National Aeronautics and Space Administration (NASA) project on telepresence battlefield surgery led to the development of the da Vinci â System (Intuitive Surgical, Sunnyvale, CA, USA) [29,30]. The design of this system was a closed console offering a 3D video system with in-line view (Fig. 2A). Three robotic arms were mounted on a cart. The da Vinci S provided better range of motion, longer robotic arms, implementation of bipolar energy, and an optional highdefinition (HD) video system or a fourth arm (Table 1) [11,12]. The unique features of this system were its Endowrist â technology with 6 df and loop-like handles enabling ergonomic working, including a clutch mechanism (Fig. 4A). Patents regarding open telepresence surgery dated back to 1994 (3D mirror technology), and all relevant patents were registered in 1999 (Appendix 1 and Table 1). In 2015, Intuitive Surgical abandoned technical support for the da Vinci Although recent patents were registered in 2007 (Appendix 1), technical support for da Vinci S will end in The da Vinci system has had a CE mark since 1999 and full FDA approval since It was designed for robot-assisted coronary artery surgery, and the first cases were performed at the Heart Centre of Leipzig [3]. In 2001, robot-assisted radical prostatectomy started in Europe [1,5 8]. Menon et al. [9] established the first full-working clinical programme. Da Vinci Si In 2009, the da Vinci Si system was launched with full CE mark and FDA approval. Its unique features were HD video technology, finger-based clutch mechanism and isocyanine green fluorescence (Fire-Fly TM technology) [13,14]. The da Vinci Si dual console allows two surgeons to collaborate during surgery, representing an ideal training platform (Fig. 2B), as proposed already in 2000 by Autschbach et al. [31]. The da Vinci Si system also allows use of the VeSPA system for robotic single-port surgery, providing instruments with only 4 df [32]. Da Vinci Xi In 2014, Intuitive Surgical introduced the da Vinci Xi system with CE mark and FDA approval (Fig. 5A). Its unique features were its 8-mm 3D HD camera to be chosen liberally at all four ports ( camera hopping ). This feature can be BJU International 2017 BJU International 825

5 Rassweiler et al. Fig. 5 Comparison of modifications of robotic arms arranged on a single cart. (A) Da Vinci XI: four-arm system with finer design of the arms providing seven joints. Camera can be used via each of the arms. (B) Amadeus RSS: arrangement of four arms with three joints on a freely movable semi-circled platform (Patent: US A1). (C) Avatera: four lightweight arms with four joints enabling use of three 5-mm instruments and one 10-mm camera arrangement. (D) Revo I: four robotic arms with three joints for three instruments and one camera. A B C D important for specific mutiquadrant procedures, such as colorectal surgery. The robotic arms have a much finer design to minimize instrument clashing, and the operating table can be moved while the robotic arms are connected ( table motion technology). With this system, the new robotic SP 1098 platform for robotic single-port surgery with 6 df can be used (Fig. 7A) [15]. Recent technological advancements include stapling devices with 6 df, or 6-df flexible instruments for the VeSPa single-port system. Abandoned Projects SR1 In 2009, Kyung Hee developed the SR1 at Seoul Yonsei University in collaboration with Samsung, consisting of two industrial robots (AS2, Samsung Automation, Korea) with 6 df and force feedback mounted at bedside with a 2D standard laparoscope. Featuring a relatively simple design, this system allowed telesurgery, similar to the ZEUS system, but it was never used clinically [18]. Amadeus In 2012, the Amadeus RSS (Titan Medical, Toronto, Canada) was presented on an experimental level and patented (Appendix 1 and Table 2). The device had similarities to the da Vinci design, with a closed console and three robotic arms aligned on a curved support (Fig. 5B) [21]. Titan Medical stopped development of the Amadeus RSS in 2013, and the system therefore never came to market. Commercially Available Alternatives to da Vinci Telelap ALF-X Supported by the European Commission, the Italian healthcare company Sofar (Milan, Italy) developed an alternative robotic 826 BJU International 2017 BJU International

6 Robotic surgery in urology Fig. 6 Comparison of modifications of robotic arms fixed separately on the operating table or on different carts. (A) Zeus: two robotic arms providing three joints and the voiced controlled camera arm (AESOP) mounted directly on the operating table. (B) MiroSurge: three lightweight arms with four joints four two instruments and camera. (C) Medicaroid: robotic arms providing six joints attached to the operating table. (D) Telelap Alf X: robotic arms with four joints mounted on three separate carts. A B D C Fig. 7 Comparison of different robotic end-effectors designed for laparoscopic single-port surgery (R-LESS). (A) SP 1098 Platform for Da Vinci XI: threedimensional (3D)/high-definition flexible telescope and three flexible instruments with a snake style wrist. The device is controlled by use of EndoWrist TM technology at the console. (B) SPORT Surgical System: 3D flexible telescope with fibre-optic-based illumination and two flexible instruments. (C) IREP: 3D telecope and two flexible arms with snake segments design, providing a passive and active segment based on parallelogram instrument design. (D) ARAKNES: two robotic arms with rotating grippers on the end (SPRINT robot) together with a fixed stereoscopic camera. A B C D Insertion tube Stereoscopic camera Left arm Right arm Grippers system, the Telelap ALF-X. The design featured a remote control station and three robotic arms mounted on three separate carts (Fig. 6D). The device uses an open console with a 3D HD screen requiring polarized glasses (Fig. 3C). Two handles similar to laparoscopic hand-pieces manipulate 4-df and 6-df instruments attached to the robotic arms (Fig. 4D). Tuebingen Scientific (T ubingen, Germany) developed instruments based on Radius technology [33]. BJU International 2017 BJU International 827

7 Rassweiler et al. Fig. 8 SurgiBot: robotic arms may compensate for most of the deficiencies of the Spider platform, such as optimal fixation, handling of instruments, integration of three-dimensional telescope, and adjustable motion scaling. MiroSurge consisted of three lightweight arms mounted on the operating table, and an open console with the surgeon sitting in front of an autofocusing monitor (Fig. 3B). The robotic arms are composed of seven joints with serial kinematics, comparable to human arms. Instruments are driven by micro-motors (Fig. 6B), optionally providing tactile feedback via potentiometers. Patents were registered in 2012 and 2013 (Appendix 1 and Table 2). Medtronic plans to initiate clinical trials in India and to launch the device in the USA in 2018 [42]. Avatera The system s unique features include haptic feedback and an eye-tracking system. Haptic feedback is realized by countermovements of the laparoscopic handle at the console according to force and direction applied at the tip of the instrument [34]. The eye-tracking system controls camera movements; for example, the image is zoomed, when the surgeon s head approaches the screen [35]. An initial patent was registered in 2007 (Appendix 1 and Table 1). In 2015, TransEnterix (Morrisville, NC, USA) acquired Sofar Surgical Robotics [36], and later a patent for 6-df instruments from Tuebingen Scientific (Appendix 1). Telelap ALF-X has had a CE mark since 2016 for indications in general surgery, gynaecology, urology and thoracic surgery. TransEnterix is preparing a submission for FDA clearance. With regard to the clinical application of this system, early clinical reports of robot-assisted hysterectomies were published in 2016 [37,38], and the first devices have been sold in Italy. Upcoming Robotic Systems: Ongoing Projects Medtronic In 2010, experimental results of MiroSurge (German Aerospace Centre, Oberpfaffenhofen, Germany) were published [39,40]. In 2013, Covedien (Dublin, Ireland) acquired the licence for its commercial use, and included further developments in their two research and development centres in the USA [41]. Since Medtronic completed the acquisition of Covidien in 2015, the company became able to develop all necessary instruments [42], and it is currently working on the 10th prototype of this system. Since 2012, Avateramedical (Jena, Germany) have been developing Avatera in cooperation with Force Dimension (Nyon, Switzerland), for transmission of handle movements at the console to the robotic arms, and with Tuebingen Scientific (T ubingen, Germany) for 6-df-instruments. It features a closed console with an integrated seat using a microscope-like technology for in-line 3D image with full HD resolution (Fig. 2C). Four robotic arms are mounted on a single cart (Fig. 5C), and 6-df instruments with a diameter of 5 mm are applied. Patents were registered in 2012 and 2013 (Appendix 1 and Table 2). The system has only been used in experimental animal trials. The validation process for CE certification was initiated in Revo-i In collaboration with Yonsei University and other Korean academic and industry groups, Meerecompany (Hwasong, Korea) designed the REVO-I platform, featuring an open console (Fig. 3D) and a four-arm system mounted on a single cart (Appendix 1, Table 2 and Fig. 5D). The system uses 6-df instruments with a diameter of 8 mm. The patent was registered in 2014 (Appendix 1 and Table 2). In 2016, the first results of animal studies were published [19,20], and approval for human trials in South Korea was received [22,43]. Medicaroid Matsuda recently reported details of the Japanese Robot during the 2016 AUA meeting [22]. In 2016, Medicaroid (Kobe, Japan) started a corporation in Silicon Valley to develop the US market for made-in-japan medical robots using the research and development and manufacturing capabilities of Sysmex and Kawasaki [44]. The device consists of three robotic arms attached to the operating table and a semi-closed console using a microscope-like ocular lens, but still requires polarized 828 BJU International 2017 BJU International

8 Robotic surgery in urology Table 1 Historical development of surgical robots for laparoscopy. Device and patents Telescope Console Robotic arms df FDA / CE approval Milestones ARTEMIS (Nuclear Research Centre Karlsruhe, Germany) Patents: US Listed: US A1 Listed: ZEUS (Computer Motion aquired by Intuitive Surgical) Patents: US A Listed: US B1 Listed: Intuitive Surgical system = da Vinci (Intuitive Surgical) Patents: US A Listed: US B1 Listed: Da Vinci S (Intuitive Surgical) Patent: US A1 Listed: Da Vinci SI (Intuitive Surgical) Patent: US A1 Listed: US B2 Listed: D coloured coupled device (CCD) technology controlled by camera arm (joy-stick) 2D/3D CCD technology (voice control) 3D CCD technology (Scholy, Denzlingen, Germany) manipulated by the two handles activated by foot pedal 3D CCD technology (Scholy) manipulated by the two handles activated by foot pedal 3D HD technology (Scholy) manipulated by the two handles activated by foot pedal Open console with 3D monitor with polarized glasses Two joy-sticks with armrest Open console with 2D/3D monitor with polarized glasses or helmet and microphone Two handles (like chopsticks) Closed console with 3D monitor based on mirror technology two handles (loops) with Endowrist Tm -technology; foot pedals for focusing, clutch, camera, monopolar cautery 3D monitor with mirror technology two handles (loops) with Endowrist technology foot pedals for focusing, clutch, camera, monoand bipolar cautery 3D-montor with mirror technology two handles (loops) with Endowristtechnology foot-pedals for focussing, clutch, camera, mono- and bipolar cautery, fingertipswitch for individual clutching Two cable-actuated robotic arms plus camera arm (FIPS) mounted on operating table Two motorized robotic arms plus the voice controlled camera arm (AESOP) mounted to operating table Two cable-driven robotic arms plus the camera arm Two cable-driven longer robotic arms plus the camera arm, optional fourth arm for retraction 2 cable-driven longer robotic arms plus the camera arm, optional 4 th arm for retraction 7 No 1996 first robotic device used in experimental surgical models. Designed for abdominal and cardiac surgery 5 Yes, but not manufactured (since 2004) 7 Yes, but not manufactured (support until 2014) 7 Yes, but not manufactured (support until 2018) First coronary bypass surgery in 1999, including harvesting of the left internal thoracic artery 1999 first experimental robotassisted pyeloplasty 2001 transcontinental robotassisted cholecystectomy (Lindbergh operation) 2004 use abandoned (Computer Motion acquired by Intuitive Surgical) 1998 First robot-assisted cholecystectomy First coronary bypass surgery in 1999 including harvesting of the left internal thoracic artery First robot-assisted laparoscopic radical prostatectomy in first gasless transaxillary robotic thyroid surgery 7 Yes 2009 release of dual-console model da Vinci SI Surgical System 2010 first use of VeSPAsystem for robotic single-port surgery with only 4 dfinstruments 2011 first use of infrared fluorescence imaging using indocyanine green dye BJU International 2017 BJU International 829

9 Rassweiler et al. Table 1 (continued) Milestones Device and patents Telescope Console Robotic arms df FDA / CE approval 7 Yes 2014 used for robotic partial nephrectomy with improved docking and minimal instrument clashing 2014 first clinical application of SP System for robotic single-port radical prostatectomy and partial nephrectomy 2016 Introduction of 7-df instruments for the VeSPA system for robotic single-port surgery Four cable-driven thinner robotic arms with additional joint each applicable as camera-arm (8 mm) Laser crosshairs aligning the patient cart with desinated camera port 3D monitor with mirror technology two handles (loops) with Endowrist technology foot pedals for focusing, clutch, camera, mono- and bipolar cautery, fingertip switch for individual clutching 3D HD technology (Scholy) manipulated by the two handles activated by foot pedal Da Vinci XI (Intuitive Surgical) Patents: US A1 Listed: US B2 Listed: US A1 Listed: US A1 Listed: experimental use for robot-assisted nephrectomy 2016 first clinical application for robot-assisted hysterectomy Yes (only CE since 2016) 7 (provided by Tuebingen Scientific, Germany) Three cable actuated robotic arms plus telescope arm arranged on three carts Open console with 3D glasses and monitor with eye-tracking system laparoscopic-like handles providing haptic feedback 3D HD technology (eye-tracking system) Telelap ALF-X (Sofar, Italy; aquired by TransEnterix, Morrisville, NC, USA) Patents: US B2 Listed: US A1 Listed: D, two-dimensional; 3D, three-dimensional; CCD, coloured coupled device; df, degrees of freedom inclusive actuation of instrument; HD, high-definition. glasses (Fig. 2D). Human trials are expected in Japan in Verb Surgical Verb Surgical was formed in 2015 as independent start-up company, backed by Google and Johnson & Johnson to harness the unique capabilities of both companies [45]. To date, there has been no detailed information available about the design of their robotic system [46]. Experimental Devices Raven The Raven Project (Universities of Santa Cruz, Berkeley, Davis) aims to produce an open-source system that would allow two surgeons to operate on a single patient simultaneously. The initial systems included two portable surgical robotic arms, each offering 7 df and a portable surgical console [47]. Raven III offers four robotic arms and optionally two cameras. Raven III is one of the most advanced surgical robotics research platforms, focused on battlefield and underwater remote surgery. Sofie The SOFIE (Surgeon s Operating Force-feedback Interface Eindhoven) includes two components (master and slave) completely separate from each other. Communication takes place over data cables arranged in an overhead-wiring boom [48]. Three different lightweight robotic arms with a maximum of 8 df are mounted on the operating table. To date, no laparoscopic application of SOFIE has been published. Robotic Systems for Single-Port/Single-Site Surgery Console-Based Devices Laparo-endoscopic single-site surgery (LESS) further minimizes access trauma of classic laparoscopic or robotassisted laparoscopic surgery as a potential step toward true natural orifice surgery. The classic LESS technique is significantly impaired, however, by suboptimal ergonomics with clashing of instruments. The VesPA system provides only 4-df instruments. Updated robotic technology may overcome these limitations (Fig. 7). SP 1098 The da Vinci Xi system also allows the use of the robotic single-port SP 1098 platform (Fig. 7A, Appendix 2 and Table 3), including a 3D HD flexible telescope and three 830 BJU International 2017 BJU International

10 Robotic surgery in urology Table 2 New robotic devices for laparoscopy with potential to be used clinically in the future Device / Patents Telescope Console Robotic arms Force feedback df FDA/CE approval Comment AMADEUS RSS (Titan Medical, Toronto, Canada) Patents: US A1 Listed: US A1 Listed: MEDTRONIC (Medtronic-Covidien, Dublin, Ireland) Based on MiroSurge (DLR, Germany, aquired by Medtronic, Ireland) Patents: US A1 Listed: US A1 Listed: Avatera (Avateramedical, Jena, Germany) Patents: US A2 Listed: US A1 Listed: REVO I (Meerecompany, Hwasong, Korea) US A1 Listed: Japanese Robot (Medicaroid, Kobe, Japan) No US patent 3D HD technology 3D screen with mirror-based technology and loophandles 3D-HD technology Open console with monitor and 3D glasses Fingertip-controlled handles Clutch mechanism Foot switches to activiate bipolar energy 3D HD technology Closed console with 3D in-line screen (immersion) based on microscopetechnology with two adjustable occulars Integrated seat with foot-switches 3D HD technology (stereo-endoscope) 2D monitor with two handles and foot controller for clutch mode and cautery 3D HD technology Semi-open console with occular-like inline technology, need of polarized glasses Three cable-actuated robotic arms plus telescope arm arranged on a curved support Three to four lightweight motorized robotic arms Four arms mounted on a superordinate carrying system including the camera Yes 7 No Development actually stopped due to patent problems Not in prototype Haptic technology available 7 CE expected 2018 Planning of optimal trocar position Zero-space positioning Only in vitro studies, clinical studies expected in 2018 No 7 (5-mm instruments) CE expected 2017 Only experimental trials Four-arm system No 7 Korean licence in 2017 Three-arm system attached to operating table No 7 Japanese license expected in 2020 Collaboration with Samsung First animal trials published Clinical trials expected in 2017 Collaboration of Sysmex and Kawaski Heavy Industries Clinical launch expected at D, two-dimensional; 3D, three-dimensional; df, degrees of freedom inclusive actuation of instrument; HD, high-definition. BJU International 2017 BJU International 831

11 Rassweiler et al. flexible instruments. Once introduced via umbilical incision, the flexible instruments with a snake-style wrist can separate to achieve triangulation. Instruments are controlled by Endowrist â technology at the closed Xi console. The system has had a CE mark since 2012 and FDA approval is in preparation. The SP 1098 platform has been used in clinical pilot studies in France, focusing on robot-assisted single-port partial nephrectomy, radical prostatectomy and perineal prostatectomy [16,49,50]. SPORT TM After the unsuccessful introduction of the Amadeus RSS, Titan Medical focused on the SPORT Surgical System as a platform for robotic LESS. SPORT has an open console with 3D HD vision controlling a 3D flexible telescope with fibre-optic based illumination and two flexible instruments (Appendix 2,Table 3 and Fig. 7B) [21,51]. The first public demonstration of SPORT was realized at SAGES 2016 in Boston. FDA approval for the system is pending [52]. Its main application is expected to be LESS cholecystectomy. Recently, robotic single-port partial nephrectomy was performed in animal models requiring additional trocars for retraction. Experimental Devices The ARAKNES project (Array of Robots Augmenting the Kinematics of Endoluminal Surgery) was funded by European Union programme to produce a micro-robotic-based smart operating system for advanced endoscopic surgery [53]. The system (SPRINT robot) is based on the common design of a remote console and two robotic arms with rotating endeffectors (Fig. 7D). The IREP (Insertable Robotic Effectors Platform) was developed at Vanderbilt University. It consists of a 3D telecope and two flexible arms with a snake design providing a passive and active segment. Enlargement of the working space may be provided based on parallelogram instrument design (Fig. 7C). The device is operated by two hand-pieces and a 2D monitor not comparable to a surgical console [54]. Bedside-Based Devices SurgiBot The Spider System (TransEnterix) represents a platform developed for LESS based on tubes in which flexible instruments can be manipulated. The initial device used wirebased manipulators only for 5-mm instruments, requiring insertion of on additional trocar for ablative renal surgery [55]. Handling of instruments was difficult, particularly concerning endoscopic suturing. TransEnterix improved the system considerably by providing the robotic-arm SurgiBot. The Spider system includes a bedside platform with multiple features, such as triangulation adjustment, multi-quadrant movement, robotic lateral movement and rotation, clutch of instruments in an ergonomic position, and a 3D HD video system (Table 4 and Fig. 8). In 2015, TransEnterix submitted an application for FDA approval [56]. LODEM A flexible locally operated end-effector manipulator (LODEM) was developed for single-site laparoscopic surgery at Osaka Institute of Technology, Japan. The device uses crank-slider and cable-rod mechanisms to achieve 5 df. The surgeon uses a robotic arm for endoscope and forceps, together with standard laparoscopic instruments [57]. The device has been tested in vitro and in vivo for surgical indications. Bedside-Based Devices For Laparoscopy MIM System The manually manipulated robot-like system MIM was developed at the Universiy of Utrecht and is an interesting modification of bedside devices for laparoscopic surgery providing 7 df [58]. This device enables instrument movement similar to the da Vinci systems based on a parallelogram design; specific instruments (i.e. bipolar forceps) have not yet been developed. The device has been tested only experimentally. Recently, Lapara Surgical ( was founded to launch the system clinically in 2019 (J. Jaspers, personal communication). ETHOS Plus Motorized 6-df Instruments The ETHOS TM chair (Ethos, Seattle, WA, USA) avoids the torero position during pelvic surgery because the surgeon sits over the patient s head rather than standing or sitting laterally. In combination with motorized instruments offering 6 df, such as the DEX robot (Dexterite, Annecy, France) or the Kymerax (Karl Storz, Tuttlingen, Germany) systems, and with 3D HD video technology, the ergonomics of laparoscopy can be significantly improved [59 62]. The surgeon has two adjustable armrests and footrests with integrated foot switches enabling electrically motorized 832 BJU International 2017 BJU International

12 Robotic surgery in urology Table 3 Robotic flexible endoscopic multi-tasking platforms for single-port surgery with possible clinical future. Device/patents Outer diameter, mm No. of instrument channels Robotic arms Length, cm Freedom of movement, df Comment SPORT Surgical System (Titan Medical, Toronto, Canada) Patent: US B1 Listed: SurgiBot (TransEnterix, Morrisville, NC, USA) Patent: WO A2 Listed: SP 1098-Platform (Intuitive Surgical, Sunnyvale, CA, USA) US A1 Registered: Insertable Robotic Effectors Platform (Columbia University, Ohio, USA) US A1 Listed: SPRINT (ARAKNES, Italy, Switzerland, Germany) Patent: US A1 Listed: FI2010A Listed: None Two robotic arms with snakelike plus deflectable telescope 21 Two working channels tubes (2 9 5 mm) plus 3D/HD flexible laparoscope (5 mm) Two steerable tubes controlled by endomechanical vertebral arms (adjustable motion scaling) 25 None 3 robotic arms with snake segments plus flexible 3D telescope 20 None 2 flexible arms with snake segments design + 3D telescope (paralleogram design) 25 None Two motor-driven robotic arms with joints for endeffectors (elbow, wrist) 30 Endoscope: 4* Instruments: 9 Due to snake design Ergonomic console with HD 3D monitor Patient cart to manipulate robot with various instruments for both arms For renal surgery additional instruments are necessary 30/50 Endoscope: 6* Robotic arm holds the device Instruments: 7 3D/HD vision by polarized glasses Motion of arms like laparoscopic instruments No console, no FDA approval yet 30 Endoscope: 6* Instruments: 9 Due to snake design 22 Endoscope: 2* Instrument: 9 due to snake design 30 Endoscope 4* Instruments: 7 Controlled by EndoWrist technology at the Da Vinci console For prostate surgery additional instruments are necessary Operated by two hand-pieces and a 2D monitor actually not comparable to a surgical console. Provides sensory feedback Still completely experimental Operated by two hand-pieces with haptic interface and a 3D monitor with glasses actually not comparable to a surgical console. Magnetically controlled endocamera tested in vivo. No invivo tests of the device have been reported yet Supported by the European Commission s Joint Research Centre Still completely experimenatl df, degrees of freedom. *Endoscope up/down left/right rotation translation; instrument up/down left/right open/close translation rotation wrist of instrument. BJU International 2017 BJU International 833

13 Rassweiler et al. Table 4 Comparison of features of existing and upcoming robots and their possible advantages. Feature Description Advantage Closed console Surgeon looks in window/ocular part of the console Open console Surgeon sits in front of a monitor using 3D polarized glasses autofocusing monitor Camera control by handles and foot pedal Surgeon activates camera movement by foot pedal and navigates the telescope via parallel move of both handles Camera control by eye-tracking Camera is navigated according to the eye and head movements of the surgeon Loop-like handle Surgeon manipulates instruments with the fingertips (thumb and index finger) and wrists Laparoscopy-like handle Surgeon manipulates instruments with laparoscopic handles (thumb and middle finger) Surgeon has imagination to immersed in the body No need of 3D polarized glasses Additional imaging information can be dysplayed on the in-line screen Vision similar to laparoscopy Better contact to the operating team Easy viewing if additional information (imaging, virtual reality) on separate screen Flexible for technical improvement (3D monitors; ultra-hd video technology) The tip of both instruments are always lateral to the telescope, enabling immedate continuation of the surgical step Automated process similar to the surgeons attitude (head closer to the monitor = zoom in) No need to activate camera navigation Full realization of the immersion-like endoscopic surgery (Endowrist technology) Additional functions can be integrated lateral to the loops (clutch function) Manipulation similar to laparoscopy Index finger can be used for further functions (rotation, activitation of haptic feedback) Easy integration of 4-df instruments (advanced sealing devices, laparoscopic forceps) Simpler realization of haptic feedback Limited for 6-df movements (needle-holder) df, degrees of freedom. 834 BJU International 2017 BJU International

14 Robotic surgery in urology movements of the chair. The motorized instruments enable 6- df movements of the tip as well as automatic rotation for suturing. All devices have a CE mark and the ETHOS chair is FDAapproved. Compared with robotic systems using a console, the design solutions of the ETHOS chair are much cheaper (< Euro). They may compensate for the deficiencies of laparoscopy, particularly during reconstructive surgery; however, the system still lacks a clutch mechanism. Robotic Devices for Retrograde Intra-Renal Surgery Avicenna Roboflex Robotic master slave systems are not limited to laparoscopic surgery [63]. Recently, the Avicenna Roboflex (Elmed, Ankara, Turkey) was introduced to perform retrograde intrarenal surgery. The surgeon sits at an open console manipulating a standard flexible ureteroscope with HD video technology. The handpiece of the scope is attached to a robotic manipulator enabling rotation, insertion and deflexion of the scope. All movements can be graduated and fine-tuned. Irrigation, activation and control of the laser fibre as well as fluoroscopy are provided by touch-screen functions and foot pedals. The Avicenna Roboflex has had a CE mark since 2014, and FDA approval is in preparation. The first multi-centric experiences of the Avicenna Roboflex are promising [64]. Discussion Over the last 15 years, Intuitive Surgical has built high barriers to new entry of surgical robots by superior product offerings, intellectual property protection, multiple regulatory clearances, a large installation base, worldwide training centres, strong customer relationships, and an excellent balance sheet [65]. Expiry of existing key patents in 2019 may soon change this status quo, and stimulate a new era of robotic master slave systems. In Europe and Asia several devices are under development, and the Telelap ALF-X has already received a CE mark [37,38]; however, FDA approval still represents a significant challenge [66]. Recent internet publications have emphasized earlier expiry of Intuitive Surgical s key patents [65,67]; however, we identified only a few 1994 patents related to construction of a console for battlefield surgery. All relevant patents of ZEUS and Da Vinci were listed in 1999 and thus will expire in 2019 (Appendix 1). Accordingly, TransEnterix will focus on first studies in Europe, Meerecompany has approval for human studies in Korea, and Avateramedical aims to have the first CE mark to enter the European market. In summary, we will see further devices being introduced clinically worldwide in the next 2 years. FDA approval for such systems, however, can be expected in 2019 at the earliest. Several modifications of master slave systems have been introduced (Table 4 and Figs 2 7). Intuitive Surgical and Avateramedical rely on the principle of a closed console with in-line 3D video technology, whereby the surgeon is immersed in the operative field and does not need to use polarized glasses, which are associated with loss of brightness (Fig. 2). The advantages of an open console include better contact with the team at bedside and the flexibility of such systems to integrate future technologies (Fig. 3). Ultra-HD (4K) video technology features larger screens and higher resolution, whereas full HD 3D screens are already used in the entertainment industries [59]. Computer Motion started with a voice-controlled camera system (AESOP), whereas Intuitive Surgical introduced navigation of telescopes by two handles. Both instruments are thereby kept at optimum distance to the telescope, thus enabling immediate continuation of the next surgical step. Sofar-TransEnterix have developed an eye-tracking system to control the telescope. All indirect camera controls (based on voice, head-moves, eye-tracking) have the risk of inadvertent movements or malfunction [59]. Fingertip-based controls of instruments use the index finger and thumb, similarly to forceps (Fig. 4). Laparoscopic handles control instruments by thumb and middle finger allowing the index finger to be used for further functions (activation of haptic feedback, rotation of instrument) and enable the use of 4-df instruments (Ligasure TM, staplers, graspers). To date, haptic feedback has been realized only for laparoscopic handles; however, only fingertip-based controls allow intuitive wrist-controlled movements, which are most relevant during endoscopic suturing. The ZEUS system used three robotic arms individually mounted on the operating table (Fig. 6A), but, for a fourth arm, the space was limited. The same limitation can occur when each arm is mounted on a cart (Fig. 6D). Conversely, individual arrangement of robotic arms is more versatile compared with a four arm-arrangement on a single cart (Fig. 5). The clutch mechanism is important for robot-assisted surgery. Clutching is usually activated via a foot pedal. The da Vinci Si features a fingertip-based clutch function for each instrument, which may be in conflict with standard instrument moves. Thus, some surgeons disable this function to prevent inadvertent finger clutching. Only bedside devices with clutch functions (i.e. SurgiBot) may have a potential for widespread clinical use. BJU International 2017 BJU International 835

15 Rassweiler et al. Intuitive Surgical entirely developed and manufactured the da Vinci system, while the 3D video technology and specific instruments (stapler, harmonic scalpel, vessel sealer) required collaborations with other companies. By contrast, joint ventures seem to play an important role for the development of upcoming robots: force dimension dominates transmission of fingertip-based movements on robotic end-effectors (Fig. 4) [63,68]. Tuebingen Scientific is involved in the production of 6-df instruments [56]. In order to develop its robotic system, Medtronic combined the German robotic technology with the know-how of Covidien on laparoscopic instruments [41,42]. As new players will soon come into the market, costs are expected to be lower [65]; however, none of the companies competing with Intuitive Surgical have obtained FDA approval yet. Indeed, the variety of new devices will have an impact on the costs, including purchase and maintenance of the robot as well as instrument prices. Upcoming devices will have to address the following issues, in order of relevance: (1) clinical outcomes; (2) FDA regulatory approval; (3) marketing development; and (4) patent approval and protection. In this scenario, cheaper bedside solutions may also represent a valid option [59 61]. The development of robotic technology will never stop. Next-generation devices might offer novel distinct features, such as haptic gloves or cellular image guidance. For example, cooperation of Google and Johnson & Johnson aims to use cellular-guided imaging in their robot [46,47]. Shademan et al. [69,70] have described in vivo supervised autonomous soft tissue surgery in an open surgical setting, enabled by a plenoptic 3D and near-infrared fluorescent imaging system that supports an autonomous suturing algorithm. Based on expert human surgical practices, a computer program generates a plan to complete complex surgical tasks on deformable soft tissue, such as suturing an intestinal anastomosis [69,70]. Despite dynamic scene changes and tissue movement during surgery, they could show that the outcome of supervised autonomous procedures was superior to surgery performed by expert surgeons and robot-assisted techniques [70]. STAR (Smart Tissue Autonomous Robot) results show the potential for autonomous robots to improve efficacy, consistency, functional outcome, and accessibility of surgical techniques [70]. Similarly, robot-assisted water-jet ablation (Procept, Redwood Shores, CA, USA) had significantly better ablation efficacy compared with standard transurethral resection [71]. Conclusions Several console-based robots for laparoscopic multi- and single-port surgery are expected to come to market within the next 5 10 years. Future developments in the field of robotic surgery are likely to focus on specific features of robotic arms (lightweight, smaller size, mounted on operating table or on separate carts), instruments (tactile feedback, micro-motors), console (open, closed, semi-open), and 3D HD video technology (polarized glasses, oculars, mirror technology). Certainly, the high technical standards of four da Vinci generations have set a high bar for upcoming devices. New platforms will need to be critically assessed, and their performance necessarily compared with the current gold standard da Vinci. Ultimately, the implementation of these new systems will depend on their actual clinical applicability and costs. How these developments will facilitate surgeons and whether their use will translate into better outcomes for our patients remains to be determined. After 15 years, robotic technology has gained an established and irreversible role in urological laparoscopic surgery, and it might start playing a role also in other areas of urology, as demonstrated by the recent introduction of robot-assisted flexible ureterorenoscopy. We have already entered the era of robotic minimally invasive surgery, and it is our responsibility to stay tuned as we witness ongoing developments in this fascinating technology-driven field of research. Conflict of Interest Jihad Kaouk was involved in the development of the SP 1098 platform (Intuitive Surgical); Koon H. Rha was involved in the development of the REVO I platform (Meerecompany); Marc Schurr holds stock in Tuebingen Scientific Medical GmbH, and is a member of the executive board of the company; Jens-Uwe Stolzenburg is a shareholder of Avateramedical N.V., the holding company of avateramedica GmbH (Jena, Germany), which is developing the Avatera system and was involved in the its development; and Jens J Rassweiler was involved in the development of the ETHOS chair (Ethos) and Avicenna Roboflex (Elmed). Alex Mottrie is consultant of Medtronic (Dublin, Ireland). References 1 Rassweiler J, Binder J, Frede T. Robotic and telesurgery: will they change our future. Curr Opin Urol 2001; 11: Wilson TG, Guru K, Rosen RC et al. Consensus Panel. Best practices in robot-assisted radical cystectomy and urinary reconstruction: recommendations of the Pasadena Consensus Panel. Eur Urol 2015; 67: Mohr FW, Falk V, Diegeler A, Autschbach R. Computer-enhanced coronary artery surgery. 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