Available and emerging robotic systems

Revo-i

The Revo-i (model MSR-500, meerecompany, Hwasong, Korea) is a Korean robot that received approval from the Korean Ministry of Food and Drug Safety in 2017. This consists of an operator console and robot design with accompanying vision cart, similar to the da Vinci Xi model ( Fig. 2.1 ). The surgeon-controlled robot contains four robotic arms with 3 DOF each, which manipulate wristed instruments. Thirteen 8-mm instrument options are available, each with 6 DOF and with monopolar and bipolar energy options. The instruments are reusable up to 15 uses, and the 3D endoscope is autoclavable (personal communication with meerecompany, October 2020). The surgeon console has a similar configuration to the traditional da Vinci Xi, with similar touchscreen, clutch control, and foot control pedals; it also incorporates collision alerts to provide surgeon feedback intraoperatively. The vision cart also has a similar layout to the da Vinci system.

The Revo-i robot has been successfully used in preclinical porcine studies to perform cholecystectomy, fallopian tube transection and anastomosis, and partial nephrectomy. The first human clinical studies were completed in 2017, with successful performance of radical prostatectomy in 17 patients and cholecystectomy in 15 patients. ^, Mean docking times ranged from 8 to 10.6 minutes, respectively, with no Clavien-Dindo complications ≥ grade 3 reported in either series. ^, More recently, safe performance of robotic pancreaticoduodenectomy has also been reported.

Surgeon satisfaction with the Revo-i console has been reported for docking, console and video monitor use, and operation time. Criticisms of the system include limited robotic arm sensitivity, insufficiently sharp scissor instruments, limitation of robotic arm motion speeds, and large robotic arm sizes. A virtual reality training program (revo-sim) has also been developed to promote adoption of the system. Future innovations include incorporation of intraoperative imaging guidance. The company is currently working toward CE mark approval, with subsequent plans for FDA approval (personal communication with meerecompany, October 2020).

Hinotori surgical robot system

The Hinotori surgical robotic system (Medicaroid Corporation, Kobe, Japan) is a multiport platform that was developed by Medicaroid Corporation, a joint venture between Kawasaki (Minato City, Tokyo, Japan) and Sysmex (Kobe, Hyogo, Japan). The system was designed specifically to improve upon and optimize the functionality of the robotic surgical effector arms. The Hinotori components were intentionally designed to be similar to the da Vinci systems in order to build upon surgeon familiarity to optimize safety and efficiency using the system (personal communication with Medicaroid Company, November 2020). It is comprised of three components: a surgeon cockpit, operation unit, and vision unit ( Fig. 2.2 ).

The surgeon cockpit incorporates an adjustable stereoscopic 3D viewer along with manual controls and foot pedals. A more open design was utilized to optimize the peripheral vision of the surgeon and enhance situational awareness in the OR. Similar finger clutch controls control the robotic instruments. The operation unit consists of four robotic arms, which are mounted to a patient cart in a cantilever fashion. These are specifically designed to be compact in order to minimize the footprint of the robotic arms in the operating field, reduce collisions, and promote flexible port placement. Additionally, the arms need not be docked to each robotic cannula; this is facilitated by software-defined remote pivot points, which also minimize trauma from cannula torque at the abdominal wall. A range of wristed instruments with 8 DOF are available. The vision unit integrates images from the endoscope for display on the surgeon cockpit and also controls voice audio.

Preclinical studies in porcine models and cadaver studies were completed in Japan, and the system received regulatory approval from the Japanese Ministry of Health, Labor, and Welfare in 2020. Further human usability studies are slated to be completed in 2021, and FDA Investigational Device Exemption (IDE) application is anticipated at the end of 2021(personal communication with Medicaroid Company, November 2020). The Medicaroid Company has also developed a training program (hi-Sen) for surgeons and surgical teams through a partnership with Mimic Technologies, Inc. (Seattle, WA).

Avatera

The Avatera robotic surgery system (avateramedical GmbH, Jena, Germany) received CE mark approval in 2019 but is not yet FDA approved. The system is comprised of just two components: a surgeon console and a patient cart. The surgeon console includes an adjustable seat, footswitches, and manual controls with haptic feedback. Additional features, such as an unobstructive eyepiece and omission of external fans, were designed to facilitate communication between the surgeon and OR team. The patient cart has a cantilever design, with four mounted robotic arms. Single-use 5 mm articulating instruments allow for smaller incisions, while still preserving 7 DOF range of motion. Current instrumentation includes bipolar Metzenbaum scissors, an atraumatic grasper, bipolar Maryland dissector, and needle holder. The company promotes the single-use concept as a means to save on sterilization costs, minimize cross-contamination, and maintain peak instrument quality. Avatera completed its first preclinical cadaver studies in 2020 and is planning to initiate the first human clinical trials for urologic and gynecologic surgeries.

Bitrack

The Bitrack System (Rob Surgical, Barcelona, Spain) grew out of a collaboration between the Polytechnic University of Catalonia and the Institute for Bioengineering. Two robotic arms and an endoscope with floating fulcrums are mounted to a single robotic tower ( Fig. 2.3 ). The robotic ports accommodate both robotic and traditional laparoscopic instruments, which may operate simultaneously. Each wristed instrument has 7 DOF and utilizes a dynamic fulcrum; these are single use to reduce cost. A separate open surgeon console incorporates a 3D screen and haptic feedback. The platform was first used to perform surgery in animal models in 2014, and human feasibility and validation studies were completed in 2015. Technical validation was completed in 2018, and FDA and CE mark approvals are in process.

Senhance

Previously known as the TELELAP Alf-X system, Senhance (Asensus Surgical Inc., Morrisville, NC; previously TransEnterix, Inc.) is a modular robotic laparoscopic platform that received CE mark approval in 2014 and FDA approval in 2017. Indications in the United States include adult use in laparoscopic gynecologic surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair, while European indications also include pediatric use. The system uses standard 5-mm laparoscopic trocars (10 mm trocar for endoscope) in a three-arm configuration; a four-arm configuration is also available in Europe and Japan ( Fig. 2.4 ). Platform compatibility with 3 mm instruments facilitates pediatric surgery. The reusable instruments connect to the individually mounted robotic arms through magnets, allowing for quick instrument exchanges. A digital fulcrum point allows for dynamic instrument pivoting. However, with the exception of an articulating needle driver, the instruments are not wristed; thus the system has been deemed more of a “digital laparoscopy” system than a true robotic platform. ^, The surgeon is seated at an open console, and 3D visualization is achieved using special polarizing glasses. Instead of the classic clutch hand controls, the Senhance hand controls more closely resemble traditional laparoscopic instrument controls to decrease training time for surgeons and facilitate conversion from laparoscopic to robotic surgical techniques.

Novel aspects of the platform include integrated eye-tracking camera control, tremor filtration, and haptic feedback. In addition, FDA and CE mark approval were recently granted in 2020 and 2021, respectively, for an “Intelligent Surgical Unit (ISU),” which utilizes machine vision capabilities to enhance the surgical experience. The ISU is capable of recognition of specific objects and locations within the surgical field and can provide 3D measurements and identify anatomic structures during surgery.

Initial phase II clinical safety and feasibility studies of the Senhance system were performed in gynecological patients undergoing a wide range of procedures for benign or malignant adnexal or uterine disease. ^, Broader applications in colorectal, general, and urologic surgeries have since been described, with safety and feasibility demonstrated by several groups. The first successful pediatric procedures were performed in Europe in October 2020. Compared to traditional laparoscopic approaches, operative times are longer with the Senhance system. ^, Reported conversion rates to traditional laparoscopic or open surgery range from 2% to 5% to 16.7%, and 1% to 5.8%, respectively. ^{, , , ,} Critiques of the system include limited haptic feedback and limited instrumentation.

Robot docking times are short, ranging from 7 to 11.5 minutes. ^{, , , ,} Use of the eye-tracking feature requires about 45 to 60 minutes of preoperative training time and re-calibration prior to each use, but overall this was felt to facilitate the operation. Surgeon learning curves are also short, with quicker operative times noted after 6 to 10 cases and proficiency after about 30 cases. ^{, ,} For surgeons with prior laparoscopic experience, even shorter learning curves are achievable. Compared to the da Vinci robotic system, the Senhance system is less expensive to use following initial acquisition; for sigmoid resection, the Senhance system was up to 900 less expensive than the da Vinci system. Depending on surgery type, use of the system costs between 229 and 800 per patient case. ^,

Versius

The Versius Surgical System (Cambridge Medical Robotics Surgical, Cambridge, United Kingdom) is a robotic laparoscopy system that received CE mark approval in 2019. However, it is not yet FDA approved for commercial sale in the United States. The Versius system adopts a modular design comprised of three individual robotic arms that are each attached to a compact, portable “bedside unit” ( Fig. 2.5 A). This facilitates flexible use of the robotic arms within different operating room layouts. The fully wristed arms have 270 degrees of rotational mobility, and the 5 mm sterilizable articulating instruments have 7 DOF. The open surgeon console integrates a 2D/3D monitor and the surgeon may operate at the console in either a standing or seated position (see Fig. 2.5 B). Specialized glasses are worn by the surgeon for 3D vision. Specialized hand-grip controllers with loops for controlling gripping and scissor actions allow manipulation of the end effectors. The endoscope is controlled by small joysticks and a series of buttons control clutching of the robotic arms, as well as monopolar or bipolar energy.

The feasibility of the Versius system was initially demonstrated in both cadaver and live porcine preclinical studies, with successful performance of hysterectomy, radical nephrectomy, prostatectomy, pelvic lymph node dissection, cholecystectomy, and small bowel enterotomy procedures. The first human safety and feasibility studies were conducted in 2019, with successful completion of 13 general surgery cases and 17 gynecologic cases. No patient required conversion to traditional laparoscopy or open surgery, and no intraoperative complications were reported. Subsequent clinical studies have further confirmed the safety and feasibility of the system for robotic hysterectomy and colorectal resection; only two conversions were reported among 53 of these patients, both of whom had an elevated body mass index. Further clinical studies with upper gastrointestinal (GI) and gynecology applications are ongoing.

Reported docking time of the Versius system ranges from 15 to 20 minutes, with decline in docking and surgical times after five cases. ^, Surgeon-reported advantages of the system included the 3D magnification, tremor filtration, and easy mobility. Vessel sealing was highlighted as a problematic area with this robotic system. ^, Ongoing training programs for the Versius system have been conducted through collaboration with several major laparoscopic and robotic surgery educational training centers. ^,

Dexter

The Dexter platform (Distalmotion SA, Epalinges, Switzerland) is a robotic-assisted minimally invasive surgical system that readily integrates into a traditional laparoscopic set-up and work-flow. The design of the robotic platform was based on the concept that robotic surgery offers an advantage primarily for longer or complex tasks during minimally invasive surgery, such as suturing and dissection, but may not be necessary during the entire procedure. The system is designed to minimize cost, learning curve, and maintain a familiar workflow while preserving the benefits of a robotic surgery approach.

The platform has a modular design and features two patient control arms, which are controlled by the surgeon working at a sterile console ( Fig. 2.6 ). These are compatible with single-use 8 mm articulating instruments with 7 DOF, including needle drivers, graspers, monopolar scissors, monopolar hooks, and Maryland forceps. The arms may be re-aligned to different trocar sites during the procedure to suit the specific needs of the operation. Port placement is similar to that of laparoscopy, and the open platform design accommodates the use of traditional laparoscopic instruments for vessel sealing, stapling, and clipping, as well as commercially available endoscopes. Rapid switching between robotic and laparoscopic approaches may be accomplished in 20 seconds. The open surgeon console may be used in either seated or standing position and features finger-clutch controls that are familiar to most robotic surgeons.

Successful preclinical cadaver studies were completed in 2019 and the first successful human use studies were completed in early 2020. Subsequent clinical feasibility and safety studies included successful performance of a Nissen fundoplication, partial cystectomy, radical nephrectomy, partial gastrectomy, sigmoid mobilization, and three cholecystectomies. The company intends to commercialize the platform in a unique “pay-per-use” rental model that forgoes lump sum investment costs in order to facilitate acquisition and utilization of the system. Overall, the system is 60% to 70% less expensive than the da Vinci system, costing about $1200 per case (personal communication with Distalmotion, December 2020). CE mark certification was granted in 2020, with first human use and prospective clinical safety and efficacy studies planned for 2021 (personal communication with Distalmotion, December 2020).

Hugo robotic-assisted surgery device

The Hugo Robotic-Assisted Surgery Device is a novel robotic system currently under development by Medtronic (Dublin, Ireland). The system consists of a video tower, open surgeon console with 3D viewer, and modular robotic arm carts that allow flexibility in robotic arm positioning and easy mobility within the OR. ^, This is also meant to optimize cost, as unused robotic arms may be repurposed for use in a different operating room within the same hospital. The system is designed to be compatible with both robotic and laparoscopic as well as open surgical approaches, further increasing its versatility. Polarizing glasses are worn by the surgeon to render a 3D view of the operative field on a high-definition (HD) flatscreen display. ^, However, the Hugo remains in the early stages of preclinical testing. CE mark and FDA investigational device exemption submissions are anticipated in 2021.

Mantra

The Mantra (SS Innovations, Andhra Pradesh, India) is a modular multiarmed robotic system designed to facilitate coronary re-vascularization procedures and to serve applications in urology, general surgery, gynecology, and thoracic, cardiac, and head and neck surgery in a cost-effective manner. Three to five robotic arms may be used, depending on the application. Each robotic arm is mounted on a moveable cart (“Arm Cart”) and is capable of 7 DOF. The robotic arms are equipped with collision detection and avoidance capabilities, and arm positioning is accurate and reproducible to 0.1 mm. Twenty-six end-effector instruments have been developed, each with articulating endo-wrists and 4 DOF instrument use. A flexible high-definition 3D endoscope with four-way articulation is controlled by a mini joystick at an open surgeon console, which has adjustable ergonomics. 3D vision is attained through the use of a 1080p 3D-HD medical grade monitor and passive 3D glasses ( Fig. 2.7 ).

To date, 20 live porcine studies, a cadaver trial, and a human pilot clinical trial involving 18 complex abdominopelvic procedures have been completed. Based on these studies and feedback from surgeons, the company intends to make additional improvements to the robotic device design, including a more ergonomic surgeon console and more slender arms to facilitate flexible instrument placement. Global multicenter human clinical studies are anticipated in the near future. ^, The company aims to make its robot available at nearly a third of the price of current robotic surgical platforms, in order to improve access to robotic surgical technology globally. Availability of the Mantra system for the Indian market is anticipated in mid to late 2021, with plans to file for CE and FDA approval in late 2021 (personal communication with SS Innovations, March 2021).