Since the initial development of the Green Telepresence system robotic platform in 1986, robotic-assisted surgery has dramatically transformed the landscape of surgical care. With the evolution of minimally invasive surgical approaches, robotic-assisted surgery improved upon the ergonomic and visualization limitations of laparoscopy while maintaining the advantages of this less invasive approach. It has been rapidly adopted within general surgery and the surgical sub-specialties, and it has become ubiquitous among hospitals and surgical training programs worldwide.
Currently, robotic surgery remains dominated by the multiport da Vinci Surgical System (Intuitive Surgical Inc., Sunnyvale, CA). The original da Vinci System was launched in 1999 and comprised of a stand-alone patient cart, surgeon console, and vision station. Four robotic surgical arms with 3 degrees of freedom (DOF) in movement were mounted on the patient cart. Wristed robotic instrumentation (“EndoWrist” technology) allowed for an additional 7 DOF in each reusable instrument. Robotic instruments were introduced through an 8 mm port, which maintained a rotational fulcrum at the level of the abdominal wall. A custom-built 12 mm endoscope with dual lenses allowed for high resolution three-dimensional (3D) visualization at a dedicated surgeon console. Tremor filtration and motion scaling capabilities further facilitated surgeon motion and optimized instrument movement.
Since its initial Conformité Européenne (CE) mark approval in 1999 and US Food and Drug Administration (FDA) approval in 2000, over 5582 da Vinci Surgical systems have been installed. The da Vinci system has since moved through four generations of development, with the most recent da Vinci Xi model launched in 2014. This system incorporates several refinements over the prior models, including revised cannula mounts and a simplified docking mechanism. The endoscope was redesigned with an integrated camera and cable, and it is compatible with any of the 8 mm ports, allowing for “port hopping” of the endoscope. Horizontal FLEX joints allow for more compact spacing of the robotic arms, which are less bulky and designed to better facilitate multiquadrant abdominal surgery. Moreover, integrated table motion with the TruSystem 700dV (Trumpf Medical, Saalfeld, Germany) bed allows for dynamic bed movement during surgery. A wide range of instrumentation has also been developed for this system, including numerous dissectors, graspers, clip appliers, vessel sealers, ultrasonic energy instruments, and staplers.
Though the da Vinci robotic surgical system (Intuitive Surgical, Sunnyvale, CA) is currently the most widely utilized robotic platform, it has several limitations. These include a large footprint, rigid arm placement configuration, lack of tactile feedback, and hindered communication between the surgeon and operative team within the closed surgeon console. Additionally, each system sells for $0.5 million to $2 million, a significant capital investment for many hospitals. A 10-life instrument use limit further contributes to utilization costs of the system.
Seeking to improve upon the limitations of the existing da Vinci surgical systems, several novel robotic surgical systems have been developed. Many of these emerging robotic surgery platforms aim to gain a competitive edge in the robotic surgery market by incorporating novel technology, reducing acquisition and use costs, and minimizing operating room (OR) footprint. With expiring da Vinci surgical platform patents in 2019, growing opportunity exists for novel robotic surgery platforms to enter the marketplace as a competitive alternative to the Intuitive surgical systems.
The realm of developing robotic surgical technologies is a broad and rapidly changing field. In this chapter, we detail emerging robotic surgical platforms, focusing on operator-robot systems for soft tissue surgery, which generally comprise a patient bedside cart and remote surgeon console. Each exists in varying stages of development, regulatory approval, and commercialization, and a particular emphasis is placed on those that are currently or imminently available for commercial use. Unique features of each surgical system are highlighted, as well as current regulatory approval status. Where available, preclinical studies, clinical studies, and surgeon experience are also reviewed.
Multiport robotic platforms
Many novel robotic surgical systems have maintained the traditional multiport patient cart design of the da Vinci surgical system, whereby each robotic arm is introduced into the abdominal cavity through a separate trocar in the body wall. However, this may be accomplished through several different design paradigms, including traditional cantilever designs, modular robotic arms, and table-mounted robotic arms. The traditional cantilever design consists of multiple robotic arms mounted to a single central column on the patient-side cart, a layout familiar to many surgeons because it recapitulates the design of the da Vinci surgical systems. A modular design provides additional flexibility in the positioning of the robotic arms for the needs of a specific surgery, but typically carries a larger footprint and requires more OR space. Lastly, table-mounted robotic arms allow for flexible robotic arm positioning while minimizing space requirements, but may be least familiar to surgeons.
Novel components for many of these systems include features to facilitate OR communication such as an open surgeon console design, flat display monitors with 3D-rendered images, and limitation of external fans. Ergonomic adjustments, such as compatibility with sitting or standing surgical positions, are included in several platforms. Additional design features to promote crossover with traditional laparoscopic approaches are also included in some systems to optimize adoption, minimize surgeon learning curves, and minimize cost.
Traditional cantilever designs
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).
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.
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.
Modular robotic surgical platforms
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. ,
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. ,
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.
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).
Table-mounted robotic surgical platforms
For the past several years, Johnson & Johnson (New Brunswick, NJ) has been developing a multiport robotic surgical platform for soft tissue applications in collaboration with Verb Surgical (Santa Clara, CA) and Verily (Alphabet Life Sciences). Dubbed Ottava, the new system was based upon the “technology pillars” of robotics, visualization, advanced instrumentation, data analytics, and connectivity, and it was designed to optimize flexibility, coordination, and control of robotic surgical procedures. The system will use Ethicon instrumentation, and it incorporates machine learning technology, advanced visualization, and integrated data capabilities to create a “digital surgery” system that provides dynamic intraoperative guidance and automation.
The platform’s six robotic arms are integrated into the OR table, allowing for a “zero-footprint” design to maximize OR space, facilitate patient access, and improve workflow. , Any number of the six robotic arms may be used in combination. Similar to the da Vinci platform, the Ottava system is capable of performing soft tissue surgery, but it will also have the ability to extend into endoluminal approaches and interventional vascular procedures. , The surgeon console is similar to that of the da Vinci console. Limited additional details are available regarding the system specifications. Platform validation is anticipated to begin in 2021, with human clinical trials slated for 2022. ,
Single port robotic platforms
Laparoendoscopic single-site (LESS) surgery was developed to further extend the advantages of a minimally invasive surgical approach by improving cosmesis, minimizing pain, and promoting convalescence. However, widespread adoption of LESS has been limited due to challenges with instrument clashing, triangulation and exposure. With the growth of robotic surgery, a trend toward robotic single-site surgery also developed, with initial experiences utilizing the multiport da Vinci surgical platform. However, robotic single-site surgery using this platform has continued to have several challenges, including instrument clashing due to the bulky profile of the robotic arms, lack of space for an assistant, inability to use the fourth robotic arm, and difficulty with triangulation. To address many of these issues, several novel single port (SP) robotic platforms have been developed specifically to facilitate single-site robotic surgery.
da Vinci single port robotic surgical system
The da Vinci SP system (Intuitive Surgical Inc., Sunnyvale, CA) is a novel robotic platform designed specifically for single port surgery. The da Vinci SP robot is currently in its second-generation model and is currently in use in over 40 centers. This system utilizes a single robotic arm and a 2.5-cm robotic cannula port that accommodates a wristed endoscope and three articulating robotic instruments ( Fig. 2.8 A). Each wristed instrument has 7 DOF and an additional elbow joint that facilitates instrument triangulation. A remote cannula pivot point minimizes torque and tension on the abdominal wall. The surgeon console is similar to that of the da Vinci Xi and also includes an additional instrument display to help the surgeon localize all of the instruments relative to the cannula and operating space (see Fig. 2.8 B). The platform received FDA approval for urology applications in 2018 and otolaryngology applications in 2019.
Safety and feasibility of the da Vinci SP robot was initially demonstrated in 2014 among 19 patients undergoing radical prostatectomy, radical nephrectomy, simple nephrectomy, and partial nephrectomy. All cases were successfully completed using the SP platform and only two patients had ≥ Clavien grade three complications. The da Vinci SP platform has since been used successfully to perform a wide range of gynecologic, urologic, otolaryngologic, general surgery, and reconstructive procedures.
Few comparative studies exist between the SP and multiport da Vinci platforms. For robotic prostatectomy, rates of high-grade complications appear similar, but there are conflicting data in the literature regarding differences in operative time, blood loss and length of stay between the two systems. Clinical outcomes also appear similar, with no reported differences in positive margin rates, lymph node yields, PSA recurrence, or erectile and urinary outcomes between SP and multiport approaches. However, the SP system appears to have advantages with regard to cosmesis and patient satisfaction; patients consistently ranked scars from robotic SP approaches more favorably than those from multiport or open approaches.
Notably, use of the SP platform does not appear to be more expensive than the multiport da Vinci platform, even after considering acquisition and maintenance costs. Institutional cost-analyses of robotic prostatectomy demonstrate similar overall costs for SP and multiport platforms ($13,512 ± 1615 vs. $13,284 ± 1360, respectively). Use of the SP platform was associated with higher disposables and instrument costs, which was offset by lower hospital length of stay and hospitalization costs.
The Enos (Titan Medical Inc., Toronto, Ontario) surgical system is a single-port robotic platform that remains in development. Previously known as the SPORT, this single-access robotic surgical system underwent rebranding in 2020. The system is comprised of a patient cart and surgeon console. The patient cart houses a single robotic arm and a 25 mm detachable camera insertion tube, which accommodates an articulating 2D/3D endoscope and two multiarticulated instruments with a wide range of end effectors. The patient cart was specifically designed to facilitate cable management, mobility, and maneuverability. An open surgeon workstation facilitates intraoperative communication between the surgeon and operative team, and it features a high-definition monitor display, adjustable elbow rests, and foot pedal positioning. , Polarizing glasses are required to render 3D vision on the display monitor.
Initial preclinical studies have been performed in over 45 porcine and cadaver studies, with successful completion of gynecologic, urologic, general surgery, and colorectal procedures. , Subsequently, 15 good laboratory practice (GLP) studies have also been completed. The system remains under continued development, with plans for initial pursuit of approval for gynecologic applications.
ColubrisMX single port surgical system
ColubrisMX (Houston, TX) is a private company born out of the Microsurgical Robotics Lab at the University of Texas Medical School that has developed two novel robotic surgery platforms: a single port surgical system and endoscopic surgical system. The single port surgical system is comprised of a robotic arm with wrist and elbow joints, which is mounted to a mobile patient cart. This houses an overtube with four channels, which accommodate three working instruments and a flexible endoscope. The compatible instruments are fully articulating with 7 DOF and include a range of dissectors, needle drivers, retractors, and clip appliers. An open surgeon console features an HD display, as well as operator controllers, armrests, and foot pedals. Polarizing glasses render 3D images of the surgical field.
Current clinical applications include general, gynecologic, and urologic surgery. To date, 30 urologic procedures have been successful completed with the system in preclinical animal studies, and 25 human clinical cases have been completed, including 13 nephrectomy, four prostatectomy, and eight pyeloplasty procedures. FDA IDE submission was started in 2020. Future developments look to incorporate haptic feedback, computer-assisted navigation, artificial intelligence, and 3D augmented reality components to the platform. A modified single port system specifically designed for microsurgery is also under development by the company, with the target application of intrauterine fetal surgery.
Miniaturized in vivo robotic assistant
The “miniaturized in vivo robotic assistant” (MIRA) platform (Virtual Incision, Lincoln, NE) is a novel miniaturized robotic surgical platform designed for use in all surgical settings, including community hospitals and ambulatory surgery centers. Weighing just 2 pounds, the device was designed to be inserted through a single midline umbilical incision. Through this approach, multiquadrant surgery may be performed using the MIRA.
The MIRA incorporates a 5 mm articulating endoscope with HD camera and two miniaturized robotic arms with 6 DOF. The endoscope and arms connect to a multiuse robotic link with 15 lives, through which disposable instruments are used; these are maintained in a triangulated position with the camera ( Fig. 2.9 ). Current instrumentation includes a bipolar grasper, monopolar scissors, hook electrocautery, and needle drivers. The platform is attached to the OR table using a holding arm and is controlled by the surgeon at a portable, open console. This includes two 2D high-definition displays for real-time surgical video, a touch-screen control panel, and foot pedal controls. Haptic feedback is provided through “pistol grip” handles. A separate mobile cart contains the electrosurgical unit and surgeon console interface pod .
Over 100 porcine and cadaver procedures have been performed in preclinical studies using the platform (personal communication with Virtual Incision, December 2020). The first successful human studies were completed in Paraguay in 2016, with successful performance of two robotic colectomies. Recent FDA Investigational Device Exemption status was granted in October 2020, with subsequent clinical safety and efficacy studies to start in early 2021.
Single-port instrument delivery extended reach and surgibot
Two single port robotic systems developed by Asensus Surgical Inc. (Morrisville, NC; previously TransEnterix, Inc.) are the Single-Port Instrument Delivery Extended Reach (SPIDER) system and the SurgiBot. Though both are commercially available, neither has achieved widespread adoption.
The SPIDER system (Asensus Surgical Inc., Morrisville, NC; previously TransEnterix, Inc.) received FDA approval in 2009 and CE mark approval in 2010. A retractable sheath covers the main cannula, which houses four working channels. Two of these are flexible instrument delivery tubes with 360 DOF distally; the other two are rigid channels for an endoscope or rigid laparoscopic instruments. Instrument size is limited to 5 mm. Three distinct ports are available for insufflation or smoke evacuation, and a support arm may be used to facilitate mounting of the device. Initial feasibility studies demonstrated successful completion of cholecystectomy, nephrectomy, partial nephrectomy, pyeloplasty, and partial cystectomy procedures in porcine models. , Subsequent human clinical studies demonstrated safety and efficacy of the system for cyst decortication and simple nephrectomy. , Growing experience with the platform has since been described in the general surgery literature, with conversion rates from the SPIDER system to a pure laparoscopic approach reported from 1.8% to 4.5%. ,
Compared to traditional laparoscopic approaches, the SPIDER system requires longer operative times, but results in similar complication rates and clinical outcomes. Despite the more significant expense, hospital stays were shorter and scar satisfaction scores were significantly better using the SPIDER system. In human use studies, the system scored highly on ease of device insertion, ease of flexible instrument insertion/exchange, and triangulation; however, instrument retraction has been identified as an area for improvement. , Additional critiques of the system include lack of depth control, as well as poor stability of the instrument tips. The SPIDER system was subsequently phased out in 2014 due to poor market performance.
A subsequent single-port device, the SurgiBot (Asensus Surgical Inc., Morrisville, NC; previously TransEnterix, Inc.) was developed based on similar robotic technology. The SurgiBot consists of a patient-side operating arm and 3D visualization cart. The single robotic port houses four instruments, including a 3D laparoscope. Successful cholecystectomy and nephrectomy were completed in preclinical porcine studies using the SurgiBot system. However, this platform was ultimately denied FDA approval in 2016 and was sold to Great Belief International Limited for alternate markets in China.
Flexible endoscopic robotic platforms
The integration of robotics into traditional endoscopic surgery has resulted in the development of a new generation of robotic surgical platforms specifically designed for a broad range of endoscopic applications. Novel systems have emerged for use in urology, otolaryngology, gastroenterology, colorectal surgery, and pulmonology. The development of such specialized platforms has also helped to pave the way for robotic natural orifice transluminal endoscopic surgery (NOTES), which is discussed later in this chapter.
Robotic ureteroscopy platforms were first described in 2008, and initial prototypes were based on modified robotic cardiac catheterization systems (Sensei; Hanson Medical, Mountainview, CA). , The Avicenna Roboflex (Elmed Medical, Orlando, FL) is a specialized system designed specifically for robotic retrograde intrarenal surgery. It received CE mark approval in 2014 and is comprised of a robotic-controlled endoscope. Endoscope deflection (275 degrees each side), rotation (225 degrees each side), and advancement or retraction are controlled by joystick controls on the surgeon console, with fine deflection adjustments attained using a central wheel on the console. , Integrated foot pedals control the laser fiber and fluoroscopy, while a central touchscreen controls ureteroscope, laser, and irrigation settings. The Roboflex maintains a memory function, which returns the ureteroscope to its previous position within the collecting system after laser fiber insertion.
Safety and efficacy of the Avicenna Roboflex system was described by Saglam et al in initial human clinical studies in 2014 and were subsequently confirmed by phase II and phase III clinical studies. , , Compared to traditional ureteroscopy, stone fragmentation and operative times were similar, but the Avicenna Roboflex resulted in lower surgeon radiation exposure and was deemed more ergonomic by surgeons. , , Stone-free rates at 3 months were also superior with the robotic approach (92.4% vs. 89.4%).
Novel robotic colonoscopy systems were designed to minimize colonic wall pressures, improve visualization, minimize patient discomfort, and optimize cecal intubation rates over conventional approaches for diagnostic and biopsy procedures. Several robotic colonoscopy systems are currently commercially available, and these are summarized in Table 2.1 . Several of the novel design elements and technologies utilized in these systems have been adapted for use in other clinical applications of robotic surgery.