Remote surgery





Introduction


Urology is a long-established specialty, and many urologists still use surgical instruments such as urethral sounds, which have been in use since at least 3000 BC and not changed much in hundreds of years of practice. Urology is also a specialization which is highly technical and promotes innovation. Endoscopic and laparoscopic surgeries dominate urological practice and, by their nature, are well suited to innovation and the introduction of innovative techniques and technology. Unsurprisingly, urologists have been at the forefront of technological innovation in recent years; in particular, the adoption of robotic surgery. But the specialty and medical community, in general, need to be proactive in the scientific evaluation of new technologies and their further evolution ( ).


Remote surgery can encompass many things, from telementoring to telesurgery. Telesurgery, specifically, is operating through the use of a surgical robot, which is actively controlled by a distant operator, and it is only possible because of the development of robotic surgical systems. Over the past 20 years, robotic surgery has become a mainstay of hospital systems around the world. The da Vinci robotic system from Intuitive Surgical Inc. (Sunnyvale, CA, USA) is the global leader at present and has led this transformation. Thanks to its innovative technology and unique revenue model, Intuitive has installed over 6730 surgical robotic systems worldwide in this time period. The rapid adoption and spread of the surgical robot have been driven by many important industry-specific factors. There was a dramatic leap from open to robotic procedures in urology and, in terms of gradual technological adoption, laparoscopic surgeries were in some instances almost entirely leap-frogged by robot-assisted laparoscopic surgeries.


Between 1998 and 2011, the number of open radical prostatectomy procedures decreased by 70%, and 18% of hospitals in the United States stopped performing the procedure altogether ( ). One study which utilized the National Inpatient Sample database found that between 2008 and 2011, the number of laparoscopic radical prostatectomy procedures dropped by 90%. The rapid adoption and fast-forwarding of a process, which is often a gradual and incremental technological progress, is not new to the field of urology. Telehealth now has a recent and relevant precedent. And the barriers to future innovations in the delivery of care need not seem so insurmountable any more.


The history of urological surgery is full of the advances offered by urological devices, and this is still true of robotics. In the past two decades, da Vinci’s intuitive systems have been market leaders. Intuitive continue to innovate with the development of the Si, X, Xi, and SP systems. Advances in robotics research and development are happening around the world in Korea, China, Japan, Ireland, Germany, the United Kingdom, and Canada, as well as continuing in the United States. It has already begun to make robots smaller and cheaper ( ).


The next major challenge in robotic surgery will be the further development of telesurgery, telementoring, telesurgery, and telepresence. Not only is there a shortage of urologists in the United States, but also a poor distribution of urologists. According to the American Urological Association, 62% of counties in the USA have no practicing urologist and it has recognized the workforce shortage as a federal advocacy priority ( ).


In the home of the world’s largest economy, great disparities exist in access to healthcare, where race, ethnicity, first spoken language, and rural dwelling status may result in being undertreated for significant diseases ( ; ). This misdistribution is likely to worsen as economic and social gaps widen, and as more and more of the population urbanizes. Telerobotics and telementoring are two strategies for providing modern robotic technology and expertise to underserved areas, and this needs to accelerate in the future. The next great leap may well be fully autonomous robotic surgery.


History of robotic surgery


The history of robotic surgery is firmly rooted in the evolution of laparoscopic surgery. In 1986, the development of the first video computer chip that enabled magnification and projection of images on television screens led to the worldwide adoption of laparoscopic surgery ( ). This rapid emergence of laparoscopic procedures sparked interest in exploring the possibilities of remote laparoscopy, which eventually led to the development of the first robotic surgical systems.


Among the first was the Green Stanford Research Institute Telepresence Surgical System (GTSS), a multidisciplinary research collaboration that began in the 1980s and was led by Dr. Phillip Green of the Stanford Research Institute. Similar to today’s “master–slave” robotic surgical systems, this system included a remote operating area, a surgical workstation, and a three-dimensional view of the operating area. While comparable to standard laparoscopic instruments, the Green Surgical System instruments retained only four degrees of freedom (3). In 1992, this research area gained further momentum when the US Defense Advanced Research Projects Agency (DARPA) envisioned a robotic telesurgical system that would allow surgeons to perform live operations remotely on the battlefield, and provided research funding ( ). Through this DARPA-funded advanced biomedical technology program, the Automated Endoscopy System for Optimal Positioning (AESOP) was developed in 1993 by Computer Motion, Inc.


After Dr. Green and his team performed the first remote telesurgical procedure on an ex-vivo pig intestine in 1994, the concept sparked the interest of Dr. Frederic Moll, a general surgeon who had previously founded and sold two companies using laparoscopic instruments: Origin Medisystems and Endotherapeutics. Moll enlisted the help of electrical engineers Robert Younge and John Freund (also a Harvard MBA graduate), and in 1995 they successfully licensed the technologies from the Stanford Research Institute, International Business Machines Corporation, and Massachusetts Institute of Technology, forming Intuitive Surgical Devices, Inc (later changed to Intuitive Surgical, Inc.). In the spring of 1996, they modified the GTSS model to include EndoWrist articulated technology, which allowed seven-degree wrist movements to mimic the human wrist, setting Intuitive apart from its competitors.


Instead of focusing on telemedicine, Intuitive sought to use EndoWrist technology to facilitate the adoption of its technology. Over the next 3 years, Intuitive would continue to review and customize its robot, until they registered with the Securities and Exchange Commission in 1998. Their registration documents with the SEC specifically did not mention radical prostatectomy as one of the possible uses of da Vinci. By the year 2000 though, several groups reported using the da Vinci to perform robotic prostatectomy using EndoWrist technology, and in May 2001, the da Vinci Surgical System received Food and Drug Administration approval for prostate surgery. As of December 2021, Intuitive Surgical had installed 6730 da Vinci robotic surgical systems worldwide, with 4139 da Vinci systems installed in the United States (and with ∼1000 being installed in the United States between 2018 and 2021). Intuitive no longer have a monopoly on robotic surgery, and it is hoped that more competition in this sphere will spur greater innovation, greater access to care and better outcomes for patients.


Less than a decade ago, Stryker (Kalamazoo, Michigan) acquired Mako Surgical and its MAKOplasty robotic-arm interactive robotic orthopedic system for knee and hip replacement. The system integrates preoperative computed tomography (CT) modeling and determines a safe surgical area, and tactile boundaries constrain the robotic arm. While the company is not focused on urological applications, their integration of imaging modalities into a robotic surgical platform is noteworthy and provides a framework for how this may be adopted and evolved for other applications.


Avatera, a joint venture between Avatera Medical (Jena, Germany) and Force Dimension (Nyon, Switzerland), has been in development since 2011 (https://www.avatera.eu/en/avatera-sistema). It operates as a “master–slave” system similar to the da Vinci Surgery System. It is an open console that uses microscope-like technology with 3D-HD resolution, forceps-like handles, seven degrees of freedom, and four robotic arms mounted on a single cart. Unique to Avatera is its disposable system which aims to reduce costs. After obtaining the CE certification in November 2019, Avatera acquired FORWARDttc in August 2020 to use its engineering experience on mechatronic systems to develop hardware and software for robotics. While the company state they have completed cadaveric trials, preclinical studies have yet to be published in peer reviewed journals.


Kawasaki and Sysmex have collaborated in forming Medicaroid in 2013 to develop Hinotori, a Japanese robotic surgical system. Kawasaki is one of the world’s largest industrial robotics companies, and Japan manufactures >50% of the world’s market share of industrial robots. Hinotori was developed by Medicaroid with a stated goal “to serve and assist humans, not to replace humans.” Hinotori has eight degrees of freedom, easy docking, and a 3D-HD viewer claiming “more than full HD resolution”. There are four robotic arms attached to the cart, and the surgeon wears polarized glasses using a semiopen console with a microscope-like ocular lens. The system received regulatory approval in Japan in August 2020 ( ).


CMR Surgical started the development of a portable and modular robotic system in 2014 which is named Versius. It is unique in its relatively small size—being just 38 × 38 cm—and is intended to be highly portable, not just between operating rooms but also between hospitals. It includes an open surgical console with 3D-HD technology, three individually cart-mounted robotic arms with seven degrees of freedom, and has the capability of allowing the surgeon to sit or stand. In 2019, Versius was first introduced in a clinical setting in Pune, India. Regulatory approval was received in Australia in February 2020 for use in general surgery, gynecologic surgery, and urology. CE marking has not yet been obtained for its use in Europe nor have regulators in the US approved the Versius system.


Ethicon, Johnson and Johnson’s medical device company, created a joint venture with Verily (a life sciences organization within Google) and created Verb Surgical in 2015. This has been seen as a combination of the medical instrument expertise of Ethicon and the artificial intelligence and visualization expertise of Google. While there is limited information on the Verb robotic system, Ethicon acquired Auris Health in February 2019. Auris developed robotic diagnostic and surgical devices, which were first used in lung cancer. A working prototype of the Verb Surgical System was reported to have been shown to Google and Johnson and Johnson executives in December 2019, but little else has been released on the system since then.


Medtronic entered the space with Hugo. Medtronic is the world’s largest medical device company by revenue and has been working on a robotic surgical system since it acquired MiroSurge as part of its Covidien acquisition in 2014. Hugo was unveiled by Medtronic in 2019 as a modular system, where the surgeon sits in an open console with 3D-HD glasses. Dublin-based Medtronic announced it had received CE Mark approval for urologic and gynaecologic procedures in October 2021 and on February 2nd, 2022, announced the first procedure using the Hugo RAS system was a robotic prostatectomy performed in Aalst Belgium. Trials to enable approval for use in the USA are ongoing.


The origins of robotic surgery and telesurgery were initially academic, with military or space applications spurring development. There now appears to have been a loss of focus on more down-to-earth applications for telesurgery in the past decade. The German Aerospace Center created MiroSurge. Used mainly in research, the minimally invasive telesurgery platform consists of three robots and is equipped with torque sensors to capture feedback from reaction forces of manipulated tissue. Stanford Research Institute (who went on to become Intuitive Surgical) had a system named M7, which was part of the NASA Extreme Mission Operations (NEEMO) project, which included remote surgeries being performed under the sea as well as completing a surgical demonstration on a zero-gravity flight in 2007. Much of this foundational work has now been subsumed by the growing robotic surgery industrial complex, where the focus has been on providing services to the many. Now the technology has evolved and patents on foundational work no longer restrict access to resource-limited healthcare systems, the needs of patients and remote communities need to take center stage once more.


Telementoring


The use of videoconferencing to support physicians overseas or in areas with increased needs or limited resources is not new. Médecins Sans Frontières uses secure videoconferencing for clinical case reviews, clinical supervision, patient consultations, and training. During the COVID-19 pandemic, surgeons became more comfortable using telepresence platforms to collaborate with colleagues. The proliferation of videoconferencing and its ability to support geographically-dispersed teams means that remote teaching and learning could play a greater role in surgical training and practice, both nationally and internationally ( ).


Several new digital platforms aim to build on traditional video conferencing, from the provision of verbal guidance in real time to telestration, allowing the distant surgeon to provide visual aides to the operating surgeon. This allows surgeons to collaborate on cases in real time with features that replicate in-person mentoring as occurs in real-world practice. One such example is Proximie, which combines video conferencing with technologies like augmented reality and allows surgeons in one location to see multiple views of an operating room in another location.


Such systems mean you can tag, outline, label and otherwise interact with the operative field of view and make real-time contributions as the case progresses. A project is underway in Makueni County, Kenya, to use this technology to improve the safety of caesarean sections. The district, which has a population of more than 900,000, has just three obstetricians and gynecologists working in two hospitals, with most caesarean sections performed by general practitioners or doctors performing compulsory service after graduation. As part of the Obstetric Safe Surgery project, supported by organizations such as Jhpiego, affiliated with John Hopkins University in the USA, Proximie technology has been implemented in five hospitals in the province with the aim of improving maternal and neonatal outcomes. Using technology, consultants guide medical officers through simulated caesarean sections, as well as training courses on infection prevention, use of the World Health Organization surgical safety checklist, administration of anesthesia, and infant care. More experienced healthcare providers are also beginning to remotely assist on elective cases, with Proximie using four theater views—the entire theater, surgical site, anesthesia, and child’s CPR room—to provide an overview of the surgery. Surgeons can remotely annotate and highlight parts of the operating field for those in the room and be guided through the procedure by their remote proctor/mentor ( ).


Intuitive Surgical also have a software solution that supports telestration, which is called Connect and is integrated into their da Vinci Surgical System. The mentor can offer verbal and video-aided guidance overlaying the surgeon’s field of view directly within the surgeon console, so the operating surgeon does not need a separate video input ( ).


Telesurgery


Remote collaboration technology is evolving to the point where surgeons in one location can use surgical robots to operate on patients in another location. A handful of such remote operations has already been performed on cadavers, animal and human models.


Operation Lindbergh was the first transcontinental telesurgical operation ever performed: In 2001, Jacques Marescaux performed a laparoscopic cholecystectomy on a 68-year-old lady in Strasbourg, France, using a ZEUS robotic system positioned in Mount Sinai Hospital in New York, USA. The procedure was performed without complication, and the patient was discharged successfully 48 hours later ( ). Other pioneering work includes the report of the insertion of a deep brain stimulator into a patient with Parkinson’s disease by a surgeon controlling a robotic arm from a city almost 3000 km away.


One of the few randomized controlled trials assessing telesurgery involved percutaneous access to the kidney and comparing human and robotic percutaneous renal access ( ). This groundbreaking study demonstrated the feasibility of remote transatlantic surgery using robots that operate with comparable efficiency and efficacy when controlled at distances of, as the others have stated, “5 meters or 5000 miles” ( ). However, despite such resounding early successes, the further development and promulgation of telesurgery has been disappointingly slow.


World’s first telesurgery service


St. Joseph’s Hospital in Hamilton, Canada and North Bay General Hospital, 400 km north of Hamilton, are the sites of the world’s first telesurgery service. It was established on February 28, 2003, and at the time, the service utilized a Zeus-TS surgical system in North Bay and a 15 Mbps commercially available internet connection. This was a combination of telementoring and tele-assisted surgery.


Local North Bay surgeons and laparoscopic nurses were trained in the use of the robotic surgical system and devices before initiation of the telesurgery service. Experienced technicians also attended each case to ensure smooth setup of the surgical arms. Meanwhile in Hamilton, the room from which the robotic surgeons work was equipped with two large screen televisions that displayed images from the North Bay operating room as well as the laparoscopic view. The sound of the North Bay operating room and the voices of the surgeon and laparoscopic staff could be heard through the loudspeakers. The environment was created so that the telerobotic surgeon could be immersed in the atmosphere of the North Bay operating room. The two surgeons also communicated constantly using wireless headphones.


Considerations on licensing and malpractice insurance for the “telesurgeon”


This pioneering work in telesurgery also draws attention to local, national, and international credentialing issues that may prove challenging. In the case of this service in Canada, all surgeons were medically insured by the Canadian Medical Protection Association. This is something which may be challenging if the service is offered across state or national boundaries, and similarly for medical licensing and credentialing. The service in Canada occurred because all staff had privileges at the hospital to perform advanced laparoscopic procedures. That, and a legal agreement between the surgeons and partners including both hospitals, the telecommunications company, the surgical system, and computer networking provider had been signed prior to the service initiating, where the scope of each party’s responsibility during telerobotic surgical cases was defined. This is no simple undertaking, and the team who made the world’s first telerobotic surgical service a reality deserve great commendation and recognition for not just pioneering this practice, but doing so in a clearly defined and collaborative manner. Their clearly defined protocols and procedures also act as a playbook, which enable further future services to build on their work.


Challenges for telesurgery


The spread of telesurgery will depend on the availability and access to two key technologies: surgical robotics and reliable, stable high-speed internet access. While we have discussed some of the encouraging innovation in surgical robotics, internet access is synonymous in some realms with a basic utility and unfortunately, like many other basic utilities, it is not as ubiquitously available or reliable as it need be. This may be in part due to the huge demands for this utility.


Many advocate for the greater availability of 5G networks as a solution to provide access to reliable and stable high-speed internet access. However, the question as to its suitability received an answer of sorts when the European Commission and the European Agency for Cybersecurity published a report warning of serious security concerns ( ). Regardless of any political or strategic policies of national interest, the technological and infrastructural advantages of 5G mean it is currently not the solution that telesurgery has sought. 5G wavelengths are in the order of millimeters, and their range is currently approximately 1000 ft. As such, to maintain a reliable signal and maintain the benefits of high speed, high bandwidth, and lower latency, each cell tower needs to have another 5G tower in similarly close proximity, or there needs to be a cabled connection to that tower. Either way, the 5G tower remains a bandwidth bottleneck, where the capacity of 5G is currently dwarfed by the capacity of a cabled connection, and 5G really doesn’t even offer “last mile” connectivity, but rather last 1000 feet connectivity. In addition, 5G competes for spectrum bands, which is becoming ever more competitive, and is discussed in more detail elsewhere in this book.


Not to detract from 5G, where speeds can range from 50 Mbit/s to the fastest of 4000 Mbit/s (∼4 Gigabits per second), fiber cables such as those used by Facebook can currently carry 13 Tpbs (more than 3000 × more), and a recent experiment by Facebook and Nokia Bell labs suggests that the fibers could carry 32 Tbps. The issue that fast and reliable internet needs to solve for in telesurgery is rural, remote, and difficult to access areas. If the distance that 5G can jump is less than one mile, then it’s not even the right technology to be discussing for telesurgery ( ).


Meanwhile satellite internet providers have proven their worth in this realm, where government bodies such as militaries use dedicated satellites for event critical missions, and where no bandwidth is shared and latency is minimal. There is much development in this space and tech companies like Viasat and Starlink may accelerate access to such technology, and others promise greater technological innovation in this field.


Such mobile networks reduce latency—the delay between sending and receiving data—to less than 1 millisecond. At the same time, it will increase the download speed to a theoretical peak of over 1 gigabit per second. Both are significant steps forward from what is currently available on 4G networks and are needed to allow the surgeon and robot to work in such an environment in real time, with no delay between the surgeon and robot’s movements.


A significant cause of latency results from the compression–decompression or encoding and decoding of high-quality video into a digital signal for transmission. A mathematical integration exists, where the degree of compression affects the size of the video, and hence the transmission time of the video from origin to destination. Almost all studies and publications describing telementoring or telesurgery suggest software is used for video compression–decompression. Groups have even implemented a form of machine learning to aide in further reducing file size whereby they sacrifice video resolution, allowing an algorithm to make the executive decision on where the focus of attention should be and encoding a portion of the video in high quality with the background region in low quality ( ). This great effort could overshadow more practical and indeed higher-quality solutions that already exist. The transmission of live video is not a new problem, and certainly not one that only telesurgery requires a solution for. Everyone from military and government intelligence services to live news networks and social media websites have a need for a solution to this problem. And indeed, most have used hardware solutions which provide far superior latency times and compression–decompression times than any software solution is capable of achieving. In fact, an entire industry exists for this one challenge, and superior solutions exist, albeit at a cost. For example, NETINT offers a commercially available hardware AV1 encoder for data centers, utilizing Codensity G5 video transcoders, and allows and enables up to 7680 FPS at 4K broadcast quality video, but with ultra-low latency performance that makes step function improvements in video transmission. Hardware encoding for telesurgery should be the current default method used as it doesn’t require sacrificing video quality for latency time.


Conclusion


Telerobotic remote surgery is already in routine use, and published data demonstrate that high-quality surgical services are possible across continents and through an already established telesurgical program offered to patients in rural communities. The hope remains that broader adoption of telesurgery will allow hospitals in remote or poor areas to access surgeons from elsewhere to perform surgeries. Technology currently available is such that there is little in the way but societal and political will to deliver such care right now.



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Mar 12, 2023 | Posted by in UROLOGY | Comments Off on Remote surgery

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