Добавил:
kiopkiopkiop18@yandex.ru t.me/Prokururor I Вовсе не секретарь, но почту проверяю Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз: Предмет: Файл:
Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5193_Библиотеки_им_академика_М_И_Перельмана.pdf
Скачиваний:
0
Добавлен:
30.08.2026
Размер:
65 Мб
Скачать
5 Versius Surgical Robot
61
Surgical andTechnical Considerations
Before taking up any surgery on this platform, the entire surgical team, including the scrub nurses, has to complete the introductory training course. Before using the system, users should complete basic system training, which includes online and practical training. There are 10 online modules, and the time to complete the entire online training is estimated as 8–10h. The minimum time for practical training for the surgeon and surgical team is as follows:
Introduction to versius training course
Time Session System use: system setup & post-operative task training 12h 20min 12h 50min
Surgical time– wet lab and dry lab 9h 8h 45min Team building 1h 20min 1hr 20min
Where a Versius Surgical System is already in use at a hospital and at least one surgical team in the hospital has been trained in the full training course, additional sterile nurses can be trained in a shorter training course. The online element of this sterile nurse training is estimated as 15h. The minimum time for practical training in the sterile nurse course is as follows:
Sterile nurse training course Session Time Team building exercises and troubleshooting 1h 10min
System use (set-up and post- operative tasks) 3h 40min Surgical time dry-lab (hands on) 3h
Surgeon Bedside team

Approved Procedures

The following are the approved surgical procedures on the Versius robotic platform.
Procedures Gynaecology General Salpingo-Oophorectomy
Endometriosis resection Radical hysterectomy Hysterectomy
Colorectal Urology
Left & Right hemicolectomy (Low) anterior resection Nephrectomy
Although thoracic procedures like esophagectomy can also be done in this system.
Cholecystectomy Inguinal Hernia Hernia repair Gastrectomy
Pyeloplasty Prostatectomy
62
S. Khanna and A. Barua
Warnings andPrecautions
• Prolonged use of the 3D display can lead to side effects such as headache, eye
strain, and nausea.
• Versius Surgical System should not be used near an X-ray source.
• The surface of the Versius arm may reach up to 55 °C during use, so direct con-
tact with patient/assistant surgeon’s skin should be avoided.
• The robotic arms should be handled only at the areas that are designated safe to
hold. There is a risk of hand traps if the arm is touched on a joint when the arm
is moving.
• To avoid the risk of permanent damage, the Versius Surgical System must be
disconnected and removed before debrillation.
• The Versius Surgical System should not be used for procedures involving the
heart, circulatory system, or central nervous system.

Some Important Safety Features

1. After the arm has been port-trained, the bedside unit brake cannot be deactivated
unless the instrument or endoscope is fully retracted out of the port or detached from the arm.
2. If the endoscope camera gets detached accidentally, the control of the surgeon on
the movement of the instrument arms is gone and the instruments freeze in that position.
3. If no hands are detected, the instrument gets disengaged, so that the accidental
movement of the hand controllers, not made by the surgeon’s hands does not injure the patient’s organs.
4. In the instrument change mode, the robot memorizes the position of the instru-
ment just prior to getting the arm in that mode. The robot does not let the instru­ment advance beyond this point to avoid visceral injury.
5. If the brake button is released before the brake is fully activated, the bottom of
the bedside unit will rise again. This is a safety feature designed to prevent inju­ries to the surgical team.

Conclusion

With the Versius taking over the robotic surgery arena rapidly, there has been a sig­nicant leap forward in the way minimally invasive surgery is being done globally. However, the true impact of Versius system remains to be seen, how it fares clini­cally and commercially. Ultimately, the Versius system's success depends on its capacity to bring actual benets to both healthcare providers and patients. If it can consistently provide better surgical outcomes, lower costs, and a favorable patient experience, it has the potential to transform the area of minimally invasive surgery. However, the question remains unanswered, and only time will tell if the Versius system actually ushers in a new age of surgical care.

Virtual Incision: MIRA Surgical System

DmitryOleynikov andShaneFarritor

Introduction

Founded in Nebraska in 2006 by Shane Farritor, MS, PhD and Dmitry Oleynikov, MD, FACS, Virtual Incision has become a trailblazer in the realm of minimally invasive surgery. The company was established with a core principle of advancing robotically assisted surgical (RAS) technology allowing surgeries to be more pre­cise, less invasive, and ultimately enhance patient recovery experiences. The com­pany is committed to make every operating room robot ready.
Like other RAS approaches, the MIRA Surgical System offers similar benets in ergonomics and dexterity. Robotic systems can increase dexterity by eliminating the motion reversal associated with LAP procedures (when the surgeon’s hand movements are perceived in the opposite direction when using laparoscopic instru­ments). MIRA also allows for motion scaling for more consistent and precise manipulation.
Virtual Incision’s groundbreaking work revolves around the development of a rst-in-class miniaturized robotically assisted surgical platform, designed to navi­gate a wide range of soft-tissue procedures. The MIRA Surgical System has ben­ets over other “mainframe” RAS systems that set it apart in a class of its own, namely miniaturized RAS.The MIRA Surgical System was developed to mitigate many of the issues that current “mainframe” robotic systems pose. Mainframe refers to the currently available RAS systems (e.g., Da Vinci Xi) that have a
6
D. Oleynikov (*) Department of Surgery, Monmouth Medical Center, Long Branch, NJ, USA
Department of Surgery, Rutgers Robert Wood Johnson Medical School, Long Branch, NJ, USA e-mail: Dmitry.Oleynikov@rwjbh.org
S. Farritor David B. and Nancy K.Lederer Professor of Engineering, Lincoln, NH, USA e-mail: sfarritor@unl.edu
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2025 S. Samreen et al. (eds.), The SAGES Manual of Robotic Surgery,
https://doi.org/10.1007/978-3-031-86927-3_6
63
64
robust, large, and heavy design to support the external articulation of their robotic arms. These “traditional” RAS systems’ large external footprint can lead to cum­bersome and long setup times, the need for draping and docking, all while the patient cart and boom are looming over the patient that can interfere with ready access to patient and communication with the operating team. The MIRA Surgical System, on the other hand, can be deployed anywhere, eliminating the need for dedicated robotic rooms and assigned blocks. Its design simplies setup time and optimizes both access to the patient and communication with the operating team, while allowing seamless operating in multiple quadrants. This lightweight, reus­able, “out-of-a-tray” design and potential cost reductions hold the promise to allow wider adoption of robotic surgery programs, allowing for more patients to benet from better outcomes and faster recovery associated with minimally inva­sive procedures.
D. Oleynikov and S. Farritor

The MIRA Surgical System

Indication
In the United States, marketing authorization was granted by the FDA on February 23, 2024, via the De Novo Classication Pathway (Class II). The MIRA Surgical System is a miniaturized robotic-assisted surgery device indicated for the mobili­zation of the colon in adults at least 5’0” (1.52m) tall and having a weight of at least 100 lbs. (45.36kg) who are undergoing minimally invasive colectomy proce­dures. It is intended to assist in the visualization of tissues and provide accurate and precise control of surgical instruments to grasp, retract, and dissect while maintaining hemostasis with electrocautery during manipulation of tissues. It is for prescription use only and is to be used by trained physicians in any operating room environment.
Architecture ofPlatform
The MIRA surgical system consists of an integrated Minibot and Camera, an open­concept surgeon console, and a companion cart (see Fig.6.1a-c). MIRA is designed to be used with the GelPort® Laparoscopic System made by Applied Medical. The single insertion port is the same device used in hand-assisted laparoscopic surgery (HALS). The Minibot and Camera are inserted into the patient’s abdominal cavity through the insertion port and are remotely controlled via the surgeon console located outside the sterile eld. The surgeon console includes a main display show­ing the real-time video feed from the camera, hand input devices, pedal inputs, and an interactive touchscreen. The system is designed to be operated by a minimum of one surgeon and one surgical assistant.
The rst-generation system has sterile, single-use bipolar graspers and monopo­lar scissors instruments. Additional instruments (e.g., needle driver, monopolar hook, vessel sealer) are currently under development.
bc
6 Virtual Incision: MIRA Surgical System
a
65
Fig. 6.1 The MIRA surgical system. (a) The surgical Minibot and articulating camera, (b) The surgeon console, (c) The patient cart
Additional Technical Information
The technical differentiator to mainframe robotics is that the motorized robotic arms triangulate inside the patient’s abdominal cavity as opposed to externally. Because the instruments triangulate internally, there are no constraints imposed by trocar port placement, which is inherent to the mainframe robotic approach. The MIRA Surgical System has two motorized arms that have six degrees of freedom (Fig. 6.2). Its cross-sectional workspace is 6.7 inches (170 mm) wide and
3.125inches (80mm) deep. This cross section is swept approximately 180° about the shoulder pitch joint (Fig.6.3). The mRASD functions equally over any sweep angle from +90° to 90°, while the articulating camera ensures that the instruments can be in view at all times. Repositioning can be easily performed by adjusting the support arm. This ability to change MIRA’s overall position, combined with the reach and dexterity of the arms enable surgery throughout the abdominal cavity.
66
Fig. 6.2 The mRASD arms have six degrees of freedom, including the open/close function of the tool. The shoulder joint can yaw (θ1), pitch (θ2), and roll (θ3) about the upper arm segment. These rst three axes of rotation approximately intersect at the shoulder joint. The mRASD elbow allows rotation (θ4) of the forearm with respect to the upper arm. Finally, the instrument can roll (θ5) about the long axis of the instrument with instruments having an open/close actuation capability
D. Oleynikov and S. Farritor
Fig. 6.3 MIRA’s reachable workspace: the cross section is swept approximately 180° about the shoulder pitch joint. The workspace cross section is approximately 6.7inches (170mm) wide and
3.125inches (80mm) deep. The mRASD functions equally over any sweep angle from +90° to
90°. The camera can sweep between +70° to 70°
Clinical Data
The MIRA Surgical System was studied in a prospective, Investigational Device Exemption (IDE) clinical study in three centers in the United States. Based on the patient demographics and clinical characteristics, the study population was found to be representative of the US population for patients undergoing colectomy. The
6 Virtual Incision: MIRA Surgical System
67
indications for surgery were cancer (40.0%), polyp(s) (40.0%), diverticulitis (16.7%), and cecal mass (3.3%). Seventy percent of patients were overweight or obese, and 53.3% had prior abdominal surgery. Sixty percent had mild systemic disease (ASA II), and 40% had severe systemic disease (ASA III). The cases per­formed were 15 (50.0%) right colectomy and 15 (50.0%) left colectomy. The over­all mean operating time was 163 (SD 56.5) minutes, with an average console time of 77min. For right colectomy, it was 147min (range, 80–228), while for left it was 179min (range, 112–309). One assist port (in addition to the hand-assist gel­port) was placed in 63% of patients, and two were used in 37%. The device was manually repositioned a mean six times. Anastomoses were performed extracorpo­really in all colectomies. Setup time of the robot was determined to be 5.6min, median 5min (range, 1–20min). All cases had the primary dissection successfully completed and hemostasis achieved with the device. No patients required intraop­erative conversion to open surgery. There were no intraoperative adverse events or surgical complications. On pathology, all malignant cases had a complete resection with negative margins and adequate lymph node sampling (median, 26; range, 17–64). Mean intraoperative blood loss was 55.8cc, and one patient received a postoperative transfusion during management of an anastomotic leak.
The median length of stay was 2 days (range, 2–26). There was one unplanned reoperation (3.3%). There were no readmissions. There were no device-related com­plications and no mortality. According to the Clavien–Dindo classication, 15 surgi­cal complications were observed in nine patients (Gr I: 6; Gr II: 5; Gr IIIa: 2; Gr IIIb: 1; Gr IVb: 1). All major/Clavien–Dindo grade III and greater complications occurred in a single patient. This patient, with severe comorbidities, operated for a stage II sigmoid adenocarcinoma, had an anastomotic leak that required reoperation with a diverting ileostomy. (Figure6.4 shows an intraoperative view of a colectomy case.)
Telesurgery
Rural and remote populations do not have access to high-quality surgical care, including critical access hospitals, requiring patients to either travel long distances. Remote sur­gery allows for experts to use the latest robotic technology to assist patients and health­care providers. Virtual Incision partnered with Savato (CA, USA) telesurgical presence system to perform experimental remote surgery at a distance of 5 miles. The Connectivity System provides highly reliable, low-latency, broad bandwidth connectivity using a
Fig. 6.4 Intraoperative view during left colectomy, dissection of left ureter
68
D. Oleynikov and S. Farritor
dedicated, private network that includes monitoring and immediately available backup networks. The A/V system provides high-quality telepresence that enables clear verbal communication between and among all caregivers and provides multiple video images of the patient and remote operating room for the surgeon who is not in the room. Multiple wet lab procedures across a distance of 5 miles using either public Internet or a dedi­cated network conrmed reliable connectivity with acceptable latency that enabled completion of hysterectomy, colectomy, and cholecystectomy in a porcine model. The surgeon and remote care team could verbally communicate naturally and effectively. The Sovato App enabled the implementation of the surgical time-out and the preopera­tive checklists, as well as providing other safety measures. The surgeon and remote care team maintained effective and comfortable verbal and visual communication through­out the setup and completion of the procedures. Remote surgery is safe and feasible, and future use in clinical trials is likely next steps.
MIRA inSpace
The MIRA Surgical System is designed to be used in an operating room and to be quickly and easily moved from room to room. The compactness and ease of use of the miniaturized RAS might enable the device to be considered an ideal candi­date for remote telesurgery in the future (e.g., for rural areas and military battle­elds). Exploring the use of miniaturized RAS in extreme environments helps understand how to remove barriers for patients. An experiment to further validate the proof of concept regarding remote telesurgery was funded by a grant awarded from the National Aeronautics and Space Administration (NASA) to the University of Nebraska through the Established Program to Competitive Research (EPSCoR) program. In January 2024, space-MIRA (a shortened version of MIRA Surgical System) was sent to the International Space Station aboard a Northrop Grumman Cygnus cargo spacecraft carried by a SpaceX Falcon 9 rocket. Testing with space­MIRA on the International Space Station assessed the impact of zero gravity when performing simulated surgical tasks. Six surgeons successfully operated from Virtual Incision’s headquarters, utilizing remote-controlled technology to direct the movements of the robot on simulated tissue (Fig.6.5).
Fig. 6.5 Space-MIRA being shown aboard the International Space Station by astronaut Loral O’Hara (February 2024)
Starting andDeveloping aRobotic Program
C.Franco-Mesa andSarahSamreen

Purpose

The advantages of minimally invasive surgery (MIS) have been known since the early twentieth century [1]. Nonetheless, the incursion of robotics drastically changed the surgical eld. Unlike other MIS tools, these consoles provide countless benets, including an increase in accuracy, three-dimensional image with depth perception, fully articulated instruments, and improved ergonomics. As a result, surgeons can com­plete meticulous surgical procedures in unfavorable anatomic locations where open or laparoscopic approaches are unable to be performed or associated with a myriad of complications that outweigh the benets. While postoperative outcomes with robotic consoles remain comparable to those with other techniques, there is a rising trend in the literature that describes shorter hospital stays, decreased complication rates, and better quality of recovery associated with the use of robotic surgery (RS) [2, 3].
RS is a rapidly growing eld in the United States that will continue to expand as training programs incorporate innovative techniques into education curriculums [4]. In the pursuit of providing outstanding patient care, surgeons expand their skill sets to deliver the tools that best t their patient’s needs. Thus, learning additional surgi­cal techniques provides a wider range of options to deliver care. RS has also been known to complement different areas of surgery. For instance, in the setting of acute care surgery (ACS), RS continues to gain favor in cases of cholecystectomy with intraoperative cholangiogram and common biliary duct exploration [5]. In this sce­nario, patients undergo a one-stage procedure compared to the more common
7
C. Franco-Mesa · S. Samreen (*) Division of General Surgery, University of Texas Medical Branch, Galveston, TX, USA e-mail: sasamree@utmb.edu
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2025 S. Samreen et al. (eds.), The SAGES Manual of Robotic Surgery,
https://doi.org/10.1007/978-3-031-86927-3_7
69
70
C. Franco-Mesa and Sarah Samreen
two- stage with endoscopic retrograde cholangiopancreatography. RS is part of the modernization of medicine and will widely spread to complement the general sur­geon’s armamentarium.
Identifying theLandscape
Before diving into developing a robotic program, it is crucial to understand the cur­rent setting and surroundings where such a program will emerge. Factors such as the type of hospital system, number of beds, operating rooms available, and functioning robotic systems will inuence the type of program built. The most known FDA­approved system in the United States is the da Vinci Surgical System from Intuitive Surgical [6]. While this may change in the future as different robots are released, it is relevant to identify the strengths and weaknesses that can be encountered in all aspects of project development (logistics, infrastructure, personnel, funding, etc.). Once the starting baseline is recognized, coherent program goals can be established.
Pillars forStarting andDeveloping aRobotic Surgery Program
Three overlapping phases constitute the tract toward building an RS program (Fig.7.1). The “adopting” stage encompasses all related to the initial engagement of leadership, basic training, and support. Followed by the “operationalizing” phase, where the learning curve takes place, complexity is escalated, cultural change is promoted, and data collection begins. Finally, during the “standardizing” period, optimization is the priority from both the procedural standpoint and the economic perspective. Other topics such as scheduling priorities, goals, and established teach­ing curriculums are also approached in the Standardizing phase.
Adopting
The rst step of the journey is to identify a leader who is knowledgeable in the eld (Fig.7.2). This “surgeon champion” should have experience with robotic systems and, more importantly, the initiative and desire to participate in the development of the RS program. The leader’s goal is to establish a vision of the future of the pro­gram and share that vision with other teammates. Furthermore, they are responsible for delivering the knowledge and methods required to manufacture said vision [7].
Adopting Operationalizing Standardizing
Fig. 7.1 Pillars of building a robotic surgery program