Robotic Surgical Devices Research Articles

Embracing industry in the development of robotic coronary bypass grafting-the sun rises in the East.

The introduction of robotic surgical devices nearly two decades ago led to a significant reduction in the invasiveness of cardiac procedures. The further worldwide implementation of robotic surgical devices in cardiac surgery, especially coronary artery bypass grafting and mitral valve repair or replacement, has, however, been stalled by numerous challenges. First, there is the high complexity of the procedures that involve a significant learning curve; second, there is the significant cost of robotic surgical devices. Furthermore, significant changes in the medical device regulation have occurred in recent years, hindering further technological development and the emergence of new players on the market. Finally, clinical evidence regarding the benefits of robotic-cardiac procedures remains scarce at this time. We invited all players active in or planning to throw themselves into robotic-assisted cardiac surgery to discuss these challenges in a semi-structured interview. Two promising and ambitious companies showed interest in participating in this project: Medicaroid and SS Innovations. The main conclusions from the interview are that both companies aim (I) to launch an affordable alternative compared to the current robotic surgical devices, (II) to further develop their robotic devices based on the opinion of physicians, and (III) to engage in overcoming the steep learning curve correlated with robotic-assisted cardiac procedures.

The Evolution of Robotic Surgery through the Machine Design Innovation

To date, robotic surgery has gained much popularity, impacting deeply on surgical fields such as genitourinary system branches, general surgery, and cardiac surgery. We aim to outline the landscape of robotic surgery, focusing on design improvements, which have improved both the technical skills of surgeons and the outcomes of minimally invasive technique for patients. A thorough narrative literature review was conducted on PubMed/MEDLINE, employing keywords such as “robotic surgical system”, “robotic surgical device”, and “robotics AND urology”. Furthermore, the reference lists of the retrieved articles were scrutinized. The analysis focused on urological surgical systems from the 2000s to the present day. Beginning with the daVinci® Era in the 2000s, new robotic competitors, including Senhance®, Revo-I®, Versius®, Avatera®, Hi-notori®, and HugoTM RAS, have entered the medical market. While daVinci® has maintained a high competitiveness, even more new platforms are now emerging in the medical market with new intriguing features. The growing competition, driven by unique features and novel designs in emerging robotic technologies, has the potential to improve application fields, enhance diffusion, and ameliorate the cost effectiveness of procedures. Since the impact of these new surgical technologies on different specialties and healthcare systems remains unclear, more experience and research are required to define their evolving role.

Robotic technology in surgery; a classification system of soft tissue surgical robotic devices

BackgroundThe field of robotic-assisted surgery is rapidly growing as many robotic surgical devices are in development and about to enter the market. Currently, there is no universally accepted language for labeling the different robotic systems. To facilitate this communication, we created what is, to our knowledge, the first classification of surgical robotic technologies that organizes and classifies surgical robots used for endoscopy, laparoscopy and thoracoscopy.MethodsWe compiled a list of surgical robots intended to be used for endoscopy, laparoscopy, and/or thoracoscopy by searching United States, European, Hong Kong, Japan, and Korean databases for approved devices. Devices showcased at the 2023 Annual Meeting for the Society of Robotic Surgery were added. We also systematically reviewed the literature for any existing surgical robotic classifications or categorizations. We then created a multidisciplinary committee of 8 surgeons and 2 engineers to construct a proposed classification of the devices included in our search.ResultsWe identified 40 robotic surgery systems intended to be used for endoscopy, laparoscopy and/or thoracoscopy. The proposed classification organizes robotic devices with regard to architecture, port design, and configuration (modular carts, multi-arm integrated cart, table-attachable or arm-table integration).ConclusionThis 3-level classification of robotic surgical devices used for endoscopy, laparoscopy and/or thoracoscopy describes important characteristics of robotic devices systematically.

User Experience Evaluation of a Spinal Surgery Robot: Workload, Usability, and Satisfaction Study.

Robotic spine surgery has continued to evolve since its US Food and Drug Administration approval in 2004, with products now including real-time video guidance and navigation during surgery. As the market for robotic surgical devices evolves, it is important to consider usability factors. The primary objective of this study was to determine the user experience of a surgical-assistive robotic device. The secondary objective was to evaluate workload, usability, the After-Scenario Questionnaire (ASQ), and the System Usability Scale (SUS). In addition, this study compares the workload, usability, and satisfaction survey of the device among different occupational groups using the device. Doctors (n=15) and nurses (n=15), the intended users of the surgical assistant robot, participated in the usability evaluation. Participants performed essential scenarios for the surgical assistant robot and provided scenario-specific satisfaction (ASQ), workload (NASA Task Load Index), and usability (SUS) scores. Both doctors and nurses had task success rates of 85% or higher for each scenario. ASQ results showed that both doctors and nurses were least satisfied with ease of completing the task of registration (group 1: mean 4.73, SD 1.57 and group 2: mean 4.47, SD 1.8), amount of time it took (group 1: mean 4.47, SD 1.63 and group 2: mean 4.40, SD 2.09), and support information satisfaction (group 1: mean 5.13, SD 1.50 and group 2: mean 5.13, SD 1.89). All participants had low workloads, and the overall Task Load Index score had a P value of .77, which is greater than .05. The SUS results showed that the overall usability mean for doctors was 64.17 (SD 16.52) and the mean for nurses was 61.67 (SD 19.18), with a P value of .84, which is greater than .05, indicating no difference between the 2 groups. In this study, doctors and nurses evaluated the interaction of the device in a simulated environment, the operating room. By evaluating the use experience and usability of the device with real intended users, we can develop a more effective and convenient user interface.

Development of robotic surgical devices and its application in colorectal surgery

Due to greater accessibility, robotic technology is becoming increasingly common in a wide range of general surgical procedures. In relation to traditional laparoscopic techniques, robotic surgery has four significant advantages: greater accessibility, visibility, accuracy, and comfortability. For example, robotic surgery is particularly beneficial for procedures in hard-to-reach areas (e.g., pelvis, rectum, and endoluminal areas) because it offers a greater range of motion and precision. In addition, surgical visibility and accuracy can be improved by providing 3D and magnified visualization of the surgical field. Robotic systems are also designed for surgeons’ comfort, allowing the operator to sit while working. For these reasons, robotic surgery is preferable for colorectal and other abdominal surgical procedures. As interest in minimally invasive surgery increases, so does the need to develop new approaches and procedures in colorectal surgery. While robotic surgery has great potential for improving outcomes, there may be disadvantages over traditional laparoscopic and open surgical procedures. For example, possible disadvantages include increased maintenance, training, and cost. This review discusses the evolution of robot-assisted surgery with respect to short-term and long-term outcomes. The development of robotic surgical devices, the new devices entering the market, and the possible future directions of robotic surgery will also be discussed.

Robotic-assisted repair of incisional hernia—early experiences of a university robotic hernia program and comparison with open and minimally invasive sublay technique (eMILOS)

PurposeWith robotic surgical devices, an innovative tool has stepped into the arena of minimally invasive hernia surgery. It combines the advantages of open (low recurrence rates and ability to perform complex procedure such as transverse abdominis release) and laparoscopic surgery (low rate of wound and mesh infections, less pain). However, a superiority to standard minimally invasive procedures has not yet been proven. We present our first experiences of robotic mesh repair of incisional hernias and a comparison of our results with open and minimally invasive sublay techniques.MethodsA retrospective analysis of all patients who underwent robotic-assisted mesh repair (RAHR) for incisional hernia between April and November 2022 (RAHR group) and patients who underwent open sublay (Sublay group) or eMILOS hernia repair (eMILOS group) between January 2018 and November 2022 was carried out. Patients in the RAHR group were matched 1:2 to patients in the Sublay group by propensity score matching. Patient demographics, preoperative hernia characteristics and cause of hernia, intraoperative variables, and postoperative outcomes were evaluated. Furthermore, a subgroup analysis of only midline hernia was performed.ResultsA total of 21 patients received robotic-assisted incisional hernia repair. Procedures performed included robotic retro-muscular hernia repair (r-RMHR, 76%), with transverse abdominis release in 56% of the cases. In one patient, r-RHMR was combined with robotic inguinal hernia repair. Two patients (10%) were operated with total extraperitoneal technique (eTEP). Robotic-assisted transabdominal preperitoneal hernia repair (r-TAPP) was performed in three patients (14%).Median (range) operating time in the RAHR group was significantly longer than in the sublay and eMILOS group (291 (122–311) vs. 109.5 (48–270) min vs. 123 (100–192) min, respectively, p < 0.001). The meshes applied in the RAHR group were significantly compared to the sublay (mean (SD) 529 ± 311 cm2 vs. 356 ± 231, p = 0.037), but without a difference compared to the eMILOS group (mean (SD) 596 ± 266 cm2). Median (range) length of hospital stay in the RAHR group was significantly shorter compared to the Sublay group (3 (2–7) vs. 5 (1–9) days, p = 0.032), but not significantly different to the eMILOS group. In short term follow-up, no hernia recurrence was observed in the RAHR and eMILOS group, with 9% in the Sublay group. The subgroup analysis of midline hernia revealed very similar results.ConclusionOur data show a promising outcome after robotic-assisted incisional hernia repair, but no superiority compared to the eMILOS technique. However, RAHR is a promising technique especially for complex hernia in patients with relevant risk factors, especially immunosuppression. Longer follow-up times are needed to accurately assess recurrence rates, and large prospective trials are needed to show superiority of robotic compared to standard open and minimally invasive hernia repair.

Robotic Surgery in Urology: History from PROBOT® to HUGOTM.

The advent of robotic surgical systems had a significant impact on every surgical area, especially urology, gynecology, and general and cardiac surgery. The aim of this article is to delineate robotic surgery, particularly focusing on its historical background, its evolution, its present status, and its future perspectives. A comprehensive literature review was conducted upon PubMed/MEDLINE, using the keywords "robotic surgical system", "robotic surgical device", "robotics AND urology". Additionally, the retrieved articles' reference lists were investigated. Analysis concentrated on urological surgical systems for laparoscopic surgery that have been given regulatory approval for use on humans. From the late 1980s, before daVinci® Era in 2000s, ancestor platform as Probot® and PUMA 560 were described to outline historical perspective. Thus, new robotic competitors of Intuitive Surgical such as Senhance®, Revo-I®, Versius®, Avatera®, Hinotori®, and HugoTM RAS were illustrated. Although daVinci® had high level competitiveness, and for many years represented the most plausible option for robotic procedures, several modern platforms are emerging in the surgical market. Growing competition through unique features of the new robotic technologies might extend applications fields, improve diffusion, and increase cost-effectiveness procedures. More experiences are needed to identify the role of these new advancements in surgical branches and in healthcare systems.

Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device.

The FDA's 510(k) process for medical devices is based on "substantial equivalence" to devices clearedpre-1976 or legally marketed thereafter, known as predicate devices. In the last decade, several high-profile device recalls have drawn attention to this regulatory clearance process and researchers have raised questions about the validity of the 510(k) process as a broad clearance mechanism. One of the issues raised is the risk of predicate creep, a cycle of technology change through repeated clearance of devices based on predicates with slightly different technological characteristics, such as materials and power sources, or have indications for different anatomical sites. This paper proposes a new way to identify potential "predicate creep" through the use of product codes and regulatory classifications. We test this method by applying it to a case study of a Robotic Assisted Surgery (RAS) device, the Intuitive Surgical Da Vinci Si Surgical System. We find that there is evidence of predicate creep using our method, and discuss implications of this method for research and policy.

EVALUATION OF NEEDLE DRIVER DESIGNS FOR ROBOT-ASSISTED NEEDLE INSERTIONS UNDER MRI GUIDANCE.

This paper presents the evaluation of two detachable MR-Conditional needle driver designs for our 4-degree-of-freedom (DOF) robotic platform for MRI-guided spinal injections. Compared to their predecessor, the new designs open up the possibility of intraoperative needle driver attachment, and in order to evaluate the feasibility of such an approach, force and torque requried during the needle driver attachment process are captured to evaluate which of the two designs are better suited for such purpose. A simulated clinical scenario is also carried out to measure the possible position change of the 4-DOF robot with respect to the patient due to intraoperative tool attachment, thus providing future guidance to the proposed clinical workflow in the framework of body-mounted robotic surgical devices.

Bending stiffness variability between a deployable robotic laser osteotome and its insertion device

Abstract Varying device stiffness on purpose can provide safety and performance improvements in interventions involving flexible minimal-invasive surgical robotic devices. For example, when flexible robotic devices are used for inserting minimal-invasive tools along curved paths into the knee joint for arthroscopy, a high device stiffness can allow precise path following where desirable. In contrast, when the minimalinvasive flexible device has reached its desired location inside the patient’s body, decoupling the surgical tool (end-effector) from the flexible robotic insertion device can be beneficial in avoiding transferring disturbances such as vibrations to the robot-patient interaction. In this paper, we investigate bending stiffness variability in dependence on the length of a flexible supply channel. Our experiments have shown that bending stiffness in fact decreases with the length of the supply channel but the highest stiffness connection is not sufficiently rigid and we plan to implement a more rigid connection to allow precise path following during insertion.

MECHANICAL DESIGN, ACTUATION AND CONTROL OF BIOINSPIRED SOFT SURGICAL ROBOTS

The design of surgical soft robots is one of the most challenging problems in modern robotics. In addition to the still pending problems of general soft robotics i.e. selection/design of materials, actuators, and mechanical structures, there are serious limitations in terms of their operating environment and conditions: interaction with biological tissues, the effect of sterilization and cleaning liquids, the shape and dimensions of the working space, as well as often occurring accidents during the surgery which poses new robotic control problems to be studied. As it is known, each object of bioinspiration (elephant trunk, octopus leg, etc.) has its own type of motion, kinematic structure, and control, therefore the comparative analysis of soft robots according to different objects of bioinspiration will facilitate their selection and application in minimally invasive surgery (MIS), taking into account, of course, the limitations associated with the surgery. A review of modern literature on mechanical design, methods and technical means of actuation and control of the main types of bioinspired soft surgical robots is presented.The design and development problems, including material selection, mechanical design and optimization, actuation, and bioinspired control for each type of the existing soft surgical robots are discussed. The results and recommendations of this study will help to develop new samples of soft surgical robotic devices with task-specific functional characteristics necessary for MIS applications.

Surgical robotic systems: What we have now? A urological perspective.

IntroductionThe coming decade will see the emergence of many surgical robotic systems that need to prove their cost‐effectiveness and clinical usability to gain the trust of robotic surgeons worldwide. Herein, we provide a concise review of the currently available robotic systems. Since the da Vinci Surgical System's patent expired and its market monopoly ended, many robotic surgical systems have, and will continue to, enter the market. Central to this is the challenge of gaining the trust of robotic surgeons in a cost‐effective manner. However, the cumulative robotic surgical experience of Intuitive Surgical over these years—which has proven itself clinically and technically—is a great challenge for new surgical robots.MethodsThis was a non‐systematic review of the literature, conducted through the PubMed search engine, using the following words: “Da Vinci,” “robotic surgical system,” and “new robotic surgical device.” Further information was obtained from the robotic system companies’ official websites and press releases.ConclusionsThe open robotic market carries great challenges for new robotic surgical systems, especially when following well‐established da Vinci Surgical System. Surgeons’ trust, clinical publications, technical support, and market distribution all represent separate challenges that require address.

Skill-Oriented and Performance-Driven Adaptive Curricula for Training in Robot-Assisted Surgery Using Simulators: A Feasibility Study.

Virtual Reality (VR) simulators represent a remarkable educational opportunity in order to acquire and refine surgical practical skills. Nevertheless, there exists no consensus regarding a standard curriculum of simulation-based training. This study introduces an automatic, adaptive curriculum where the training session is real-time scheduled on the basis of the trainee's performances. An experimental study using the master console of the da Vinci Research Kit (Intuitive Surgical Inc., Sunnyvale, US) was carried out to test this approach. Tasks involving fundamental skills of robotic surgery were designed and simulated in VR. Twelve participants without medical background along with twelve medical residents were randomly and equally divided into two groups: a control group, self-managing the training session, and an experimental group, undergoing the proposed adaptive training. The performances of the experimental users were significantly better with respect to the ones of the control group after training (non-medical: p < 0.01; medical: p = 0.02). This trend was analogous in the non-medical and medical populations and no significant difference was identified between these two classes (even in the baseline assessment). The analysis of the learning of the involved surgical skills highlighted how the proposed adaptive training managed to better identify and compensate for the trainee's gaps. The absence of initial difference between the non-medical and medical users underlines that robotic surgical devices require specific training before clinical practice. This feasibility study could pave the way towards the improvement of simulation-based training curricula.

Pediatric and adolescent gynecology: Treatment perspectives in minimally invasive surgery.

Minimally invasive surgery (MIS) is widely utilized across multiple surgical disciplines, including gynecology. To date, laparoscopy is considered a common surgical modality in children and adolescents to treat gynecological conditions. Robotic surgical devices were developed to circumvent the limitations of laparoscopy and have expanded the surgical armamentarium with better magnification, dexterity enhanced articulating instruments with 5-7 degrees of freedom, and ability to scale motion thus eliminating physiologic tremor. There are well-documented advantages of MIS over laparotomy, including decreased post-operative pain, shorter recovery times, and better cosmetic results. Indications for MIS in pediatric gynecology are reported in this review and technical considerations are described to highlight new treatment perspectives in children and adolescents, which have already been described in the literature regarding adult patients.

50 years of minimally invasive surgery in Urology

The development of minimally invasive surgery (MIS) in Urology includes transurethral techniques, endourology and extracorporeal shock wave lithotripsy, uroradiology as well as laparoscopy and robot-assisted suregry. Based on personal experiences with the introduction of minimal-invasiven procedures since the late seventees we present a historical analysis of the literature aiming to work out the most important milestones of MIS in Urology.The drastic development of MIS in Urology was promoted by the introduction of digital videotechnology, laser technology, advances in electronic surgery together with the excellent performance of mainly German manufacturers of medical devices anf instruments. In this scenario, the good cooperation between urologists, engineers, and interventional radiologists was of upmost importance.The introduction of Robotics led to a decrease of importance of classical laparoscopy. Nevertheless laparoscopy and retroperitoneoscopy underwent significant technological improvements during the last decade including introduction 3D-HD-videosystems and ergonomic platforms (ETHOS-chairR). The monopoly of robotic surgical devices will end this year, because key-patents of Intuitive Surgical will expire. This will lead to an interesing competition in among new manufacturers of robotic surgical devices, which however have to prove that they meet the high quality standard of the current Da Vinci-series. There are also robotic systems used in endourology: Avicenna RoboflexR and the AquaBeamR-System for robot-assisted aquablation therapy of the prostate. While RoboflexR improves the ergonomics of flexbile ureteroscopy, AquaBeamR may for the first time eliminate the surgeon.

La cirugía del siglo XXI

Recibido: 1 de mayo de 2019Aprobado: 1 de junio de 2019La mayoría de los cirujanos estarían de acuerdo en que las nuevas tecnología en el campo de a cirugía como la robótica y/o la cirugía asistida por computadora serán una parte importante del futuro de la cirugía dentro de una década, pero pocos pueden articular una visión de cómo será, o cómo se llegará allí. La generación actual de dispositivos quirúrgicos robóticos representa un punto de partida para esta evolución. Los cirujanos que no participan en el desarrollo de la robótica tendrán preguntas legítimas sobre esta tecnología emergente. En el presente artículo se esbozan algunos comentarios sobre la cirugía actual en perspectiva del futuro de esta rama de la ciencia médica. Los robots ofrecen la promesa de mejoras en la cirugía laparoscópica que permitirán a la mayoría de los cirujanos realizar operaciones laparoscópicas más difíciles. También traerán operaciones técnicas más difíciles (ahora generalmente realizadas por incisión) al alcance de la cirugía laparoscópica.

Status of Robotic-Assisted Surgery (RAS) in the Department of Defense (DoD)

Since inception of robotic-assisted surgery (RAS) in 1999, there has been an exponential rise in RAS in both number and complexity of surgical cases performed. The majority of these cases are gynecologic surgery in nature, with only a quarter of them labeled as general surgery. The purpose of this study is to determine if RAS in the Department of Defense (DoD) mirrors these trends. A total of 6,204 RAS cases from across the DoD were reviewed between 01 January 2015 and 30 September 2017 from every Military Treatment Facility (MTF) that employs a robotic surgical device (various models of the da Vinci robotic surgical system by Intuitive Surgical). Specialty, number, and surgeon were recorded for each case. These end points were also examined for trends overtime and compared to similar civilian data. The number of MTFs performing robotic surgery and the number of cases performed increased significantly. An average of 373 cases per quarter-year were performed in 2015, 647 in 2016, and 708 in 2017. The number of RAS cases increased by about 10% every quarter-year during this time period. RAS was most commonly performed by general surgery in 10 of the 14 MTFs examined. MTFs implemented RAS much later than the civilian world. However, since its implementation, the frequency of RAS use has increased at a faster rate in the DoD than in the civilian world. Possible reasons for this are a younger pool of surgeons in the military and less demands on cost-effective productivity, allowing these younger surgeons to focus on emerging technology rather than maximizing surgical cost efficiency. General surgery constitutes the majority of RAS cases in the DoD. It is unclear why this difference from the civilian world exists.

Transmediastinal approach for esophageal cancer: A new trend toward radical surgery.

Esophageal squamous cell carcinoma (ESCC), the most common histology of esophageal cancer in Japan and Asia, shows extensive mediastinal spread from an early stage. Therefore, transthoracic esophagectomy with extensive mediastinal lymphadenectomy, including in the upper mediastinum along the recurrent laryngeal nerves, is the gold standard of radical surgery for ESCC. Minimally invasive thoracoscopic esophagectomy has now become a standard option for ESCC. However, transhiatal esophagectomy is regarded as less invasive because it avoids thoracotomy. Yet, it is also considered less curative because it offers a limited surgical view and insufficient mediastinal lymphadenectomy even when conventional specialized mediastinoscopy is used. Recent clinical studies on radical esophagectomy without thoracotomy for ESCC have been reported from Japan. The introduction of novel minimally invasive techniques for the transcervical or transhiatal approach, such as single-port or robotic surgical devices, have enabled transmediastinal radical esophagectomy for ESCC. This review focuses on the transmediastinal approach for esophageal cancer surgery, which employs minimally invasive techniques to reduce morbidity, and its application to radical surgery for ESCC.

The future of laparoscopy and robotics in urology

The introduction of robotics led to a decrease in the importance of classical laparoscopy. Nevertheless laparoscopy and retroperitoneoscopy underwent significant technological improvements during the last decade, including introduction of 4k Ultra HD video technology, 3D-HD-videosystems, minaturised instruments, advanced sealing devices, instruments with 7 degrees of freedom, and ergonomic platforms Ethos Chair®. The monopoly of robotic surgical devices will end in 2019, because key patents of Intuitive Surgical will expire. This will lead to an interesing competition among new manufacturers of robotic surgical devices, which however have to prove that they meet the high quality standard of the current da Vinci series, such as type of console, arrangement of robotic arms, technology of 3D-videosystem, and quality and degrees of freedom of end effectors. There are also robotic systems used in endourology: Avicenna Roboflex® and the AquaBeam®-System for robot-assisted aquablation therapy of the prostate. While Roboflex improves the ergonomics of flexbile ureteroscopy, AquaBeam may for the first time eliminate the surgeon.

A randomised trial of observational learning from 2D and 3D models in robotically assisted surgery

BackgroundAdvances in 3D technology mean that both robotic surgical devices and surgical simulators can now incorporate stereoscopic viewing capabilities. While depth information may benefit robotic surgical performance, it is unclear whether 3D viewing also aids skill acquisition when learning from observing others. As observational learning plays a major role in surgical skills training, this study aimed to evaluate whether 3D viewing provides learning benefits in a robotically assisted surgical task.Methods90 medical students were assigned to either (1) 2D or (2) 3D observation of a consultant surgeon performing a training task on the daVinci S robotic system, or (3) a no observation control, in a randomised parallel design. Subsequent performance and instrument movement metrics were assessed immediately following observation and at one-week retention.ResultsBoth 2D and 3D groups outperformed no observation controls following the observation intervention (ps < 0.05), but there was no difference between 2D and 3D groups at any of the timepoints. There was also no difference in movement parameters between groups.ConclusionsWhile 3D viewing systems may have beneficial effects for surgical performance, these results suggest that depth information has limited utility during observational learning of surgical skills in novices. The task constraints and end goals may provide more important information for learning than the relative motion of surgical instruments in 3D space.