Safety and Efficacy of a Novel Miniaturized Robotic-Assisted Surgery System in Colectomy: A Prospective, Investigational Device Exemption Clinical Study Using the IDEAL Framework.

BACKGROUND: Robotics has increased rates of minimally invasive surgery, with distinct advantages over open surgery. However, current commercially available robotic platforms have device and system issues that limit robotic-assisted surgery expansion. OBJECTIVE: To demonstrate the safety and efficacy of a novel miniaturized robotic-assisted surgery device in colectomy. DESIGN: Prospective, Investigational Device Exemption clinical study following the idea, development, exploration, assessment, and long-term follow-up framework (stage 2b, exploration). SETTINGS: Three centers with high-volume robotic colorectal cases and surgeons. PATIENTS: Patients scheduled for a right or left colectomy for benign or malignant disease. INTERVENTION: Colectomy with the novel miniaturized robotic-assisted surgery device. MAIN OUTCOME MEASURES: For safety, intraoperative and device-related adverse events and 30-day morbidity. For efficacy, successful completion of predefined procedural steps without conversion. RESULTS: Thirty patients (13 women, 17 men) were analyzed. The mean age was 59.4 (SD 13.4) years. Seventy percent of patients (n = 21) were overweight/obese and 53.3% of patients (n = 16) had prior abdominal surgery. Forty percent of patients had malignant and 60% had benign disease. Cases were 15 right and 15 left colectomies. Overall operative time was a median of 146 (range, 80-309) minutes; console time was 70 (range, 34-174) minutes. There were no conversions to open surgery and no intraoperative or device-related adverse events. In 100% of patients (n = 30), the primary dissection was completed, and hemostasis was maintained with the novel miniaturized robotic-assisted surgery device. The morbidity rate was 26.7% minor and 3.3% major. The median length of stay was 2 days. There were no mortalities. LIMITATIONS: Single-arm study, short-term follow-up. CONCLUSIONS: This first clinical study of a novel miniaturized robotic-assisted surgery device along the IDEAL framework demonstrated that it was safe and effective. Given this success, further assessment and long-term follow-up of the miniaturized robotic-assisted surgery device are planned for comparative clinical and economic effectiveness in colorectal surgery. See Video Abstract . SEGURIDAD Y EFICACIA DE UN NOVEDOSO SISTEMA DE CIRUGA ASISTIDA POR ROBOT MINIATURIZADO EN COLECTOMA UN ESTUDIO CLNICO PROSPECTIVO DE INVESTIGACIN DE EXENCIN DE DISPOSITIVO QUE UTILIZA EL MARCO IDEAL: ANTECEDENTES:La robótica ha aumentado las tasas de cirugía mínimamente invasiva, con claras ventajas sobre la cirugía abierta. Sin embargo, las plataformas robóticas actualmente disponibles comercialmente tienen problemas con los dispositivos y sistemas que limitan la expansión de la cirugía asistida por robot.OBJETIVO:Demostrar la seguridad y eficacia de un novedoso dispositivo de cirugía asistida por robot miniaturizado en colectomía.DISEÑO:Estudio clínico prospectivo de investigación de exención de dispositivo siguiendo el marco IDEAL (Etapa 2b, exploración).ESCENARIO:Tres centros con cirujanos y casos colorrectales robóticos de gran volumen.PACIENTES:Pacientes programados para colectomía derecha o izquierda por enfermedad benigna o maligna.INTERVENCIÓN:Colectomía con el nuevo dispositivo de cirugía asistida por robot miniaturizado.PRINCIPALES MEDIDAS DE RESULTADO:Para la seguridad, eventos adversos intraoperatorios y relacionados con el dispositivo y morbilidad a 30 días. Para la evaluación de la eficacia, la finalización exitosa de los pasos predefinidos sin conversión.RESULTADOS:Se analizaron treinta pacientes (13 mujeres, 17 hombres). La edad media fue 59,4 (DE 13,4) años. El 70% (n=21) tenía sobrepeso/obesidad y el 53,3% (n=16) había tenido cirugía abdominal previa. El 40% tenía enfermedad maligna y el 60% benigna. Los casos fueron 15 colectomías derechas y 15 izquierdas. La mediana del tiempo operatorio general fue de 146 (rango, 80-309) minutos; 70 (rango, 34-174) minutos fue el tiempo de consola. No hubo conversiones a cirugía abierta ni eventos adversos intraoperatorios o relacionados con el dispositivo. En el 100% (n=30), se completó la disección primaria y se mantuvo la hemostasia con el novedoso dispositivo de cirugía asistida por robot miniaturizado. La tasa de morbilidad menor fue de un 26,7% y mayor un 3,3%. La mediana de estadía fue de 2 días. No hubo mortalidad.LIMITACIONES:Estudio de un solo brazo, corto plazo de seguimiento.CONCLUSIONES:Este primer estudio clínico de un novedoso dispositivo de cirugía asistida por robot miniaturizado según el marco IDEAL demostró que era seguro y eficaz. Dado este éxito, se planean evaluaciones adicionales y seguimiento a largo plazo del dispositivo de cirugía asistida por robot miniaturizado para comparar la efectividad clínica y económica en la cirugía colorrectal. (Traducción-Dr. Felipe Bellolio ).

One year follow-up of the colon cancer patient cohort treated with a novel miniaturized robotic-assisted surgery device (mRASD).

BACKGROUND: With the proven benefits of minimally invasive surgery, there is steady growth in robotic surgery use and interest in novel robotic platforms. A miniaturized Robotic-Assisted Surgery Device (mRASD) has been in clinical use under a multi-center, investigational device exemption (IDE) study for right and left colectomy. The goal of this work was to report the short-term and 12-month outcomes specifically for the cohort of colon cancer patients that underwent surgery using the mRASD. METHOD: From the IDE study that included both benign and malignant diseases, long-term follow-up was only conducted for patients with colon cancer. The main outcome measures were the oncologic quality metrics (Overall Survival, OS and Disease-free Survival, DFS). Secondary outcomes included incidence of intra-operative, device-related, and procedure-related adverse events. Frequency statistics were performed to assess the measures of central tendency and variability in short (within 30 days) and long-term (1-year) outcomes. RESULTS: Thirty total patients underwent a colectomy with mRASD; 17 (57%) were diagnosed with a malignancy and included in this analysis. The mean patient age was 59.9 ± 13.2 years. There were no intraoperative or device-related adverse events. In 100% of cases (n = 17), the primary dissection was completed and hemostasis maintained using the mRASD, and negative margins were achieved. At 30 days postoperatively, the major complication rate was 6%, and there was one unplanned reoperation for anastomotic leak. At one-year follow-up, the OS and DFS rates were 100 and 94%, respectively. In one patient, omental implants were discovered at the time of surgery, and the patient opted to not undergo additional therapy. CONCLUSIONS: The first experience with mRASD for colectomy in colon cancer demonstrated technical effectiveness and an acceptable surgical safety profile in line with other minimally invasive procedures. The study continues to monitor disease recurrence and survival outcomes in this cohort.

Real-time three-dimensional soft tissue reconstruction for laparoscopic surgery.

BACKGROUND: Accurate real-time 3D models of the operating field have the potential to enable augmented reality for endoscopic surgery. A new system is proposed to create real-time 3D models of the operating field that uses a custom miniaturized stereoscopic video camera attached to a laparoscope and an image-based reconstruction algorithm implemented on a graphics processing unit (GPU). METHODS: The proposed system was evaluated in a porcine model that approximates the viewing conditions of in vivo surgery. To assess the quality of the models, a synthetic view of the operating field was produced by overlaying a color image on the reconstructed 3D model, and an image rendered from the 3D model was compared with a 2D image captured from the same view. RESULTS: Experiments conducted with an object of known geometry demonstrate that the system produces 3D models accurate to within 1.5 mm. CONCLUSIONS: The ability to produce accurate real-time 3D models of the operating field is a significant advancement toward augmented reality in minimally invasive surgery. An imaging system with this capability will potentially transform surgery by helping novice and expert surgeons alike to delineate variance in internal anatomy accurately.

Miniature surgical robot for laparoendoscopic single-incision colectomy.

BACKGROUND: This study aimed to demonstrate the effectiveness of using a multifunctional miniature in vivo robotic platform to perform a single-incision colectomy. Standard laparoscopic techniques require multiple ports. A miniature robotic platform to be inserted completely into the peritoneal cavity through a single incision has been designed and built. The robot can be quickly repositioned, thus enabling multiquadrant access to the abdominal cavity. METHODS: The miniature in vivo robotic platform used in this study consists of a multifunctional robot and a remote surgeon interface. The robot is composed of two arms with shoulder and elbow joints. Each forearm is equipped with specialized interchangeable end effectors (i.e., graspers and monopolar electrocautery). RESULTS: Five robotic colectomies were performed in a porcine model. For each procedure, the robot was completely inserted into the peritoneal cavity, and the surgeon manipulated the user interface to control the robot to perform the colectomy. The robot mobilized the colon from its lateral retroperitoneal attachments and assisted in the placement of a standard stapler to transect the sigmoid colon. This objective was completed for all five colectomies without any complications. CONCLUSIONS: The adoption of both laparoscopic and single-incision colectomies currently is constrained by the inadequacies of existing instruments. The described multifunctional robot provides a platform that overcomes existing limitations by operating completely within one incision in the peritoneal cavity and by improving visualization and dexterity. By repositioning the small robot to the area of the colon to be mobilized, the ability of the surgeon to perform complex surgical tasks is improved. Furthermore, the success of the robot in performing a completely in vivo colectomy suggests the feasibility of using this robotic platform to perform other complex surgeries through a single incision.

Miniature in vivo robot for laparoendoscopic single-site surgery.

BACKGROUND: The aim of this study was to develop a multidexterous robot capable of generating the required forces and speeds to perform surgical tasks intra-abdominally. Current laparoscopic surgical robots are expensive, bulky, and fundamentally constrained by a small entry incision. A new approach to minimally invasive surgery places the robot completely within the patient. Miniature in vivo robots may allow surgeons to overcome current laparoscopic constraints such as dexterity, orientation, and visualization. METHODS: A collaborative research group from the Department of Surgery at the University of Nebraska Medical Center and the College of Engineering at the University of Nebraska-Lincoln designed and built a surgical robot prototype capable of performing specific surgical tasks within the peritoneal cavity. RESULTS: The basic robotic design consists of two arms each connected to a central body. Each arm has three degrees of freedom and rotational shoulder and elbow joints. This combination allows a surgeon to grasp, manipulate, cauterize, and perform intracorporeal suturing. The robot's workspace is a hollow hemisphere with an inner radius of 75 mm and an outer radius of 205 mm. Its versatility was demonstrated in four procedures performed in a porcine model: cholecystectomy, partial colectomy, abdominal exploration, and intracorporeal suturing. CONCLUSIONS: Miniature in vivo robots have the potential to address the limitations of using articulated instrumentation to perform advanced laparoscopic surgical procedures. Once inserted into the peritoneal cavity, the robot provides a stable platform for visualization with sufficient dexterity and speed to perform surgical tasks from multiple orientations and workspaces.

Miniature in vivo robotics and novel robotic surgical platforms.

Robotic surgical systems, such as the da Vinci Surgical System (Intuitive Surgical, Inc., Sunnyvale, California), have revolutionized laparoscopic surgery but are limited by large size, increased costs, and limitations in imaging. Miniature in vivo robots are being developed that are inserted entirely into the peritoneal cavity for laparoscopic and natural orifice transluminal endoscopic surgical (NOTES) procedures. In the future, miniature camera robots and microrobots should be able to provide a mobile viewing platform. This article discusses the current state of miniature robotics and novel robotic surgical platforms and the development of future robotic technology for general surgery and urology.

Video. Natural Orifice Translumenal Endoscopic Surgery with a miniature in vivo surgical robot.

BACKGROUND: The application of flexible endoscopy tools for Natural Orifice Translumenal Endoscopic Surgery (NOTES) is constrained due to limitations in dexterity, instrument insertion, navigation, visualization, and retraction. Miniature endolumenal robots can mitigate these constraints by providing a stable platform for visualization and dexterous manipulation. This video demonstrates the feasibility of using an endolumenal miniature robot to improve vision and to apply off-axis forces for task assistance in NOTES procedures. METHODS: A two-armed miniature in vivo robot has been developed for NOTES. The robot is remotely controlled, has on-board cameras for guidance, and grasper and cautery end effectors for manipulation. Two basic configurations of the robot allow for flexibility during insertion and rigidity for visualization and tissue manipulation. Embedded magnets in the body of the robot and in an exterior surgical console are used for attaching the robot to the interior abdominal wall. This enables the surgeon to arbitrarily position the robot throughout a procedure. RESULTS: The visualization and task assistance capabilities of the miniature robot were demonstrated in a nonsurvivable NOTES procedure in a porcine model. An endoscope was used to create a transgastric incision and advance an overtube into the peritoneal cavity. The robot was then inserted through the overtube and into the peritoneal cavity using an endoscope. The surgeon successfully used the robot to explore the peritoneum and perform small-bowel dissection. CONCLUSION: This study has demonstrated the feasibility of inserting an endolumenal robot per os. Once deployed, the robot provided visualization and dexterous capabilities from multiple orientations. Further miniaturization and increased dexterity will enhance future capabilities.

Surgery with cooperative robots.

Advances in endoscopic techniques for abdominal procedures continue to reduce the invasiveness of surgery. Gaining access to the peritoneal cavity through small incisions prompted the first significant shift in general surgery. The complete elimination of external incisions through natural orifice access is potentially the next step in reducing patient trauma. While minimally invasive techniques offer significant patient advantages, the procedures are surgically challenging. Robotic surgical systems are being developed that address the visualization and manipulation limitations, but many of these systems remain constrained by the entry incisions. Alternatively, miniature in vivo robots are being developed that are completely inserted into the peritoneal cavity for laparoscopic and natural orifice procedures. These robots can provide vision and task assistance without the constraints of the entry incision, and can reduce the number of incisions required for laparoscopic procedures. In this study, a series of minimally invasive animal-model surgeries were performed using multiple miniature in vivo robots in cooperation with existing laparoscopy and endoscopy tools as well as the da Vinci Surgical System. These procedures demonstrate that miniature in vivo robots can address the visualization constraints of minimally invasive surgery by providing video feedback and task assistance from arbitrary orientations within the peritoneal cavity.

In vivo robotics for natural orifice transgastric peritoneoscopy.

Natural Orifice Translumenal Endoscopic Surgery (NOTES) is potentially the next paradigm shift in minimally invasive surgery. Currently, NOTES procedures are performed using modified endoscopic tools with significant constraints. New tools are necessary that allow the surgeon to better visualize and dexterously manipulate within the surgical environment. In this study, a two-armed dexterous miniature in vivo robot with stereoscopic vision capabilities has been developed that addresses many of these constraints. The design and kinematic configuration of the robot allows for its complete insertion into the peritoneal cavity, and provides intuitive visualization and sufficient force application for tissue manipulation within the dexterous workspace. The NOTES robot successfully demonstrated various capabilities in a non-survival natural orifice surgical procedure in a porcine model suggesting the feasibility of using miniature in vivo robots for performing natural orifice procedures within the peritoneal cavity.

Natural orifice surgery with an endoluminal mobile robot.

Natural orifice transgastric endoscopic surgery promises to eliminate skin incisions and reduce postoperative pain and discomfort. Such an approach provides a distinct benefit as compared with conventional laparoscopy, in which multiple entry incisions are required for tools and camera. Endoscopy currently is the only method for performing procedures through the gastrointestinal tract. However, this approach is limited by instrumentation and the need to pass the entire scope into the patient. In contrast, an untethered miniature robot inserted through the mouth would be able to enter the abdominal cavity through a gastrotomy for exploration of the entire peritoneal cavity. In this study, the authors developed an endoluminal robot capable of transgastric abdominal exploration under esophagogastroduodenoscopic (EGD) control. Under EGD control, a gastrotomy was created, and the miniature robot was deployed into the abdominal cavity under remote control. Ultimately, future procedures will include a family of robots working together inside the gastric and abdominal cavities after their insertion through the esophagus. Such technology will help to reduce patient trauma while providing surgical flexibility.

Mobile in vivo biopsy and camera robot.

A mobile in vivo biopsy robot has been developed to perform a biopsy from within the abdominal cavity while being remotely controlled. This robot provides a platform for effectively sampling tissue. The robot has been used in vivo in a porcine model to biopsy portions of the liver and mucosa layer of the bowel. After reaching the specified location, the grasper was actuated to biopsy the tissue of interest. The biopsy specimens were gathered from the grasper after robot retraction from the abdominal cavity. This paper outlines the steps towards the successful design of an in vivo biopsy robot. The clamping forces required for successful biopsy are presented and in vivo performance of this robot is addressed.

Toward in vivo mobility.

Today's laparoscopic tools impose severe ergonomic limitations and are constrained to only four degrees of freedom. These constraints limit the surgeon's ability to orient the tool tips arbitrarily, and can contribute to a variety of complications. Robots external to the patient have been used to aid in the manipulation of the tools and improve dexterity. However, these robots are expensive, bulky, and are used for only select procedures. In vivo robotic assistants have the potential to enhance the capabilities of the surgeon, reduce costs, and reduce patient trauma. The motion of these in vivo robots will not be constrained by the insertion incisions. Such assistants will need to attain optimal viewing angles by traversing the abdominal organs without causing trauma. This paper presents an experimental analysis of miniature in vivo robot wheels.

Mapping of an insufflated peritoneal cavity - biomed 2013.

A study at the University of Nebraska-Lincoln in conjunction with the University of Nebraska Medical Center aimed to map the location of organs in an insufflated human abdominal cavity. The goal was to be able to give the location of organs and the abdominal wall in a coordinate system by specifying two angles and a depth. The surgeons assembled two sets of measurements from eight cadavers, four male and four female. One set of measurements mapped the insufflated abdominals walls, while the other set of measurements mapped important landmarks found within the abdominal cavity such as the pancreas and stomach. By using common statistical methods to analyze the end result, we were able to identify average locations of organs during insufflations. A better knowledge of the peritoneal cavity when insufflated can help us when designing miniature robots. Size will be of particular importance, since they are inserted completely into the peritoneal cavity.

Single-site colectomy with miniature in vivo robotic platform.

There has been a continuing push to reduce the invasiveness of surgery by accessing the abdominal cavity through a single incision, such as with laparoendoscopic single-site (LESS) surgery. Although LESS procedures offer significant benefits, added complexities still inhibit the procedures. Robotic surgery is proving to be an excellent option to overcome these limitations. This paper presents the experimental results of the single-incision in vivo surgical robot (SISR), a multifunctional, dexterous, two-armed robot capable of performing surgical tasks while overcoming the issues associated with manual LESS operations. In vivo surgical procedures have been used to demonstrate the efficacy of using a robotic platform over traditional laparoscopic tools. The most recent experimental test resulted in the first successful in vivo robotic LESS colectomy utilizing a robot completely contained within the abdominal cavity. In this test, SISR showed significant benefits including access to all quadrants in the peritoneal cavity and improved dexterity.

Laparoendoscopic single-site surgery using a multi-functional miniature in vivo robot.

BACKGROUND: Existing methods used to perform laparoendoscopic single-site surgery (LESS) require multiple laparoscopic tools that are inserted into the peritoneal cavity through a single, specialized port. These methods are inherently limited in visualization and dextrous capabilities by working through a single access point. A miniature in vivo robotic platform that is completely inserted into the peritoneal cavity through a single incision can address these limitations, providing more intuitive manipulation capabilities and improved visualization. METHODS: The miniature in vivo robotic platform for LESS consists of a multi-functional robot and a remote surgeon interface. The robot has two arms and specialized end effectors that can be interchanged to provide monopolar cautery, tissue manipulation, and intracorporeal suturing capabilities. RESULTS: This robot has been demonstrated in multiple non-survival procedures in a porcine model, including four cholecystectomies. CONCLUSION: This study demonstrates the effectiveness of using a multi-functional miniature in vivo robot platform to perform LESS.

Miniature in vivo cameras for use in single-incision robotic surgery - biomed 2011.

Single-incision surgery provides numerous benefits over traditional open and laparoscopic surgery techniques including reduced pain, shortened recovery times, and minimal tissue scarring. The use of miniature in vivo robots inserted through a single incision offers additional advantages over conventional laparoscopy in improved maneuverability and dexterity. One consequence of performing surgical procedures through a small single incision is the loss of direct visualization through a large open incision or visualization via laparoscopic cameras inserted through additional ports. For this reason, a miniature in vivo actuated camera was designed to pass through a single incision and attach to a miniature in vivo robot, providing live video feedback at the control of the surgeon. The device was tested in a lab setting and porcine model surgery and demonstrated successful movement, control, and high-quality visualization, indicating the device’s functionality and feasibility for use in single-incision robotic surgery.

In vivo miniature robots for natural orifice surgery: State of the art and future perspectives.

Natural orifice translumenal endoscopic surgery (NOTES) is the integration of laparoscopic minimally invasive surgery techniques with endoscopic technology. Despite the advances in NOTES technology, the approach presents several unique instrumentation and technique-specific challenges. Current flexible endoscopy platforms for NOTES have several drawbacks including limited stability, triangulation and dexterity, and lack of adequate visualization, suggesting the need for new and improved instrumentation for this approach. Much of the current focus is on the development of flexible endoscopy platforms that incorporate robotic technology. An alternative approach to access the abdominal viscera for either a laparoscopic or NOTES procedure is the use of small robotic devices that can be implanted in an intracorporeal manner. Multiple, independent, miniature robots can be simultaneously inserted into the abdominal cavity to provide a robotic platform for NOTES surgery. The capabilities of the robots include imaging, retraction, tissue and organ manipulation, and precise maneuverability in the abdominal cavity. Such a platform affords several advantages including enhanced visualization, better surgical dexterity and improved triangulation for NOTES. This review discusses the current status and future perspectives of this novel miniature robotics platform for the NOTES approach. Although these technologies are still in pre-clinical development, a miniature robotics platform provides a unique method for addressing the limitations of minimally invasive surgery, and NOTES in particular.

Semi-autonomous surgical tasks using a miniature in vivo surgical robot.

Natural Orifice Translumenal Endoscopic Surgery (NOTES) is potentially the next step in minimally invasive surgery. This type of procedure could reduce patient trauma through eliminating external incisions, but poses many surgical challenges that are not sufficiently overcome with current flexible endoscopy tools. A robotic platform that attempts to emulate a laparoscopic interface for performing NOTES procedures is being developed to address these challenges. These robots are capable of entering the peritoneal cavity through the upper gastrointestinal tract, and once inserted are not constrained by incisions, allowing for visualization and manipulations throughout the cavity. In addition to using these miniature in vivo robots for NOTES procedures, these devices can also be used to perform semi-autonomous surgical tasks. Such tasks could be useful in situations where the patient is in a location far from a trained surgeon. A surgeon at a remote location could control the robot even if the communication link between surgeon and patient has low bandwidth or very high latency. This paper details work towards using the miniature robot to perform simple surgical tasks autonomously.

The future of NOTES instrumentation: Flexible robotics and in vivo minirobots.

Natural orifice translumenal endoscopic surgery (NOTES) bridges the gap between standard endoluminal and extraluminal surgery and, as such, presents unique instrumentation challenges, including lack of stable platforms, loss of spatial orientation, and limited instrument tip maneuverability. The proper instrumentation remains to be established, and the incorporation of robotic technology will be essential moving forward. Flexible robotics has been applied to ureteroscopy and holds promise for NOTES. Miniature in vivo robots will potentially play a role. The current status and future implications of these technologies are reviewed.

The current state of miniature in vivo laparoscopic robotics.

Minimally invasive surgery (MIS) reduces patient trauma and shortens recovery time, but also limits the dexterity of the surgeon because degrees of freedom are lost due to the fulcrum effect of the entry incisions. Visual feedback is also limited by the laparoscope, which typically provides two-dimensional feedback and is constrained by the entry incision. Developments within surgical robotics aim to mitigate these constraints. However, these developments have primarily included large external machines that augment vision and improve dexterity, but are still fundamentally constrained by the use of long tools through small incisions. An alternative concept is the use of miniature in vivo surgical robots that can be placed entirely into the peritoneal cavity through either an abdominal incision, or, after insertion into the stomach through the esophagus, can enter through a gastrotomy. This paper reviews the development of fixed-base camera robots for providing auxiliary views of the surgical field and of mobile robots with a movable platform for vision and task assistance in laparoscopic procedures. Moreover, the progress towards the application of similar robots for natural orifice transluminal endoscopic surgery (NOTES) and forward environments is discussed.