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 robot-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 (IDEAL) 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 pre-defined procedural steps without conversion. RESULTS: Thirty patients (13 female, 17 male) were analyzed. The mean age was 59.4 (SD 13.4) years. Seventy percent (n = 21) were overweight/obese and 53.3% (n = 16) had prior abdominal surgery. Forty percent had malignant and 60% benign disease. Cases were 15 right and 15 left colectomies. Overall operative time was median 146 (range, 80-309) minutes; 70 (range, 34-174) minutes was console time. There were no conversions to open surgery, and no intraoperative or device-related adverse events. In 100% (n = 30), the primary dissection was completed, and hemostasis 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 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.

End-Effector Contact and Force Detection for Miniature Autonomous Robots Performing Lunar and Expeditionary Surgery.

INTRODUCTION: The U.S. Space Force was stood up on December 20, 2019 as an independent branch under the Air Force consisting of about 16,000 active duty and civilian personnel focused singularly on space. In addition to the Space Force, the plans by NASA and private industry for exploration-class long-duration missions to the moon, near-earth asteroids, and Mars makes semi-independent medical capability in space a priority. Current practice for space-based medicine is limited and relies on a "life-raft" scenario for emergencies. Discussions by working groups on military space-based medicine include placing a Role III equivalent facility in a lunar surface station. Surgical capability is a key requirement for that facility. MATERIALS AND METHODS: To prepare for the eventuality of surgery in space, it is necessary to develop low-mass, low power, mini-surgical robots, which could serve as a celestial replacement for existing terrestrial robots. The current study focused on developing semi-autonomous capability in surgical robotics, specifically related to task automation. Two categories for end-effector tissue interaction were developed: Visual feedback from the robot to detect tissue contact, and motor current waveform measurements to detect contact force. RESULTS: Using a pixel-to-pixel deep neural network to train, we were able to achieve an accuracy of nearly 90% for contact/no-contact detection. Large torques were predicted well by a trained long short-term memory recursive network, but the technique did not predict small torques well. CONCLUSION: Surgical capability on long-duration missions will require human/machine teaming with semi-autonomous surgical robots. Our existing small, lightweight, low-power miniature robots perform multiple essential tasks in one design including hemostasis, fluid management, suturing for traumatic wounds, and are fully insertable for internal surgical procedures. To prepare for the inevitable eventuality of an emergency surgery in space, it is essential that automated surgical robot capabilities be developed.

An Optimization-Based Algorithm for Trajectory Planning of an Under-Actuated Robotic Arm to Perform Autonomous Suturing.

In single-port access surgeries, robot size is crucial due to the limited workspace. Thus, a robot may be designed under-actuated. Suturing, in contrast, is a complicated task and requires full actuation. This study aims to overcome this shortcoming by implementing an optimization-based algorithm for autonomous suturing for an under-actuated robot. The proposed algorithm approximates the ideal suturing trajectory by slightly reorienting the needle while deviating as little as possible from the ideal, full degree-of-freedom suturing case. The deviation of the path taken by a custom robot with respect to the ideal trajectory varies depending on the suturing starting location within the workspace as well as the needle size. A quantitative analysis reveals that in 13% of the investigated workspace, the accumulative deviation was less than 10 mm. In the remaining workspace, the accumulative deviation was less than 30 mm. Likewise, the accumulative deviation of a needle with a radius of 10 mm was 2.2 mm as opposed to 8 mm when the radius was 20 mm. The optimization-based algorithm maximized the accuracy of a four-DOF robot to perform a path-constrained trajectory and illustrates the accuracy-workspace correlation.

Telesurgery With Miniature Robots to Leverage Surgical Expertise in Distributed Expeditionary Environments.

This study aimed to evaluate the capability of performing telesurgery via radio transmission for military arenas where wired internet connections may not be practical. Most existing robotic surgery systems are too large to effectively deploy with first responders. The miniature surgical platform in this study consists of a multifunctional robot suite that can fit easily into a briefcase. METHODS: The focus of this study is to explore the implications of radio control of the robot. The hypothesis is that an in vivo robot and its control boards can be controlled using off-the-shelf wireless components. An experiment was designed with off-the-shelf wireless components to test the capability of our newest generation of miniature surgical robot to become battery-operated and wireless. RESULTS: Wireless transmission of control signals has provided proof of concept and has exposed areas of the software that can be built upon to improve responsiveness. Wireless transmission of the video feed can be adequately performed with basic off-the-shelf components.

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.

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 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.

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.

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.

Stereo image-based arm tracking for in vivo surgical robotics.

Motor-based tracking and image-based tracking are considered for three-dimensional in vivo tracking of the arms of a surgical robot during minimally invasive surgery. Accurate tracking is necessary for tele-medical applications and for the future automation of surgical procedures. An experiment is performed to compare the accuracy of the two methods, and results show that the positioning error of image-based tracking is significantly less than that of motor-based tracking.

Multifunction robotic platform for natural orifice surgery.

A new robotic platform for natural orifice surgery is described. The robot is designed to carry multiple tool tips in a single end-effector arm. Design and experimental validation are presented. Although the design is still being improved, results suggest that the new robotic tool will enable dexterous abdominal surgery with improved force transmission capability.

Dexterous miniature robot for advanced minimally invasive surgery.

This study demonstrates the feasibility of using a miniature robot to perform complex, single-incision, minimal access surgery. Instrument positioning and lack of triangulation complicate single-incision laparoscopic surgery, and open surgical procedures are highly invasive. Using minimally invasive techniques with miniature robotic platforms potentially offers significant clinical benefits. A miniature robot platform has been designed to perform advanced laparoscopic surgery with speed, dexterity, and tissue-handling capabilities comparable to standard laparoscopic instruments working through trocars. The robotic platform includes a dexterous in vivo robot and a remote surgeon interface console. For this study, a standard laparoscope was mounted to the robot to provide vision and lighting capabilities. In addition, multiple robots could be inserted through a single incision rather than the traditional use of four or five different ports. These additional robots could provide capabilities such as tissue retraction and supplementary visualization or lighting. The efficacy of this robot has been demonstrated in a nonsurvival cholecystectomy in a porcine model. The procedure was performed through a single large transabdominal incision, with supplementary retraction being provided by standard laparoscopic tools. This study demonstrates the feasibility of using a dexterous robot platform for performing single-incision, advanced laparoscopic 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.

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.

A modular wireless in vivo surgical robot with multiple surgical applications.

The use of miniature in vivo robots that fit entirely inside the peritoneal cavity represents a novel approach to laparoscopic surgery. Previous work demonstrates that both mobile and fixed-based robots can successfully operate inside the abdominal cavity. A modular wireless mobile platform has also been developed to provide surgical vision and task assistance. This paper presents an overview of recent test results of several possible surgical applications that can be accommodated by this modular platform. Applications such as a biopsy grasper, stapler and clamp, video camera, and physiological sensors have been integrated into the wireless platform and tested in vivo in a porcine model. The modular platform facilitates rapid development and conversion from one type of surgical task assistance to another. These self-contained surgical devices are much more transportable and much lower in cost than current robotic surgical assistants. These devices could ultimately be carried and deployed by non-medical personnel at the site of an injury. A remotely located surgeon could use these robots to provide critical first response medical intervention.