Andrea Moglia

Capsule endoscopy: progress update and challenges ahead

Capsule endoscopy (CE) enables remote diagnostic inspection of the gastrointestinal tract without sedation and with minimal discomfort. Initially intended for small-bowel endoscopy, modifications to the original capsule have since been introduced for imaging of the esophagus and the colon. This Review presents a research update on CE. Emphasis is placed on PillCam™ SB, PillCam™ ESO, and PillCam™ COLON (Given Imaging, Yoqneam, Israel) since the majority of published studies have investigated these devices. Discussion of initial reports on competing devices, such as EndoCapsule™ (Olympus, Tokyo, Japan) and MiroCam™ (IntroMedic Co., Seoul, Republic of Korea) are also included. The last section of this Review outlines ongoing research and development directed at the identification of capsule location, control of capsule movement and expansion of the capability of microcameras to enhance the diagnostic power of CE. Research efforts aimed at endowing the capsule with a range of functionalities are also discussed, from tissue sampling for biopsy to optical biopsy and, in some cases, actual treatment (interventional CE), so that CE may ultimately replace both diagnostic and interventional flexible endoscopy.

Recent Patents on Wireless Capsule Endoscopy

Wireless capsule endoscopy is a medical procedure which has revolutionized endoscopy as it has enabled for the first time a painless inspection of the small intestine. The procedure was unveiled in 2000 and is based on a vitamin- size pill which captures images of the digestive tract while it is transported passively by peristalsis. The device consists of an image sensor, an illumination module, a radio-frequency transmitter and a battery. Wireless capsule endoscopy is a novel breakthrough in the biomedical industry and future progresses in key technologies are expected to drive the development of the next generation of such devices. Therefore, the purpose of this review is to illustrate the most recent and significant inventions patented from 2005 to present in those areas concerning measurement of human body parameters, advanced imaging features, localization, energy management and active propulsion. Finally, the manuscript reports a discussion on current and future developments in wireless capsule endoscopy.

Shape memory alloy clamping devices of a capsule for monitoring tasks in the gastrointestinal tract

This paper describes the development of an active clamping mechanism to be integrated into a swallowable pill for the diagnosis of the gastrointestinal (GI) tract. The clamping system allows us to stop the pill at desired sites of the GI tract for long monitoring purposes. After discussing the major technical constraints, the design of the core component, i.e. the gripper, based on FEA (finite element analysis), is illustrated as well as its fabrication process. Symmetric and asymmetric gripper designs are described. The actuation is provided by shape memory alloys (SMA), and it is driven by a dedicated electrical interface. Then the working prototypes have been tested in vitro: for both kinds of grippers a pull-back force up to 0.6 N has been measured. A preliminary theoretical model for the gripper has been derived and compared to the experimental results.

A Systematic Review of Virtual Reality Simulators for Robot-assisted Surgery

CONTEXT No single large published randomized controlled trial (RCT) has confirmed the efficacy of virtual simulators in the acquisition of skills to the standard required for safe clinical robotic surgery. This remains the main obstacle for the adoption of these virtual simulators in surgical residency curricula. OBJECTIVE To evaluate the level of evidence in published studies on the efficacy of training on virtual simulators for robotic surgery. EVIDENCE ACQUISITION In April 2015 a literature search was conducted on PubMed, Web of Science, Scopus, Cochrane Library, the Clinical Trials Database (US) and the Meta Register of Controlled Trials. All publications were scrutinized for relevance to the review and for assessment of the levels of evidence provided using the classification developed by the Oxford Centre for Evidence-Based Medicine. EVIDENCE SYNTHESIS The publications included in the review consisted of one RCT and 28 cohort studies on validity, and seven RCTs and two cohort studies on skills transfer from virtual simulators to robot-assisted surgery. Simulators were rated good for realism (face validity) and for usefulness as a training tool (content validity). However, the studies included used various simulation training methodologies, limiting the assessment of construct validity. The review confirms the absence of any consensus on which tasks and metrics are the most effective for the da Vinci Skills Simulator and dV-Trainer, the most widely investigated systems. Although there is consensus for the RoSS simulator, this is based on only two studies on construct validity involving four exercises. One study on initial evaluation of an augmented reality module for partial nephrectomy using the dV-Trainer reported high correlation (r=0.8) between in vivo porcine nephrectomy and a virtual renorrhaphy task according to the overall Global Evaluation Assessment of Robotic Surgery (GEARS) score. In one RCT on skills transfer, the experimental group outperformed the control group, with a significant difference in overall GEARS score (p=0.012) during performance of urethrovesical anastomosis on an inanimate model. Only one study included assessment of a surgical procedure on real patients: subjects trained on a virtual simulator outperformed the control group following traditional training. However, besides the small numbers, this study was not randomized. CONCLUSIONS There is an urgent need for a large, well-designed, preferably multicenter RCT to study the efficacy of virtual simulation for acquisition competence in and safe execution of clinical robotic-assisted surgery. PATIENT SUMMARY We reviewed the literature on virtual simulators for robot-assisted surgery. Validity studies used various simulation training methodologies. It is not clear which exercises and metrics are the most effective in distinguishing different levels of experience on the da Vinci robot. There is no reported evidence of skills transfer from simulation to clinical surgery on real patients.

Use of the new Da Vinci Xi® during robotic rectal resection for cancer: technical considerations and early experience

Dear Editor: Robotic rectal resection with the Da Vinci Si System (Intuitive Surgical, Sunnyvale, CA, USA) is a well-defined approach to rectal cancer. The tremor filter, three-dimensional vision, and wrist-like movements facilitate the preparation of autonomic nerves in a narrow space such as the pelvis. These technical advantages translate into clinical and surgical benefits as suggested by a reduced conversion rate, a shorter learning curve, and good functional outcomes compared with the same parameters applied to standard laparoscopy. Nevertheless, there are still several limitations in robotic rectal surgery, such as the reduced skill to perform a multi-quadrant operation, which could result in difficulty performing a complete splenic flexure mobilization. Additionally, a fixed position of the patient after docking limits the possibility to change it during the procedure. These characteristics may require multiple undocking and re-docking, repositioning the entire platform, or use of conventional laparoscopy. Recently, Intuitive Surgical marketed a new product called Da Vinci Xi®, which is expected to overcome some of the limitations of the previous platform, thereby increasing the acceptance of its use for minimally invasive techniques in all surgical fields. Whereas increasingly more studies are being published about the use of the Da Vinci Si® System for robot-assisted proctectomy to treat rectal cancer, the Da Vinci Xi® is still in its infancy. Hence, correct standardization is required for all surgical procedures but explicitly for rectal resection. Rectal cancer surgery could be a valid benchmark for testing the new robotic platform because of its multi-quadrant approach for splenic and left colon mobilization and the need to deal with the risks of external collision and problems related to rectal transection down the pelvis. Additionally, the technique for full robotic rectal resection with total mesorectal excision (TME) using the new Da Vinci Xi® is not yet well defined. Particularly, patient and port positions have not yet been standardized. We describe our successful experience with robot, patient, and trocar positioning that allowed us to perform ten consecutive full robotic rectal resections for a low-lying cancer using Da Vinci Xi® between January and May 2015. For the first phase of the procedure (left colon mobilization, ligation of the inferior mesenteric vessels, and complete mobilization of the splenic flexure), the patients were placed in a modified lithotomy position, with 30° Trendelenberg, and tilted to the right side. After establishing the pneumoperitoneum at 12 mmHg, the first 8-mm robotic trocar was placed in the umbilical region along the right pararectal line. More trocars were then placed following the Universal Port Placement Guidelines provided by Intuitive Surgical for Bleft lower^ abdominal procedures. Four trocars were then inserted under visualization: an 8-mm port in the right iliac fossa, a 12-mm assistant trocar in the right flank, and two 8-mm robotic ports in the periumbilical region and the left hypochondriac space, respectively. A modified version of the Universal Port Placement Guidelines for Bleft lower^ abdominal procedures^ was the same as just described but translating all the trocars of 2–5 cm to the right side. BPatient-left^ was the selected approach, and the surgical cart was driven to position the * Gregorio Di Franco gregoriodifranco@yahoo.it

Patient specific surgical simulator for the evaluation of the movability of bimanual robotic arms

This work presents a simulator based on patient specific data for bimanual surgical robots. Given a bimanual robot with a particular geometry and kinematics, and a patient specific virtual anatomy, the aim of this simulator was to evaluate if a dexterous movability was obtainable to avoid collisions with the surrounding virtual anatomy in order to prevent potential damages to the tissues during the real surgical procedure. In addition, it could help surgeons to find the optimal positioning of the robot before entering the operative room. This application was tested using a haptic device to reproduce the interactions of the robot with deformable organs. The results showed good performances in terms of frame rate for the graphic, haptic, and dynamic processes.

Science, medicine, and the future: Capsule endoscopy

Capsule endoscopy was unveiled at Digestive Disease Week 2000 in San Diego, California, USA, by Paul Swain, gastroenterologist at Imperial College St Mary’s Hospital, London, and Given Imaging, a Yoqneam (Israel) company, as the product of collaborative research and development activities between the two groups. The past few years have seen advances in this technology, which is now part of established clinical practice in North America, Europe, the Far East, and Australia, particularly for imaging the small bowel. This article describes current clinical applications of capsule endoscopy and looks at future developments. What is capsule endoscopy?

Clamping Tools of a Capsule for Monitoring the Gastrointestinal Tract Problem Analysis and Preliminary Technological Activity

This paper describes the development of an active clamping mechanism to be integrated into a swallowable pill for the diagnosis of the gastrointestinal (GI) tract. The clamping system allows to stop the pill in desired sites of the GI tract for long monitoring purposes. After discussing the major technical constraints, the design of the clamping system, based on FEA (Finite Element Analysis), is illustrated as well as its fabrication process. The clamping unit is actuated exploiting Shape Memory Alloys (SMA), in wires and spring configuration, and it is driven by a dedicated electrical interface. A fine tuning has been performed in order to limit the power consumption. Then a working prototype is fabricated and preliminarily tested, pointing out a capability of the grasping system over 40 g.

Use of a new integrated table motion for the da Vinci Xi in colorectal surgery

Dear Editor: Integrated Table Motion (ITM) for the da Vinci Xi surgical system (Intuitive Surgical Inc., Sunnyvale, CA, USA) is a new feature comprising a unique operating table by Trumpf Medical Systems that communicates wirelessly with the da Vinci Xi. The ITM feature allows surgical staff to reposition the patient without undocking the robot and without removing instruments from inside the abdomen. The da Vinci Xi surgical system and the TruSystem 7000dV operating table (TS7000dV, TRUMPF Medizin Systeme GmbH & Co. KG, Saalfeld, Germany) have been specifically developed to address some technical limitations of the da Vinci Si surgical system, and to improve multiquadrant robotic surgery. An important drawback during robotic procedures with the previous da Vinci Si system is the inability to move the table position with the robotic arms docked. This problem may be particularly amplified in multiquadrant operations, such as colorectal surgery, in which the patient and the robot itself need to be rearranged several times to optimally achieve different surgical targets or provide patient relief. Herein, we present the first study on human use of this device in colorectal surgery. The purpose of this study was to evaluate the efficacy, feasibility, and safety of ITM for the da Vinci Xi system in performing robotic colorectal resections. Between May and October 2015, the first human use of ITMwas carried out in a post-market study in the EU in which 40 cases from different specialties (general surgery, urology, or gynecology) were prospectively enrolled. The Ethics Committee of our institution approved this study. Patients who planned to undergo minimally invasive surgery within the specialties of general surgery, urology, or gynecology with the commercially available da Vinci Xi surgical system and who were eligible based on the inclusion and exclusion criteria of this study were offered enrolment. Study-specific informed consent was obtained in writing from each patient before any procedure specific to the clinical investigation was performed. Inclusion criteria were as follows: bodymass index ≤45 kg/ m; age 18 years or older; suitable for minimally invasive surgery; undergoing a surgical procedure in urology, gynecology, or general surgery; ability to tolerate the Trendelenburg position; willingness to participate as demonstrated by giving written informed consent. Exclusion criteria were as follows: American Society of Anesthesiologists (ASA) IV patients; pregnancy; lack of cooperation due to psychological or severe systemic illness; comorbid medical conditions contraindicating general anesthesia or standard surgical approaches; vulnerable population (such as prisoners, mentally disabled); anatomy unsuitable for endoscopic visualization or minimally invasive surgery; extensive previous abdominal surgery; patient not Study supported by the ARPA foundation, www.fondazionearpa.it

Patient-specific surgical simulator for the pre-operative planning of single-incision laparoscopic surgery with bimanual robots

Introduction: The trend of surgical robotics is to follow the evolution of laparoscopy, which is now moving towards single-incision laparoscopic surgery. The main drawback of this approach is the limited maneuverability of the surgical tools. Promising solutions to improve the surgeons dexterity are based on bimanual robots. However, since both robot arms are completely inserted into the patients body, issues related to possible unwanted collisions with structures adjacent to the target organ may arise. Materials and Methods: This paper presents a simulator based on patient-specific data for the positioning and workspace evaluation of bimanual surgical robots in the pre-operative planning of single-incision laparoscopic surgery. Results: The simulator, designed for the pre-operative planning of robotic laparoscopic interventions, was tested by five expert surgeons who evaluated its main functionalities and provided an overall rating for the system. Discussion: The proposed system demonstrated good performance and usability, and was designed to integrate both present and future bimanual surgical robots.