Colorectal endoscopic submucosal dissection using novel articulating devices: a comparative study in a live porcine model.

BACKGROUND AND AIMS: Colonic endoscopic submucosal dissection (ESD) is time-consuming and bears a high risk of perforation. The aim of the present study was to compare the safety and efficacy between novel articulating devices and conventional ESD in live porcine colon models. METHODS: Thirty ESDs in ten pigs were carried out at three different locations (15, 25, and 35 cm from the anus) by the conventional method (n = 15) and by the new method (n = 15). Procedure times, adverse events (perforation, bleeding), and damage to the muscular layer were recorded, and the ESD time per unit area of the specimens was calculated. RESULTS: The perforation rate using the conventional method was 6.7% (1/15), whereas that using the new method was 0.0%. The number of sites of muscular damage was significantly lower in the new than conventional method (6 vs. 37, respectively; P = 0.024). The mean procedure time was significantly shorter in the new than conventional method (4.6 ± 2.0 vs. 7.0 ± 4.1 min/cm2, respectively; P = 0.042). CONCLUSIONS: Use of the new ESD method allows for reduced adverse events and a shortened resection time.

A new robotic-assisted flexible endoscope with single-hand control: endoscopic submucosal dissection in the ex vivo porcine stomach.

BACKGROUND: Difficulties in endoscopic operations and therapeutic procedures seem to occur due to the complexity of operating the endoscope dial as well as difficulty in performing synchronized movements with both hands. We developed a prototype robotic-assisted flexible endoscope that can be controlled with a single hand in order to simplify the operation of the endoscope. The aim of this study was to confirm the operability of the robotic-assisted flexible endoscope (RAFE) by performing endoscopic submucosal dissection (ESD). METHODS: Study 1: ESD was performed manually or with RAFE by an expert endoscopist in ex vivo porcine stomachs; six operations manually and six were performed with RAFE. The procedure time per unit circumferential length/area was calculated, and the results were statistically analyzed. Study 2: We evaluated how smoothly a non-endoscopist can move a RAFE compared to a manual endoscope by assessing the designated movement of the endoscope. RESULTS: Study 1: En bloc resection was achieved by ESD using the RAFE. The procedure time was gradually shortened with increasing experience, and the procedure time of ESD performed with the RAFE was not significantly different from that of ESD performed with a manual endoscope. Study 2: The time for the designated movement of the endoscope was significantly shorter with a RAFE than that with a manual endoscope as for a non-endoscopist. CONCLUSIONS: The RAFE that we developed enabled an expert endoscopist to perform the ESD procedure without any problems and allowed a non-endoscopist to control the endoscope more easily and quickly than a manual endoscope. The RAFE is expected to undergo further development.

Improving the strength of sutureless laser-assisted vessel repair using preloaded longitudinal compression on tissue edge.

BACKGROUND AND OBJECTIVE: Little is known about the approximation of coapted edges in sutureless laser-assisted vessel welding. Tissue shrinkage by laser irradiation may cause coapted edges to separate, reducing strength of welding. This may be avoided by preloaded longitudinal compression on the tissue edges to be welded. This study compared welding strength with and without preloaded compression in ex vivo animal experiments. MATERIALS AND METHODS: This study evaluated 24 samples of harvested porcine carotid arteries, each having a length of 3 cm and an inner diameter of 1.0-2.0 mm. A half circumferential incision was made at the center of each sample. A steel shaft 2.0 mm in diameter was inserted into each sample to approximate the incised edges. The samples were longitudinally compressed to 6 mm. Incision sites were repaired by irradiation with a 970-nm diode laser. No glue or die was used. The repair strength was evaluated by measuring the bursting point (BP) of all samples. In a pilot study, the welding conditions, including power, duration, and interval of the laser spots, were tested by trial and error in 18 samples, including six treated under optimum conditions. As a control group, six samples were welded under optimum conditions, but without compression. RESULTS: Optimum conditions, consisting of 2.4 W power, 30-second duration, and 1-mm intervals of laser spots, yielded the highest BP (623 ± 236 mmHg), which was significantly higher than in the control group without compression (204 ± 208 mmHg, P = 0.009). Defining BP > 400 mmHg as successful repair, the success rates in the compression and control groups were 83% and 17%, respectively. CONCLUSION: Preloaded longitudinal compression on the coapted edges may be important for sutureless laser-assisted vessel repair and anastomosis and may affect the strength of welding. Lasers Surg. Med. 49:533-538, 2017. © 2017 Wiley Periodicals, Inc.

Gastric endoscopic submucosal dissection using novel 2.6-mm articulating devices: an ex vivo comparative and in vivo feasibility study.

BACKGROUND AND STUDY AIMS: The conventional procedure of endoscopic submucosal dissection (ESD) is technically demanding. This study investigated the efficiency of novel articulating devices (maximum diameter 2.6 mm), which can be used with commercially available, standard endoscopes. PATIENTS AND METHODS: In an ex vivo comparative study, eight endoscopists were divided into novices and experienced operators, and performed ESD using new devices and the conventional setup. An in vivo animal experiment was performed by two experts. Procedure times for incision and dissection were recorded, and unit times for circumferential length and area of specimens were calculated. RESULTS: All procedures were successfully completed with en bloc resection. In the ex vivo study, the unit procedure times for incision and dissection by novices were significantly shorter using the new system (P < 0.01 and P < 0.05), whereas there was no significant difference for experienced endoscopists. Perforation occurred during one procedure in which the new system was used. The in vivo experiments were successfully completed without adverse events. CONCLUSIONS: ESD using novel articulating devices was feasible. These devices were able to reduce the procedure time for novices.

Next-generation robotic surgery--from the aspect of surgical robots developed by industry.

At present, much of the research conducted worldwide focuses on extending the ability of surgical robots. One approach is to extend robotic dexterity. For instance, accessibility and dexterity of the surgical instruments remains the largest issue for reduced port surgery such as single port surgery or natural orifice surgery. To solve this problem, a great deal of research is currently conducted in the field of robotics. Enhancing the surgeon's perception is an approach that uses advanced sensor technology. The real-time data acquired through the robotic system combined with the data stored in the robot (such as the robot's location) provide a major advantage. This paper aims at introducing state-of-the-art products and pre-market products in this technological advancement, namely the robotic challenge in extending dexterity and hopefully providing the path to robotic surgery in the near future.

Usefulness of three-dimensional imaging in a flexible endoscopic surgery platform with multi-degrees-of-freedom articulating devices.

BACKGROUND AND AIMS: Recent studies on endoscopic submucosal dissection have aimed to reduce the difficulty of the procedure by using multi-degrees-of-freedom articulating devices. In this study, we evaluated the usefulness of adding three-dimensional (3D) video imaging into simulated endoscopic submucosal dissection tasks using multi-degrees-of-freedom devices. METHODS: We designed an endoscopic platform with a 3D camera and two multi-degrees-of-freedom devices. Four ex vivo bench tasks were created, and a crossover study comparing 2D and 3D conditions was conducted on 15 volunteers. In each task, performance such as procedure time and accuracy were objectively evaluated. Additionally, a comprehensive visual analogue scale questionnaire was conducted. RESULTS: In the tasks simulating submucosal flap grasping, marking, and full-area incision, the use of 3D imaging significantly improved the speed and accuracy of the multi-degrees-of-freedom device manipulation (p < .01). No significant differences were observed in the task that simulated the dissection procedure. Furthermore, it appears that the accuracy of recognizing curved surfaces may be reduced in the 3D environment. Operators reported subjective increases in recognizability and operability with the 3D camera, along with an increase in asthenopia (p < .01). CONCLUSIONS: 3D vision improves the technical accuracy of certain simulated multi-degrees-of-freedom endoscopic submucosal dissection tasks and subjectively improved operating conditions, at the cost of increased eye strain.

2.5-mm articulated endoluminal forceps using a compliant mechanism.

PURPOSE: Gastrointestinal cancer can be treated using a flexible endoscope through a natural orifice. However, treatment instruments with limited degrees of freedom (DOFs) require a highly skilled operator. Articulated devices useful for endoluminal procedures, such as endoscopic submucosal dissection and biopsy, have been developed. These devices enable dexterous operation in a narrow lumen; however, they suffer from limitations such as large size and high cost. To overcome these limitations, we developed a 2.5-mm articulated forceps that can be inserted into a standard endoscope channel based on a compliant mechanism. METHODS: The compliant mechanism allows the device to be compact and affordable, which is possible due to its monolithic structure. The proposed mechanism consists of two segments, 1-DOF grasping and 2-DOF bending, that are actuated by tendon-sheath mechanisms. A prototype was designed based on finite element analysis results. RESULTS: To confirm the effectiveness of the proposed mechanism, we fabricated the prototype using a 3D printer. A series of mechanical performance tests on the prototype revealed that it achieved the following specifications: (1) DOF: 1-DOF grasping + 2-DOF bending, (2) outer diameter: 2.5 mm, (3) length of the bending segment: 30 mm, and (4) range of motion: [Formula: see text] to [Formula: see text] (grasping) and [Formula: see text] to [Formula: see text] (bending). Finally, we performed a tissue manipulation test on an excised porcine colon and found that a piece of mucous membrane tissue was successfully resected using an electric knife while being lifted with the developed forceps. CONCLUSION: The results of the evaluation experiment demonstrated a positive feasibility of the proposed mechanism, which has a simpler structure compared to those of other conventional mechanisms; furthermore, it is potentially more cost-effective and is disposable. The mechanical design, prototype implementation, and evaluations are reported in this paper.

Surgical Robot for Intraluminal Access: An Ex Vivo Feasibility Study.

Early-stage gastrointestinal cancer is often treated by endoscopic submucosal dissection (ESD) using a flexible endoscope. Compared with conventional percutaneous surgery, ESD is much less invasive and provides a high quality of life for the patient because it does not require a skin incision, and the organ is preserved. However, the operator must be highly skilled because ESD requires using a flexible endoscope with energy devices, which have limited degrees of freedom. To facilitate easier manipulation of these flexible devices, we developed a surgical robot comprising a flexible endoscope and two articulating instruments. The robotic system is based on a conventional flexible endoscope, and an extrapolated motor unit moves the endoscope in all its degrees of freedom. The instruments are thin enough to allow insertion of two instruments into the endoscope channel, and each instrument has a bending section that allows for up-down, right-left, and forward-backward motion. In this study, we performed an ex vivo feasibility evaluation using the proposed robotic system for ESD in a porcine stomach. The procedure was successfully performed by five novice operators without complications. Our findings demonstrated the feasibility of the proposed robotic system and, furthermore, suggest that even operators with limited experience can use this system to perform ESD.

Construction of Automatic Scoring System to Support Objective Evaluation of Clinical Skills in Medical Education.

In this study, we focused on the automatic scoring of medical clinical abilities. The objective clinical ability tests that all undergraduate students take before starting clinical practice were considered. As these tests evaluate practical skills, there is a problem that the learning method is poor compared to the examination of other lectures. Therefore, in this study, we recorded the voice of a student examining a simulated patient using a microphone. We constructed a system comprising a speech recognition module and a scoring system that performed automatic scoring by checking against a prepared example answer. This system was evaluated by medical doctors.

Objective assessment of robotic suturing skills with a new computerized system: A step forward in the training of robotic surgeons.

INTRODUCTION: The purpose of this study was to assess robot-assisted suturing skills on a laparoscopic intestinal anastomosis model by using a novel computerized objective assessment system. METHODS: This study compared the suturing skills of 13 surgically naïve participants on an artificial intestinal anastomosis model that mimics real tissue. Each examinee sutured using da Vinci robot assistance under 2-D and 3-D visualization and with conventional laparoscopy (CL). Pressure-measuring and image-processing devices were employed to quantitatively evaluate suturing skills. Five unique criteria were used to evaluate the skills of participants. RESULTS: Suturing under 3-D visualization (P < 0.01) and with CL (P < 0.05) were significantly faster than under 2-D visualization. Sutures placed under 3-D (P < 0.05) and 2-D (P < 0.01) visualization had significantly better suture tension than those placed with CL, which did not meet acceptable values for suture tension. Sutures placed with CL had significantly better air pressure leakage than those placed under 2-D visualization (P < 0.05), which did not meet acceptable values for air pressure leakage and wound opening area. One participants failed to achieve full-thickness sutures with 2-D, two participants with CL, and one participant with 3-D. CONCLUSION: Using 3-D vision is necessary for complex maneuvering during robot-assisted minimally invasive surgery. Our quantitative assessment system is useful for evaluating the skill acquisition of surgeon-trainees undergoing robotic surgery training.

Principles and development of collagen-mediated tissue fusion induced by laser irradiation.

The mechanism underlying tissue fusion mediated by laser irradiation remains unclear. We clarify the mechanisms underlying laser-mediated tissue fusion using a novel model. Microscopic examinations of morphological changes within the adventitia of a bovine carotid artery and a collagen sheet prepared from bovine dermis showed collagen fibril bundle loosening and collagen fibre swelling following heating at 46 °C. An incised bovine carotid artery covered with a collagen sheet to which pressure and laser heat of 40 °C-52 °C were applied created a structure that was pressure resistant to >300 mmHg. Microscopic analyses of the irradiation site showed collagen fibril interdigitation. Hence, low-temperature laser-mediated tissue fusion causes collagen fibril bundles to loosen and swell, and crimping causes the fibres to intertwine. As the temperature declines, the loosened and swollen fibrils and fibres tighten, and collagen fibre interdigitation is completed. This technology could be applied to fuse tissues during surgery.

Laparoscopic ultrasound manipulator with a spring-based elastic mechanism.

PURPOSE: Image guidance is a key technology that can improve the outcome of laparoscopic surgery. However, due to the large deformation caused by digestive organs, a computer-aided navigation system based on preoperative imaging data cannot indicate the correct target position of the lesion (e.g., liver tumors and vessels invisible from the organ surface). To overcome this issue, we developed a laparoscopic ultrasound manipulator with two motorized degrees of freedom at the tip, allowing for the performance of a dexterous ultrasound scan in a confined laparoscopic surgical area. METHOD: The developed manipulator consists of a compact and elastic structure using springs, enabling a safe ultrasound scan and avoiding excess force on the inspected organs. The manipulator is a handheld device equipped with four buttons at the handle, which the surgeon directly grasps to send a motion command to the tip structure. The developed prototype realizes two motorized degree-of-freedom motion at the tip. The size of prototype is 15.0 mm in diameter that is usable in conventional laparoscopy. The tip of the manipulator was carefully designed by considering the kinematic model and the results of the finite element analysis. RESULTS: To assess the prototype, accuracy and rigidity were measured by using a motion processing microscope. The accuracy test showed that the proposed device has a fairly accurate characteristic as a handheld device. This was supposedly caused by the nature of compliant mechanism, which does not have mechanical play in motion. In addition, the intrinsic elastic structure (approximately 2.0 N/mm in most of the range of motion) allowed the ultrasound probe to adequately fit on the curved organ surface without extra effort of manipulation during the inspection. In the in vivo experiment, the yaw motion was found to be effective for investigating the vascular network because the manipulator allows the probe to be rotated while maintaining the same position. CONCLUSION: The mechanical evaluation and in vivo test results showed high feasibility of the prototype. We are currently working on further mechanical improvement for commercialization and development of a real-time navigation system that can perform three-dimensional reconstruction of ultrasonographic images by implementing a magnetic position sensor at the tip of the manipulator.

Articulated minimally invasive surgical instrument based on compliant mechanism.

PURPOSE: In minimally invasive surgery, instruments are inserted from the exterior of the patient's body into the surgical field inside the body through the minimum incision, resulting in limited visibility, accessibility, and dexterity. To address this problem, surgical instruments with articulated joints and multiple degrees of freedom have been developed. The articulations in currently available surgical instruments use mainly wire or link mechanisms. These mechanisms are generally robust and reliable, but the miniaturization of the mechanical parts required often results in problems with size, weight, durability, mechanical play, sterilization, and assembly costs. METHODS: We thus introduced a compliant mechanism to a laparoscopic surgical instrument with multiple degrees of freedom at the tip. To show the feasibility of the concept, we developed a prototype with two degrees of freedom articulated surgical instruments that can perform the grasping and bending movements. The developed prototype is roughly the same size of the conventional laparoscopic instrument, within the diameter of 4 mm. The elastic parts were fabricated by Ni-Ti alloy and SK-85M, rigid parts ware fabricated by stainless steel, covered by 3D- printed ABS resin. The prototype was designed using iterative finite element method analysis, and has a minimal number of mechanical parts. RESULTS: The prototype showed hysteresis in grasping movement presumably due to the friction; however, the prototype showed promising mechanical characteristics and was fully functional in two degrees of freedom. In addition, the prototype was capable to exert over 15 N grasping that is sufficient for the general laparoscopic procedure. The evaluation tests thus positively showed the concept of the proposed mechanism. CONCLUSION: The prototype showed promising characteristics in the given mechanical evaluation experiments. Use of a compliant mechanism such as in our prototype may contribute to the advancement of surgical instruments in terms of simplicity, size, weight, dexterity, and affordability.

Human abdomen recognition using camera and force sensor in medical robot system for automatic ultrasound scan.

Physicians use ultrasound scans to obtain real-time images of internal organs, because such scans are safe and inexpensive. However, people in remote areas face difficulties to be scanned due to aging society and physician's shortage. Hence, it is important to develop an autonomous robotic system to perform remote ultrasound scans. Previously, we developed a robotic system for automatic ultrasound scan focusing on human's liver. In order to make it a completely autonomous system, we present in this paper a way to autonomously localize the epigastric region as the starting position for the automatic ultrasound scan. An image processing algorithm marks the umbilicus and mammary papillae on a digital photograph of the patient's abdomen. Then, we made estimation for the location of the epigastric region using the distances between these landmarks. A supporting algorithm distinguishes rib position from epigastrium using the relationship between force and displacement. We implemented these algorithms with the automatic scanning system into an apparatus: a Mitsubishi Electric's MELFA RV-1 six axis manipulator. Tests on 14 healthy male subjects showed the apparatus located the epigastric region with a success rate of 94%. The results suggest that image recognition was effective in localizing a human body part.