Clinical efficacy and performance evaluation of a bendable remote robot system for a bone tumour surgery: A pilot animal study.

BACKGROUND: Traditional open surgery for bone tumours sometimes has as a consequence an excessive removal of healthy bone tissue because of the limitations of rigid surgical instruments, increasing infection risk and recovery time. METHODS: We propose a remote robot with a 4.5-mm diameter bendable end-effector, offering four degrees of freedom for accessing the inside of the bone and performing tumour debridement. The preclinical studies evaluated the effectiveness, clinical scenario, and usability across 12 total surgeries-six phantom surgeries and six bovine bone surgeries. Evaluation criteria included skin incision size, bone window size, surgical time, removal rate, and conversion to open surgery. RESULTS: Preclinical studies demonstrated that the robotic approach requires significantly smaller incision size and procedure times than traditional open curettage. CONCLUSION: This study validated the performance of the proposed system by assessing its preclinical effectiveness and optimising surgical methods using human phantom and bovine bone tumour models.

Clinical evaluation of a fluoroscopic image-based laser guidance system in bone tumor surgery: A technical note.

This study presents a laser guidance system developed to enhance surgical accuracy and reduce radiation exposure in orthopedic surgeries. The system can project the actual position corresponding to the appointed position selected by the surgeon on a fluoroscopic image using a line laser and has laser projection ability to mark the corresponding point using a line laser. The surgeon does not have to perform anatomical marker placement for calibration. Three patients with bone tumors underwent surgeries using the laser guidance system, and the projection accuracy was evaluated by measuring the distance error between the appointed and laser-marking positions. The installation time, including calibration, was also assessed for clinical usability. The average projection accuracy in bone tumor surgery was 2.86 mm, and the average installation time was 7 min. These results demonstrate that the laser guidance system, with a projection error of <3 mm, could be useful in bone tumor surgeries.

Robot-patient registration for optical tracker-free robotic fracture reduction surgery.

BACKGROUND AND OBJECTIVE: Image-guided robotic surgery for fracture reduction is a medical procedure in which surgeons control a surgical robot to align the fractured bones by using a navigation system that shows the rotation and distance of bone movement. In such robotic surgeries, it is necessary to estimate the relationship between the robot and patient (bone), a task known as robot-patient registration, to realize the navigation. Through the registration, a fracture state in real-world can be simulated in virtual space of the navigation system. METHODS: This paper proposes an approach to realize robot-patient registration for an optical-tracker-free robotic fracture-reduction system. Instead of the optical tracker which is a three-dimensional position localizer, X-ray images are used to realize the robot-patient registration, combining the relationship of both the robot and patient with regards to C-arm. The proposed method consists of two steps of registration, where initial registration is followed by refined registration which adopts particle swarm optimization with the minimum cross-reprojection error based on bidirectional X-ray images. To address the unrecognizable features due to interference between the robot and bone, we also developed attachable robot features. The allocated robot features could be clearly extracted from the X-ray images, and precise registration could be realized through the particle swarm optimization. RESULTS: The proposed method was evaluated in phantom and ex-vivo experiments involving a caprine cadaver. For the phantom experiments, the average translational and rotational errors were 1.88 mm and 2.45°, respectively, and the corresponding errors in the ex vivo experiments were 2.64 mm and 3.32° The results demonstrated the effectiveness of the proposed robot-patient registration. CONCLUSIONS: The proposed method enable to estimate the three-dimensional relationship between fractured bones in real-world by using only two-dimensional images, and the relationship is accurately simulated in virtual reality for the navigation. Therefore, a reduction procedure for successful treatment of bone fractures in image-guided robotic surgery can be expected with the aid of the proposed registration method.

Human-robot-robot cooperative control using positioning robot and 1-DOF traction device for robot-assisted fracture reduction system.

While performing musculoskeletal long bone fracture reduction surgery, assistant surgeons can often suffer from physical fatigue as they provide resistance against the tension from surrounding muscles pulling on the patient's broken bones. These days, robotic systems are being actively developed to mitigate this physical workload by realigning and holding these fractured bones for surgeons. This has led to one consortium proposing the development of a robot-assisted fracture reduction system consisting of a 6-DOF positioning robot along with a 1-DOF traction device. With the introduction of the 1-DOF traction device, the positioning robot does not have to fight these contraction forces so can be compact improving its maneuverability and overall convenience; however, considering surgeon-robot interactions, this approach adds the requirement of controlling two different types of robots simultaneously. As such, an advanced cooperative control methodology is required to control the proposed bone fracture reduction robot system. In this paper, a human-robot-robot cooperative control (HRRCC) scheme is proposed for collaboration between the surgeon, the positioning robot, and the traction device. First, the mathematical background of this HRRCC scheme is provided. Next, we describe a series of experiments that show how the proposed scheme facilitates a reduction in the load placed on the positioning robot from strong muscular contraction forces making it possible to conduct fracture reduction procedures more safely despite the muscular forces.

Fluoroscopic images-based aiming and targeting system with two line lasers for insertion guidance of interlocking screw.

PURPOSE: Minimally invasive surgery is widely used for managing fractures; however, it is difficult to determine the exact screwing position of intramedullary nails inserted into bone. To address this problem, we developed the aiming and targeting system by laser (ATLAS) using two line lasers to mark the position of the surgical tool directly on the skin. METHODS: ATLAS consists of a laser module, controller, personal computer, and display device. The laser module is fixed to the intensifier side of the C-arm. Calibration with dedicated markers is required prior to using the system. After calibration, the laser modules can mark the selected point on a fluoroscopic image acquired with the C-arm as the intersection of the two line lasers on the skin. RESULTS: To verify the effectiveness of ATLAS, marking accuracy was measured. The average control error of the device itself was 0.57 mm. In the experimental setting using C-arm fluoroscopy, the accuracy was within 1.5 mm at 23 of the 25 measurement points and within 3 mm at the remaining two points. CONCLUSION: ATLAS shows the corresponding points in real space with respect to fluoroscopic images using cross-points of lasers. The proposed method is clinically useful to aid the insertion of interlocking screws in minimally invasive surgeries for bone fractures. We believe that ATLAS enables more accurate marking through C-arm fluoroscopy and is more convenient, and it can thus be applied in various orthopedic surgeries.

Generative approach for data augmentation for deep learning-based bone surface segmentation from ultrasound images.

PURPOSE: Precise localization of cystic bone lesions is crucial for osteolytic bone tumor surgery. Recently, there is a move toward ultrasound imaging over plain radiographs (X-rays) for intra-operative navigation due to the radiation-free and cost-effectiveness of the modality. In this process, the intra-operative bone model reconstructed from the segmented ultrasound image is registered with the pre-operative bone model. Deep learning approaches have recently shown remarkable success in bone surface segmentation from ultrasound images. However, to train deep learning models effectively with limited dataset size, data augmentation is essential. This study investigates the applicability of the generative approach for data augmentation as well as identifies standard data augmentation approaches for bone surface segmentation from ultrasound images. METHODS: The generative approach we used in our work is based on Pix2Pix image-to-image translation network. We have proposed a multiple-snapshot approach, which mitigates the uni-modal deterministic output issue in the Pix2Pix network without using any complex architecture and training process. We also identified standard data augmentation approaches necessary for ultrasound bone surface segmentation through experiments. RESULTS: We have evaluated our networks using 800 ultrasound images from trained regions (humerus bone) and 1200 ultrasound images from untrained regions (tibia and femur bones) using four different augmentation approaches. The results show that the generative augmentation approach has a positive impact on accuracy in both trained (+ 4.88%) and untrained regions (+ 25.84%) compared to using only standard augmentations. Moreover, compared to standard augmentation approaches, the addition of the generative augmentation approach also showed a similar trend in both trained (+ 8.74%) and untrained (+ 11.55%) regions. CONCLUSION: Generative approaches are very beneficial for data augmentation, where limited dataset size is prevalent, such as ultrasound bone segmentation. The proposed multiple-snapshot Pix2Pix approach has the potential to generate multimodal images, which enlarges the dataset considerably.

An all-joint-control master device for single-port laparoscopic surgery robots.

PURPOSE: Robots for single-port laparoscopic surgery (SPLS) typically have all of their joints located inside abdomen during surgery, whereas with the da Vinci system, only the tip part of the robot arm is inserted and manipulated. A typical master device that controls only the tip with six degrees of freedom (DOFs) is not suitable for use with SPLS robots because of safety concerns. METHODS: We designed an ergonomic six-DOF master device that can control all of the joints of an SPLS robot. We matched each joint of the master, the slave, and the human arm to decouple all-joint motions of the slave robot. Counterbalance masses were used to reduce operator fatigue. Mapping factors were determined based on kinematic analysis and were used to achieve all-joint control with minimal error at the tip of the slave robot. RESULTS: The proposed master device has two noteworthy features: efficient joint matching to the human arm to decouple each joint motion of the slave robot and accurate mapping factors, which can minimize the trajectory error of the tips between the master and the slave. CONCLUSIONS: We confirmed that the operator can manipulate the slave robot intuitively with the master device and that both tips have similar trajectories with minimal error.

Development of femoral bone fracture model simulating muscular contraction force by pneumatic rubber actuator.

In femoral fracture reduction, orthopedic surgeons must pull distal bone fragments with great traction force and return them to their correct positions, by referring to 2D-fluoroscopic images. Since this method is physically burdensome, the introduction of robotic assistance is desirable. While such robots have been developed, adequate control methods have not yet been established because of the lack of experimental data. It is difficult to obtain accurate data using cadavers or animals because they are different from the living human body's muscle characteristics and anatomy. Therefore, an experimental model for simulating human femoral characteristics is required. In this research, human muscles are reproduced using a McKibben-type pneumatic rubber actuator (artificial muscle) to develop a model that simulates typical femur muscles using artificial muscles.

Direct minimally invasive intraoperative electrophysiological mapping of the heart.

INTRODUCTION: Cardiac electrophysiology aims to describe and treat the electrical activity of the heart. Although an epicardial approach is valuable in many surgical treatments such as coronary artery bypass grafting, maze ablation, and cell transplantation, very few techniques suited for minimally invasive surgery are available for measurement of epicardial electrophysiology. MATERIAL AND METHODS: We developed a novel endoscopically-deployable expanding electrode array that can be applied for minimally invasive surgery. Our device consists of a flexible electrode array attached to arms which open and close the electrode sheet. Furthermore, we also developed a computer program to overlay an epicardial electrophysiological map on an endoscopic image. We performed both laboratory and in vivo experiments to examine the feasibility in clinical situations. RESULTS: Evaluation experiments demonstrated that our novel mapping process that assumes spherical deformation of the electrode array enables us to overlay each electrode position with an accuracy of < 1 mm. Results of animal experiments using large animals (one dog and two pigs) demonstrated that our system enables construction of epicardial electrophysiological maps. CONCLUSION: A novel endoscopically deployable expanding electrode array was developed. Evaluation experiments demonstrated that our device can be manipulated in simulated minimally invasive surgery, and enables construction of epicardial electrophysiological maps.

Image-based electrode array tracking for epicardial electrophysiological mapping in minimally invasive arrhythmia surgery.

PURPOSE: Electrophysiological mapping is effective in realizing a precise minimally invasive arrhythmia surgery. Recently, an epicardial electrophysiological mapping system for minimally invasive arrhythmia surgery was reported. The system requires a small electrode array, a tracking system and a global mapping algorithm. The optical tracking system employed in the research requires line of sight and complicated configuration. This paper proposes a new tracking method for locating an electrode array. METHODS: We developed a small electrode array and optical markers. Center points of respective optical markers and the electrode array are tracked via an endoscopic stream and calculated in image space. The orientation of the electrode array is calculated using the dot product between the vector joining two center points of two upper optical markers and the vector joining two end points of the longest edge of the electrode array. RESULTS: Mean tracking errors of position and orientation of the electrode array were 0.51 mm and 0.64°, respectively. And the processing time was constant at 46 ms per frame. Our method could successfully track the electrode array on the epicardium during in vivo experiment and a global epicardial electrophysiological map was reconstructed from separately measured epicardial electrograms by the small electrode array. CONCLUSIONS: An image-based tracking method for locating an electrode array was proposed. Tracking accuracy, processing time and applicability to surgical environment of our method proved to be acceptable. Consequently, our method enables the electrode array tracking system to be simplified with no separate tracking system.

High-sensitive fluorescence endoscope using electrocardiograph-synchronized multiple exposure.

PURPOSE: Fluorescence-based measurement of cardiac disease, using autofluorescent substances that already exist in the heart, has not been used for endoscopic surgery because the endoscopic lenses cannot transmit sufficient light. A highly sensitive fluorescence endoscope using an electrocardiograph (ECG)-synchronized multiple exposure (ESME) approach was developed that provides a bright fluorescent image. METHODS: A system was developed consisting of an endoscope, an excitation light, an ECG amplifier, a trigger and delay unit, and a computer. This system is based on periodic motion of the heart. Since the shape of the heart can be photographed by ECG triggering in a similar manner, a bright image can be synthesized by accumulating multiple trigger-captured images. Laboratory and in vivo experiments were performed to confirm the effectiveness of ESME. RESULTS: The experimental results revealed that the trigger unit generated the synchronization signals required to produce high-quality images of the heart depending on heart rate. The difference among trigger-captured images from the actual organ, which affects the quality of ESME images, was estimated at 0.65 mm from the calculated displacement of a marker on the heart. The results also revealed that a bright fluorescent image can be captured by ESME. CONCLUSION: A highly sensitive fluorescence endoscope using ESME was developed and successfully tested. The experimental results indicated that the method enabled high-quality image acquisition in a very low illumination environment. This system is effective for the observation of faint fluorescence in the heart and is useful for the intraoperative examination of the heart status.

A robot assisted hip fracture reduction with a navigation system.

A fracture reduction robot is described as assisting in safe and precise fracture reduction. The robot is connected with pins that are inserted into the patient's bone fragments, together with a customized jig. The robot has six degrees of freedom with high precision, so that precise fracture reduction can be conducted. The failsafe unit of the fracture reduction robot can mitigate excessive reduction force that may cause complications such as avascular necrosis. We have integrated the fracture reduction robot with a navigation system that tracks the relative position of the bone fragments and generates the reduction path. The integrated system is evaluated with the simulated fracture reduction of a hip fracture model (n = 8). Three-dimensional parameters related to the mechanical axis--the proximal femur angle, the distal femur angle, and the length of the mechanical axis--were evaluated by comparing the normal values with those after reduction; these average differences are 1.76 degrees , 0.28 degrees and 0.76mm, respectively. The automated fracture reduction feature makes it possible for medical staff to work at a distance from radiation sources; for patients, the integrated fracture reduction system has the potential to reduce fractures with high precision.