Feasibility and accuracy of a robotic guidance system for navigated spine surgery in a hybrid operating room: a cadaver study.

The combination of navigation and robotics in spine surgery has the potential to accurately identify and maintain bone entry position and planned trajectory. The goal of this study was to examine the feasibility, accuracy and efficacy of a new robot-guided system for semi-automated, minimally invasive, pedicle screw placement. A custom robotic arm was integrated into a hybrid operating room (OR) equipped with an augmented reality surgical navigation system (ARSN). The robot was mounted on the OR-table and used to assist in placing Jamshidi needles in 113 pedicles in four cadavers. The ARSN system was used for planning screw paths and directing the robot. The robot arm autonomously aligned with the planned screw trajectory, and the surgeon inserted the Jamshidi needle into the pedicle. Accuracy measurements were performed on verification cone beam computed tomographies with the planned paths superimposed. To provide a clinical grading according to the Gertzbein scale, pedicle screw diameters were simulated on the placed Jamshidi needles. A technical accuracy at bone entry point of 0.48 ± 0.44 mm and 0.68 ± 0.58 mm was achieved in the axial and sagittal views, respectively. The corresponding angular errors were 0.94 ± 0.83° and 0.87 ± 0.82°. The accuracy was statistically superior (p < 0.001) to ARSN without robotic assistance. Simulated pedicle screw grading resulted in a clinical accuracy of 100%. This study demonstrates that the use of a semi-automated surgical robot for pedicle screw placement provides an accuracy well above what is clinically acceptable.

Design and control of an image-guided robot for spine surgery in a hybrid OR.

BACKGROUND: Minimally invasive spine (MIS) fusion surgery requires image guidance and expert manual dexterity for a successful, efficient, and accurate pedicle screw placement. Operating room (OR)-integrated robotic solution can provide precise assistance to potentially minimize complication rates and facilitate difficult MIS procedures. METHODS: A 5-degrees of freedom robot was designed specifically for a hybrid OR with integrated surgical navigation for guiding pedicle screw pilot holes. The system automatically aligns an instrument following the surgical plan using only instrument tracking feedback. Contrary to commercially available robotic systems, no tracking markers on the robotic arm are required. The system was evaluated in a cadaver study. RESULTS: The mean targeting error (N = 34) was 1.27±0.57 mm and 1.62±0.85°, with 100% of insertions graded as clinically acceptable. CONCLUSIONS: A fully integrated robotic guidance system, including intra-op imaging, planning, and physical guidance with optimized robot design and control, can improve workflow and provide pedicle screw guidance with less than 2 mm targeting error.

A tissue stabilization device for MRI-guided breast biopsy.

We present a breast tissue stabilization device that can be used in magnetic resonance imaging-guided biopsy. The device employs adjustable support plates with an optimized geometry to minimize the biopsy target displacement using smaller compression than the conventional parallel plates approach. It is expected that the reduced compression will cause less patient discomfort and improve image quality by enhancing the contrast intake. Precomputed optimal positions of the stabilization plates for a given biopsy target location are provided in a look-up table. The results of several experiments with a prototype of the device carried out on chicken breast tissue demonstrate the effectiveness of the new design when compared with conventional stabilization methods. The proposed stabilization mechanism provides excellent flexibility in selecting the needle insertion point and can be used in manual as well as robot-assisted biopsy procedures.

A system for laparoscopic surgery ergonomics and skills evaluation.

This article presents a system for tracking, recording, and analysis of instrument and surgeon's arm motion in minimally invasive surgeries. The captured trajectories can be objectively analyzed for both ergonomic assessment and skills evaluation. The system consists of two special infrared (IR) markers that are used for 6 degrees of freedom (DOF) laparoscopic instrument tracking and a set of 3DOF IR markers attached to elbows and shoulders. A compact IR camera tracks and records the markers during a standardized training task (eg, suturing). The instrument markers were purposely designed to provide good tracking while minimizing their volume. The accuracy of the instrument markers was evaluated showing a root mean square error of 0.61 mm, 1.0 mm, and 2.4 mm at distances from the camera of 0.5 m, 0.68 m, and 1 m respectively. Furthermore, some sample trajectories were recorded during an in-trainer suturing task. The Results section presents the values of basic skills metrics computed from the acquired data.

GPU implementation of a deformable 3D image registration algorithm.

We present a parallel implementation of a new deformable image registration algorithm using the Computer Unified Device Architecture (CUDA). The algorithm co-registers preoperative and intraoperative 3-dimensional magnetic resonance (MR) images of a deforming organ. It employs a linear elastic dynamic finite-element model of the deformation and distance measures such as mutual information and sum of squared differences to align volumetric image data sets. Computationally intensive elements of the method such as interpolation, displacement and force calculation are significantly accelerated using a Graphics Processing Unit (GPU). The result of experiments carried out with a realistic breast phantom tissue shows a 37 fold speedup for the GPU-based implementation compared with an optimized CPU-based implementation in high resolution MR image registration. The GPU implementation is capable of registering 512 × 512 × 136 image sets in just over 2 seconds, making it suitable for clinical applications requiring fast and accurate processing of medical images.

Model based stabilization of soft tissue targets in needle insertion procedures.

This paper presents a soft tissue target stabilization method during needle insertion procedures. The object considered in this study may have fixed boundary sections and limited surface exposed to external manipulation. The target must be stabilized along the needle path during the needle insertion. It is assumed that a paddle with fixed geometry is available for deformable object manipulation. Two approaches were considered for the target stabilization problem. The first approach uses a static paddle placed on the available boundary, at a strategic location, such that the target motion orthogonal to the needle axis is minimized during the needle insertion. The second approach uses a dynamic paddle attached to the available boundary for the active compensation of the target deflection. In this paper we analyze the optimal paddle placement for the two proposed approaches and present initial numerical results for the case of homogeneous and nonhomogeneous deformable objects. The results show that the first approach is sensitive to possible non-homogeneities in the object, therefore it is not robust to modeling errors. The results also show that optimal placement for the second approach is less sensitive to modeling errors, making it more desirable for physical applications.

Transperineal prostate intervention: robot for fully automated MR imaging--system description and proof of principle in a canine model.

The study was approved by the animal care and use committee. The purpose of the study was to prospectively establish proof of principle in vivo in canines for a magnetic resonance (MR) imaging-compatible robotic system designed for image-guided prostatic needle intervention. The entire robot is built with nonmagnetic and dielectric materials and in its current configuration is designed to perform fully automated brachytherapy seed placement within a closed MR imager. With a 3.0-T imager, in four dogs the median error for MR imaging-guided needle positioning and seed positioning was 2.02 mm (range, 0.86-3.18 mm) and 2.50 mm (range, 1.45-10.54 mm), respectively. The robotic system is capable of accurate MR imaging-guided prostatic needle intervention within a standard MR imager in vivo in a canine model.

"MRI Stealth" robot for prostate interventions.

The paper reports an important achievement in MRI instrumentation, a pneumatic, fully actuated robot located within the scanner alongside the patient and operating under remote control based on the images. Previous MRI robots commonly used piezoelectric actuation limiting their compatibility. Pneumatics is an ideal choice for MRI compatibility because it is decoupled from electromagnetism, but pneumatic actuators were hardly controllable. This achievement was possible due to a recent technology breakthrough, the invention of a new type of pneumatic motor, PneuStep 1, designed for the robot reported here with uncompromised MRI compatibility, high-precision, and medical safety. MrBot is one of the "MRI stealth" robots today (the second is described in this issue by Zangos et al.). Both of these systems are also multi-imager compatible, being able to operate with the imager of choice or cross-imaging modalities. For MRI compatibility the robot is exclusively constructed of nonmagnetic and dielectric materials such as plastics, ceramics, crystals, rubbers and is electricity free. Light-based encoding is used for feedback, so that all electric components are distally located outside the imager's room. MRI robots are modern, digital medical instruments in line with advanced imaging equipment and methods. These allow for accessing patients within closed bore scanners and performing interventions under direct (in scanner) imaging feedback. MRI robots could allow e.g. to biopsy small lesions imaged with cutting edge cancer imaging methods, or precisely deploy localized therapy at cancer foci. Our robot is the first to show the feasibility of fully automated in-scanner interventions. It is customized for the prostate and operates transperineally for needle interventions. It can accommodate various needle drivers for different percutaneous procedures such as biopsy, thermal ablations, or brachytherapy. The first needle driver is customized for fully automated low-dose radiation seed brachytherapy. This paper gives an introduction to the challenges of MRI robot compatibility and presents the solutions adopted in making the MrBot. Its multi-imager compatibility and other preclinical tests are included. The robot shows the technical feasibility of MRI-guided prostate interventions, yet its clinical utility is still to be determined.

Automatic brachytherapy seed placement under MRI guidance.

The paper presents a robotic method of performing low dose rate prostate brachytherapy under magnetic resonance imaging (MRI) guidance. The design and operation of a fully automated MR compatible seed injector is presented. This is used with the MrBot robot for transperineal percutaneous prostate access. A new image-registration marker and algorithms are also presented. The system is integrated and tested with a 3T MRI scanner. Tests compare three different registration methods, assess the precision of performing automated seed deployment, and use the seeds to assess the accuracy of needle targeting under image guidance. Under the ideal conditions of the in vitro experiments, results show outstanding image-guided needle and seed placement accuracy.

Respiratory biofeedback during CT-guided procedures.

PURPOSE: Respiratory motion can be a complicating factor during image-guided interventions. The ability to reproduce breath-holds may facilitate safer needle-based procedures. The purpose of this study was to evaluate if respiratory biofeedback decreased variability among breath-holds and if the signals from the respiratory bellows belt can be used to measure target motion. MATERIALS AND METHODS: In phase 1 of the study, a respiratory bellows belt was applied to patients before image-guided interventional procedures. Belt stretch from respiratory motion was converted into voltage readings and displayed on a monitor as biofeedback. Patients were asked to perform inspiratory, expiratory, and midcycle breath-holds with and without the biofeedback. The variability in voltage readings between breath-holds with and without biofeedback was compared. In phase 2, the respiratory bellows belt was used during computed tomography (CT)-guided procedures with the patients blinded to the biofeedback. Voltage readings and CT series numbers were recorded as patients were asked to hold their breath during scans. The variability of CT z-axis targets was compared with the variability of voltage readings. RESULTS: A significant decrease in variability was found during expiratory breath-holds (P = .0083) with trends toward significance with midcycle and inspiratory breath-holds. A positive correlation (Kendall tau = 0.5; P = .024) was shown between CT z-axis and belt stretch variability in subjects who received smaller doses of moderate sedation compared with those who received larger doses or general anesthesia. CONCLUSIONS: Biofeedback may help the patient to have a more consistent breath-hold. The belt could decrease the error and unpredictability from craniocaudal motion of targets during image-guided interventions.

An evaluation method for the mechanical performance of guide-wires and catheters in accessing the upper urinary tract.

The placement of guide-wires and catheters to gain access to the upper urinary tract can induce undesirable stresses on tissues. Previous studies have characterized the performance of wires and catheters by evaluating their physical properties such as stiffness and friction coefficient. However, the results of these studies do not directly quantify the wire's effects on tissues. Furthermore, the individual physical properties of wires and catheters investigated in previous studies cannot be simply summed up to characterize the behavior of an entire wire/catheter ensemble. This paper presents an objective method for testing guide-wires and catheters that estimates the forces applied by these instruments to anatomical structures during urological procedures. Our model utilizes a computer-controlled test stand that simulates a urological environment by including a tortuous path and a stone obstruction. Experimental results using this model show significant promise in reflecting the performance of guide-wires and catheters measuring the stress exerted upon relevant anatomical structures. Furthermore, due to the modularity of the approach, the model can be easily reconfigured to simulate environments relevant to other medical fields.

A New Type of Motor: Pneumatic Step Motor.

This paper presents a new type of pneumatic motor, a pneumatic step motor (PneuStep). Directional rotary motion of discrete displacement is achieved by sequentially pressurizing the three ports of the motor. Pulsed pressure waves are generated by a remote pneumatic distributor. The motor assembly includes a motor, gearhead, and incremental position encoder in a compact, central bore construction. A special electronic driver is used to control the new motor with electric stepper indexers and standard motion control cards. The motor accepts open-loop step operation as well as closed-loop control with position feedback from the enclosed sensor. A special control feature is implemented to adapt classic control algorithms to the new motor, and is experimentally validated. The speed performance of the motor degrades with the length of the pneumatic hoses between the distributor and motor. Experimental results are presented to reveal this behavior and set the expectation level. Nevertheless, the stepper achieves easily controllable precise motion unlike other pneumatic motors. The motor was designed to be compatible with magnetic resonance medical imaging equipment, for actuating an image-guided intervention robot, for medical applications. For this reason, the motors were entirely made of nonmagnetic and dielectric materials such as plastics, ceramics, and rubbers. Encoding was performed with fiber optics, so that the motors are electricity free, exclusively using pressure and light. PneuStep is readily applicable to other pneumatic or hydraulic precision-motion applications.

Magnetic resonance imaging compatible robotic system for fully automated brachytherapy seed placement.

OBJECTIVES: To introduce the development of the first magnetic resonance imaging (MRI)-compatible robotic system capable of automated brachytherapy seed placement. METHODS: An MRI-compatible robotic system was conceptualized and manufactured. The entire robot was built of nonmagnetic and dielectric materials. The key technology of the system is a unique pneumatic motor that was specifically developed for this application. Various preclinical experiments were performed to test the robot for precision and imager compatibility. RESULTS: The robot was fully operational within all closed-bore MRI scanners. Compatibility tests in scanners of up to 7 Tesla field intensity showed no interference of the robot with the imager. Precision tests in tissue mockups yielded a mean seed placement error of 0.72 +/- 0.36 mm. CONCLUSIONS: The robotic system is fully MRI compatible. The new technology allows for automated and highly accurate operation within MRI scanners and does not deteriorate the MRI quality. We believe that this robot may become a useful instrument for image-guided prostate interventions.

Technology insight: telementoring and telesurgery in urology.

The rapid expansion of the field of minimally invasive surgery has been accompanied by a number of controversies. These novel surgical techniques offer benefits to the patient with regard to length of hospital stay, return to full activity, and cosmesis; also, they are often more cost-effective than open procedures. On the other hand, they are technically demanding, have a significant learning curve, and can be associated with high initial complication rates unless performed by experienced endoscopic surgeons. Telemedicine, which uses real-time video and information transfer, offers the potential to increase the availability of minimally invasive surgery through video-assisted surgery and through remote instruction. At present, remote communities, especially those within developed countries, can most immediately benefit from telesurgical approaches. Enthusiasm must be tempered by the issues of cost, security, surgeon liability and availability of the technology itself which have yet to be fully resolved. In this Review, the field of telemedicine, focusing specifically on telementoring and telesurgery, and its relevance to urology are discussed. From early experimental work to current clinical usage, the advantages of and problems in this evolving field are explored.

Robotic prostate surgery.

The increasing popularity of robot-assisted radical prostatectomy has put the field of robotics in the spotlight. However, the relationship between medical robotics and the field of urology is older than most urologists know and it will most likely have a bright future beyond any contemporary application. The objective of this review is to provide an insight into the fundamentals of medical robotics and to highlight the history, the present and the future of urological robotic systems with an emphasis on robotic prostate interventions.

Tumor ablation treatment planning coupled to robotic implementation: a feasibility study.

The technical development described herein was undertaken to create a tumor ablation treatment system that consists of a software component and a robotic hardware component. First, the software treatment planning system enables applicator placement planning before tumor ablation. For example, it allows creation of overlapping ablations with the goal of treating larger tumors. Second, the robotic hardware system allows accurate applicator placement. The combined treatment system integrates treatment planning with treatment execution by taking the coordinates dictated by the planning system and feeding them to the robotic system for implementation. The feasibility of this system was tested in two patients with large hepatic metastases that required overlapping ablations.

Synthetic torso for training in and evaluation of urologic laparoscopic skills.

BACKGROUND: The expanding use of advanced minimally invasive surgical techniques demands more advanced training methods, objective measures of resident performance, and more realistic and anatomically correct training models. MATERIALS AND METHODS: A new synthetic torso for urologic laparoscopy training was developed and assessed. The trainer, Lapman, was based on the Visible Human Model and has the exact shape of a human torso. The torso models the outer shape of the body and the abdominal and pulmonary cavities. Animal or synthetic models of the abdominal organs may be placed in the abdominal cavity. An abdominal wall provides access and seals the cavity and can be replaced after repeated punctures with laparoscopic instruments. The thoracic cavity connects to a pneumatic pump to simulate breathing. In order to render realistic mechanic properties, the torso is cast of materials with elastic properties similar to those of soft tissue and incorporates a synthetic skeleton. These similar mechanical properties and the thoracic insufflation create realistic ventilatory motion simulation. RESULTS: Twenty-five individuals--medical students, residents, and attending urologists--participated in a study comparing Lapman with a standard training box. Lapman presented several advantages over the traditional training box, specifically with regard to internal and external views and the incorporation of a realistically shaped abdominal wall. A significant and recurrent theme was the value of the synthetic wall as a tool to gain a greater appreciation of the importance of port placement. Study participants at all levels of training appreciated that Lapman gives a more realistic approximation of the operative procedure. CONCLUSIONS: The novelty of the trainer consists in its anatomic shape, realistic mechanical properties, and ventilatory simulation. This paper reports on its design, construction, and preliminary tests.

Robotically assisted prostate brachytherapy with transrectal ultrasound guidance--Phantom experiments.

PURPOSE: To report the preliminary experimental results obtained with a robot-assisted transrectal ultrasound (TRUS)-guided prostate brachytherapy system. METHODS AND MATERIALS: The system consists of a TRUS unit, a spatially coregistered needle insertion robot, and an FDA-approved treatment planning and image-registered implant system. The robot receives each entry/target coordinate pair of the implant plan, inserts a preloaded needle, and then the seeds are deposited. The needles/sources are tracked in TRUS, thus allowing the plan to be updated as the procedure progresses. RESULTS: The first insertion attempt was recorded for each needle, without adjustment. All clinically relevant locations were reached in a prostate phantom. Nonparallel and parallel needle trajectories were demonstrated. Based on TRUS, the average transverse placement error was 2 mm (worst case 2.5 mm, 80% less than 2 mm), and the average sagittal error was 2.5 mm (worst case 5.0 mm, 70% less than 2.5 mm). CONCLUSIONS: The concept and technical viability of robot-assisted brachytherapy were demonstrated in phantoms. The kinematically decoupled robotic assistant device is inherently safe. Overall performance was promising, but further optimization is necessary to prove the possibility of improved dosimetry.

A randomized controlled trial of human versus robotic and telerobotic access to the kidney as the first step in percutaneous nephrolithotomy.

OBJECTIVE: We present results from the first randomized controlled trial of human vs. telerobotic access to the kidney during percutaneous nephrolithotomy. METHODS: To compare (a) human with robotic percutaneous needle access and (b) local robotic with trans-Atlantic robotic percutaneous needle access, we used a validated kidney model into which a needle was inserted 304 times. Half the insertions were performed by a robotic arm and the other half by urological surgeons. Order was decided randomly except for a sub-group of 30 trans-Atlantic robotic procedures that were controlled by a team at Johns Hopkins, Baltimore, via four ISDN lines. RESULTS: All attempts were successful within three passes with a median time of 35 s for human attempts compared with a median of 57 s for robotic attempts. The robot was slower than the human to complete insertions (p < 0.001, Mann-Whitney U test), but was more accurate when compared with human operators as it made fewer attempts (88% robotic vs. 79% human first attempt success; p = 0.046, chi-squared test). Times for trans-Atlantic robotic needle insertion (median = 59 s) were comparable to times taken for local robotic needle insertion (median = 56 s) with no difference in accuracy. CONCLUSION: Telerobotics is an accurate and feasible tool for future minimally invasive surgery.

Robotic telementoring/telesurgical system and randomized evaluation study.

The paper presents a new telementoring system incorporating audio-video communication and remote robotic control. The system was developed around an off the shelf ISDN video conferencing system enhanced with video annotation and remote robot control features. The user can remotely control a robot of perform needle alignment and insertion in a Percutaneous access procedure. Particular attention was devoted to ensure the safety of the procedure. The data connection is continuously monitored and in the event of a failure the robot control is switched to the local operator. Two series of randomized trials were performed between Baltimore and London. The accuracy and procedure time were evaluated for manual needle placement, local robotic needle placement and remotely controlled robotic needle placement. The test showed that while the procedure time is not improved by the robotic approach there is an improvement in the accuracy of the procedure. The study showed also that there is no significant difference between the locally controlled robotic needled placement and the remotely controlled robotic needle placement. Thus, the proposed system can be safely used for remote robotic percutaneous access procedures.