Transperineal in-bore 3-T MR imaging-guided prostate biopsy: a prospective clinical observational study.

PURPOSE: To determine the detection rate, clinical relevance, Gleason grade, and location of prostate cancer ( PCa prostate cancer ) diagnosed with and the safety of an in-bore transperineal 3-T magnetic resonance (MR) imaging-guided prostate biopsy in a clinically heterogeneous patient population. MATERIALS AND METHODS: This prospective retrospectively analyzed study was HIPAA compliant and institutional review board approved, and informed consent was obtained. Eighty-seven men (mean age, 66.2 years ± 6.9) underwent multiparametric endorectal prostate MR imaging at 3 T and transperineal MR imaging-guided biopsy. Three subgroups of patients with at least one lesion suspicious for cancer were included: men with no prior PCa prostate cancer diagnosis, men with PCa prostate cancer who were undergoing active surveillance, and men with treated PCa prostate cancer and suspected recurrence. Exclusion criteria were prior prostatectomy and/or contraindication to 3-T MR imaging. The transperineal MR imaging-guided biopsy was performed in a 70-cm wide-bore 3-T device. Overall patient biopsy outcomes, cancer detection rates, Gleason grade, and location for each subgroup were evaluated and statistically compared by using χ(2) and one-way analysis of variance followed by Tukey honestly significant difference post hoc comparisons. RESULTS: Ninety biopsy procedures were performed with no serious adverse events, with a mean of 3.7 targets sampled per gland. Cancer was detected in 51 (56.7%) men: 48.1% (25 of 52) with no prior PCa prostate cancer , 61.5% (eight of 13) under active surveillance, and 72.0% (18 of 25) in whom recurrence was suspected. Gleason pattern 4 or higher was diagnosed in 78.1% (25 of 32) in the no prior PCa prostate cancer and active surveillance groups. Gleason scores were not assigned in the suspected recurrence group. MR targets located in the anterior prostate had the highest cancer yield (40 of 64, 62.5%) compared with those for the other parts of the prostate (P < .001). CONCLUSION: In-bore 3-T transperineal MR imaging-guided biopsy, with a mean of 3.7 targets per gland, allowed detection of many clinically relevant cancers, many of which were located anteriorly.

3T MR-guided in-bore transperineal prostate biopsy: A comparison of robotic and manual needle-guidance templates.

PURPOSE: To demonstrate the utility of a robotic needle-guidance template device as compared to a manual template for in-bore 3T transperineal magnetic resonance imaging (MRI)-guided prostate biopsy. MATERIALS AND METHODS: This two-arm mixed retrospective-prospective study included 99 cases of targeted transperineal prostate biopsies. The biopsy needles were aimed at suspicious foci noted on multiparametric 3T MRI using manual template (historical control) as compared with a robotic template. The following data were obtained: the accuracy of average and closest needle placement to the focus, histologic yield, percentage of cancer volume in positive core samples, complication rate, and time to complete the procedure. RESULTS: In all, 56 cases were performed using the manual template and 43 cases were performed using the robotic template. The mean accuracy of the best needle placement attempt was higher in the robotic group (2.39 mm) than the manual group (3.71 mm, P < 0.027). The mean core procedure time was shorter in the robotic (90.82 min) than the manual group (100.63 min, P < 0.030). Percentage of cancer volume in positive core samples was higher in the robotic group (P < 0.001). Cancer yields and complication rates were not statistically different between the two subgroups (P = 0.557 and P = 0.172, respectively). CONCLUSION: The robotic needle-guidance template helps accurate placement of biopsy needles in MRI-guided core biopsy of prostate cancer.

Tendon-Driven Continuum Robot for Endoscopic Surgery: Preclinical Development and Validation of a Tension Propagation Model.

In this paper, we present a tendon-driven continuum robot for endoscopic surgery. The robot has two sections for articulation actuated by tendon wires. By actuating the two sections independently, the robot can generate a variety of tip positions while maintaining the tip direction. This feature offers more flexibility in positioning the tip for large viewing angles of up to 180 degrees than does a conventional endoscope. To accurately estimate the tip position at large viewing angles, we employed kinematic mapping with a tension propagation model including friction between the tendon wires and the robot body. In a simulation study using this kinematic-mapping, the two-section robot at a target scale (outer diameter 1.7 mm and length 60 mm) produced a variety of tip positions within 50-mm ranges at the 180°-angle view. In the experimental validation, a 10:1 scale prototype performed three salient postures with different tip positions at the 180°-angle view. The proposed forward kinematic mapping (FKM) predicted the tip position within a tip-to-tip error of 6 mm over the 208-mm articulating length. The tip-to-tip error by FKM was significantly less than the one by conventional piecewise-constant-curvature approximation (PCCA) (FKM: 5.9 ± 2.9 mm vs. PCCA: 23.7 ± 3.6 mm, n=15, P < 0.01).

Design and Fabrication of Micro Saw Enabling Root-Side Cutting of Bone.

A novel micro saw was fabricated using a combination of photolithography and electroplating techniques, resembling a miniature timing belt with sideways blades. The rotation or oscillation direction of the micro saw is designed to be perpendicular to the cutting direction so that transverse cutting of the bone is attainable to extract a preoperatively planned bone-cartilage donor for osteochondral auto-graft transplantation. The mechanical property of the fabricated micro saw obtained using the nanoindentation test shows that the mechanical properties of the micro saw are almost an order of magnitude higher than bone, which indicates its potential bone-cutting application. To demonstrate the cutting capability of the fabricated micro saw, an in vitro animal bone cutting was performed using a custom test rig consisting of a microcontroller, 3D printer, and other readily available parts.

Tool parameters to minimize temperature changes in bone drilling.

BACKGROUND: Drilling is a common technique used in orthopedic surgery procedures but causes increases in temperature that can lead to cell damage and death. The extent of this depends largely on the magnitude of the increase in temperature. The commonly accepted limit to prevent osteonecrosis is less than 47 °C for 60 s. There is controversy when it comes to the optimal drilling parameters that limit temperature increases and cell death. In addition to this, less research has been done on the drilling effects in the osteochondral area of joints. Osteochondral tissue damage can interfere with the daily lives of patients and if severe enough will need to be treated. We hypothesize that increasing tool speed and drill bit size will increase temperature that could be above the osteonecrosis limit. METHODS: Ex-vivo experiments were conducted on porcine shoulder joints that tested the thermal effects of different tool speeds and drill bit sizes. A thermal camera was used to record and measure real time temperature changes while drilling. Three drill bit sizes and five tool speeds were used. Statistical analyses includes Welch's ANOVA with Games-Howell Post Hoc analyses, multivariate linear regression, and surface response regression were used to explore the association of tool speeds and drill bit size on temperature. RESULTS AND CONCLUSIONS: All the tool speed and drill bit size combinations lead to an increase in temperature that were under the commonly accepted limit. The highest temperature reached was 44 °C with a tool speed of 1150 RPM and 3070 RPM and drill bit size 5.159 mm. It was found that increasing the tool speed increased the temperature change and increasing the drill bit size increased the temperature change.

Development and Evaluation of an Actuated MRI-Compatible Robotic System for MRI-Guided Prostate Intervention.

This paper reports the design, development, and magnetic resonance imaging (MRI) compatibility evaluation of an actuated transrectal prostate robot for MRI-guided needle intervention in the prostate. The robot performs actuated needle MRI-guidance with the goals of providing (i) MRI compatibility, (ii) MRI-guided needle placement with accuracy sufficient for targeting clinically significant prostate cancer foci, (iii) reducing interventional procedure times (thus increasing patient comfort and reducing opportunity for needle targeting error due to patient motion), (iv) enabling real-time MRI monitoring of interventional procedures, and (v) reducing the opportunities for error that arise in manually actuated needle placement. The design of the robot, employing piezo-ceramic-motor actuated needle guide positioning and manual needle insertion, is reported. Results of a MRI compatibility study show no reduction of MRI signal-to-noise-ratio (SNR) with the motors disabled. Enabling the motors reduces the SNR by 80% without RF shielding, but SNR is only reduced by 40% to 60% with RF shielding. The addition of radio-frequency shielding is shown to significantly reduce image SNR degradation caused by the presence of the robotic device. An accuracy study of MRI-guided biopsy needle placements in a prostate phantom is reported. The study shows an average in-plane targeting error of 2.4 mm with a maximum error of 3.7 mm. These data indicate the system's needle targeting accuracy is similar to that obtained with a previously reported manually actuated system, and is sufficient to reliably sample clinically significant prostate cancer foci under MRI-guidance.

Robotic Surgery Techniques to Improve Traditional Laparoscopy.

Introduction: Laparoscopic instruments and techniques are constantly improving, as the ability to perform minimally invasive surgery is crucial in modern medicine. The progression from open surgery to minimally invasive surgery over the years eventually led to the use of robotic devices to either assist or completely replace patient-side surgery with a separate console. Though robotic surgery has been praised for its surgical outcomes, certain situations limit its use, such as cost-effectiveness or physical space constraints. The objectives of this review were to perform a search and discuss the trends in the literature. Methods: A literature search using keywords ((laparoscopic) OR (laparoscopy) OR (minimally invasive)) AND ((instrument) OR (instrumentation) OR (tool) OR (device) OR (apparatus)) AND ((advancement) OR (upgrade)) AND ((hysterectomy) OR (prostatectomy) OR (transoral) OR (cholecystectomy)) AND (robot) in PubMed, looking for trends in advancements or appeals for change. Results: This search provides a framework for these trends to facilitate discussion of ways in which laparoscopic surgery can be improved using the benefits of robotic surgical systems. This allows others to approach the successes of the current robotic systems for laparoscopic surgery with the intention of deriving advancements toward traditional laparoscopic surgery.

Kinematic and mechanical modelling of a novel 4-DOF robotic needle guide for MRI-guided prostate intervention.

Traditionally ultrasound-guided biopsy has been used to diagnose prostate cancer despite of its poor soft tissue contrast and frequent false negative results. Magnetic Resonance Imaging (MRI) has the advantage of excellent soft tissue contrast for guiding and monitoring prostate biopsy. However, its working area and access in the confined MRI bore space limit the use of interventional guide devices including robotic systems. To provide robotic precision, greater access, and compact design, we designed a novel robotic mechanism that can provide four degrees of freedom (DOF) manipulation in a compact form comparable to size of manual templates. To develop the mechanism, we established a mathematical model of inverse and forward kinematics and prototyped a proof-of-concept needle guide for MRI guided prostate biopsy. The mechanism was materialized using four discs that house small passive spherical joints that can be moved by rotating the discs consisting of grooved profile. With an initial needle insertion angle range of ±15°, we identified mathematical and kinematic parameters for the mechanism design and fabricated the first prototype that has dimension of 40 × 110 × 180 mm3. The prototype demonstrated that the unique robotic manipulation can physically be delivered and could provide precise needle guidance including angulated needle insertion with higher structural rigidity.

Feasibility Study and Experimental Evaluation of the Design of Nodule Prototype Developed for Palpation Display Apparatus: A Novel Device for Contactless Primary Tactile Diagnosis.

BACKGROUND: Lack of feasible palpation display for primary diagnosis of a tumor without any need of physician to patient physical contact has been reported as one of the major concerns. To further explore this area, we developed a novel palpation device consisting of a uniquely designed nodule mechanism (based on optimizing nodule top and bottom hemisphere wall thickness and manipulating granular jamming method) that can vary stiffness while maintaining the shape of the same nodule display, for which current devices are not capable of in terms of aping a tumor. METHODS: This paper evaluates the manufacturing approach of the nodule, exploring several iterations of the nodule prototype. Experiments were performed on nodule prototypes of varying wall thicknesses in order to evaluate its effect on stiffness and deformation. RESULTS AND CONCLUSIONS: Experimental results showed that nodule top and bottom wall thickness had a significant effect on the stiffness and deformation of the nodule. The higher the thickness of the top hemisphere and the lower the thickness of the bottom hemisphere, the greater the stiffness the nodule can achieve. Similarly, the display shape of the nodule can be maintained with minimal or no deformation if the nodule top hemisphere thickness is optimally higher than bottom hemisphere thickness.

Correction to: Review of Robotic Needle Guide Systems for Percutaneous Intervention.

Sentences under the sections "Needle Guide Systems Based on Imaging Modalities" and "Image Compatibility for Needle Guide Systems" contained incorrect data referred from other articles.

Review of Robotic Needle Guide Systems for Percutaneous Intervention.

Numerous research groups in the past have designed and developed robotic needle guide systems that improve the targeting accuracy and precision by either providing a physical guidance for manual insertion or enabling a complete automated intervention. Here we review systems that have been reported in the last 11 years and limited to straight line needle interventions. Most systems fall under the category of image guided systems as they either use magnetic resonance image, computed tomography, ultrasound or a combination of these modalities for real time image feedback of the intervention path being followed. Actuation and control technology along with materials used for construction are the main aspects that differentiate these systems from each other and have been reviewed here. Image compatibility test details and results are also reviewed as they are used to ensure proper functioning of these systems under the respective imaging environments. We have also reviewed needle guide systems which either don't use any image feedback or have not reported any but provide physical guidance. Throughout this paper, we provide a comprehensive review of the technological aspects and trends in the field of robotic, straight line, needle guide intervention systems.

Soft robotic sleeve supports heart function.

There is much interest in form-fitting, low-modulus, implantable devices or soft robots that can mimic or assist in complex biological functions such as the contraction of heart muscle. We present a soft robotic sleeve that is implanted around the heart and actively compresses and twists to act as a cardiac ventricular assist device. The sleeve does not contact blood, obviating the need for anticoagulation therapy or blood thinners, and reduces complications with current ventricular assist devices, such as clotting and infection. Our approach used a biologically inspired design to orient individual contracting elements or actuators in a layered helical and circumferential fashion, mimicking the orientation of the outer two muscle layers of the mammalian heart. The resulting implantable soft robot mimicked the form and function of the native heart, with a stiffness value of the same order of magnitude as that of the heart tissue. We demonstrated feasibility of this soft sleeve device for supporting heart function in a porcine model of acute heart failure. The soft robotic sleeve can be customized to patient-specific needs and may have the potential to act as a bridge to transplant for patients with heart failure.

Body-mounted robotic instrument guide for image-guided cryotherapy of renal cancer.

PURPOSE: Image-guided cryotherapy of renal cancer is an emerging alternative to surgical nephrectomy, particularly for those who cannot sustain the physical burden of surgery. It is well known that the outcome of this therapy depends on the accurate placement of the cryotherapy probe. Therefore, a robotic instrument guide may help physicians aim the cryotherapy probe precisely to maximize the efficacy of the treatment and avoid damage to critical surrounding structures. The objective of this paper was to propose a robotic instrument guide for orienting cryotherapy probes in image-guided cryotherapy of renal cancers. The authors propose a body-mounted robotic guide that is expected to be less susceptible to guidance errors caused by the patient's whole body motion. METHODS: Keeping the device's minimal footprint in mind, the authors developed and validated a body-mounted, robotic instrument guide that can maintain the geometrical relationship between the device and the patient's body, even in the presence of the patient's frequent body motions. The guide can orient the cryotherapy probe with the skin incision point as the remote-center-of-motion. The authors' validation studies included an evaluation of the mechanical accuracy and position repeatability of the robotic instrument guide. The authors also performed a mock MRI-guided cryotherapy procedure with a phantom to compare the advantage of robotically assisted probe replacements over a free-hand approach, by introducing organ motions to investigate their effects on the accurate placement of the cryotherapy probe. Measurements collected for performance analysis included accuracy and time taken for probe placements. Multivariate analysis was performed to assess if either or both organ motion and the robotic guide impacted these measurements. RESULTS: The mechanical accuracy and position repeatability of the probe placement using the robotic instrument guide were 0.3 and 0.1 mm, respectively, at a depth of 80 mm. The phantom test indicated that the accuracy of probe placement was significantly better with the robotic instrument guide (4.1 mm) than without the guide (6.3 mm, p<0.001), even in the presence of body motion. When independent organ motion was artificially added, in addition to body motion, the advantage of accurate probe placement using the robotic instrument guide disappeared statistically [i.e., 6.0 mm with the robotic guide and 5.9 mm without the robotic guide (p = 0.906)]. When the robotic instrument guide was used, the total time required to complete the procedure was reduced from 19.6 to 12.7 min (p<0.001). Multivariable analysis indicated that the robotic instrument guide, not the organ motion, was the cause of statistical significance. The statistical power the authors obtained was 88% in accuracy assessment and 99% higher in duration measurement. CONCLUSIONS: The body-mounted robotic instrument guide allows positioning of the probe during image-guided cryotherapy of renal cancer and was done in fewer attempts and in less time than the free-hand approach. The accuracy of the placement of the cryotherapy probe was better using the robotic instrument guide than without the guide when no organ motion was present. The accuracy between the robotic and free-hand approach becomes comparable when organ motion was present.

A novel four-wire-driven robotic catheter for radio-frequency ablation treatment.

PURPOSE:    Robotic catheters have been proposed to increase the efficacy and safety of the radio-frequency ablation treatment. The robotized motion of current robotic catheters mimics the motion of manual ones-namely, deflection in one direction and rotation around the catheter. With the expectation that the higher dexterity may achieve further efficacy and safety of the robotically driven treatment, we prototyped a four-wire-driven robotic catheter with the ability to deflect in two- degree-of-freedom motions in addition to rotation. METHODS:    A novel quad-directional structure with two wires was designed and developed to attain yaw and pitch motion in the robotic catheter. We performed a mechanical evaluation of the bendability and maneuverability of the robotic catheter and compared it with current manual catheters. RESULTS:    We found that the four-wire-driven robotic catheter can achieve a pitching angle of 184.7[Formula: see text] at a pulling distance of wire for 11 mm, while the yawing angle was 170.4[Formula: see text] at 11 mm. The robotic catheter could attain the simultaneous two- degree-of-freedom motions in a simulated cardiac chamber. CONCLUSION:    The results indicate that the four-wire-driven robotic catheter may offer physicians the opportunity to intuitively control a catheter and smoothly approach the focus position that they aim to ablate.

Prototype Design and Phantom Evaluation of a Device for Co-registered MRI/TRUS Imaging of the Prostate.

Magnetic Resonance Imaging (MRI) and transrectal Ultrasound (TRUS) are both used in imaging interventions in men suspected of having and with prostate cancer for diagnosis as well as treatment. Due to the widespread availability and ease of use of TRUS, it is widely acknowledged that availability of spatially registered MRI/TRUS data could provide the optimal combination for characterization of prostate tissue and interventional guidance. To provide such spatially aligned data, we propose a device to support co-registered acquisition of MRI and TRUS data while maintaining a stable configuration (shape) of the prostate. We present the design and evaluation of a custom sleeve that can be introduced transrectally, and can accommodate both TRUS and endorectal MRI probes. Our experiments on a phantom have demonstrated that imaging with this sleeve did not compromise differentiation of internal structures and did not affect the quality of the MR acquisition. Reduction of the signal and contrast were however observed and quantified in the TRUS data. Further evaluation and modification of the device necessary for possible patient studies are discussed.

Multi-section continuum robot for endoscopic surgical clipping of intracranial aneurysms.

We propose the development and assessment of a multi-section continuum robot for endoscopic surgical clipping of intracranial aneurysms. The robot has two sections for bending actuated by tendon wires. By actuating the two sections independently, the robot can generate a variety of posture combinations by these sections while maintaining the tip angle. This feature offers more flexibility in positioning of the tip than a conventional endoscope for large viewing angles of up to 180 degrees. To estimate the flexible positioning of the tip, we developed kinematic mapping with friction in tendon wires. In a kinematic-mapping simulation, the two-section robot at the target scale (i.e., an outer diameter of 1.7 mm and a length of 60 mm) had a variety of tip positions within 50-mm ranges at the 180 degree-angled view. In the experimental validation, the 1:10 scale prototype performed the three salient postures with different tip positions at the 1800-angled view.

A workspace-orientated needle-guiding robot for 3T MRI-guided transperineal prostate intervention: evaluation of in-bore workspace and MRI compatibility.

BACKGROUND: Magnetic resonance imaging (MRI)-guided prostate interventions have been introduced to enhance the cancer detection. For accurate needle positioning, in-bore-operated robotic systems have been developed and optimal use of the confined in-bore space become a critical engineering challenge. METHODS: As preliminary evaluation of our prostate intervention robot, we conducted a workspace design analysis, using a new evaluation method that we developed for in-bore-operated robots for transperineal prostate interventions, and an MRI compatibility study. RESULTS: The workspace analysis resulted in the effective workspace (VW ) of 0.32, which is greater than that of our early prototype, despite the current robot being ca. 50% larger than the early prototype in sectional space. The MRI compatibility study resulted in < 15% signal:noise ratio (SNR) reduction. CONCLUSIONS: The new workspace evaluation method quantifies the workspace utilization of the in-bore-operated robots for MRI-guided transperineal prostate interventions, providing a useful tool for evaluation and new robot design. The robot creates insignificant electromagnetic noise during typical prostate imaging sequences.

Development and preliminary evaluation of a motorized needle guide template for MRI-guided targeted prostate biopsy.

To overcome the problems of limited needle insertion accuracy and human error in the use of a conventional needle guide template in magnetic resonance imaging (MRI)-guided prostate intervention, we developed a motorized MRI-compatible needle guide template that resembles a transrectal ultrasound-guided prostate template. The motorized template allows automated, gapless needle guidance in a 3T MRI scanner with minimal changes in the current clinical procedure. To evaluate the impact of the motorized template on MRI, signal-to-noise ratio and distortion were measured under various system configurations. A maximum of 44% signal-to-noise ratio decrease was found when the ultrasonic motors were running, and a maximum of 0.4% image distortion was observed due to the presence of the motorized template. To measure needle insertion accuracy, we performed four sets of five random target needle insertions mimicking four biopsy procedures, which resulted in an average in-plane targeting error of 0.94 mm with a standard deviation of 0.34 mm. The evaluation studies indicated that the presence and operation of the motorized template in the MRI bore create insignificant image degradation, and provide submillimeter targeting accuracy. The automated needle guide that is directly controlled by navigation software eliminates human error so that the safety of the procedure can be improved.

Configurable automatic detection and registration of fiducial frames for device-to-image registration in MRI-guided prostate interventions.

We propose a novel automatic fiducial frame detection and registration method for device-to-image registration in MRI-guided prostate interventions. The proposed method does not require any manual selection of markers, and can be applied to a variety of fiducial frames, which consist of multiple cylindrical MR-visible markers placed in different orientations. The key idea is that automatic extraction of linear features using a line filter is more robust than that of bright spots by thresholding; by applying a line set registration algorithm to the detected markers, the frame can be registered to the MRI. The method was capable of registering the fiducial frame to the MRI with an accuracy of 1.00 +/- 0.73 mm and 1.41 +/- 1.06 degrees in a phantom study, and was sufficiently robust to detect the fiducial frame in 98% of images acquired in clinical cases despite the existence of anatomical structures in the field of view.

Accuracy study of a robotic system for MRI-guided prostate needle placement.

BACKGROUND: Accurate needle placement is the first concern in percutaneous MRI-guided prostate interventions. In this phantom study, different sources contributing to the overall needle placement error of a MRI-guided robot for prostate biopsy have been identified, quantified and minimized to the possible extent. METHODS: The overall needle placement error of the system was evaluated in a prostate phantom. This error was broken into two parts: the error associated with the robotic system (called 'before-insertion error') and the error associated with needle-tissue interaction (called 'due-to-insertion error'). Before-insertion error was measured directly in a soft phantom and different sources contributing into this part were identified and quantified. A calibration methodology was developed to minimize the 4-DOF manipulator's error. The due-to-insertion error was indirectly approximated by comparing the overall error and the before-insertion error. The effect of sterilization on the manipulator's accuracy and repeatability was also studied. RESULTS: The average overall system error in the phantom study was 2.5 mm (STD = 1.1 mm). The average robotic system error in the Super Soft plastic phantom was 1.3 mm (STD = 0.7 mm). Assuming orthogonal error components, the needle-tissue interaction error was found to be approximately 2.13 mm, thus making a larger contribution to the overall error. The average susceptibility artifact shift was 0.2 mm. The manipulator's targeting accuracy was 0.71 mm (STD = 0.21 mm) after robot calibration. The robot's repeatability was 0.13 mm. Sterilization had no noticeable influence on the robot's accuracy and repeatability. CONCLUSIONS: The experimental methodology presented in this paper may help researchers to identify, quantify and minimize different sources contributing into the overall needle placement error of an MRI-guided robotic system for prostate needle placement. In the robotic system analysed here, the overall error of the studied system remained within the acceptable range.