Chunwoo Kim

MRI-Safe Robot for Endorectal Prostate Biopsy

This paper reports the development of an MRI-Safe robot for direct (interventional) MRI-guided endorectal prostate biopsy. The robot is constructed of nonmagnetic and electrically nonconductive materials, and is electricity free, using pneumatic actuation and optical sensors. Targeting biopsy lesions of MRI abnormality presents substantial clinical potential for the management of prostate cancer. This paper describes MRI-Safe requirements and presents the kinematic architecture, design, and construction of the robot, and a comprehensive set of preclinical tests for MRI compatibility and needle targeting accuracy. The robot has a compact and simple three degree-of-freedom (DoF) structure, two for orienting a needle-guide and one to preset the depth of needle insertion. The actual insertion is performed manually through the guide and up to the preset depth. To reduce the complexity and size of the robot next to the patient, the depth setting DoF is remote. Experimental results show that the robot is safe to use in any MRI environment (MRI-Safe). Comprehensive MRI tests show that the presence and motion of the robot in the MRI scanner cause virtually no image deterioration or signal-to-noise ratio change. Robots accuracy in bench test, CT-guided in-vitro, MRI-guided in-vitro , and animal tests are 0.37, 1.10, 2.09, and 2.58 mm, respectively. These values are acceptable for clinical use.

Tandem-robot Assisted Laparoscopic Radical Prostatectomy to Improve the Neurovascular Bundle Visualization: A Feasibility Study

OBJECTIVES To examine the feasibility of image-guided navigation using transrectal ultrasound (TRUS) to visualize the neurovascular bundle (NVB) during robot-assisted laparoscopic radical prostatectomy (RALP). The preservation of the NVB during radical prostatectomy improves the postoperative recovery of sexual potency. The accompanying blood vessels in the NVB can serve as a macroscopic landmark to localize the microscopic cavernous nerves in the NVB. METHODS A novel, robotic transrectal ultrasound probe manipulator (TRUS Robot) and three-dimensional (3-D) reconstruction software were developed and used concurrently with the daVinci surgical robot (Intuitive Surgical, Inc., Sunnyvale, CA) in a tandem-robot assisted laparoscopic radical prostatectomy (T-RALP). RESULTS After appropriate approval and informed consent were obtained, 3 subjects underwent T-RALP without associated complications. The TRUS Robot allowed a steady handling and remote manipulation of the TRUS probe during T-RALP. It also tracked the TRUS probe position accurately and allowed 3-D image reconstruction of the prostate and surrounding structures. Image navigation was performed by observing the tips of the daVinci surgical instruments in the live TRUS image. Blood vessels in the NVB were visualized using Doppler ultrasound. CONCLUSIONS Intraoperative 3-D image-guided navigation in T-RALP is feasible. The use of TRUS during radical prostatectomy can potentially improve the visualization and preservation of the NVB. Further studies are needed to assess the clinical benefit of T-RALP.

Does Needle Rotation Improve Lesion Targeting

Image‐guided robots are manipulators that operate based on medical images. Perhaps the most common class of image‐guided robots are robots for needle interventions. Typically, these robots actively position and/or orient a needle guide, but needle insertion is still done by the physician. While this arrangement may have safety advantages and keep the physician in control of needle insertion, actuated needle drivers can incorporate other useful features.

Geometric evaluation of systematic transrectal ultrasound guided prostate biopsy.

PURPOSE Transrectal ultrasound guided prostate biopsy results rely on physician ability to target the gland according to the biopsy schema. However, to our knowledge it is unknown how accurately the freehand, transrectal ultrasound guided biopsy cores are placed in the prostate and how the geometric distribution of biopsy cores may affect the prostate cancer detection rate. MATERIALS AND METHODS To determine the geometric distribution of cores, we developed a biopsy simulation system with pelvic mock-ups and an optical tracking system. Mock-ups were biopsied in a freehand manner by 5 urologists and by our transrectal ultrasound robot, which can support and move the transrectal ultrasound probe. We compared 1) targeting errors, 2) the accuracy and precision of repeat biopsies, and 3) the estimated significant prostate cancer (0.5 cm(3) or greater) detection rate using a probability based model. RESULTS Urologists biopsied cores in clustered patterns and under sampled a significant portion of the prostate. The robot closely followed the predefined biopsy schema. The mean targeting error of the urologists and the robot was 9.0 and 1.0 mm, respectively. Robotic assistance significantly decreased repeat biopsy errors with improved accuracy and precision. The mean significant prostate cancer detection rate of the urologists and the robot was 36% and 43%, respectively (p <0.0001). CONCLUSIONS Systematic biopsy with freehand transrectal ultrasound guidance does not closely follow the sextant schema and may result in suboptimal sampling and cancer detection. Repeat freehand biopsy of the same target is challenging. Robotic assistance with optimized biopsy schemas can potentially improve targeting, precision and accuracy. A clinical trial is needed to confirm the additional benefits of robotic assistance.

Endocavity Ultrasound Probe Manipulators

We developed two similar structure manipulators for medical endocavity ultrasound probes with 3 and 4 degrees of freedom (DoF). These robots allow scanning with ultrasound for 3-D imaging and enable robot-assisted image-guided procedures. Both robots use remote center of motion kinematics, characteristic of medical robots. The 4-DoF robot provides unrestricted manipulation of the endocavity probe. With the 3-DoF robot the insertion motion of the probe must be adjusted manually, but the device is simpler and may also be used to manipulate external-body probes. The robots enabled a novel surgical approach of using intraoperative image-based navigation during robot-assisted laparoscopic prostatectomy (RALP), performed with concurrent use of two robotic systems (Tandem, T-RALP). Thus far, a clinical trial for evaluation of safety and feasibility has been performed successfully on 46 patients. This paper describes the architecture and design of the robots, the two prototypes, control features related to safety, preclinical experiments, and the T-RALP procedure.

Ultrasound Probe and Needle-Guide Calibration for Robotic Ultrasound Scanning and Needle Targeting

Image-to-robot registration is a typical step for robotic image-guided interventions. If the imaging device uses a portable imaging probe that is held by a robot, this registration is constant and has been commonly named probe calibration. The same applies to probes tracked by a position measurement device. We report a calibration method for 2-D ultrasound probes using robotic manipulation and a planar calibration rig. Moreover, a needle guide that is attached to the probe is also calibrated for ultrasound-guided needle targeting. The method is applied to a transrectal ultrasound (TRUS) probe for robot-assisted prostate biopsy. Validation experiments include TRUS-guided needle targeting accuracy tests. This paper outlines the entire process from the calibration to image-guided targeting. Freehand TRUS-guided prostate biopsy is the primary method of diagnosing prostate cancer, with over 1.2 million procedures performed annually in the U.S. alone. However, freehand biopsy is a highly challenging procedure with subjective quality control. As such, biopsy devices are emerging to assist the physician. Here, we present a method that uses robotic TRUS manipulation. A 2-D TRUS probe is supported by a 4-degree-of-freedom robot. The robot performs ultrasound scanning, enabling 3-D reconstructions. Based on the images, the robot orients a needle guide on target for biopsy. The biopsy is acquired manually through the guide. In vitro tests showed that the 3-D images were geometrically accurate, and an image-based needle targeting accuracy was 1.55 mm. These validate the probe calibration presented and the overall robotic system for needle targeting. Targeting accuracy is sufficient for targeting small, clinically significant prostatic cancer lesions, but actual in vivo targeting will include additional error components that will have to be determined.

MR Safe Robot, FDA Clearance, Safety and Feasibility of Prostate Biopsy Clinical Trial

Compatibility of mechatronic devices with the MR environment has been a very challenging engineering task. After over a decade of developments, we report the successful translation to clinical trials of our MR safe robot technology. MrBot is a six degree of freedom, pneumatically actuated robot for transperineal prostate percutaneous access, built exclusively of electrically nonconductive and nonmagnetic materials. Its extensive preclinical tests have been previously reported. Here, we present the latest technology developments, an overview of the regulatory protocols, and technically related results of the clinical trial. The Food and Drug Administration (FDA) has approved the MrBot for the biopsy trial, which was successfully performed in five patients. With no trajectory corrections and no unsuccessful attempts to target a site, the robot achieved an MRI-based needle targeting accuracy of 2.55 mm. To the best of our knowledge, this is the first robot approved by the FDA for the MR environment. The results confirm that it is possible to perform safe and accurate robotic manipulation in the MRI scanner, and the development of MR safe robots is no longer a daunting technical challenge.

MRI-safe robot for targeted transrectal prostate biopsy: Animal experiments

To study the feasibility and safety of using a magnetic resonance imaging (MRI)‐safe robot for assisting MRI‐guided transrectal needle placement and biopsy in the prostate, using a canine model. To determine the accuracy and precision afforded by the use of the robot while targeting a desired location in the organ.

Robot for ultrasound-guided prostate imaging and intervention

The paper presents a new robot for manipulating a transrectal ultrasound probe for image-guided intervention of the prostate, the TRUS robot. The robot positions and orients the probe for image scanning and needle targeting of the prostate. Image slices and their respective position are mapped three-dimensionally to render volumetric images. The robot is designed to accommodate the constraints of the clinical prostate intervention. The robot includes all 4 degrees-of-freedom that are available in manual handling of the probe. In-vitro studies on pelvic mockups verify 3D imaging capabilities. The robot is clinically used in robot-assisted laparoscopic radical prostatectomy for providing intraoperative ultrasound-based navigation for the surgeon.

Safety and Feasibility of Direct Magnetic Resonance Imaging-guided Transperineal Prostate Biopsy Using a Novel Magnetic Resonance Imaging-safe Robotic Device

OBJECTIVE To evaluate safety and feasibility in a first-in-human trial of a direct magnetic resonance imaging (MRI)-guided prostate biopsy using a novel robotic device. METHODS MrBot is an MRI-safe robotic device constructed entirely with nonconductive, nonmetallic, and nonmagnetic materials and developed by our group. A safety and feasibility clinical trial was designed to assess the safety and feasibility of a direct MRI-guided biopsy with MrBot and to determine its targeting accuracy. Men with elevated prostate-specific antigen levels, prior negative prostate biopsies, and cancer-suspicious regions (CSRs) on MRI were enrolled in the study. Biopsies targeting CSRs, in addition to sextant locations, were performed. RESULTS Five men underwent biopsy with MrBot. Two men required Foley catheter insertion after the procedure, with no other complications or adverse events. Even though this was not a study designed to detect prostate cancer, biopsies confirmed the presence of a clinically significant cancer in 2 patients. On a total of 30 biopsy sites, the robot achieved an MRI-based targeting accuracy of 2.55 mm and a precision of 1.59 mm normal to the needle, with no trajectory corrections and no unsuccessful attempts to target a site. CONCLUSION Robot-assisted MRI-guided prostate biopsy appears safe and feasible. This study confirms that a clinically significant prostate cancer (≥5-mm radius, 0.5 cm3) depicted in MRI may be accurately targeted. Direct confirmation of needle placement in the CSR may present an advantage over fusion-based technology and gives more confidence in a negative biopsy result. Additional study is warranted to evaluate the efficacy of this approach.