Camera sheath with transformable head for minimally invasive surgical instruments.

INTRODUCTION: This paper presents a camera sheath that can be assembled to various minimally invasive surgical instruments and provide the localized view of the instrument tip. MATERIAL AND METHODS: The advanced transformable head structure (ATHS) that overcomes the trade-off between the camera resolution and the instrument size is designed for the sheath. Design solutions to maintain the alignment between the camera's line of sight and the instrument tip direction during the transformation of the ATHS are derived and applied to the prototype of the sheath. RESULTS: The design solution ensured proper alignment between the line of sight and the tip direction. The prototype was used with the curved micro-debrider blades in simulated functional endoscopic sinus surgery (FESS). Deep regions of the sinus that were not observable with the conventional endoscopes was accessed and observed using the prototype. CONCLUSIONS: The presented camera sheath allows the delivery of the instrument and camera to the surgical site with minimal increase in port size. It may be applied to various surgeries to reduce invasiveness and provide additional visual information to the surgeons.

Feasibility of Percutaneous Robot-Assisted Epiduroscopic System.

BACKGROUND: Endoscopy has replaced open surgery, especially in spinal surgery. Among them, image-guided epiduroscopy allows pain generators to be identified, including epidural adhesion, fibrotic tissues, root compression, and spinal stenosis. However, the heavy lead apron worn by pain physicians to avoid exposure to radiation can induce occupational hazards, such as orthopedic complications and radiation-induced cancer. Hence, we developed a robotic system to address these problems. OBJECTIVE: The aim of the study was to evaluate the feasibility of a robot-controlled epiduroscopic system. STUDY DESIGN: In vivo animal experiment. SETTING: University in Republic of Korea. METHODS: The robot-controlled epiduroscopic system was developed using the open architecture robot system (The Raven Surgical Robotic System, CITRIS, Berkley, CA, USA). The robotic system consists of a lab-made epiduroscope, steering section, robotic arm, and manipulator. For the in vivo study, 2 Yorkshire pigs were used to simulate an epiduroscopic procedure with the robotic system. RESULTS: The insertion and steering of the catheter was performed safely, and epiduroscopic visualization was obtained without side effects. There were no device-related complications. Radiation exposure for the primary operator was 80% lower than the levels found during conventional epiduroscopic procedures. All live pigs showed normal behavior without any signs of pain. The mean time to reach the target region was less than 8 minutes. LIMITATIONS: The epiduroscopic procedure was performed on pigs and not on humans. The dimensions of the spinal canal of pigs cannot compare to those of humans. CONCLUSIONS: We demonstrated the feasibility of the robot-assisted epiduroscopic system. KEY WORDS: Epiduroscopy, robotic system, spine, pig, animal model.

MR Safe Robot, FDA Clearance, Safety and Feasibility 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 6-degree-of-freedom, pneumatically actuated robot for transperineal prostate percutaneous access, built exclusively of electrically nonconductive and nonmagnetic materials. Its extensive pre-clinical 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 FDA has approved the MrBot for the biopsy trial, which was successfully performed in 5 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.

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.

Geometric systematic prostate biopsy.

OBJECTIVE: The common sextant prostate biopsy schema lacks a three-dimensional (3D) geometric definition. The study objective was to determine the influence of the geometric distribution of the cores on the detection probability of prostate cancer (PCa). METHODS: The detection probability of significant (>0.5 cm3) and insignificant (<0.2 cm3) tumors was quantified based on a novel 3D capsule model of the biopsy sample. The geometric distribution of the cores was optimized to maximize the probability of detecting significant cancer for various prostate sizes (20-100cm3), number of biopsy cores (6-40 cores) and biopsy core lengths (14-40 mm) for transrectal and transperineal biopsies. RESULTS: The detection of significant cancer can be improved by geometric optimization. With the current sextant biopsy, up to 20% of tumors may be missed at biopsy in a 20 cm3 prostate due to the schema. Higher number and longer biopsy cores are required to sample with an equal detection probability in larger prostates. Higher number of cores increases both significant and insignificant tumor detection probability, but predominantly increases the detection of insignificant tumors. CONCLUSION: The study demonstrates mathematically that the geometric biopsy schema plays an important clinical role, and that increasing the number of biopsy cores is not necessarily helpful.

MRI-safe robot for targeted transrectal prostate biopsy: animal experiments.

OBJECTIVES: 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. MATERIALS AND METHODS: In a study approved by the Institutional Animal Care and Use Committee, six healthy adult male beagles with prostates of at least 15 × 15 mm in size at the largest transverse section were chosen for the procedure. The probe portion of the robot was placed into the rectum of the dog, images were acquired and image-to-robot registration was performed. Images acquired after placement of the robot were reviewed and a radiologist selected targets for needle placement in the gland. Depending on the size of the prostate, up to a maximum of six needle placements were performed on each dog. After needle placement, robot-assisted core biopsies were performed on four dogs that had larger prostate volumes and extracted cores were analysed for potential diagnostic value. RESULTS: Robot-assisted MRI-guided needle placements were performed to target a total of 30 locations in six dogs, achieving a targeting accuracy of 2.58 mm (mean) and precision of 1.31 mm (SD). All needle placements were successfully completed on the first attempt. The mean time required to select a desired target location in the prostate, align the needle guide to that point, insert the needle and perform the biopsy was ∼ 3 min. For this targeting accuracy study, the inserted needle was also imaged after its placement in the prostate, which took an additional 6-8 min. Signal-to-noise ratio analysis indicated that the presence of the robot within the scanner bore had minimal impact on the quality of the images acquired. Analysis of intact biopsy core samples indicated that the samples contained prostatic tissues, appropriate for making a potential diagnosis. Dogs used in the study did not experience device- or procedure-related complications. CONCLUSIONS: Results from this preclinical pilot animal study suggest that MRI-targeted transrectal biopsies are feasible to perform and this procedure may be safely assisted by an MRI-safe robotic device.

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.

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. The paper describes MRI-Safe requirements, 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 3 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 (SNR) change. Robot's accuracy in bench test, CT-guided in-vitro, MRI-guided in-vitro and animal tests are 0.37mm, 1.10mm, 2.09mm, and 2.58mm respectively. These values are acceptable for clinical use.

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.

Does needle rotation improve lesion targeting?

BACKGROUND: 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. METHODS: We first present a new needle driver that can actively insert and rotate a needle. With this device we investigate the use of needle rotation in controlled in-vitro experiments performed with a specially developed revolving needle driver. RESULTS: These experiments show that needle rotation can improve targeting and may reduce errors by as much as 70%. CONCLUSION: The new needle driver provides a unique kinematic architecture that enables insertion with a compact mechanism. Perhaps the most interesting conclusion of the study is that lesions of soft tissue organs may not be perfectly targeted with a needle without using special techniques, either manually or with a robotic device. The results of this study show that needle rotation may be an effective method of reducing targeting errors.

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.