Transurethral Anastomosis after Transurethral Radical Prostatectomy: A Phantom Study on Intraluminal Suturing With Concentric Tube Robots.

Current surgical approaches to radical prostatectomy are associated with high rates of erectile dysfunction and incontinence. These complications occur secondary to the disruption of surrounding healthy tissue, which is required to expose the prostate. The urethra offers the least invasive access to the prostate, and feasibility has been demonstrated of enucleating the prostate with an endoscope using Holmium laser, which can itself be aimed by concentric tube robots. However, the transurethral approach to radical prostatectomy has thus far been limited by the lack of a suitable means to perform an anastomosis of the urethra to the bladder after prostate removal. Only a few intraluminal anastomotic devices currently exist, and none are small enough to pass through the urethra. In this paper we describe a new way to perform an anastomosis in the small luminal space of the urethra, harnessing the dexterity and customizability of concentric tube manipulators. We demonstrate a successful initial proof-of-concept anastomosis in an anthropomorphic phantom of the urethra and bladder.

A Novel Robotic Endoscopic Device Used for Operative Hysteroscopy.

To trial the use of a novel endoscopic robot that functions using concentric tube robots, enabling 2-handed surgery in small spaces, in a bioengineering laboratory. This was a feasibility study of the endoscopic robot for hysteroscopic applications, including removal of a simulated endometrial polyp. The endoscopic robot was successfully used to resect a simulated endometrial polyp from a porcine uterine tissue model in a fluid environment. The potential advantages of this platform to the surgeon may include improved exposure, finer dissection capability, and use of a 2-handed surgical technique. Further study regarding the safe, efficient, and cost-effective use of the endoscopic robot in gynecology is needed.

A Concentric Tube Robot System for Rigid Bronchoscopy: A Feasibility Study on Central Airway Obstruction Removal.

New robotic systems have recently emerged to assist with peripheral lung access, but a robotic system for rigid bronchoscopy has yet to be developed. We describe a new robotic system that can deliver thin robotic manipulators through the ports of standard rigid bronchoscopes. The manipulators bend and elongate to provide maneuverability of surgical tools at the endoscope tip, without endoscope motion. We describe an initial feasibility study on the use of this system to bronchoscopically treat a central airway obstruction (CAO). CAO is prevalent and can be life-threatening in patients with large tumors, and conventional rigid bronchoscopic treatments place patients at risk of complications including broken teeth, neck trauma and damage to oropharyngeal structures due to significant forces induced by bronchoscope tilting and manipulation. In this study, we used an ex vivo ovine airway model to demonstrate the ability of a physician using the robotic system to efficiently remove tissue and restore the airway. Pre- and post-operative CT scans showed that the robot was able to reduce the degree of airway obstruction stenosis from 75 to 14% on average for five CAO resections performed in an ex vivo animal model. Using cadaver experiments, we demonstrated the potential of the robotic system to substantially reduce the intraoperative forces applied to the patient's head and neck (from 80.6 to 4.1 N). These preliminary results illustrate that CAO removal is feasible with our new rigid bronchoscopy robot system, and that this approach has the potential to reduce forces applied to the patient due to bronchoscope angulation, and thereby reduce the risk of complications encountered during CAO surgery.

Investigating variability in cochlear implant electrode array alignment and the potential of visualization guidance.

Background Internal cochlear anatomy is difficult to discern from external inspection, hindering cochlear implant electrode insertion. Methods A user study characterized the repeatability of standard surgical technique and examined the role of visual inspection and guidance cues in reducing electrode array insertion misalignment. Results Without guidance, a large spread in angles of insertion, up to 30°, was observed, highlighting the need for intraoperative guidance. Visual inspection did not significantly improve overall orientation, suggesting the need for alternate intracochlear visualization methods and/or increased training to effectively improve surgeon understanding of the visualized images. Visual cues and guidance software increased repeatability of surgeon performance, reducing one metric of repeatability to ±2°. Conclusions This study establishes a baseline for surgeon variability in cochlear implant insertion and supports the need and lays the groundwork for future intraoperative guidance techniques.

Endoscopic Ear Surgery Skills Training Improves Medical Student Performance.

OBJECTIVE: Analyze medical student performance using an endoscopic ear surgery (EES) skills trainer over time. DESIGN: Simulation experience. SETTING: Surgical skills lab. PARTICIPANTS: Five medical students and 1 expert surgeon completed 3 training sessions using an EES trainer to practice specific tasks designed to improve instrument control. During each session, participants performed 3 tasks, such as placing beads onto wires, 5 times per session for a total of 15 trials per task. Exercises were scored based on completion time. Results were compared before and after training. Pre- and post-task surveys were administered. RESULTS: Prior to skills training, 0% of medical students reported feeling comfortable holding an endoscope or ear instruments. For students, overall mean completion times decreased significantly for each exercise by the conclusion of the training experience: placing beads on wires improved from 152 to 44 seconds (p < 0.001), placing simulated prostheses from 264 to 93 seconds (p < 0.001), and navigating a pattern from 193 to 66 seconds (p = 0.002). Individual analysis showed varying learning curves among participants and between exercises, with some students exhibiting rapid improvement. At the conclusion of training, 80% of students felt comfortable holding the endoscope and using otologic instruments, and 100% were satisfied with the experience. CONCLUSIONS: Novice surgeons can exhibit significant skill improvement with repetitive practice on an EES trainer. Variable baseline skill and improvement rates highlight the individual characteristics of skill acquisition, which may be important factors during otolaryngology and endoscopic ear surgery training.

Through the Eustachian Tube and Beyond: A New Miniature Robotic Endoscope to See Into The Middle Ear.

This paper presents a novel miniature robotic endoscope that is small enough to pass through the Eustachian tube and provide visualization of the middle ear (ME). The device features a miniature bending tip previously conceived of as a small-scale robotic wrist that has been adapted to carry and aim a small chip-tip camera and fiber optic light sources. The motivation for trans-Eustachian tube ME inspection is to provide a natural-orifice-based route to the ME that does not require cutting or lifting the eardrum, as is currently required. In this paper, we first perform an analysis of the ME anatomy and use a computational design optimization platform to derive the kinematic requirements for endoscopic inspection of the ME through the Eustachian tube. Based on these requirements, we fabricate the proposed device and use it to demonstrate the feasibility of ME inspection in an anthropomorphic model, i.e. a 3D-printed ME phantom generated from patient image data. We show that our prototype provides > 74% visibility coverage of the sinus tympani, a region of the ME crucial for diagnosis, compared to an average of only 6.9% using a straight, non-articulated endoscope through the Eustachian Tube.

In vivo measurement of vocal fold surface resistance.

OBJECTIVES/HYPOTHESIS: A custom-designed probe was developed to measure vocal fold surface resistance in vivo. The purpose of this study was to demonstrate proof of concept of using vocal fold surface resistance as a proxy of functional tissue integrity after acute phonotrauma using an animal model. STUDY DESIGN: Prospective animal study. METHODS: New Zealand White breeder rabbits received 120 minutes of airflow without vocal fold approximation (control) or 120 minutes of raised intensity phonation (experimental). The probe was inserted via laryngoscope and placed on the left vocal fold under endoscopic visualization. Vocal fold surface resistance of the middle one-third of the vocal fold was measured after 0 (baseline), 60, and 120 minutes of phonation. After the phonation procedure, the larynx was harvested and prepared for transmission electron microscopy. RESULTS: In the control group, vocal fold surface resistance values remained stable across time points. In the experimental group, surface resistance (X% ± Y% relative to baseline) was significantly decreased after 120 minutes of raised intensity phonation. This was associated with structural changes using transmission electron microscopy, which revealed damage to the vocal fold epithelium after phonotrauma, including disruption of the epithelium and basement membrane, dilated paracellular spaces, and alterations to epithelial microprojections. In contrast, control vocal fold specimens showed well-preserved stratified squamous epithelia. CONCLUSIONS: These data demonstrate the feasibility of measuring vocal fold surface resistance in vivo as a means of evaluating functional vocal fold epithelial barrier integrity. Device prototypes are in development for additional testing, validation, and for clinical applications in laryngology. LEVEL OF EVIDENCE: NA Laryngoscope, 127:E364-E370, 2017.

Human Kinematics of Cochlear Implant Surgery: An Investigation of Insertion Micro-Motions and Speed Limitations.

Objectives Document human motions associated with cochlear implant electrode insertion at different speeds and determine the lower limit of continuous insertion speed by a human. Study Design Observational. Setting Academic medical center. Subjects and Methods Cochlear implant forceps were coupled to a frame containing reflective fiducials, which enabled optical tracking of the forceps' tip position in real time. Otolaryngologists (n = 14) performed mock electrode insertions at different speeds based on recommendations from the literature: "fast" (96 mm/min), "stable" (as slow as possible without stopping), and "slow" (15 mm/min). For each insertion, the following metrics were calculated from the tracked position data: percentage of time at prescribed speed, percentage of time the surgeon stopped moving forward, and number of direction reversals (ie, going from forward to backward motion). Results Fast insertion trials resulted in better adherence to the prescribed speed (45.4% of the overall time), no motion interruptions, and no reversals, as compared with slow insertions (18.6% of time at prescribed speed, 15.7% stopped time, and an average of 18.6 reversals per trial). These differences were statistically significant for all metrics ( P < .01). The metrics for the fast and stable insertions were comparable; however, stable insertions were performed 44% slower on average. The mean stable insertion speed was 52 ± 19.3 mm/min. Conclusion Results indicate that continuous insertion of a cochlear implant electrode at 15 mm/min is not feasible for human operators. The lower limit of continuous forward insertion is 52 mm/min on average. Guidelines on manual insertion kinematics should consider this practical limit of human motion.

Pre-operative Screening and Manual Drilling Strategies to Reduce the Risk of Thermal Injury During Minimally Invasive Cochlear Implantation Surgery.

This article presents the development and experimental validation of a methodology to reduce the risk of thermal injury to the facial nerve during minimally invasive cochlear implantation surgery. The first step in this methodology is a pre-operative screening process, in which medical imaging is used to identify those patients that present a significant risk of developing high temperatures at the facial nerve during the drilling phase of the procedure. Such a risk is calculated based on the density of the bone along the drilling path and the thermal conductance between the drilling path and the nerve, and provides a criterion to exclude high-risk patients from receiving the minimally invasive procedure. The second component of the methodology is a drilling strategy for manually-guided drilling near the facial nerve. The strategy utilizes interval drilling and mechanical constraints to enable better control over the procedure and the resulting generation of heat. The approach is tested in fresh cadaver temporal bones using a thermal camera to monitor temperature near the facial nerve. Results indicate that pre-operative screening may successfully exclude high-risk patients and that the proposed drilling strategy enables safe drilling for low-to-moderate risk patients.

Coffee: the key to safer image-guided surgery-a granular jamming cap for non-invasive, rigid fixation of fiducial markers to the patient.

PURPOSE: Accurate image guidance requires a rigid connection between tracked fiducial markers and the patient, which cannot be guaranteed by current non-invasive attachment techniques. We propose a new granular jamming approach to firmly, yet non-invasively, connect fiducials to the patient. METHODS: Our granular jamming cap surrounds the head and conforms to the contours of the patient's skull. When a vacuum is drawn, the device solidifies in a manner conceptually like a vacuum-packed bag of ground coffee, providing a rigid structure that can firmly hold fiducial markers to the patient's skull. By using the new Polaris Krios optical tracker, we can also use more fiducials in advantageous configurations to reduce registration error. RESULTS: We tested our new approach against a clinically used headband-based fiducial fixation device under perturbations that could reasonably be expected to occur in a real-world operating room. In bump testing, we found that the granular jamming cap reduced average TRE at the skull base from 2.29 to 0.56 mm and maximum TRE at the same point from 7.65 to 1.30 mm. Clinically significant TRE reductions were also observed in head repositioning and static force testing experiments. CONCLUSION: The granular jamming cap concept increases the robustness and accuracy of image-guided sinus and skull base surgery by more firmly attaching fiducial markers to the patient's skull.

Cadaveric Testing of Robot-Assisted Access to the Internal Auditory Canal for Vestibular Schwannoma Removal.

HYPOTHESIS: An image-guided robotic system can safely perform the bulk removal of bone during the translabyrinthine approach to vestibular schwannoma (VS). BACKGROUND: The translabyrinthine approach to VS removal involves extensive manual milling in the temporal bone to gain access to the internal auditory canal (IAC) for tumor resection. This bone removal is time consuming and challenging due to the presence of vital anatomy (e.g., facial nerve) embedded within the temporal bone. A robotic system can use preoperative imaging and segmentations to guide a surgical drill to remove a prescribed volume of bone, thereby preserving the surgeon for the more delicate work of opening the IAC and resecting the tumor. METHODS: Fresh human cadaver heads were used in the experiments. For each trial, the desired bone resection volume was planned on a preoperative computed tomography (CT) image, the steps in the proposed clinical workflow were undertaken, and the robot was programmed to mill the specified volume. A postoperative CT scan was acquired for evaluation of the accuracy of the milled cavity and examination of vital anatomy. RESULTS: In all experimental trials, the facial nerve and chorda tympani were preserved. The root mean squared surface accuracy of the milled cavities ranged from 0.23 to 0.65 mm and the milling time ranged from 32.7 to 57.0 minute. CONCLUSION: This work shows feasibility of using a robot-assisted approach for VS removal surgery. Further testing and system improvements are necessary to enable clinical translation of this technology.

Safety margins in robotic bone milling: from registration uncertainty to statistically safe surgeries.

BACKGROUND: When robots mill bone near critical structures, safety margins are used to reduce the risk of accidental damage due to inaccurate registration. These margins are typically set heuristically with uniform thickness, which does not reflect the anisotropy and spatial variance of registration error. METHODS: A method is described to generate spatially varying safety margins around vital anatomy using statistical models of registration uncertainty. Numerical simulations are used to determine the margin geometry that matches a safety threshold specified by the surgeon. RESULTS: The algorithm was applied to CT scans of five temporal bones in the context of mastoidectomy, a common bone milling procedure in ear surgery that must approach vital nerves. Safety margins were generated that satisfied the specified safety levels in every case. CONCLUSIONS: Patient safety in image-guided surgery can be increased by incorporating statistical models of registration uncertainty in the generation of safety margins around vital anatomy.

Accuracy of linear drilling in temporal bone using drill press system for minimally invasive cochlear implantation.

PURPOSE: A minimally invasive approach for cochlear implantation involves drilling a narrow linear path through the temporal bone from the skull surface directly to the cochlea for insertion of the electrode array without the need for an invasive mastoidectomy. Potential drill positioning errors must be accounted for to predict the effectiveness and safety of the procedure. The drilling accuracy of a system used for this procedure was evaluated in bone surrogate material under a range of clinically relevant parameters. Additional experiments were performed to isolate the error at various points along the path to better understand why deflections occur. METHODS: An experimental setup to precisely position the drill press over a target was used. Custom bone surrogate test blocks were manufactured to resemble the mastoid region of the temporal bone. The drilling error was measured by creating divots in plastic sheets before and after drilling and using a microscope to localize the divots. RESULTS: The drilling error was within the tolerance needed to avoid vital structures and ensure accurate placement of the electrode; however, some parameter sets yielded errors that may impact the effectiveness of the procedure when combined with other error sources. The error increases when the lateral stage of the path terminates in an air cell and when the guide bushings are positioned further from the skull surface. At contact points due to air cells along the trajectory, higher errors were found for impact angles of [Formula: see text] and higher as well as longer cantilevered drill lengths. CONCLUSION: The results of these experiments can be used to define more accurate and safe drill trajectories for this minimally invasive surgical procedure.

Increasing Safety of a Robotic System for Inner Ear Surgery Using Probabilistic Error Modeling Near Vital Anatomy.

Safe and effective planning for robotic surgery that involves cutting or ablation of tissue must consider all potential sources of error when determining how close the tool may come to vital anatomy. A pre-operative plan that does not adequately consider potential deviations from ideal system behavior may lead to patient injury. Conversely, a plan that is overly conservative may result in ineffective or incomplete performance of the task. Thus, enforcing simple, uniform-thickness safety margins around vital anatomy is insufficient in the presence of spatially varying, anisotropic error. Prior work has used registration error to determine a variable-thickness safety margin around vital structures that must be approached during mastoidectomy but ultimately preserved. In this paper, these methods are extended to incorporate image distortion and physical robot errors, including kinematic errors and deflections of the robot. These additional sources of error are discussed and stochastic models for a bone-attached robot for otologic surgery are developed. An algorithm for generating appropriate safety margins based on a desired probability of preserving the underlying anatomical structure is presented. Simulations are performed on a CT scan of a cadaver head and safety margins are calculated around several critical structures for planning of a robotic mastoidectomy.

Making Robots Mill Bone More Like Human Surgeons: Using Bone Density and Anatomic Information to Mill Safely and Efficiently.

Surgeons and robots typically use different approaches for bone milling. Surgeons adjust their speed and tool incidence angle constantly, which enables them to efficiently mill porous bone. Surgeons also adjust milling parameters such as speed and depth of cut throughout the procedure based on proximity to sensitive structures like nerves and blood vessels. In this paper we use image-based bone density estimates and segmentations of vital anatomy to make a robot mill more like a surgeon and less like an industrial computer numeric controlled (CNC) milling machine. We produce patient-specific plans optimizing velocity and incidence angles for spherical cutting burrs. These plans are particularly useful in bones of variable density and porosity like the human temporal bone. They result in fast milling in non-critical areas, reducing overall procedure time, and lower forces near vital anatomy. We experimentally demonstrate the algorithm on temporal bone phantoms and show that it reduces mean forces near vital anatomy by 63% and peak forces by 50% in comparison to a CNC-type path, without adding time to the procedure.

Incorporating Target Registration Error Into Robotic Bone Milling.

Robots have been shown to be useful in assisting surgeons in a variety of bone drilling and milling procedures. Examples include commercial systems for joint repair or replacement surgeries, with in vitro feasibility recently shown for mastoidectomy. Typically, the robot is guided along a path planned on a CT image that has been registered to the physical anatomy in the operating room, which is in turn registered to the robot. The registrations often take advantage of the high accuracy of fiducial registration, but, because no real-world registration is perfect, the drill guided by the robot will inevitably deviate from its planned path. The extent of the deviation can vary from point to point along the path because of the spatial variation of target registration error. The allowable deviation can also vary spatially based on the necessary safety margin between the drill tip and various nearby anatomical structures along the path. Knowledge of the expected spatial distribution of registration error can be obtained from theoretical models or experimental measurements and used to modify the planned path. The objective of such modifications is to achieve desired probabilities for sparing specified structures. This approach has previously been studied for drilling straight holes but has not yet been generalized to milling procedures, such as mastoidectomy, in which cavities of more general shapes must be created. In this work, we present a general method for altering any path to achieve specified probabilities for any spatial arrangement of structures to be protected. We validate the method via numerical simulations in the context of mastoidectomy.

A Compact, Bone-Attached Robot for Mastoidectomy.

Otologic surgery often involves a mastoidectomy, which is the removal of a portion of the mastoid region of the temporal bone, to safely access the middle and inner ear. The surgery is challenging because many critical structures are embedded within the bone, making them difficult to see and requiring a high level of accuracy with the surgical dissection instrument, a high-speed drill. We propose to automate the mastoidectomy portion of the surgery using a compact, bone-attached robot. The system described in this paper is a milling robot with four degrees-of-freedom (DOF) that is fixed to the patient during surgery using a rigid positioning frame screwed into the surface of the bone. The target volume to be removed is manually identified by the surgeon pre-operatively in a computed tomography (CT) scan and converted to a milling path for the robot. The surgeon attaches the robot to the patient in the operating room and monitors the procedure. Several design considerations are discussed in the paper as well as the proposed surgical workflow. The mean targeting error of the system in free space was measured to be 0.5 mm or less at vital structures. Four mastoidectomies were then performed in cadaveric temporal bones, and the error at the edges of the target volume was measured by registering a postoperative computed tomography (CT) to the pre-operative CT. The mean error along the border of the milled cavity was 0.38 mm, and all critical anatomical structures were preserved.

Preliminary Testing of a Compact, Bone-Attached Robot for Otologic Surgery.

Otologic surgery often involves a mastoidectomy procedure, in which part of the temporal bone is milled away in order to visualize critical structures embedded in the bone and safely access the middle and inner ear. We propose to automate this portion of the surgery using a compact, bone-attached milling robot. A high level of accuracy is required to avoid damage to vital anatomy along the surgical path, most notably the facial nerve, making this procedure well-suited for robotic intervention. In this study, several of the design considerations are discussed and a robot design and prototype are presented. The prototype is a 4 degrees-of-freedom robot similar to a four-axis milling machine that mounts to the patient's skull. A positioning frame, containing fiducial markers and attachment points for the robot, is rigidly attached to the skull of the patient, and a CT scan is acquired. The target bone volume is manually segmented in the CT by the surgeon and automatically converted to a milling path and robot trajectory. The robot is then attached to the positioning frame and is used to drill the desired volume. The accuracy of the entire system (image processing, planning, robot) was evaluated at several critical locations within or near the target bone volume with a mean free space accuracy result of 0.50 mm or less at all points. A milling test in a phantom material was then performed to evaluate the surgical workflow. The resulting milled volume did not violate any critical structures.

An experimental evaluation of the force requirements for robotic mastoidectomy.

HYPOTHESIS: During robotic milling of the temporal bone, forces on the cutting burr may be lowered by choice of cutting parameters. BACKGROUND: Robotic bone removal systems are used in orthopedic procedures, but they are currently not accurate enough for safe use in otologic surgery. We propose the use of a bone-attached milling robot to achieve the required accuracy and speed. To design such a robot and plan its milling trajectories, it is necessary to predict the forces that the robot must exert and withstand under likely cutting conditions. MATERIALS AND METHODS: We measured forces during bone removal for several surgical burr types, drill angles, depths of cut, cutting velocities, and bone types (cortical/surface bone and mastoid) on human temporal bone specimens. RESULTS: Lower forces were observed for 5-mm diameter burrs compared with 3-mm burrs for a given bone removal rate. Higher linear cutting velocities and greater cutting depths independently resulted in higher forces. For combinations of velocities and depths that resulted in the same overall bone removal rate, lower forces were observed in parameter sets that combined higher cutting velocities and shallower depths. Lower mean forces and higher variability were observed in the mastoid compared with cortical/surface bone. CONCLUSION: Forces during robotic milling of the temporal bone can be predicted from the parameter sets tested in this study. This information can be used to guide the design of a sufficiently rigid and powerful bone-attached milling robot and to plan efficient milling trajectories. To reduce the time of the surgical intervention without creating very large forces, high linear cutting velocities may be combined with shallow depths of cut. Faster and deeper cuts may be used in mastoid bone compared with the cortical bone for a chosen force threshold.