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.

Minimally invasive image-guided cochlear implantation surgery: first report of clinical implementation.

OBJECTIVES/HYPOTHESIS: Minimally invasive image-guided approach to cochlear implantation (CI) involves drilling a narrow, linear tunnel to the cochlea. Reported herein is the first clinical implementation of this approach. STUDY DESIGN: Prospective cohort study. METHODS: On preoperative computed tomography (CT), a safe linear trajectory through the facial recess targeting the scala tympani was planned. Intraoperatively, fiducial markers were bone-implanted, a second CT was acquired, and the trajectory was transferred from preoperative to intraoperative CT. A customized microstereotactic frame was rapidly designed and constructed to constrain a surgical drill along the desired trajectory. Following sterilization, the frame was employed to drill the tunnel to the middle ear. After lifting a tympanomeatal flap and performing a cochleostomy, the electrode array was threaded through the drilled tunnel and into the cochlea. RESULTS: Eight of nine patients were successfully implanted using the proposed approach with six insertions completely within the scala tympani. Traditional mastoidectomy was performed on one patient following difficulty threading the electrode array via the narrow tunnel. Other difficulties encountered included use of the backup implant when an electrode was dislodged during threading via the tunnel, tip fold-over, and facial nerve paresis (House-Brackmann II/VI at 12 months) secondary to heat during drilling. The average time of intervention was 182 ± 36 minutes. CONCLUSIONS: Minimally invasive image-guided CI is clinically achievable. Further clinical study is necessary to address technological difficulties during drilling and insertion, and to assess potential benefits including decreased time of intervention, standardization of surgical intervention, and decreased tissue dissection potentially leading to shorter recovery and earlier implant activation.

Minimally invasive image-guided cochlear implantation for pediatric patients: clinical feasibility study.

OBJECTIVE: Minimally invasive image-guided cochlear implantation (CI) involves accessing the cochlea via a linear path from the lateral skull to the cochlea avoiding vital structures including the facial nerve. Herein, we describe and demonstrate the feasibility of the technique for pediatric patients. STUDY DESIGN: Prospective. SETTING: Children's Hospital. SUBJECTS AND METHODS: Thirteen pediatric patients (1.5 to 8 years) undergoing traditional CI participated in this Institutional Review Board-approved study. Three fiducial markers were bone-implanted surrounding the ear, and a CT scan was acquired. The CT scan was processed to identify the marker locations and critical structures of the temporal bone. A safe linear path was determined to target the cochlea avoiding damage to vital structures. A custom microstereotactic frame was fabricated that would mount on the fiducial markers and constrain a tool to the desired trajectory. After traditional mastoidectomy and prior to cochleostomy, the custom microstereotactic frame was mounted on the bone-implanted markers to confirm that the achieved trajectory was safe and accurately accessed the cochlea. RESULTS: For all the 13 patients, it was possible to determine a safe trajectory to the cochlea. Custom microstereotactic frames were validated successfully on 9 patients. Two of these patients had inner ear malformations, and this technique helped the surgeon confirm ideal location for cochleostomy. For patients with normal anatomy, the mean and standard deviation of the closest distance of the trajectory to facial nerve and chorda tympani were 1.1 ± 0.3 mm and 1.2 ± 0.5 mm, respectively. CONCLUSION: Minimally invasive image-guided CI is feasible for pediatric patients.

Forces and trauma associated with minimally invasive image-guided cochlear implantation.

OBJECTIVE: Minimally invasive image-guided cochlear implantation (CI) utilizes a patient-customized microstereotactic frame to access the cochlea via a single drill-pass. We investigate the average force and trauma associated with the insertion of lateral wall CI electrodes using this technique. STUDY DESIGN: Assessment using cadaveric temporal bones. SETTING: Laboratory setup. SUBJECTS AND METHODS: Microstereotactic frames for 6 fresh cadaveric temporal bones were built using CT scans to determine an optimal drill path following which drilling was performed. CI electrodes were inserted using surgical forceps to manually advance the CI electrode array, via the drilled tunnel, into the cochlea. Forces were recorded using a 6-axis load sensor placed under the temporal bone during the insertion of lateral wall electrode arrays (2 each of Nucleus CI422, MED-EL standard, and modified MED-EL electrodes with stiffeners). Tissue histology was performed by microdissection of the otic capsule and apical photo documentation of electrode position and intracochlear tissue. RESULTS: After drilling, CT scanning demonstrated successful access to cochlea in all 6 bones. Average insertion forces ranged from 0.009 to 0.078 N. Peak forces were in the range of 0.056 to 0.469 N. Tissue histology showed complete scala tympani insertion in 5 specimens and scala vestibuli insertion in the remaining specimen with depth of insertion ranging from 360° to 600°. No intracochlear trauma was identified. CONCLUSION: The use of lateral wall electrodes with the minimally invasive image-guided CI approach was associated with insertion forces comparable to traditional CI surgery. Deep insertions were obtained without identifiable trauma.

Implantation of the completely ossified cochlea: an image-guided approach.

OBJECTIVES: To report a novel modification of the cochlear drill-out procedure that uses customized microstereotactic frames as drill guides. PATIENT(S): A 34-year-old man with an 18-year history of profound bilateral hearing loss and completely ossified cochleae that underwent a previous unsuccessful conventional cochlear drill-out procedure in the contralateral ear. INTERVENTIONS: Image-guided cochlear implantation using customized microstereotactic frames to drill linear basal and apical cochlear tunnels. MAIN OUTCOME MEASURES: Transfacial recess cochlear drill-out procedure with full electrode insertion. RESULTS: Two linear paths were drilled using customized microstereotactic frames targeting the proximal and distal basal turn followed by a full split array insertion. Postoperative imaging confirmed 2 cochlear tunnels straddling the modiolus with adequate clearance of the facial nerve and internal carotid artery. The patient received auditory benefit with device use and did not experience any surgical complication. CONCLUSION: Successful cochlear implantation in the setting of total scalar obliteration poses a significant challenge. Image guidance technology may assist in navigating the ossified cochlea facilitating safe and precise cochlear tunnel drilling.

Validation of minimally invasive, image-guided cochlear implantation using Advanced Bionics, Cochlear, and Medel electrodes in a cadaver model.

PURPOSE: Validation of a novel minimally invasive, image-guided approach to implant electrodes from three FDA-approved manufacturers-Medel, Cochlear, and Advanced Bionics-in the cochlea via a linear tunnel from the lateral cranium through the facial recess to the cochlea. METHODS: Custom microstereotactic frames that mount on bone-implanted fiducial markers and constrain the drill along the desired path were utilized on seven cadaver specimens. A linear tunnel was drilled from the lateral skull to the cochlea followed by a marginal, round window cochleostomy and insertion of the electrode array into the cochlea through the drilled tunnel. Post-insertion CT scan and histological analysis were used to analyze the results. RESULTS: All specimens ([Formula: see text]) were successfully implanted without visible injury to the facial nerve. The Medel electrodes ([Formula: see text]) had minimal intracochlear trauma with 8, 8, and 10 (out of 12) electrodes intracochlear. The Cochlear lateral wall electrodes (straight research arrays) ([Formula: see text]) had minimal trauma with 20 and 21 of 22 electrodes intracochlear. The Advanced Bionics electrodes ([Formula: see text]) were inserted using their insertion tool; one had minimal insertion trauma and 14 of 16 electrodes intracochlear, while the other had violation of the basilar membrane just deep to the cochleostomy following which it remained in scala vestibuli with 13 of 16 electrodes intracochlear. CONCLUSIONS: Minimally invasive, image-guided cochlear implantation is possible using electrodes from the three FDA-approved manufacturers. Lateral wall electrodes were associated with less intracochlear trauma suggesting that they may be better suited for this surgical technique.

Design of a bone-attached parallel robot for percutaneous cochlear implantation.

Access to the cochlea requires drilling in close proximity to bone-embedded nerves, blood vessels, and other structures, the violation of which can result in complications for the patient. It has recently been shown that microstereotactic frames can enable an image-guided percutaneous approach, removing reliance on human experience and hand-eye coordination, and reducing trauma. However, constructing current microstereotactic frames disrupts the clinical workflow, requiring multiday intrasurgical manufacturing delays, or an on-call machine shop in or near the hospital. In this paper, we describe a new kind of microsterotactic frame that obviates these delay and infrastructure issues by being repositionable. Inspired by the prior success of bone-attached parallel robots in knee and spinal procedures, we present an automated image-guided microstereotactic frame. Experiments demonstrate a mean accuracy at the cochlea of 0.20 ± 0.07 mm in phantom testing with trajectories taken from a human clinical dataset. We also describe a cadaver experiment evaluating the entire image-guided surgery pipeline, where we achieved an accuracy of 0.38 mm at the cochlea.