Dataset Information

Robotic middle ear access for cochlear implantation: First in man.

ABSTRACT: To demonstrate the feasibility of robotic middle ear access in a clinical setting, nine adult patients with severe-to-profound hearing loss indicated for cochlear implantation were included in this clinical trial. A keyhole access tunnel to the tympanic cavity and targeting the round window was planned based on preoperatively acquired computed tomography image data and robotically drilled to the level of the facial recess. Intraoperative imaging was performed to confirm sufficient distance of the drilling trajectory to relevant anatomy. Robotic drilling continued toward the round window. The cochlear access was manually created by the surgeon. Electrode arrays were inserted through the keyhole tunnel under microscopic supervision via a tympanomeatal flap. All patients were successfully implanted with a cochlear implant. In 9 of 9 patients the robotic drilling was planned and performed to the level of the facial recess. In 3 patients, the procedure was reverted to a conventional approach for safety reasons. No change in facial nerve function compared to baseline measurements was observed. Robotic keyhole access for cochlear implantation is feasible. Further improvements to workflow complexity, duration of surgery, and usability including safety assessments are required to enable wider adoption of the procedure.

SUBMITTER: Caversaccio M

PROVIDER: S-EPMC6677292 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Robotic middle ear access for cochlear implantation: First in man.

Caversaccio Marco M Wimmer Wilhelm W Anso Juan J Mantokoudis Georgios G Gerber Nicolas N Rathgeb Christoph C Schneider Daniel D Hermann Jan J Wagner Franca F Scheidegger Olivier O Huth Markus M Anschuetz Lukas L Kompis Martin M Williamson Tom T Bell Brett B Gavaghan Kate K Weber Stefan S

PloS one 20190802 8

To demonstrate the feasibility of robotic middle ear access in a clinical setting, nine adult patients with severe-to-profound hearing loss indicated for cochlear implantation were included in this clinical trial. A keyhole access tunnel to the tympanic cavity and targeting the round window was planned based on preoperatively acquired computed tomography image data and robotically drilled to the level of the facial recess. Intraoperative imaging was performed to confirm sufficient distance of th ...[more]

PMID: 31374092

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Project description:Image-guided and robot-assisted surgeries have found their applications in skullbase surgery. Technological improvements in terms of accuracy also opened new opportunities for robotically-assisted cochlear implantation surgery (RACIS). The HEARO® robotic system is an otological next-generation surgical robot to assist the surgeon. It first provides software-defined spatial boundaries for orientation and reference information to anatomical structures during otological and neurosurgical procedures. Second, it executes a preplanned drill trajectory through the temporal bone. Here, we report how safe the HEARO procedure can provide an autonomous minimally invasive inner ear access and the efficiency of this access to subsequently insert the electrode array during cochlear implantation. In 22 out of 25 included patients, the surgeon was able to complete the HEARO® procedure. The dedicated planning software (OTOPLAN®) allowed the surgeon to reconstruct a three-dimensional representation of all the relevant anatomical structures, designate the target on the cochlea, i.e., the round window, and plan the safest trajectory to reach it. This trajectory accommodated the safety distance to the critical structures while minimizing the insertion angles. A minimal distance of 0.4 and 0.3 mm was planned to facial nerve and chorda tympani, respectively. Intraoperative cone-beam CT supported safe passage for the 22 HEARO® procedures. The intraoperative accuracy analysis reported the following mean errors: 0.182 mm to target, 0.117 mm to facial nerve, and 0.107 mm to chorda tympani. This study demonstrates that microsurgical robotic technology can be used in different anatomical variations, even including a case of inner ear anomalies, with the geometrically correct keyhole to access to the inner ear. Future perspectives in RACIS may focus on improving intraoperative imaging, automated segmentation and trajectory, robotic insertion with controlled speed, and haptic feedback. This study [Experimental Antwerp robotic research otological surgery (EAR2OS) and Antwerp Robotic cochlear implantation (25 refers to 25 cases) (ARCI25)] was registered at clinicalTrials.gov under identifier NCT03746613 and NCT04102215.Clinical trial registrationhttps://www.clinicaltrials.gov, Identifier: NCT04102215.

Project description:Objective: During robotic cochlear implantation, an image-guided robotic system provides keyhole access to the scala tympani of the cochlea to allow insertion of the cochlear implant array. To standardize minimally traumatic robotic access to the cochlea, additional hard and soft constraints for inner ear access were proposed during trajectory planning. This extension of the planning strategy aims to provide a trajectory that preserves the anatomical and functional integrity of critical intra-cochlear structures during robotic execution and allows implantation with minimal insertion angles and risk of scala deviation. Methods: The OpenEar dataset consists of a library with eight three-dimensional models of the human temporal bone based on computed tomography and micro-slicing. Soft constraints for inner ear access planning were introduced that aim to minimize the angle of cochlear approach, minimize the risk of scala deviation and maximize the distance to critical intra-cochlear structures such as the osseous spiral lamina. For all cases, a solution space of Pareto-optimal trajectories to the round window was generated. The trajectories satisfy the hard constraints, specifically the anatomical safety margins, and optimize the aforementioned soft constraints. With user-defined priorities, a trajectory was parameterized and analyzed in a virtual surgical procedure. Results: In seven out of eight cases, a solution space was found with the trajectories safely passing through the facial recess. The solution space was Pareto-optimal with respect to the soft constraints of the inner ear access. In one case, the facial recess was too narrow to plan a trajectory that would pass the nerves at a sufficient distance with the intended drill diameter. With the soft constraints introduced, the optimal target region was determined to be in the antero-inferior region of the round window membrane. Conclusion: A trend could be identified that a position between the antero-inferior border and the center of the round window membrane appears to be a favorable target position for cochlear tunnel-based access through the facial recess. The planning concept presented and the results obtained therewith have implications for planning strategies for robotic surgical procedures to the inner ear that aim for minimally traumatic cochlear access and electrode array implantation.

Project description:Objective: Robotic cochlear implantation is an emerging surgical technique for patients with sensorineural hearing loss. Access to the middle and inner ear is provided through a small-diameter hole created by a robotic drilling process without a mastoidectomy. Using the same image-guided robotic system, we propose an electrode lead management technique using robotic milling that replaces the standard process of stowing excess electrode lead in the mastoidectomy cavity. Before accessing the middle ear, an electrode channel is milled robotically based on intraoperative planning. The goal is to further standardize cochlear implantation, minimize the risk of iatrogenic intracochlear damage, and to create optimal conditions for a long implant life through protection from external trauma and immobilization in a slight press fit to prevent mechanical fatigue and electrode migrations. Methods: The proposed workflow was executed on 12 ex-vivo temporal bones and evaluated for safety and efficacy. For safety, the difference between planned and resulting channels were measured postoperatively in micro-computed tomography, and the length outside the planned safety margin of 1.0 mm was determined. For efficacy, the channel width and depth were measured to assess the press fit immobilization and the protection from external trauma, respectively. Results: All 12 cases were completed with successful electrode fixations after cochlear insertions. The milled channels stayed within the planned safety margins and the probability of their violation was lower than one in 10,000 patients. Maximal deviations in lateral and depth directions of 0.35 and 0.29 mm were measured, respectively. The channels could be milled with a width that immobilized the electrode leads. The average channel depth was 2.20 mm, while the planned channel depth was 2.30 mm. The shallowest channel depth was 1.82 mm, still deep enough to contain the full 1.30 mm diameter of the electrode used for the experiments. Conclusion: This study proposes a robotic electrode lead management and fixation technique and verified its safety and efficacy in an ex-vivo study. The method of image-guided robotic bone removal presented here with average errors of 0.2 mm and maximal errors below 0.5 mm could be used for a variety of other otologic surgical procedures.

Dataset Information

Robotic middle ear access for cochlear implantation: First in man.

Publications

Robotic middle ear access for cochlear implantation: First in man.

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