Conclusion: A system for robotic cochlear implantation (rCI) has been developed and a corresponding surgical workflow has been described. The clinical feasibility was demonstrated through the conduction of a safe and effective rCI procedure. Objectives: To define a clinical workflow for rCI and demonstrate its feasibility, safety, and effectiveness within a clinical setting. Method: A clinical workflow for use of a previously described image guided surgical robot system for rCI was developed. Based on pre-operative images, a safe drilling tunnel targeting the round window was planned and drilled by the robotic system. Intra-operatively the drill path was assessed using imaging and sensor-based data to confirm the proximity of the facial nerve. Electrode array insertion was manually achieved under microscope visualization. Electrode array placement, structure preservation, and the accuracy of the drilling and of the safety mechanisms were assessed on post-operative CT images. Results: Robotic drilling was conducted with an accuracy of 0.2 mm and safety mechanisms predicted proximity of the nerves to within 0.1 mm. The approach resulted in a minimal mastoidectomy and minimal incisions. Manual electrode array insertion was successfully performed through the robotically drilled tunnel. The procedure was performed without complications, and all surrounding structures were preserved.

Image-guided robotic surgery, designed for operating on small structures, is demonstrated for robotic cochlear implantation.

Conclusion: A robot built specifically for stereotactic cochlear implantation provides equal or better accuracy levels together with a better integration into a clinical environment, when compared with existing approaches based on industrial robots. Objectives: To evaluate the technical accuracy of a robotic system developed specifically for lateral skull base surgery in an experimental set-up reflecting the intended clinical application. The invasiveness of cochlear electrode implantation procedures may be reduced by replacing the traditional mastoidectomy with a small tunnel slightly larger in diameter than the electrode itself. Methods: The end-to-end accuracy of the robot system and associated image-guided procedure was evaluated on 15 temporal bones of whole head cadaver specimens. The main components of the procedure were as follows: reference screw placement, cone beam CT scan, computer-aided planning, pair-point matching of the surgical plan, robotic drilling of the direct access tunnel, and postoperative cone beam CT scan for accuracy assessment. Results: The mean accuracy at the target point (round window) was 0.56 ± 0.41 mm with an angular misalignment of 0.88 ± 0.40°. The procedural time for the registration process through the completion of the drilling procedure was 25 ± 11 min. The robot was fully operational in a clinical environment.

A previously developed image-guided robot system can safely drill a tunnel from the lateral mastoid surface, through the facial recess, to the middle ear, as a viable alternative to conventional mastoidectomy for cochlear electrode insertion. Direct cochlear access (DCA) provides a minimally invasive tunnel from the lateral surface of the mastoid through the facial recess to the middle ear for cochlear electrode insertion. A safe and effective tunnel drilled through the narrow facial recess requires a highly accurate image-guided surgical system. Previous attempts have relied on patient-specific templates and robotic systems to guide drilling tools. In this study, we report on improvements made to an image-guided surgical robot system developed specifically for this purpose and the resulting accuracy achieved in vitro. The proposed image-guided robotic DCA procedure was carried out bilaterally on 4 whole head cadaver specimens. Specimens were implanted with titanium fiducial markers and imaged with cone-beam CT. A preoperative plan was created using a custom software package wherein relevant anatomical structures of the facial recess were segmented, and a drill trajectory targeting the round window was defined. Patient-to-image registration was performed with the custom robot system to reference the preoperative plan, and the DCA tunnel was drilled in 3 stages with progressively longer drill bits. The position of the drilled tunnel was defined as a line fitted to a point cloud of the segmented tunnel using principle component analysis (PCA function in MatLab). The accuracy of the DCA was then assessed by coregistering preoperative and postoperative image data and measuring the deviation of the drilled tunnel from the plan. The final step of electrode insertion was also performed through the DCA tunnel after manual removal of the promontory through the external auditory canal. Drilling error was defined as the lateral deviation of the tool in the plane perpendicular to the drill axis (excluding depth error). Errors of 0.08 ± 0.05 mm and 0.15 ± 0.08 mm were measured on the lateral mastoid surface and at the target on the round window, respectively (n =8). Full electrode insertion was possible for 7 cases. In 1 case, the electrode was partially inserted with 1 contact pair external to the cochlea. The purpose-built robot system was able to perform a safe and reliable DCA for cochlear implantation. The workflow implemented in this study mimics the envisioned clinical procedure showing the feasibility of future clinical implementation.