Design of a Tool Integrating Force Sensing With Automated Insertion in Cochlear Implantation.

The quality of hearing restored to a deaf patient by a cochlear implant in hearing preservation cochlear implant surgery (and possibly also in routine cochlear implant surgery) is believed to depend on preserving delicate cochlear membranes while accurately inserting an electrode array deep into the spiral cochlea. Membrane rupture forces, and possibly, other indicators of suboptimal placement, are below the threshold detectable by human hands, motivating a force sensing insertion tool. Furthermore, recent studies have shown significant variability in manual insertion forces and velocities that may explain some instances of imperfect placement. Toward addressing this, an automated insertion tool was recently developed by Hussong et al. By following the same insertion tool concept, in this paper, we present mechanical enhancements that improve the surgeon's interface with the device and make it smaller and lighter. We also present electomechanical design of new components enabling integrated force sensing. The tool is designed to be sufficiently compact and light that it can be mounted to a microstereotactic frame for accurate image-guided preinsertion positioning. The new integrated force sensing system is capable of resolving forces as small as 0.005 N, and we provide experimental illustration of using forces to detect errors in electrode insertion.

Determination of the curling behavior of a preformed cochlear implant electrode array.

PURPOSE: Accurate insertion of a cochlear implant electrode array into the cochlea's helical shape is a crucial step for residual hearing preservation. In image-guided surgery, especially using an automated insertion tool, the overall accuracy of the operative procedure can be improved by adapting the electrode array's intracochlear movement to the individual cochlear shape. METHODS: The curling characteristic of a commercially available state-of-the-art preformed electrode array (Cochlear Ltd. Contour Advance(TM) Electrode Array) was determined using an image-processing algorithm to detect its shape in series of images. An automatic image-processing procedure was developed using Matlab and the Image Processing Toolbox (MathWorks, Natick, Massachusetts, USA) to determine the complete curvature of the electrode array by identifying the 22 platinum contacts of the electrode. A logarithmic spiral was used for a comprehensive mathematical description of the shape of the electrode array. A fitting algorithm for nonlinear least-squares problems was used to provide a complete mathematical description of the electrode array. The system was tested for curling behavior as a function of stylet extraction using nine Contour Advance Research Electrodes (RE) and additionally for nine Contour Advance Practice Electrodes (PE). RESULTS: All arrays show a typical pattern of curling with adequate predictability after the first 2 or 3 millimeters of stylet extraction. Although non-negligible variations in the overall curling behavior were detected, the electrode arrays show a characteristic movement due to the stylet extraction and only vary minimally after this initial phase. CONCLUSION: These results indicate that the risk of intracochlear trauma can be reduced if the specific curling behavior of the electrode carrier is incorporated into the insertion algorithm. Furthermore, the determination of the curling behavior is an essential step in computer-aided cochlear implant electrode development. Experimental data are required for accurate evaluation of the simulation model.

Accuracy of computer-aided geometric 3D reconstruction based on histological serial microgrinding preparation.

PURPOSE: For our research on computer-optimised and automated cochlear implant surgery, we pursue a model-based approach to overcome the limitations of currently available clinical imaging modalities. A serial cross section preparation procedure has been developed and evaluated concerning accuracy to serve for modelling of a digital anatomic atlas to make delicate soft tissue structures available for pre-operative planning. METHODS: A special grinding tool was developed allowing the setting of a specific amount of abrasion as equidistant slice thickness was considered a crucial step. Additionally, each actual abrasion was accurately measured and used during three-dimensional reconstruction of the serial cross-sectional images obtained via digital photo documentation after each microgrinding step. A well-known reference object was prepared using this procedure and evaluated in terms of accuracy. RESULTS: Reconstruction of the whole sample was achieved with an error less than 0.4%, and the edge lengths in the direction of abrasion could be reconstructed with an average error of 0.6 ± 0.3 mm; both prove the realisation of equidistant abrasion. Using artificial registration fiducials and a custom-made algorithm for image alignment, parallelism and rectangularity could be preserved with average errors less than 0.4° ± 0.3°. CONCLUSION: We present a systematic, practicable and reliable method for the geometrically accurate reconstruction of anatomical structures, which is especially suitable for the middle and inner ear anatomy including soft tissue structures. For the first time, the quality of such a reconstruction process has been quantified and successfully proven for its usability.

An automated insertion tool for cochlear implants: another step towards atraumatic cochlear implant surgery.

PURPOSE: Atraumatic electrode insertion has been identified to be a crucial step for the preservation of residual hearing abilities, which allows hybrid electro-acoustic stimulation (EAS). The authors propose a tool for automation of the insertion process to achieve this. METHODS: General benefits as well as concept and design of an automated insertion tool are presented. Thirty insertions of Nucleus 24 Contour Advance Practice Electrodes in an artificial scala tympani model as well as 20 insertions in a human cochlea specimen were performed using the tool, implementing the AOS technique. For both studies, the achieved insertion depth angle was evaluated by photographic or X-ray documentation. RESULTS: The mean achieved insertion depth angle was 410 degrees for the lubricated model and 330 degrees for the human cochlea specimen. CONCLUSION: The automated insertion tool has proven its capability to perform electrode insertions with final insertion depth angles within the target range of a standard cochlear implant surgery. Additionally, to the knowledge of the authors, it represents the only possibility to automatically insert cochlear implant electrodes via minimally invasive approaches.

Automated insertion of preformed cochlear implant electrodes: evaluation of curling behaviour and insertion forces on an artificial cochlear model.

PURPOSE: As a substantial part of our concept of a minimally invasive cochlear implant (CI) surgery, we developed an automated insertion tool. Studies on an artificial scala tympani model were performed in order to evaluate force application when using the insertion tool. METHODS: Contour electrodes were automatically inserted into a transparent cochlea model in Advance Off-Stylet technique. Occurring forces were measured by the use of a load cell and correlated with observed intracochlear movement of the electrode carriers. RESULTS: Mean insertion forces were measured up to 20 mN comparable to previous studies on temporal bones. The most influencing factor is the implant's 2D curling behaviour in comparison to the 3D helical shape of the cochlea. CONCLUSION: The study confirms the functionality and reliability of the automated insertion tool for insertion of preformed CI. Improved insertion strategies considering patient-specific anatomy become possible.

Force measurement of insertion of cochlear implant electrode arrays in vitro: comparison of surgeon to automated insertion tool.

CONCLUSIONS: We have demonstrated that an automated insertion tool (i.e. a robot) can be used to duplicate a complex surgical motion in inserting cochlear implant (CI) electrode arrays via the 'advance-off-stylet' (AOS) technique. As compared with human operators, the forces generated by the robot were slightly larger but the robot was more reliable (i.e. less force maxima). OBJECTIVES: We present force data collected during CI electrode insertion by human operators and by an automated insertion tool. MATERIALS AND METHODS: Using a three-dimensional, anatomically correct, translucent model of the scala tympani chamber of the cochlea, CI electrodes were inserted either by one of three surgeons (26 insertions) or by the robotic insertion tool (8 insertions). Force was recorded using a load beam cell calibrated for expected forces of <0.1 Newtons (N). The insertions were also videotaped to allow correlation of force with depth of penetration into the cochlea and speed of insertion. RESULTS: Average insertion force used by the surgeons was 0.004+/-0.001 N and for the insertion tool it was 0.005+/-0.014 N (p<0.00001, Student's t test). While the average insertion force of the automated tool was larger than that of the surgeons, the surgeons did have intermittent peaks during the AOS component of the insertion (between 120 degrees and 200 degrees ).

Conception and design of an automated insertion tool for cochlear implants.

Cochlear implants (CI) are electronic devices incorporating an electrode inserted into the human cochlea for direct electric stimulation of the auditory nerve. The implantation has become the standard treatment for patients with severe-to-profound sensorineural loss not aidable with conventional hearing aids. The state of the art operative technique is a facial recess approach to the middle ear, following the opening of the scala tympani (cochleostomy) and insertion of the electrode array. The facial recess approach is applicable only by experienced surgeons and optimal CI results primarily depend on optimal electrode placement and minimal traumatic insertion. This also requires a certain amount of experience. Additionally several groups work on minimally-invasive approaches to the cochlea, resulting in the necessity to insert the implant via a keyhole access, which is not applicable with current techniques. This paper presents a mechatronic device for an automated insertion of the electrode array of a cochlear implant system. Being designed especially for minimally-invasive approaches, the tool is also applicable for regular facial recess approaches. Moreover the device allows reliable and repeatable insertion studies at synthetic models or cadaver specimen. The functionality of the tool is proofed with first experiments on a synthetic model.