Individual Optimization of the Insertion of a Preformed Cochlear Implant Electrode Array

Purpose. The aim of this study was to show that individual adjustment of the curling behaviour of a preformed cochlear implant (CI) electrode array to the patient-specific shape of the cochlea can improve the insertion process in terms of reduced risk of insertion trauma. Methods. Geometry and curling behaviour of preformed, commercially available electrode arrays were modelled. Additionally, the anatomy of each small, medium-sized, and large human cochlea was modelled to consider anatomical variations. Finally, using a custom-made simulation tool, three different insertion strategies (conventional Advanced Off-Stylet (AOS) insertion technique, an automated implementation of the AOS technique, and a manually optimized insertion process) were simulated and compared with respect to the risk of insertion-related trauma. The risk of trauma was evaluated using a newly developed “trauma risk” rating scale. Results. Using this simulation-based approach, it was shown that an individually optimized insertion procedure is advantageous compared with the AOS insertion technique. Conclusion. This finding leads to the conclusion that, in general, consideration of the specific curling behaviour of a CI electrode array is beneficial in terms of less traumatic insertion. Therefore, these results highlight an entirely novel aspect of clinical application of preformed perimodiolar electrode arrays in general

Three-dimensional histological specimen preparation for accurate imaging and spatial reconstruction of the middle and inner ear

PURPOSE:    This paper presents a highly accurate cross-sectional preparation technique. The research aim was to develop an adequate imaging modality for both soft and bony tissue structures featuring high contrast and high resolution. Therefore, the advancement of an already existing microgrinding procedure was pursued. The central objectives were to preserve spatial relations and to ensure the accurate three-dimensional reconstruction of histological sections. METHODS:    Twelve human temporal bone specimens including middle and inner ear structures were utilized. They were embedded in epoxy resin, then dissected by serial grinding and finally digitalized. The actual abrasion of each grinding slice was measured using a tactile length gauge with an accuracy of one micrometre. The cross-sectional images were aligned with the aid of artificial markers and by applying a feature-based, custom-made auto-registration algorithm. To determine the accuracy of the overall reconstruction procedure, a well-known reference object was used for comparison. To ensure the compatibility of the histological data with conventional clinical image data, the image stacks were finally converted into the DICOM standard. RESULTS:    The image fusion of data from temporal bone specimens’ and from non-destructive flat-panel-based volume computed tomography confirmed the spatial accuracy achieved by the procedure, as did the evaluation using the reference object. CONCLUSION:    This systematic and easy-to-follow preparation technique enables the three-dimensional (3D) histological reconstruction of complex soft and bony tissue structures. It facilitates the creation of detailed and spatially correct 3D anatomical models. Such models are of great benefit for image-based segmentation and planning in the field of computer-assisted surgery as well as in finite element analysis. In the context of human inner ear surgery, three-dimensional histology will improve the experimental evaluation and determination of intra-cochlear trauma after the insertion of an electrode array of a cochlear implant system

Experimental visualization of labyrinthine structure with optical coherence tomography

Introduction: Visualization of inner ear structures is a valuable strategy for researchers and clinicians working on hearing pathologies. Optical coherence tomography (OCT) is a high-resolution imaging technology which may be used for the visualization of tissues. In this experimental study we aimed to evaluate inner ear anatomy in well-prepared human labyrinthine bones. Materials and Methods: Three fresh human explanted temporal bones were trimmed, chemically decalcified with ethylenediaminetetraacetic acid (EDTA), and mechanically drilled under visual control using OCT in order to reveal the remaining bone shell. After confirming decalcification with a computed tomography (CT) scan, the samples were scanned with OCT in different views. The oval window, round window, and remnant part of internal auditory canal and cochlear turn were investigated. Results: Preparation of the labyrinthine bone and visualization under OCT guidance was successfully performed to a remaining bony layer of 300μm thickness. OCT images of the specimen allowed a detailed view of the intra-cochlear anatomy. Conclusion: OCT is applicable in the well-prepared human inner ear and allows visualization of soft tissue parts.DFG/EXC/Hearing4allDFG/MA 4038/3-2Institute of Mechatronic System (IMES) OCT II/OR 196/17-

Toward steerable electrodes: an overview of concepts and current research

Restoration of hearing is a demanding surgical task which requires the insertion of a cochlear implant electrode array into the inner ear while preserving the delicate basilar membrane inside the cochlea for an atraumatic insertion. Already shortly after the first clinical success with early versions of cochlear implants the desire for a controlled insertion of the electrode array arose. Such a steerable electrode should be in its shape adaptable to the individual path of the helical inner ear in order to avoid any contact between the implant and the surrounding tissue. This article provides a short overview of concepts and actuator mechanisms investigated in the past and present with the objective of developing a steerable electrode array for an individualized insertion process. Although none of these concepts has reached clinical implementation, there are promising experimental results indicating that insertion forces can be reduced up to 60% compared to straight and not steerable electrodes. Finally, related research topics are listed which require considerable further improvements until steerable electrodes will reach clinical applicability

Force measurement at the insertion process of cochlear implant electrodes

Several research groups have reported studies on the insertion force measurement at different cochlear implant electrodes. So far, all experimental setups to measure the forces applied to the electrode outside the cochlea (inner ear), ie have measured externally. Our aim was to integrate the sensors into an automatically operating instrument insertion, so that the forces can be measured, which act directly on the electrode, ie an internal force measurement

Toward automated cochlear implant insertion using tubular manipulators

During manual cochlear implant electrode insertion the surgeon is at risk to damage the intracochlear fine-structure, as the electrode array is inserted through a small opening in the cochlea blindly with little force-feedback. This paper addresses a novel concept for cochlear electrode insertion using tubular manipulators to reduce risks of causing trauma during insertion and to automate the insertion process. We propose a tubular manipulator incorporated into the electrode array composed of an inner wire within a tube, both elastic and helically shaped. It is our vision to use this manipulator to actuate the initially straight electrode array during insertion into the cochlea by actuation of the wire and tube, i.e. translation and slight axial rotation. In this paper, we evaluate the geometry of the human cochlea in 22 patient datasets in order to derive design requirements for the manipulator. We propose an optimization algorithm to automatically determine the tube set parameters (curvature, torsion, diameter, length) for an ideal final position within the cochlea. To prove our concept, we demonstrate that insertion can be realized in a follow-the-leader fashion for 19 out of 22 cochleas. This is possible with only 4 different tube/wire sets. © 2016 SPIE

Impact of anatomical variations on insertion forces: an investigation using artificial cochlear models

The choice of a cochlear implant electrode carrier for the individual patient is influenced by cochlear size, as this parameter has an impact on the risk of scala dislocations. Therefore, size and morphology should be represented in artificial cochlear models too, since these are generally used for insertion studies evaluating newly developed cochlear implant electrode carriers and insertion techniques, before human temporal bone studies are applied for. Within this study custom-made electrode carrier test samples were inserted into nine artificial cochlear models of different shape. To fabricate them, four human temporal bone samples have been processed by a serial cross-sectioning technique; the other four samples have been scanned with micro computed tomography. The cochlea was segmented on this data using rotating, midmodiolar slice planes, followed by the generation of a three-dimensional digital model, which finally was projected on a plane and 2D models were milled out of PTFE. The ratios of length to width of the cochlear basal turn of our samples were found to be within previously reported range. For comparative reasons a model used in previous studies was included in this study too. The maximal insertion forces per cochlear model followed a normal distribution. The insertion depth at initial insertion force increase is correlated to the length of cochlear basal turn. Using the here presented cochlear models with varying anatomical measures may help to increase the clinical relevance of insertion studies in artificial cochlear models

Analysis of the customized implantation process of a compliant mechanism with fluidic actuation used for cochlear implant electrode carriers

Patients suffering from severe to profound hearing loss, can be treated with a cochlea implant to restore hearing due to direct electrical stimulation of neurons. Hence, a silicone electrode carrier has to be implanted into the spiral-shaped organ of the cochlea (inner ear). The here presented fluid actuation by use of a compliant mechanism within the electrode carrier is designed to enable an active steering of the implant and its bending in order to achieve contactless insertion into the cochlea and a preset final position under a certain pressurization. An averaged small, middle and large spiral cochlea path has been defined based on the segmentation of 23 3D-datasets of human cochleae in order to enable the synthesis of individual implants. The fit of these implants within all three sizes of cochleae was adapted by variation of the pressure load which induces the bending of the implant

Histological evaluation of a cochlear implant electrode array with electrically activated shape change for perimodiolar positioning

For the treatment of deafness or severe hearing loss cochlear implants (CI) are used to stimulate the auditory nerve of the inner ear. In order to produce an electrode array which is both atraumatic and reaches a perimodiolar final position a design featuring shape memory effect was proposed. A Nitinol wire with a diameter of 100 μm was integrated in a state of the art lateral wall electrode array. The wire serves as an actuator after it has been ‘trained’ to adopt the spiral shape of an average human cochlea. Three small diameter platinum-iridium wires (each 20 μm) were crimped to the Nitinol wire in order to produce thermal energy. An insertion test was pursued using a human temporal bone specimen. The prototype electrode array was cooled down by means of immersion in ice water and freeze spray to enable sufficient straightening. Thereafter, insertion into the cochlea through the round window as performed. Insertion was feasible but difficult as premature curling of the electrode occurred during the movement towards the inner ear while passing the middle ear cavity. Therefore, the insertion had to be performed faster than usual. The shape memory actuator was subsequently activated with 450mA current at 5V for 3 seconds. After insertion the specimen was embedded in epoxy resin, microgrinded and all histological slices were assessed for trauma. Perimodiolar position was achieved. No insertion trauma was observed and there were no indications of thermal damage caused by the electrical heating. To the best of our knowledge, this is the first histological evaluation of the insertion trauma caused by an electrically activated shape memory electrode array. These promising results support further research on shape memory CI electrode arrays