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

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

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

Flexible tactile digital feedback for clinical applications

Trauma and damage to the delicate structures of the inner ear frequently occurs during insertion of electrode array into the cochlea. This is strongly related to the excessive manual insertion force of the surgeon without any tool/tissue interaction feedback. The research is examined tool-tissue interaction of large prototype scale (12.5:1) digit embedded with distributive tactile sensor based upon cochlear electrode and large prototype scale (4.5:1) cochlea phantom for simulating the human cochlear which could lead to small scale digit requirements. This flexible digit classified the tactile information from the digit-phantom interaction such as contact status, tip penetration, obstacles, relative shape and location, contact orientation and multiple contacts. The digit, distributive tactile sensors embedded with silicon-substrate is inserted into the cochlea phantom to measure any digit/phantom interaction and position of the digit in order to minimize tissue and trauma damage during the electrode cochlear insertion. The digit is pre-curved in cochlea shape so that the digit better conforms to the shape of the scala tympani to lightly hug the modiolar wall of a scala. The digit have provided information on the characteristics of touch, digit-phantom interaction during the digit insertion. The tests demonstrated that even devices of such a relative simple design with low cost have potential to improve cochlear implants surgery and other lumen mapping applications by providing tactile feedback information by controlling the insertion through sensing and control of the tip of the implant during the insertion. In that approach, the surgeon could minimize the tissue damage and potential damage to the delicate structures within the cochlear caused by current manual electrode insertion of the cochlear implantation. This approach also can be applied diagnosis and path navigation procedures. The digit is a large scale stage and could be miniaturized in future to include more realistic surgical procedures

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

DeepNav: Joint View Learning for Direct Optimal Path Perception in Cochlear Surgical Platform Navigation

Although much research has been conducted in the field of automated cochlear implant navigation, the problem remains challenging. Deep learning techniques have recently achieved impressive results in a variety of computer vision problems, raising expectations that they might be applied in other domains, such as identifying the optimal navigation zone (OPZ) in the cochlear. In this paper, a 2.5D joint-view convolutional neural network (2.5D CNN) is proposed and evaluated for the identification of the OPZ in the cochlear segments. The proposed network consists of 2 complementary sagittal and bird-view (or top view) networks for the 3D OPZ recognition, each utilizing a ResNet-8 architecture consisting of 5 convolutional layers with rectified nonlinearity unit (ReLU) activations, followed by average pooling with size equal to the size of the final feature maps. The last fully connected layer of each network has 4 indicators, equivalent to the classes considered: the distance to the adjacent left and right walls, collision probability and heading angle. To demonstrate this, the 2.5D CNN was trained using a parametric data generation model, and then evaluated using anatomically constructed cochlea models from the micro-CT images of different cases. Prediction of the indicators demonstrates the effectiveness of the 2.5D CNN, for example the heading angle has less than 1° error with computation delays of less that <1 milliseconds

Beitrag zur Minimierung der Insertionskräfte von Cochlea-Implantat-Elektrodenträgern: Untersuchung gerader, lateral liegender Elektrodenträger sowie deren Funktionalisierung mittels nachgiebiger Aktuatoren

Sensorineurale Hörstörungen können mit einem Cochlea-Implantat behandelt werden. Dazu wird ein Elektrodenträger (ET) vom Chirurgen in die Cochlea inseriert, um dort die geschädigten Haarzellen zu ersetzen. Die vorliegende Arbeit befasst sich mit dem ET und dessen Insertionsprozess in die Cochlea. Dazu werden digitale und anschließend physikalische, planare Modelle der humanen Cochlea erstellt. Es werden Einflussfaktoren auf den Insertionsprozess systematisiert. Mit dem Ziel einer Reduktion der Insertionskräfte werden drei ausgewählte Einflussfaktoren mit eigens hergestellten Labormustern untersucht: Die Geometrie der Cochleamodelle, die Insertionsgeschwindigkeit des ETs und eine Alginat-Beschichtung des ETs. Abschließend wird ein fluidisch-aktuierter, nachgiebiger Mechanismus zur Funktionalisierung des ETs betrachtet. Die Skalierbarkeit dieses Mechanismus wird analytisch und numerisch gezeigt. Die Synthese des fluidmechanischen Aktuators liefert dessen geometrische Maße, um unter Druckbeaufschlagung mit definiertem Druck einer vorgegebenen Form zu entsprechen

Seeing sound: a new way to illustrate auditory objects and their neural correlates

This thesis develops a new method for time-frequency signal processing and examines the relevance of the new representation in studies of neural coding in songbirds. The method groups together associated regions of the time-frequency plane into objects defined by time-frequency contours. By combining information about structurally stable contour shapes over multiple time-scales and angles, a signal decomposition is produced that distributes resolution adaptively. As a result, distinct signal components are represented in their own most parsimonious forms.  Next, through neural recordings in singing birds, it was found that activity in song premotor cortex is significantly correlated with the objects defined by this new representation of sound. In this process, an automated way of finding sub-syllable acoustic transitions in birdsongs was first developed, and then increased spiking probability was found at the boundaries of these acoustic transitions. Finally, a new approach to study auditory cortical sequence processing more generally is proposed. In this approach, songbirds were trained to discriminate Morse-code-like sequences of clicks, and the neural correlates of this behavior were examined in primary and secondary auditory cortex. It was found that a distinct transformation of auditory responses to the sequences of clicks exists as information transferred from primary to secondary auditory areas. Neurons in secondary auditory areas respond asynchronously and selectively -- in a manner that depends on the temporal context of the click. This transformation from a temporal to a spatial representation of sound provides a possible basis for the songbird's natural ability to discriminate complex temporal sequences

Modiolus-Hugging Intracochlear Electrode Array with Shape Memory Alloy

In the cochlear implant system, the distance between spiral ganglia and the electrodes within the volume of the scala tympani cavity significantly affects the efficiency of the electrical stimulation in terms of the threshold current level and spatial selectivity. Because the spiral ganglia are situated inside the modiolus, the central axis of the cochlea, it is desirable that the electrode array hugs the modiolus to minimize the distance between the electrodes and the ganglia. In the present study, we propose a shape-memory-alloy-(SMA-) embedded intracochlear electrode which gives a straight electrode a curved modiolus-hugging shape using the restoration force of the SMA as triggered by resistive heating after insertion into the cochlea. An eight-channel ball-type electrode array is fabricated with an embedded titanium-nickel SMA backbone wire. It is demonstrated that the electrode array changes its shape in a transparent plastic human cochlear model. To verify the safe insertion of the electrode array into the human cochlea, the contact pressures during insertion at the electrode tip and the contact pressures over the electrode length after insertion were calculated using a 3D finite element analysis. The results indicate that the SMA-embedded electrode is functionally and mechanically feasible for clinical applications