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

A Tool to Enable Intraoperative Insertion Force Measurements for Cochlear Implant Surgery

Objective: Residual hearing preservation during cochlear implant (CI) surgery is closely linked to the magnitude of intracochlear forces acting during the insertion process. So far, these forces have only been measured in vitro. Therefore, the range of insertion forces and the magnitude of damage-inducing thresholds in the human cochlea in vivo remain unknown. We aimed to develop a method to intraoperatively measure insertion forces without negatively affecting the established surgical workflow. Initial experiments showed that this requires the compensation of orientation-dependent gravitational forces. Methods: We devised design requirements for a force-sensing manual insertion tool. Experienced CI surgeons evaluated the proposed design for surgical safety and handling quality. Measured forces from automated and manual insertions into an artificial cochlea model were evaluated against data from a static external force sensor representing the gold standard. Results: The finalized manual insertion tool uses an embedded force sensor and inertial measurement unit to measure insertion forces. The evaluation of the proposed design shows the feasibility of orientation-independent insertion force measurements. Recorded forces correspond well to externally recorded reference forces after reliable removal of gravitational disturbances. CI surgeons successfully used the tool to insert electrode arrays into human cadaver cochleae. Conclusion: The presented positive evaluation poses the first step towards intraoperative use of the proposed tool. Further in vitro experiments with human specimens will ensure reliable in vivo measurements. Significance: Intraoperative insertion force measurements enabled by this tool will provide insights on the relationship between forces and hearing outcomes in cochlear implant surgery

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

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

The feasibility of a novel sensing system for robotic cochlear electrode array feed for hearing preservation

A cochlear implant (CI) was a small electronic device that could provide direct electrical stimulation to the auditory nerve. Unlike a hearing aid, a cochlear implant turned sounds into electrical pulses which were sent directly to the auditory nerve. During a cochlear implant surgery, intracochlear electrode array insertion was considered to be a crucial process. However, the behaviour of the intracochlear electrode array during the insertion remained unclear to surgeons and the behaviour was hardly diagnosed by normal methods. In order to minimize or eliminate the trauma induced by electrode array insertion, we proposed an electrode capacitive sensing method to discriminate among certain signal patterns and notify the surgeons whether the array was placed correctly during the insertion process. In this thesis, we firstly investigated the mechanical behaviour of a CI electrode array during the insertion process. A force model simulating the first contact between the array tip and cochlear inner wall was proposed. Experimental results demonstrated that insertion force was not an effective method for detecting the array behaviours inside of the cochlea. Secondly, we investigated the theory and influencing factors of the capacitive sensing measurements. The relationship between capacitance measured and environmental effect, structural effect and applied force were examined and assessed. Our exploration demonstrated that the measured bipolar capacitive signals were recognised to be sensitive, consistent and reliable. Experiment results revealed that electrode capacitance values were systematically affected by intracochlear forces between the scala tympani wall and the contact electrode. Thirdly, by analysing the bipolar capacitance experimental results, three CI electrode array insertion patterns between the array and the cochlear lateral wall were classified. The possibility of the three patterns which an unknown insertion would fall into could be discriminated by the Principal Component Analysis (PCA) and The Pearson Correlation Coefficient (PCC) analysis. Experiment results showed the overall identification success rate was over 80%. Finally, a multi-channel switch board was proposed to measure multiple electrode pairs at the same time during the array insertion. Measurements and verification based on the board were carried out and shown to be efficient for capacitive signals measuring and recording

In-Vitro Study of Speed and Alignment Angle in Cochlear Implant Electrode Array Insertions

Objective: The insertion of the electrode array is a critical step in cochlear implantation. Herein we comprehensively investigate the impact of the alignment angle and feed-forward speed on deep insertions in artificial scala tympani models with accurate macro-anatomy and controlled frictional properties. Methods: Motorized insertions (n=1033) were performed in six scala tympani models with varying speeds and alignment angles. We evaluated reaction forces and micrographs of the insertion process and developed a mathematical model to estimate the normal force distribution along the electrode arrays. Results: Insertions parallel to the cochlear base significantly reduce insertion energies and lead to smoother array movement. Non-constant insertion speeds allow to reduce insertion forces for a fixed total insertion time compared to a constant feed rate. Conclusion: In cochlear implantation, smoothness and peak forces can be reduced with alignment angles parallel to the scala tympani centerline and with non-constant feed-forward speed profiles. Significance: Our results may help to provide clinical guidelines and improve surgical tools for manual and automated cochlear implantation

Active surgical positioning device for a cochlear implant electrode array

Cochlear implants have been of great benefit in restoring auditory function to individuals with profound bilateral sensorineural deafness. The implants are used to directly stimulate auditory nerves and send a signal to the brain that is then interpreted as sound. This project focuses on the development of a surgical positioning tool to accurately and effectively place an array of stimulating electrodes deep within the cochlea. This will lead to improved efficiency and performance of the stimulating electrodes, reduced surgical trauma to the cochlea, and as a result, improved overall performance to the implant recipient. The positioning tool reported here consists of multiple fluidic chambers providing localized curvature control along the length of the attached silicon electrode array. The chambers consist of 200μm inner diameter PET (polyethylene therephthalate) tubes with 4μm wall thickness. The chambers are molded in a tapered helical configuration to correspond to the cochlear shape upon relaxation of the actuators. This ensures that the optimal electrode placement within the cochlea is retained after the positioning tool becomes dormant (for chronic implants). Actuation is achieved by injecting fluid into the PET chambers and regulating the fluidic pressure. The chambers are arranged in a stacked, overlapping design to provide fluid connectivity with the non-implantable pressure controller and allow for local curvature control of the device. The stacked tube configuration allows for localized curvature control of various areas along the length of the electrode and additional stiffening and actuating power towards the base. Curvature is affected along the entire length of a chamber and the result is cumulative in sections of multiple chambers. The actuating chambers are bonded to the back of a silicon electrode array

Neuroengineering Tools/Applications for Bidirectional Interfaces, Brain–Computer Interfaces, and Neuroprosthetic Implants – A Review of Recent Progress

The main focus of this review is to provide a holistic amalgamated overview of the most recent human in vivo techniques for implementing brain–computer interfaces (BCIs), bidirectional interfaces, and neuroprosthetics. Neuroengineering is providing new methods for tackling current difficulties; however neuroprosthetics have been studied for decades. Recent progresses are permitting the design of better systems with higher accuracies, repeatability, and system robustness. Bidirectional interfaces integrate recording and the relaying of information from and to the brain for the development of BCIs. The concepts of non-invasive and invasive recording of brain activity are introduced. This includes classical and innovative techniques like electroencephalography and near-infrared spectroscopy. Then the problem of gliosis and solutions for (semi-) permanent implant biocompatibility such as innovative implant coatings, materials, and shapes are discussed. Implant power and the transmission of their data through implanted pulse generators and wireless telemetry are taken into account. How sensation can be relayed back to the brain to increase integration of the neuroengineered systems with the body by methods such as micro-stimulation and transcranial magnetic stimulation are then addressed. The neuroprosthetic section discusses some of the various types and how they operate. Visual prosthetics are discussed and the three types, dependant on implant location, are examined. Auditory prosthetics, being cochlear or cortical, are then addressed. Replacement hand and limb prosthetics are then considered. These are followed by sections concentrating on the control of wheelchairs, computers and robotics directly from brain activity as recorded by non-invasive and invasive techniques

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