Identification of factors influencing insertion characteristics of cochlear implant electrode carriers

Insertion studies in artificial cochlea models (aCM) are used for the analysis of insertion characteristics of different cochlear implant electrode carrier (EC) designs by measuring insertion forces. These forces are summed forces due to the measuring position which is directly underneath the aCM. The current hypothesis is that they include dynamic friction forces during the insertion process and the forces needed to bend an initially straight EC into the curved form of the aCM. For the purposes of the present study, straight EC substitutes with a constant diameter of 0.7 mm and 20.5 mm intracochlear length were fabricated out of silicone in two versions with different stiffness by varying the number of embedded wires. The EC substitutes were inserted into three different models made of polytetrafluoroethylene (PTFE), each model showing only one constant radius. Three different insertion speeds were used (0.11 / 0.4 / 1.6 mm/s) with an automated insertion test bench. For each parameter combination (curvature, speed, stiffness) twelve insertions were conducted. Measurements included six full insertions and six paused insertions. Paused insertions include a ten second paused time interval without further insertion movement each five millimetres. Measurements showed that dynamic and static components of the measured summed forces can be identified. Dynamic force components increase with increased insertion speeds and also with increased stiffness of the EC substitutes. Both force components decrease with larger radius of the PTFE model. After the insertion, the EC substitutes showed a curved shape, which indicates a plastic deformation of the embedded wires due to the insertion into the curved models. The results can be used for further research on an analytical model to predict the insertions forces of a specific combination of selected parameters as insertion speed and type of EC, combined with given factors such as cochlear geometry

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

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

Compliant mechanism with hydraulic activation used for implants and medical instruments

The hydraulic actuation of cochlear implant is considered in this research. The deformation behavior of the compliant mechanism by hydraulic actuation is of interest to facilitate the insertion of the implant or the instrument used in the non-linear access paths to the target area, and to avoid any damage, which could occur during the surgical procedure. The described implant is a hydraulically actuated compliant structure with a symmetric internal hollow core and with a non-stretchable thin fibre embedded in the wall. Under inner pressure of 6 bar, the structure is bended, thus the insertion will facilitate during the operation. With the help of the simulations, a specific geometry of the compliant structure is determined for the target deformation executed by hydraulic actuation. In this paper a Finite Element (FE) model and an analytical model is demonstrated for simulation the deformation behavior of the fibre The maximum difference between both model results for simulated fibre curves is about 0.5 mm. This is 1.6% of the entire length of the implant

Characterization of a measurement setup for the thermomechanical characterization of curved shape memory alloy actuators

The bend and free recovery (BFR) test according to ASTM F2082 is a standard method to determine the transition temperatures of Nitinol shape memory alloys (SMAs). Unfortunately, this standard method is limited to SMA wires which are straight in its trained shape. Thus, the standard BFR test is not suitable for thermomechanical characterization of curved Nitinol SMA wires which should serve as actuators in cochlear implants in future. We developed a modified BFR measurement setup to determine the active austenite finish (AF) temperature of these very thin wires (Ø100 μm). The active AF temperature specifies the completion of the shape recovery upon heating. A parametric study of the measurement setup was carried out to investigate the influence of the heating rate on the observed active AF temperature and to verify the repeatability of the measurement setup. First, the curved wire was straightened in a cold water bath before inserting it into a water bath that is gradually heated from 5 °C to 45 °C. The shape change of the previously straightened wire was then recorded throughout the experiment using a digital microscope. Five different heating rates were employed: 0.25 K/min, 0.33 K/min, 0.5 K/min, 1 K/min as well as an unregulated maximum heating rate achievable of approximately 1.5 K/min. Furthermore, an investigation on the test-retest reliability was performed with three wires by repeating the experiment ten times with each wire. The results of this study revealed no influence of the heating rate on the thermomechanical response of the wires. Based on data from this study, a regulated heating rate of 1 K/min is suggested for future investigations, as this reduces the duration of the measurement from four hours to less than an hour. The values obtained from each wire through the test-retest reliability investigation showed a standard deviation of 1.9 K, 1.1 K and 2.1 K respectively. Our developed measurement setup demonstrates appropriate repeatability of the measurements

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

Coating stability and insertion forces of an alginate-cell-based drug delivery implant system for the inner ear

Long-term drug delivery to the inner ear for neuroprotection might improve the outcome for hearing disabled patients treated with a cochlear implant (CI). Neurotrophic factor (NTF) producing cells encapsulated in an alginate-matrix, to shield them from the host immune system and to avoid migration, and applied as viscose solution or electrode coating could address this requirement. Both application methods were tested for their feasibility in an artificial human cochlea model. Since both strategies potentially influence the electrode implantability, insertion forces and coating stability were analyzed on custom-made electrode arrays. Both, injection of the alginate-cell solution into the model and a manual dip coating of electrode arrays with subsequent insertion into the model were possible. The insertion forces of coated arrays were reduced by 75% of an uncoated reference. In contrast, filling of the model with non-crosslinked alginate-cell solution slightly increased the insertion forces. A good stability of the coating was observed after first insertion (85%) but abrasion increased after multiple insertions (50%). Both application strategies are possible options for cell-induced drug-delivery to the inner ear, but an alginate-cell coating of CI-electrodes has a great potential to combine an endogenous NTF-source with a strong reduction of insertion forces

Minimally invasive mastoidectomy approach using a mouldable surgical targeting system: a proof of concept

Hearing restoration using a cochlear implant requires a surgical access to the inner ear. In order to enhance patient safety, reduce trauma, and shorten the patient’s time under anaesthesia current research focusses on minimally invasive cochlear implantation surgery by drilling only a single bore hole. This demands a highly accurate surgical assistance device to guide the drill along a predetermined trajectory planned in patient’s image data. In this study a recently developed surgical targeting system was evaluated for the first time in a human cadaver trial. After screwing a reference frame on a temporal bone specimen and imaging of both, a trajectory through the facial recess was planned in order to reach the middle ear. Based on this plan a patient specific surgical template including a linear guide for the surgical drill was composed utilizing bone cement. After the hardening of the bone cement the surgical template was mounted on top of the reference frame. The drilling could be performed as previously planned without harming facial nerve and chorda tympani. The deviation of the actual drill hole to the planned trajectory was 0.17 mm at the level of the facial recess. The minimal distance of the drill hole to the facial nerve was 0.59 mm. This proof-of-concept study demonstrates the feasibility of performing the access to the middle ear in a minimally invasive manner using the mouldable surgical targeting system. The presented process allows the patient specific individualization of a drill guide under sterile conditions. This might facilitate its integration into clinical routine