Silke Hügl

Impact of anatomical variations on insertion forces

Abstract 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.

Minimally invasive mastoidectomy approach using a mouldable surgical targeting system

Abstract 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.

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

Abstract 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.

Abstract 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.