Wilhelm Wimmer

In vitro accuracy evaluation of image-guided robot system for direct cochlear access

Hypothesis A previously developed image-guided robot system can safely drill a tunnel from the lateral mastoid surface, through the facial recess, to the middle ear, as a viable alternative to conventional mastoidectomy for cochlear electrode insertion. Background Direct cochlear access (DCA) provides a minimally invasive tunnel from the lateral surface of the mastoid through the facial recess to the middle ear for cochlear electrode insertion. A safe and effective tunnel drilled through the narrow facial recess requires a highly accurate image-guided surgical system. Previous attempts have relied on patient-specific templates and robotic systems to guide drilling tools. In this study, we report on improvements made to an image-guided surgical robot system developed specifically for this purpose and the resulting accuracy achieved in vitro. Materials and Methods The proposed image-guided robotic DCA procedure was carried out bilaterally on 4 whole head cadaver specimens. Specimens were implanted with titanium fiducial markers and imaged with cone-beam CT. A preoperative plan was created using a custom software package wherein relevant anatomical structures of the facial recess were segmented, and a drill trajectory targeting the round window was defined. Patient-to-image registration was performed with the custom robot system to reference the preoperative plan, and the DCA tunnel was drilled in 3 stages with progressively longer drill bits. The position of the drilled tunnel was defined as a line fitted to a point cloud of the segmented tunnel using principle component analysis (PCA function in MatLab). The accuracy of the DCA was then assessed by coregistering preoperative and postoperative image data and measuring the deviation of the drilled tunnel from the plan. The final step of electrode insertion was also performed through the DCA tunnel after manual removal of the promontory through the external auditory canal. Results Drilling error was defined as the lateral deviation of the tool in the plane perpendicular to the drill axis (excluding depth error). Errors of 0.08 ± 0.05 mm and 0.15 ± 0.08 mm were measured on the lateral mastoid surface and at the target on the round window, respectively (n =8). Full electrode insertion was possible for 7 cases. In 1 case, the electrode was partially inserted with 1 contact pair external to the cochlea. Conclusion The purpose-built robot system was able to perform a safe and reliable DCA for cochlear implantation. The workflow implemented in this study mimics the envisioned clinical procedure showing the feasibility of future clinical implementation.

Cone beam and micro-computed tomography validation of manual array insertion for minimally invasive cochlear implantation.

Delivering cochlear implants through a minimally invasive tunnel (1.8 mm in diameter) from the mastoid surface to the inner ear is referred to as direct cochlear access (DCA). Based on cone beam as well as micro-computed tomography imaging, this in vitro study evaluates the feasibility and efficacy of manual cochlear electrode array insertions via DCA. Free-fitting electrode arrays were inserted in 8 temporal bone specimens with previously drilled DCA tunnels. The insertion depth angle, procedural time, tunnel alignment as well as the inserted scala and intracochlear trauma were assessed. Seven of the 8 insertions were full insertions, with insertion depth angles higher than 520°. Three cases of atraumatic scala tympani insertion, 3 cases of probable basilar membrane rupture and 1 case of dislocation into the scala vestibuli were observed (1 specimen was damaged during extraction). Manual electrode array insertion following a DCA procedure seems to be feasible and safe and is a further step toward clinical application of image-guided otological microsurgery.

Semiautomatic Cochleostomy Target and Insertion Trajectory Planning for Minimally Invasive Cochlear Implantation

A major component of minimally invasive cochlear implantation is atraumatic scala tympani (ST) placement of the electrode array. This work reports on a semiautomatic planning paradigm that uses anatomical landmarks and cochlear surface models for cochleostomy target and insertion trajectory computation. The method was validated in a human whole head cadaver model (n = 10 ears). Cochleostomy targets were generated from an automated script and used for consecutive planning of a direct cochlear access (DCA) drill trajectory from the mastoid surface to the inner ear. An image-guided robotic system was used to perform both, DCA and cochleostomy drilling. Nine of 10 implanted specimens showed complete ST placement. One case of scala vestibuli insertion occurred due to a registration/drilling error of 0.79 mm. The presented approach indicates that a safe cochleostomy target and insertion trajectory can be planned using conventional clinical imaging modalities, which lack sufficient resolution to identify the basilar membrane.

An image-guided robot system for direct cochlear access

Abstract The aim of direct cochlear access (DCA) is to replace the standard mastoidectomy with a small diameter tunnel from the lateral bone surface to the cochlea for electrode array insertion. In contrast to previous attempts, the approach described in this work not only achieves an unprecedented high accuracy, but also contains several safety sub-systems. This paper provides a brief description of the system components, and summarizes accuracy results using the system in a cadaver model over the past two years.

Robotic cochlear implantation: surgical procedure and first clinical experience

Abstract Conclusion: A system for robotic cochlear implantation (rCI) has been developed and a corresponding surgical workflow has been described. The clinical feasibility was demonstrated through the conduction of a safe and effective rCI procedure. Objectives: To define a clinical workflow for rCI and demonstrate its feasibility, safety, and effectiveness within a clinical setting. Method: A clinical workflow for use of a previously described image guided surgical robot system for rCI was developed. Based on pre-operative images, a safe drilling tunnel targeting the round window was planned and drilled by the robotic system. Intra-operatively the drill path was assessed using imaging and sensor-based data to confirm the proximity of the facial nerve. Electrode array insertion was manually achieved under microscope visualization. Electrode array placement, structure preservation, and the accuracy of the drilling and of the safety mechanisms were assessed on post-operative CT images. Results: Robotic drilling was conducted with an accuracy of 0.2 mm and safety mechanisms predicted proximity of the nerves to within 0.1 mm. The approach resulted in a minimal mastoidectomy and minimal incisions. Manual electrode array insertion was successfully performed through the robotically drilled tunnel. The procedure was performed without complications, and all surrounding structures were preserved.

Significant Artifact Reduction at 1.5T and 3T MRI by the Use of a Cochlear Implant with Removable Magnet: An Experimental Human Cadaver Study

Objective Cochlear implants (CIs) are standard treatment for postlingually deafened individuals and prelingually deafened children. This human cadaver study evaluated diagnostic usefulness, image quality and artifacts in 1.5T and 3T magnetic resonance (MR) brain scans after CI with a removable magnet. Methods Three criteria (diagnostic usefulness, image quality, artifacts) were assessed at 1.5T and 3T in five cadaver heads with CI. The brain magnetic resonance scans were performed with and without the magnet in situ. The criteria were analyzed by two blinded neuroradiologists, with focus on image distortion and limitation of the diagnostic value of the acquired MR images. Results MR images with the magnet in situ were all compromised by artifacts caused by the CI. After removal of the magnet, MR scans showed an unequivocal artifact reduction with significant improvement of the image quality and diagnostic usefulness, both at 1.5T and 3T. Visibility of the brain stem, cerebellopontine angle, and parieto-occipital lobe ipsilateral to the CI increased significantly after magnet removal. Conclusions The results indicate the possible advantages for 1.5T and 3T MR scanning of the brain in CI carriers with removable magnets. Our findings support use of CIs with removable magnets, especially in patients with chronic intracranial pathologies.

Manual Electrode Array Insertion Through a Robot-Assisted Minimal Invasive Cochleostomy: Feasibility and Comparison of Two Different Electrode Array Subtypes.

Hypothesis To evaluate the feasibility and the results of insertion of two types of electrode arrays in a robotically assisted surgical approach. Background Recent publications demonstrated that robot-assisted surgery allows the implantation of free-fitting electrode arrays through a cochleostomy drilled via a narrow bony tunnel (DCA). We investigated if electrode arrays from different manufacturers could be used with this approach. Methods Cone-beam CT imaging was performed on fivecadaveric heads after placement of fiducial screws. Relevant anatomical structures were segmented and the DCA trajectory, including the position of the cochleostomy, was defined to target the center of the scala tympani while reducing the risk of lesions to the facial nerve. Med-El Flex 28 and Cochlear CI422 electrodes were implanted on both sides, and their position was verified by cone-beam CT. Finally, temporal bones were dissected to assess the occurrence of damage to anatomical structures during DCA drilling. Results The cochleostomy site was directed in the scala tympani in 9 of 10 cases. The insertion of electrode arrays was successful in 19 of 20 attempts. No facial nerve damage was observed. The average difference between the planned and the postoperative trajectory was 0.17 ± 0.19 mm at the level of the facial nerve. The average depth of insertion was 305.5 ± 55.2 and 243 ± 32.1 degrees with Med-El and Cochlear arrays, respectively. Conclusions Robot-assisted surgery is a reliable tool to allow cochlear implantation through a cochleostomy. Technical solutions must be developed to improve the electrode array insertion using this approach.

A multiscale imaging and modelling dataset of the human inner ear

Understanding the human inner ear anatomy and its internal structures is paramount to advance hearing implant technology. While the emergence of imaging devices allowed researchers to improve understanding of intracochlear structures, the difficulties to collect appropriate data has resulted in studies conducted with few samples. To assist the cochlear research community, a large collection of human temporal bone images is being made available. This data descriptor, therefore, describes a rich set of image volumes acquired using cone beam computed tomography and micro-CT modalities, accompanied by manual delineations of the cochlea and sub-compartments, a statistical shape model encoding its anatomical variability, and data for electrode insertion and electrical simulations. This data makes an important asset for future studies in need of high-resolution data and related statistical data objects of the cochlea used to leverage scientific hypotheses. It is of relevance to anatomists, audiologists, computer scientists in the different domains of image analysis, computer simulations, imaging formation, and for biomedical engineers designing new strategies for cochlear implantations, electrode design, and others.

Speech Intelligibility in Noise With a Single-Unit Cochlear Implant Audio Processor.

Introduction The Rondo is a single-unit cochlear implant (CI) audio processor comprising the identical components as its behind-the-ear predecessor, the Opus 2. An interchange of the Opus 2 with the Rondo leads to a shift of the microphone position toward the back of the head. This study aimed to investigate the influence of the Rondo wearing position on speech intelligibility in noise. Methods Speech intelligibility in noise was measured in 4 spatial configurations with 12 experienced CI users using the German adaptive Oldenburg sentence test. A physical model and a numerical model were used to enable a comparison of the observations. Results No statistically significant differences of the speech intelligibility were found in the situations in which the signal came from the front and the noise came from the frontal, ipsilateral, or contralateral side. The signal-to-noise ratio (SNR) was significantly better with the Opus 2 in the case with the noise presented from the back (4.4 dB, p < 0.001). The differences in the SNR were significantly worse with the Rondo processors placed further behind the ear than closer to the ear. Conclusion The study indicates that CI users with the receiver/stimulator implanted in positions further behind the ear are expected to have higher difficulties in noisy situations when wearing the single-unit audio processor.

Instrument flight to the inner ear

Image-guided robotic surgery, designed for operating on small structures, is demonstrated for robotic cochlear implantation. Surgical robot systems can work beyond the limits of human perception, dexterity, and scale, making them inherently suitable for use in microsurgical procedures. However, despite extensive research, image-guided robotics applications for microsurgery have seen limited introduction into clinical care to date. Among others, challenges are geometric scale and haptic resolution at which the surgeon cannot sufficiently control a device outside the range of human faculties. Mechanisms are required to ascertain redundant control on process variables that ensure safety of the device, much like instrument flight in avionics. Cochlear implantation surgery is a microsurgical procedure, in which specific tasks are at submillimetric scale and exceed reliable visuo-tactile feedback. Cochlear implantation is subject to intra- and interoperative variations, leading to potentially inconsistent clinical and audiological outcomes for patients. The concept of robotic cochlear implantation aims to increase consistency of surgical outcomes, such as preservation of residual hearing, and to reduce invasiveness of the procedure. We report successful image-guided, robotic cochlear implantation in human. The robotic treatment model encompasses computer-assisted surgery planning, precision stereotactic image guidance, in situ assessment of tissue properties, and multipolar neuromonitoring, all based on in vitro, in vivo, and pilot data. The model is expandable to integrate additional robotic functionalities such as cochlear access and electrode insertion. Our results demonstrate the feasibility and possibilities of using robotic technology for microsurgery on the lateral skull base. It has the potential for benefit in other microsurgical domains for which there is no task-oriented robotic technology available at present.