Development of a Navigation-Based Insertion Tool for Trajectory Optimization during Cochlear Implantation

Abstract: The Cochlear Implant (CI) is the primary treatment modality for patients with severe to profound hearing loss, while continual advances in the preservation of intracochlear structures during implantation make this a viable option for those with residual hearing. Surgical strategies for preserving cochlear function include atraumatic techniques such as slow and consistent insertions, surgical planning, and avoiding intracochlear structures through better understanding of insertion trajectory. However, studies have suggested that trauma to the cochlea during electrode insertion results in damage to delicate inner ear structures, and up to 50% of patients experience delayed hearing loss following surgery resulting in a diminished quality of life.1 In this SBIR, iotaMotion aims to develop a navigation-based cochlear implant insertion system that optimizes trajectory while enabling slow and consistent electrode array insertions. The anticipated impact of this technology will be to improve short and long-term hearing outcomes for CI patients by enhancing structural preservation of the cochlea. The project will develop a working prototype and demonstrate the capability of the device in a cadaveric model via the following three aims: AIM 1: Develop a working benchtop prototype of a robotic-assistive insertion tool with real-time navigation. The first stage of development will include the design, fabrication, and testing of an electromagnetic tracking sensor in a laboratory setting; demonstrating that the drive unit and trajectory of insertion can be visualized and manipulated in a virtual environment in real time. AIM 2: Integrate automated pre-operative imaging and optimal trajectory analysis into virtual environment. Following prototype fabrication, the next stage of development will integrate the device into a patient scan virtual environment in which the optimal trajectory is defined via pre-operative imaging software. The Graphical User Interface and software from Vanderbilt’s current system will be updated to allow the user to visualize the drive unit in relation to the optimal trajectory. AIM 3: Demonstrate proof of concept capability to robotically control electrode array insertion with optimal trajectory in a cadaveric model. The final aim will evaluate the functionality of the prototype in a cadaver model for which the hypothesis is that orientation of a robotic insertion tool in accordance with a preoperative plan based on CT imaging will be more accurate and consistent relative to manual alignment techniques. Ultimately, the success of Phase I will allow development of this insertion system to progress to a second iteration of the design (based on the knowledge gained in Phase I) and further clinical testing to establish the efficacy of the device as compared to the current gold standard of implantations. SBIR funding will help secure additional outside investment and bring us closer to commercializing this much needed treatment for people suffering from disabling hearing loss.