ImgGydD LLC is working on development of a novel device - “AccuGyd" - a highly accurate and precise drill and catheter guide, Rapid, easy to install and to utilize, the device may be affixed either to the skull or a stereotaxic frame. A single MRI scan will yield information to calculate the trajectory between AccuGyd and the tissue target. A major advantages of the AccuGyd technology for MIS include: 1) it utilizes much smaller holes in the skull for brain access and device placement; 2) it is extremely reproducible and mechanically stable; and 3) it substantially reduces the time for an MRI guided procedure. The firm's early focus will be on tasks required to incorporate AccuGyd into a comprehensive MRI Guidance platform that can be be used in a larger Phase II study. Further development of the device itself -will prototype fabrication, development and implementation of an algorithm to define the optimal trajectory of the AccuGyd based on MRI image features, and validation of accuracy and precision using a realistic head-shaped phantom and human head cadavers. The result will be a validated AccuGyd prototype that is ready to enter the FDA 510(k) clearance process.Project Narrative: Minimally invasive surgical methods are desired in all areas of medicine, but particularly in brain surgery, yielding significant reductions of surgical time, complications, recovery time, and the disruption of otherwise normal tissue. Magnetic resonance imaging (MRI) can guide devices to precisely targeted locations within the brain and then deliver electrical stimulation, heat, or drugs, but the process of accessing the brain and then orienting a catheter or other device to a specific target location takes on the order of 2 hours per hole. This proposal aims to build a MRI-compatible drill guide that will allow surgeons to drill a minimal hole and orient the inserted device through the hole and to its target within 1 millimeter in 30 minutes; the reduced complexity of the surgery will allow more neurosurgeons to use MRI guidance for advanced therapy procedures.
