Research Project
9622538
Project Summary We will finalize development of a microhook-based device for quick and consistently effective repair of nerve injuries. This ?microhook nerve tape? consists of an array of microscale hooks, distributed across a fine, flexible meshwork and embedded in a biologic backing. This device will be used during nerve repair surgeries in place of microsutures to wrap around and bind the approximated ends of a severed nerve (or the ends of a nerve graft). The short microhooks penetrate only into the outer, connective tissue layers of the nerve, forming an effective mechanical attachment and distributing tension evenly across the device. Microhook nerve tape can be applied easily and lowers surgery time and complexity as compared to the current clinical standard of microsuture repair. The ease and intuitiveness of microhook nerve tape application will enable consistent high-quality repairs to optimize recovery after nerve injuries. In Phase I, we refined the device design to produce a set of prototypes consisting of a stainless steel-based microhook mesh laminated within a biologic layer of porcine small intestinal mucosa (SIS). In biomechanical testing, nerves were held together by the device with strength comparable to that of microsuture repairs. In in vivo rabbit testing, the device was well tolerated by the surrounding tissue, and nerves that were cut and repaired with microhook nerve tape regenerated comparably vs. microsuture repaired nerves. We subsequently developed an enhanced Nitinol- based version of the device more suitable to clinical translation, and we demonstrated the superior performance of this device in biomechanical testing. In Phase II we will finalize the design of the microhook nerve tape device with Nitinol-based microhooks, and we will develop efficient manufacturing and production methods. We will conduct extensive validation testing of safety and efficacy in comprehensive rabbit studies and apply for FDA 510(k) clearance. The final commercialization-ready product will be an FDA- approved nerve repair device that can be stored on the shelf for use during nerve repair procedures. Microhook nerve tape will reduce the technical demands and time costs of nerve repair, while improving repair consistency and overall quality.
