MicroFlex technology will provide unprecedented flexibility and controllability for the tip of endoscopes, enabling minimally invasive surgery in previously inaccessible spaces, direct visualization of structures there, and fine tool manipulation capabilities for diagnostic, therapeutic and surgical procedures. MicroFlex combines innovations in actuation, sensing, control and assembly to produce a 3mm diameter digitally or robotically controlled endoscope more flexible and controllable than those currently available. This project will use technology proven in the Phase I study to fabricate and functionally test MicroFlex prototypes for sinus diagnosis and surgery. MicroFlex prototypes will be assembled and tested in the laboratory for force and motion capabilities, a control manipulative and associated control electronics and software will be developed, and rhinologists will test the integrated system in cadavers for function and usability. Since the MicroFlex tip is controlled by temperature change in internal actuator elements, thermal effects on surrounding tissue will be assessed in detail, including advanced engineering models for temperature distribution and live animal testing for thermal damage. Sterilization robustness and effectiveness of a prototype device will also be tested. MicroFlex technology, fabrication processes and prototypes will be refined by integrating input from practicing sinus surgeons, engineers with expertise in medical product design, and prospective Phase III manufacturing partners and suppliers of complementary navigation and visualization technology. Potential Phase III manufacturing partners will be identified and utilized for Phase II prototype components, where possible, to accelerate the commercialization process. MicroFlex Tools to Improve Sinus Diagnostics and Surgery
