The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will improve patient outcomes through non-invasive nasal drug delivery. The nasal cavity is a non-invasive drug delivery conduit that is rapid-acting and inexpensive. Topical intranasal medications treat sinus-nasal, neurologic, and systemic diseases. The proposed innovation will significantly improve nasal drug delivery and patient outcomes by getting medication exactly where it needs to go. It will be the first miniaturized atomization technology and can be broadly applied to other fields. The initial envisioned application is chronic sinusitis, which affects 10% of the population and costs US healthcare $12 billion/year. This Small Business Innovation Research (SBIR) Phase I project advances a new nasal drug delivery system. Current topical drug deliveries have limited effectiveness because they rely on distant particle atomization through complex nasal anatomy. To overcome this, a self-administered, catheter-based atomization drug delivery device that delivers drug directly to the anatomic target will be developed. However, atomization only exists in larger, rigid form factors. The objective of this research is to develop an novel atomizer that maintains a small, flexible form factor to be incorporated into the catheter tip. A new system like this is crucial for effective, tolerable nasal drug delivery. Computational Fluid Dynamics simulations will be performed to determine prototype design and construction. Designs will be manufactured through micromolding, extrusion manipulation, and overmolding with micro-3D printing. Designs will be tested using laser diffraction to evaluate spray characteristics (droplet size distribution, spray angle, velocity, and plume geometry) and anatomic models to evaluate fluid deposition.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
