SBIR Phase I: Development of a Novel Miniature Spray Mechanism for Nasal Drug Delivery

这项小型企业创新研究（SBIR） I期项目的更广泛影响/商业潜力将通过无创鼻腔给药改善患者的治疗效果。鼻腔是一种快速、廉价的非侵入性药物输送管道。局部鼻内药物治疗鼻窦、神经系统和全身疾病。拟议中的创新将通过将药物准确地送到需要的地方，显著改善鼻腔给药和患者的治疗效果。这将是第一个小型化的雾化技术，可以广泛应用于其他领域。最初设想的应用是慢性鼻窦炎，它影响10%的人口，每年花费美国医疗保健120亿美元。这个小企业创新研究（SBIR）一期项目推进了一种新的鼻腔给药系统。目前的局部药物递送效果有限，因为它们依赖于通过复杂的鼻腔解剖进行远距离颗粒雾化。为了克服这一点，将开发一种自我给药的、基于导管的雾化给药装置，将药物直接输送到解剖目标。然而，雾化只存在于较大的刚性形状因素中。本研究的目的是开发一种新颖的雾化器，保持一个小的，灵活的形状因素，以纳入导管尖端。像这样的新系统对于有效、可耐受的鼻腔给药至关重要。计算流体动力学模拟将执行，以确定原型设计和施工。设计将通过微成型，挤压操作和微3d打印的复模制造。设计将使用激光衍射来评估喷雾特性（液滴尺寸分布、喷雾角度、速度和羽流几何形状）和解剖模型来评估流体沉积。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.