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

这一小型企业创新研究(SBIR)第一阶段项目的广泛影响/商业潜力将通过非侵入性鼻腔给药改善患者的预后。鼻腔是一种非侵入性的药物输送管道，作用迅速，成本低廉。鼻腔局部用药治疗鼻窦、神经和全身疾病。这项拟议的创新将通过将药物准确地送往需要的地方，显著改善鼻腔药物的输送和患者的预后。这将是第一个微型化雾化技术，并可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。这个小型企业创新研究(SBIR)第一阶段项目推进了一种新的鼻腔给药系统。目前的局部给药效果有限，因为它们依赖于通过复杂的鼻部解剖进行的远程颗粒雾化。为了克服这一点，将开发一种自行给药的、基于导管的雾化给药装置，将药物直接输送到解剖靶点。然而，雾化只存在于更大、更硬的形状因素中。这项研究的目的是开发一种新型的雾化器，它保持了小的、灵活的形状因子，可以并入导管尖端。像这样的新系统对于有效、可耐受的鼻腔给药至关重要。将进行计算流体动力学模拟，以确定原型设计和建造。设计将通过微成型、挤压操作和微3D打印的超塑制造。设计将使用激光衍射进行测试，以评估喷雾特性(液滴尺寸分布、喷雾角度、速度和羽流几何形状)和解剖模型，以评估流体沉积。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.