SBIR Phase I: Filter Removal of Glass - A better way of filtering injectables

这个小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是一个集成的单针过滤器，可以从注射液体中去除玻璃碎片。液体药品和药物通常储存在玻璃安瓿中。为了获得这些药物，每个安瓿都是由卫生保健提供者在颈部手工打破的。这可能导致玻璃碎片进入药物，导致患者血肿和/或内出血。美国法规目前规定，所有安瓿在注射前必须由卫生保健提供者过滤，这需要使用多个针头和针头交换进行多步骤过滤过程。该项目旨在开发一种单一的、有效的、内联过滤器，它只需要目前这个过程的一半时间，同时通过减少针头刺伤的风险来提高患者和医护人员的安全性。其商业潜力是成为价值30亿美元的全球过滤器市场的护理标准，每年消费超过60亿个一次性玻璃安瓿。这个小型企业创新研究（SBIR）的第一阶段项目是一种新型的、一次性的、在线的机械过滤器，具有最佳的孔隙率和密度，可以去除玻璃安瓿碎片。目前的做法是在患者的脖子上打破药瓶以获取药物，结果导致碎片，目前在给药之前使用过滤针手动过滤。必须取出并丢弃过滤针，并将第二根无菌针放在注射器上进行注射。该公司的目标是开发一种新颖的、一体化的过滤器和针系统，该系统利用一个单一的内钝针，在远端与当前的近端（Luer loc所在的近端）安装一个新的过滤器。该解决方案将实现玻璃过滤和药物注射的单步过程。活动范围包括泄漏、拉力、死体积、标签和包装、处理安全性、可重复性/一致性以及公司专有设计概念的加速老化的工程和验证测试。该项目旨在提供一种适合人类使用的组件，该组件可以以经济有效的方式大规模制造。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 is an integrated, single needle filter which removes glass shards from injectable fluids. Liquid pharmaceuticals and medications are often stored in glass ampoules. To gain access to these medications, each ampoule is manually broken at the neck by a health care provider. This can result in glass shards entering the medication that can cause patient hematomas and/or internal bleeding. United States regulations currently mandate all ampoules must be filtered by health care providers prior to injection which requires a multi-step filter process using multiple needles and needle exchanges. This project aims to develop a single, effective, inline filter which that requires half the time of this current process, while improving safety for the patient and the healthcare worker by reducing the risks of needle stick injuries. The commercial potential is to become the standard of care for the $3 billion global filter market and consumes over six billion disposable glass ampoules every year.This Small Business Innovation research (SBIR) Phase I project is a novel, disposable, inline, mechanical filter with optimal porosity and density to remove glass ampoule shards. The current practice of breaking ampules at their neck to access medication results in shards that are currently manually filtered using a filter needle prior to administration into the patient. The filter needle must be removed and discarded, and a second sterile needle placed on the syringe for injection. The company aims to develop a novel, all-in-one, integrated filter and needle system utilizing a single inner blunt needle with a novel filter located at the distal end versus the current proximal end where the Luer loc is located. This solution will enable a single step process for glass filtering and medication injection. The scope of activities includes engineering and validation tests of leakage, pull force, dead volume, labeling and packaging, handling safety, repeatability/consistency, and accelerated aging of the company’s proprietary design concepts. This project aims to provide an assembly suitable for human use that is manufacturable at scale in a cost-effective manner.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.