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

该小型企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是一种集成的单针过滤器，可从注射液中去除玻璃碎片。 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，每一个病人的脖子都要由医疗保健提供者手动折断。这可能导致玻璃碎片进入药物，从而导致患者血肿和/或内出血。美国法规目前要求所有安瓿在注射前必须由医疗保健提供者过滤，这需要使用多个针头和针头交换的多步骤过滤过程。该项目旨在开发一种单一、有效的在线过滤器，其所需时间为当前工艺的一半，同时通过降低针刺伤害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30亿美元全球过滤器市场的护理标准，每年消耗超过60亿个一次性玻璃安瓿。这个小型企业创新研究（SBIR）第一阶段项目是一种新型的一次性在线机械过滤器，具有最佳的孔隙率和密度，可去除玻璃碎片。目前在安瓿颈部折断安瓿以获取药物的做法导致碎片，这些碎片目前在给药到患者体内之前使用过滤针手动过滤。必须取出过滤器针头并丢弃，并将第二个无菌针头放置在注射器上进行注射。该公司旨在开发一种新型的一体化集成滤器和针头系统，该系统采用单个内部钝针头，在远端（而不是当前鲁尔锁定器所在的近端）安装一个新型滤器。 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确认测试。该项目旨在提供一种适合人类使用的组件，以具有成本效益的方式大规模制造。该奖项反映了NSF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.