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

Carrtech Llc, Frederick MD

Investigators

Abstract

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.