SBIR Phase II:A novel, microfluidic device to improve collection and analysis of biopsy samples from ocular paracentesis

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to transform current eye care by providing a novel tool for ocular fluid biopsies. The fluid in the eye is isolated from the rest of the body by a blood-ocular barrier, so obtaining blood work does not help for diagnosing most ocular problems. Testing of ocular fluid has been shown to decrease rates of blindness in cases of ocular infections. However, this procedure is under-utilized due to the flaws with the current method for collecting fluid. Because of this, ocular infections can be misdiagnosed and undertreated, which can lead to increased rates of vision loss. Additionally, ocular fluid is an untapped reservoir for emerging biomarkers which has created an unmet need for better tools to collect this fluid. This project will result in a new product that can be used to collect ocular fluid for analyses that will guide treatment of some of the most common sight-threatening conditions including macular degeneration, glaucoma, and diabetes. This technology will open a new frontier in ocular diagnosis and improve vision outcomes for patients. _x000D__x000D_ This Small Business Innovation Research (SBIR) Phase II project is focused on fabricating a new medical device for ocular fluid biopsies. This project will create an instrument that is specifically designed to collect of fluid from the front of the eye. The research will include optimization of the needle to decrease the force of entry. This new tool will enhance the surgeon’s control during the procedure and decrease risk of injury. This research will also investigate the fluid dynamics of collection with the integration of a microfluidic chamber and specialized collection system that is designed to handle small fluid volumes. A significant limitation of the current procedure is that the fluid volumes collected are small and the current method leads to fluid loss and inaccurate results. Additional development will evaluate advanced engineering features to connect the device for drug delivery. The expected outcome of this research is an innovative surgical tool that will enable ophthalmologists to perform ocular fluid biopsies more reliably and achieve better results._x000D_ _x000D_ 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.