Design and Fabrication of a Device for Non-Invasive Transdermal Opioid Biomarker Sensing

Georgetown University, Washington DC

Investigators

Abstract

This project will design and develop innovative medical products to address the opioid crisis in the U.S. Although blood is the body fluid which provides the most accurate quantitative data on biomolecular concentration when compared with other traditional sample matrices, blood-draws are extremely invasive, uncomfortable and, in the context of persons either denying or dealing with opioid addiction, are met with resistance and trepidation. An expanding pathway for biomolecular detection is through interstitial fluid (ISF), which surrounds cells in all living tissue and organs, and contains constituents of blood. By passively harvesting this fluid from just beneath the skin surface in a non-invasive, non-inflammatory manner, blood-borne biomarkers for illicit opioid use can be detected in the ISF using traditional clinical tools. An important advantage of harvesting ISF using a non-invasive dermal patch, or Band-Aid-like devices, is that the fluid is pre-filtered by the capillary system so that large biomolecules do not exist in the sample. Specifically, the device will sample ISF via noninvasive micro-pore generation using highly-controlled micro-heater ablation of the uppermost (dead) skin layer. The microliter quantity of ISF exuded from the skin can be transported via microfluidics to a reservoir for subsequent external pipetting. Using the laboratory facilities at the FDA-CDRH the detection of standard biomarkers of opioid abuse will be undertaken using the sampled ISF biomarker (meconin, and other standard opioid abuse biomarkers. 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.