An Acoustofluidic Device for Biocompatible Platelet Separation

Abstract Isolating a high-purity, high-quality, and high-concentration platelet sample in an efficient and cost- effective manner is of paramount importance to both hematological research and clinical therapy settings. Even though there are several methods for isolating platelets on the market today, most current methods have low biocompatibility (i.e., activate platelets, alter their morphology, and reduce membrane integrity during the platelet separation process). These drawbacks detract from the overall utility of current practices, and can even have a negative impact on patients. For example, measurements of platelet units in U.S. hospitals have found that platelet activation rates range between 23% to 50%. Studies have shown that when patients receive activated platelets, they require more platelet transfusion than patients who receive non-activated platelets. Overall, up to 30% of platelet transfusions performed in the U.S. are ineffective. Although there are many factors that influence the clinical outcomes of platelet transfusions, the quality of isolated platelets has been shown to play a crucial role. The objective of this SBIR project is to overcome the limitations of existing platelet separation technologies and address the unmet needs in the market by developing and commercializing a biocompatible platelet separation and enrichment platform using acoustofluidic (i.e., the fusion of acoustics and fluid mechanics) technologies. During our work on the Phase I project, we successfully demonstrated the utility and feasibility of the proposed biocompatible platelet separation and enrichment devices by meeting or exceeding the target values for each of the six key parameters identified in the Measures of Success. In Phase II, our commercialization activities will improve the performance of the acoustofluidic-based platelet separation and enrichment chips, develop self-contained, beta-testing-ready prototypes, and validate their performance with end users. The proposed acoustofluidic technology will have significantly improved biocompatibility when compared to the benchmark technologies (isolating platelets that are more morphologically and chemically intact). We believe that our superior biocompatibility compared to traditional platelet isolation techniques will enable the development and commercialization of an acoustofluidic platform that has the potential to significantly improve the effectiveness, speed, and economy of both clinical and research applications of platelets.