SBIR-STTR Award

The ability to perform platelet separation with a high throughput, high recovery rate, high purity, and high platelet integrity is extremely important in many biomedical research studies and therapeutic applications (such as platelet transfusions). Centrifugation is currently the ?gold standard? laboratory technique used to obtain platelets from whole blood. However, this current approach for platelet separation often sacrifices the integrity of the platelets and disturbs them from their resting state. It has been reported that centrifugation processes significantly activate platelets, alter their morphology, reduce their membrane integrity, and affect platelet functions. These drawbacks limit the usefulness of the resulting platelet samples in many biomedical studies and clinical applications, resulting in many unmet needs. Our objective is to address these unmet needs by developing an acoustofluidic (i.e., the fusion of acoustics and fluid mechanics) based, platelet separation method that can maintain platelets in their resting state and preserve their properties and functions. When compared to conventional platelet separation techniques, our proposed acoustofluidic approach has already demonstrated a significantly lower level of activation, a higher platelet morphology score, and better membrane integrity. In Phase I of this SBIR project, we will demonstrate the feasibility and utility of this acoustofluidic platelet separation device. With unprecedented capabilities for maintaining platelet integrity, our acoustofluidic device will not only become a more compact and affordable replacement to the existing platelet separation approaches, but also fulfill many unmet needs in both fundamental biomedical research and therapeutics.

Project Terms:
Acoustics; Address; Affect; base; Biological; biomaterial compatibility; Biomedical Research; Blood; Blood Cells; Blood coagulation; Blood Component Removal; Blood Platelets; Cells; Centrifugation; clinical application; cost; Custom; design; Development; Devices; Dimensions; Effectiveness; Electronics; Erythrocytes; Excision; Goals; Gold; Hematology; Hemorrhage; Human; improved; Industry Standard; Laboratories; Lead; Leukocytes; Life; Liquid substance; Liver Regeneration; Mechanics; Membrane; Methods; Morphology; nanobiotechnology; Neoplasm Metastasis; novel; One-Step dentin bonding system; Patients; Performance; Phase; Physiological Processes; Platelet Activation; Platelet Transfusion; point of care; prevent; Procedures; Process; Property; prototype; Recovery; Reporting; Research; Research Personnel; research study; response; Rest; Sampling; Savings; Series; Shock; simulation; Small Business Innovation Research Grant; System; Systems Integration; Techniques; Technology; Testing; Therapeutic; tool; tumor; Universities; Whole Blood; Wound Healing;

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 therapysettings. Even though there are several methods for isolating platelets on the market today, most currentmethods have low biocompatibility (i.e., activate platelets, alter their morphology, and reduce membraneintegrity during the platelet separation process). These drawbacks detract from the overall utility ofcurrent practices, and can even have a negative impact on patients. For example, measurements ofplatelet 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 transfusionthan patients who receive non-activated platelets. Overall, up to 30% of platelet transfusions performedin the U.S. are ineffective. Although there are many factors that influence the clinical outcomes of platelettransfusions, the quality of isolated platelets has been shown to play a crucial role. The objective of thisSBIR project is to overcome the limitations of existing platelet separation technologies and address theunmet needs in the market by developing and commercializing a biocompatible platelet separation andenrichment 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 theproposed biocompatible platelet separation and enrichment devices by meeting or exceeding the targetvalues for each of the six key parameters identified in the Measures of Success. In Phase II, ourcommercialization activities will improve the performance of the acoustofluidic-based platelet separationand enrichment chips, develop self-contained, beta-testing-ready prototypes, and validate theirperformance with end users. The proposed acoustofluidic technology will have significantly improvedbiocompatibility when compared to the benchmark technologies (isolating platelets that are moremorphologically and chemically intact). We believe that our superior biocompatibility compared totraditional platelet isolation techniques will enable the development and commercialization of anacoustofluidic platform that has the potential to significantly improve the effectiveness, speed, andeconomy of both clinical and research applications of platelets.

Public Health Relevance Statement:
Project Narrative The goal of the proposed project is to develop and commercialize tools that can effectively isolate and enrich platelets from blood without affecting the properties and functions of blood components. The proposed technology has the potential to address many unmet needs in the market, and has the potential to transform both fundamental biomedical research and therapeutics (e.g., platelet transfusion).

Project Terms: