An Acoustofluidic Device for Biocompatible Platelet Separation

摘要 分离出高纯度、高质量、高浓度的血小板样品，效率高、成本低。 有效的治疗方法对血液学研究和临床治疗都是至关重要的 设置。尽管今天市场上有几种分离血小板的方法，但最流行的是 这些方法的生物相容性较低(例如，激活血小板、改变其形态和减少膜 在血小板分离过程中保持完整性)。这些缺点削弱了 目前的做法，甚至可能对患者产生负面影响。例如，测量 美国医院的血小板单位发现，血小板激活率在23%到50%之间。 研究表明，当患者接受激活的血小板时，他们需要更多的血小板输注 而不是接受未激活的血小板的患者。总体而言，高达30%的血小板输注 在美国是无效的。尽管有许多因素影响着血小板的临床结果 在输血过程中，分离的血小板的质量已被证明起着至关重要的作用。这样做的目的是 SBIR项目旨在克服现有血小板分离技术的局限性，解决 通过开发和商业化生物兼容的血小板分离器和 采用声流技术(即声学和流体力学的融合)的浓缩平台。 在第一阶段项目的工作中，我们成功地证明了 建议的生物相容的达到或超过目标的血小板分离和浓缩装置 成功衡量标准中确定的六个关键参数中的每一个的值。在第二阶段，我们的 商业化活动将提高基于声流控的血小板分离的性能 和浓缩芯片，开发自包含的、可进行Beta测试的原型，并验证其 提高最终用户的绩效。拟议的声流控技术将有显著的改进 与基准技术相比的生物兼容性(分离更多 在形态上和化学上完好无损)。我们相信，我们的卓越生物兼容性与 传统的血小板分离技术将使一种 声流平台，有可能显著提高效率、速度和 血小板临床应用和研究应用的经济性。

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.