Drop-of-blood technology for home-use monitoring of anticoagulant therapy

项目总结 每天有500多万美国患者服用口服抗凝剂预防和治疗 血栓栓塞症。他们大多是门诊病人，需要经常在家中监测抗凝剂 心理治疗。根据《国家药品不良事件预防行动计划》，抗凝剂是 卫生保健环境中不良反应的常见原因“。在老年人的所有紧急住院中，33%是 意外服用过量抗凝剂所致。然而，尽管抗凝治疗存在这些重大问题 管理，可用于家庭使用的监测口服抗凝剂治疗的设备不仅对 凝血状态，也对口服抗凝剂的剂量效应不敏感。 这个SBIR第一阶段项目的长期目标是开发一个用于家庭使用监测的原型设备 抗凝治疗。Levisonics Inc.开发了一种独特的滴中实验室技术，用于血液凝固分析， 称为“准静态声钳血栓弹性测定法”或QATT。在QATT中，血栓的时间变化 坚固性是通过在声辐射下漂浮在空气中的一滴血(体积为4-6微升)来评估的 武力。QATT通过以下破坏性功能解决了家庭护理点凝血测试的问题：1) 样本量要求小；2)非接触式测量提高了可靠性和准确性；3)快速 凝血状态的评估。 这项SBIR提案的目标将通过三项任务实现。第一，现有的实验室研究 设备将被小型化和精细化到适合家庭使用的形状因素(具体目标1)，并简化用户 面向目标人群的界面。第二，将实施手指到设备的样品递送方法(具体 目的2)只需要一次手指刺血。第三，开发的家庭使用原型的可行性 将通过检测正常志愿者的毛细血管和静脉血来建立特定目标1(特定目标3) 暴露于受控变化的肝素和口服抗凝剂剂量。

PROJECT SUMMARY More than 5 million U.S. patients take oral anticoagulants daily for the prevention and treatment of thromboembolic events. Most of them are outpatients in need of frequent at‐home monitoring of anticoagulant therapy. According to the National Action Plan for Adverse Drug Event (ADE) Prevention, anticoagulants are “the most common causes of ADEs across health care settings”. 33% of all emergent hospitalizations among older adults are the result of unintentional anticoagulant overdose. Yet despite these significant problems in anticoagulation therapy management, available devices for home‐use monitoring of oral anticoagulant therapy are not only poor predictors of coagulation status, but also not sensitive to dosage effects of oral anticoagulants. The long‐term objective of this SBIR Phase I project is to develop a prototype device for home‐use monitoring of anticoagulant therapy. Levisonics Inc. has developed a unique lab‐in‐a‐drop technology for blood coagulation analysis, referred to as “quasi‐static acoustic tweezing thromboelastometry” or QATT. In QATT, temporal changes in clot firmness are assessed from a single drop of blood (4‐6 microliters in volume) levitating in air under the acoustic radiation force. QATT addresses the issues of home point‐of‐care coagulation testing through the following disruptive features: 1) small sample volume requirement; 2) increased reliability and accuracy due to non‐contact measurement; and 3) rapid assessment of blood coagulation status. The objective of this SBIR proposal will be accomplished in three tasks. First, the existing laboratory research apparatus will be miniaturized and refined to a form factor suitable for home use (Specific Aim 1), with a simplified user interface for the target population. Second, a finger‐to‐device sample delivery method will be implemented (Specific Aim 2) requiring only a single finger‐prick drop of blood. Third, the feasibility of the home use prototype developed in Specific Aim 1 will be established by testing both capillary and venous blood from normal volunteers (Specific Aim 3) exposed to controlled variations of heparin and oral anticoagulant doses.