SBIR Phase I: Novel Optical Platform for Patient Self Monitoring of Coagulation in Whole Blood

SBIR 第一阶段：用于患者全血凝血自我监测的新型光学平台

• 批准号: 0944944
• 负责人: Paul Lingane
• 金额: $ 14.95万
• 依托单位: ThromboMetrix, Inc
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=0944944&HistoricalAwards=false
• 关键词: SBIR; Phase; Novel; Optical; Platform

This Small Business Innovation Research Phase I project develops a novel optical system for use in home monitoring of oral anticoagulation therapy, of particular benefit in situations where a patient is dangerously at risk of injury from a bleed. Current systems that are sold for use in home testing appear to have issues of precision and accuracy at the high end of the range, which may contribute to significant morbidity and mortality. In the period from 2006 to 2008 there were close to 4000 adverse events reported to the FDA associated with the use of this generation of handheld testing devices. In the most serious of these adverse events, the devices erroneously reported values within a clinically acceptable range, while the patient displayed clinical symptoms of bleeding, and laboratory tests showed that the patient was dangerously over anticoagulated. The detection system proposed in this project seeks to monitor the aggregation and dis-aggregation of rouleaux as an indicator of clot formation. The proposed optical system, if successful, is tuned particularly to the dis-aggregation of rouleaux and thus, will be more accurate and precise in the supratherapeutic range. There are three million people in the US who are on long term oral anticoagulant therapy and who would benefit from tighter control of their dosages enabled by the availability of home testing systems. The number of people who perform home testing has grown since Medicare first provided coverage in 2003 and then expanded coverage in 2008, yet currently the number of people who perform home testing represents only a small percentage of all persons eligible. As home testing becomes more popular, there can be expected a concomitant increase in the number of adverse events. Home test systems must give accurate results over their entire reporting range, as there is no opportunity for a health care professional to judge the result in the context of a patient?s clinical symptoms. When used properly, home test systems can be of particular value to those who find it difficult to visit a lab or clinic for regular testing, such as the elderly, the economically disadvantaged, and those who are geographically dispersed in rural areas. Development and commercialization of a home test system that implements the innovations proposed by this research is expected to increase the safety of home monitoring of oral anticoagulant therapy.

该小型企业创新研究I期项目开发了一种新型光学系统，用于口服抗凝治疗的家庭监测，特别适用于患者因出血而有受伤危险的情况。 目前出售用于家庭测试的系统似乎在范围的高端具有精确度和准确度的问题，这可能导致显著的发病率和死亡率。 在2006年至2008年期间，向FDA报告了近4000起与使用这一代手持式测试设备相关的不良事件。在最严重的不良事件中，器械错误地报告了临床可接受范围内的数值，而患者显示出出血的临床症状，实验室检查显示患者危险地过度抗凝。 本项目中提出的检测系统旨在监测作为凝块形成指标的红细胞叠连的聚集和分解。 所提出的光学系统，如果成功的话，特别是调整到的rouleaux的解聚，因此，将更准确和精确的超治疗范围。 美国有300万人正在接受长期口服抗凝剂治疗，他们将受益于家庭测试系统的可用性对剂量的更严格控制。 自2003年医疗保险首次提供覆盖范围并于2008年扩大覆盖范围以来，进行家庭测试的人数有所增加，但目前进行家庭测试的人数仅占所有合格人员的一小部分。 随着家庭测试变得越来越流行，可以预期不良事件的数量也会随之增加。 家庭测试系统必须在其整个报告范围内给出准确的结果，因为医疗保健专业人员没有机会在患者的背景下判断结果。的临床症状。 如果使用得当，家庭测试系统对那些难以前往实验室或诊所进行定期测试的人特别有价值，例如老年人，经济弱势群体以及地理上分散在农村地区的人。 实现本研究提出的创新的家庭测试系统的开发和商业化预计将增加口服抗凝剂治疗的家庭监测的安全性。