SBIR Phase I: Noninvasive Sensor for Remote Monitoring of Peripheral Artery Disease

SBIR 第一阶段：用于远程监测外周动脉疾病的无创传感器

• 批准号: 1620855
• 负责人: Reza Shekarriz
• 金额: $ 22.5万
• 依托单位: Exhalix, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2017-10-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1620855&HistoricalAwards=false
• 关键词: SBIR; Phase; Noninvasive; Sensor; Remote

The broader impact/commercial potential of this Small Business Innovations Research (SBIR) Phase I project is the potential to overcome some of the current lack of similar devices for screening and monitoring of PAD and will allow greater access at lower cost for current and future patients suffering from PAD. Today, hospitalization costs for diagnosis and treatment of PAD patients exceed $10,000 per patient for 8 to 10 million Americans suffering from lower-extremity PAD. The current options for PAD diagnosis are too expensive and impractical to monitor or diagnose the condition in its early stages before it is too late to initiate therapy to reverse or slow progress. Regular screening as well as monitoring of PAD after an initial diagnosis by medical professionals has the potential to significantly reduce the current cost of managing PAD patients, including prevention of many of the 150,000 ischemic amputations performed annually in the US through early intervention. The proposed project addresses the need for a more practical, accessible, user-friendly, and inexpensive technique, for monitoring PAD. The proposed our transdermal gasotransmitter sensor employs an innovative, patented gas-phase detector to non-invasively provide real-time measure of the target molecule. It is anticipated that this approach would provide accurate, cost-effective monitoring of onset and severity through monitoring plasma H2S levels, which could also enable subsequent therapeutic measures in real-time. During this Phase I study, a prototype of a TGS module will be developed and its performance will be demonstrated. Prior data and results will be utilized to design and develop a breadboard prototype for remote gasotransmitter monitoring. Key technical challenges of developing a disposable sensor will be addressed, including size, cost, and ease of use. Feasibility will be tested under simulated laboratory conditions with membranes and animal skin. Furthermore, the breadboard prototype will be implemented in ongoing studies on healthy and diabetic rats. Building on Phase I findings, more advanced prototype development and further testing is planned for Phase II efforts.

这项小型企业创新研究（SBIR）I期项目的更广泛的影响/商业潜力是克服目前缺乏类似的筛查和监视PAD的类似设备的潜力，并且将使患有PAD患者的当前和未来患者以较低的成本访问。如今，诊断和治疗PAD患者的住院费用超过每名患者的10,000美元，其中8至1000万美国人患有低超级垫。当前的PAD诊断选择过于昂贵且不切实际，无法在早期阶段监测或诊断病情，但为时已晚，无法开始治疗以逆转或缓慢进展。医疗专业人员初步诊断后进行定期筛查以及对PAD的监测有可能显着降低当前管理PAD患者的成本，包括预防美国每年在美国每年通过早期干预进行的15万缺血性截肢。拟议的项目解决了对监视垫的更实用，可访问，用户友好和廉价的技术的需求。提出的我们的透皮质递质传感器采用创新的，专利的气相检测器，非侵入性地提供目标分子的实时度量。可以预计，这种方法将通过监测血浆H2S水平来提供准确，具有成本效益的发作和严重性监测，这也可以实时实时实时进行治疗措施。在此阶段I研究中，将开发一个TGS模块的原型，并将证明其性能。先前的数据和结果将用于设计和开发面包板原型，以用于远程燃烧机监视。将解决开发一次性传感器的关键技术挑战，包括尺寸，成本和易用性。可行性将在模拟实验室条件下进行膜和动物皮肤进行测试。此外，面包板原型将在正在进行的有关健康和糖尿病大鼠的研究中实施。在第一阶段发现的基础上，计划进行更先进的原型开发和进一步的测试，以进行第二阶段的工作。