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

这项小企业创新研究（SBIR）一期项目的更广泛的影响/商业潜力是有可能克服目前缺乏类似设备筛查和监测PAD的一些问题，并使当前和未来的PAD患者能够以更低的成本获得更多的设备。今天，患有下肢PAD的800万到1000万美国人，诊断和治疗PAD患者的住院费用超过每名患者1万美元。目前的PAD诊断方法过于昂贵且不切实际，无法在早期阶段进行监测或诊断，以免为时已晚，无法开始治疗以逆转或减缓进展。医疗专业人员在初步诊断后对PAD进行定期筛查和监测，有可能显著降低目前管理PAD患者的成本，包括通过早期干预预防美国每年15万例缺血性截肢中的许多截肢。拟议的项目解决了对监测PAD的更实用、更容易获得、用户友好和廉价技术的需要。我们提出的透皮气体传输传感器采用创新的专利气相检测器，非侵入性地提供目标分子的实时测量。预计该方法将通过监测血浆H2S水平提供准确、经济有效的发病和严重程度监测，这也可以实现后续的实时治疗措施。在第一阶段的研究中，将开发一个TGS模块的原型并演示其性能。先前的数据和结果将用于设计和开发用于远程气体变送器监测的面包板原型。开发一次性传感器的关键技术挑战将得到解决，包括尺寸、成本和易用性。可行性将在模拟实验室条件下用膜和动物皮肤进行测试。此外，面包板原型将在健康大鼠和糖尿病大鼠的持续研究中实施。基于第一阶段的发现，第二阶段计划进行更先进的原型开发和进一步的测试。

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.