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

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是克服目前缺乏类似设备用于筛查和监测PAD的潜力，并将允许当前和未来患有PAD的患者以更低的成本获得更多的机会。今天，对于800万至1000万患有下肢PAD的美国人来说，PAD患者的诊断和治疗的住院费用超过每位患者10，000美元。目前的PAD诊断方法过于昂贵，而且不切实际，无法在早期阶段监测或诊断病情，否则就太晚了，无法开始逆转或减缓进展的治疗。在医疗专业人员初步诊断后定期筛查和监测PAD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进行的150，000例缺血性截肢中的许多。拟议的项目解决了对监测PAD的更实用、更容易获得、更方便用户和更便宜的技术的需求。我们提出的经皮气体传感器采用创新的专利气相检测器，以非侵入性方式提供目标分子的实时测量。预计这种方法将通过监测血浆H2S水平来提供对发作和严重程度的准确、具有成本效益的监测，这也可以实现后续的实时治疗措施。在第一阶段研究期间，将开发TGS模块的原型，并展示其性能。以前的数据和结果将被用来设计和开发远程gasotransmitter监控的试验板原型。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。将在模拟实验室条件下使用膜和动物皮肤测试可行性。此外，面包板原型将在健康和糖尿病大鼠的持续研究中实施。在第一阶段研究结果的基础上，计划为第二阶段的工作开发更先进的原型并进行进一步测试。

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.