I-Corps: Non-invasive, multimode, hand-held technology for wound assessment

该I-Corps项目更广泛的影响/商业潜力是开发多模态光学成像系统，该系统定量测量组织生物标志物以表征糖尿病伤口的愈合。在美国，糖尿病伤口每年影响超过800万患者，估计经济负担约为300亿美元。对于可以非侵入性地测量多种生物标志物、阐明糖尿病伤口中的潜在组织变化并为个体化治疗提供解剖学和功能信息的综合成像工具存在未满足的需求。此外，需要客观的伤口评估工具来为临床医生和护理人员提供确定伤口愈合/不愈合状态的快速和定量方法。申报器械有可能评估发生溃疡的风险，对溃疡状态进行分级，并量化几种生物标志物，以帮助指导治疗。此外，该技术不仅可以应用于糖尿病足溃疡，还可以应用于烧伤伤口、手术伤口、压疮，甚至截肢部位。这种好处可能会影响伤口诊所、家庭保健机构和长期护理设施。该I-Corps项目基于非侵入性、多模式、手持式技术的开发，该技术结合了热、反射和荧光成像，以提供组织代谢状态、组织氧合、脉管系统和温度指数的体内评估。所提出的技术可用于提供治疗计划，该治疗计划可被调整并记录在患者的电子医疗记录中以告知决策。生物标志物的监测可以为临床医生提供伤口愈合期间并发症的早期指示，从而导致更清晰和更有效的干预或伤口护理方案的改变。在伤口护理领域已经有了技术进步。然而，大多数监测技术集中在单一的生物标志物。这项技术旨在通过结合几种生物标志物的测量来填补空白，从而对伤口进行更全面的评估。生物标志物的组合加上LED和摄像机技术的最新进展使得多模式设备成为可能。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is the development of a multimodal optical imaging system that quantitatively measures tissue biomarkers to characterize healing in diabetic wounds. Diabetic wounds in the US affect more than eight million patients annually with an estimated economic burden of around $30 billion. There is an unmet need for comprehensive imaging tools that can non-invasively measure multiple biomarkers, elucidate underlying tissue changes in diabetic wounds, and provide anatomical and functional information for individualized therapy. In addition, there is a need for objective wound assessment tools to furnish clinicians and caregivers with fast and quantitative methods of determining wound healing/nonhealing status. The proposed device has the potential to assess the risk of developing ulcers and to grade the status of an ulcer as well as to quantify several biomarkers to help guide treatment. Additionally, this technology may be applied to not only diabetic foot ulcers but also burn wounds, surgical wounds, pressure ulcers, and even amputation sites. The benefit may impact wound clinics, home health institutions, and long-term care facilities. This I-Corps project is based on the development of a non-invasive, multimodal, hand-held technology that combines thermal, reflectance, and fluorescence imaging to provide in vivo evaluation of tissue metabolic state, tissue oxygenation, vasculature, and temperature indices. The proposed technology may be used to provide treatment plans that can be adjusted and documented in a patient’s electronic medical record to inform decision-making. Monitoring of biomarkers may give clinicians early indication of complications during wound healing, leading to clearer and more effective interventions or changes in the wound care regime. There have been technological advances within the field of wound care. However, most monitoring technologies focus on a single biomarker. The proposed technology aims to fill in the gaps by combining the measurements of several biomarkers to give a more complete assessment of a wound. The combination of biomarkers plus recent advances in LED and camera technology have allowed for a multi-modal device to now be possible.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.