SBIR Phase I: CapScan: Non-Invasive Sampling and Analysis of the Human GI Tract to Advance Inflammatory Bowel Disease Research

这个小型企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是开发一种工具，用于非侵入性地测量各种医疗条件下人体胃肠道（GI）内的炎症标志物，微生物和代谢特征。最初，该设备可用于炎症性肠病（IBD）的诊断和管理。该设备及其收集的数据将用于改善肥胖和相关代谢紊乱（如II型糖尿病）的治疗，这些疾病每年累计给美国经济造成超过2000亿美元的损失。鉴于肠道生理学对人类健康的重要性，该技术可能会在监测人类健康方面有更多用途，最终使其成为常规和信息的血液测试是今天在医学实践中。这个小企业创新研究第一阶段项目将提供一个药丸-在一个实施例中，将一个或多个尺寸的装置递送到人胃肠道的远端小肠区域，并触发该区域中的管腔内容物的收集。 该装置将需要适应人类肠道生理学的巨大变化。采样装置将遇到pH 1至pH 8的生化环境。将采样装置递送到胃肠道的期望区域的正常消化所需的时间将在3至10小时之间变化。此外，成本和安全约束强烈地倾向于使用没有有源供电的传感器或致动器的无源装置。利用机械和材料科学创新的多学科方法可以应对这些挑战，并使拟议的设备成为IBD和一般GI疾病的平台采样技术。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 Small Business Innovation Research (SBIR) Phase I project is to develop a tool to non-invasively measure inflammatory markers, microbes and metabolic profiles inside the human gastrointestinal (GI) tract for a variety of medical conditions. Initially, the device can be used for the diagnosis and management of inflammatory bowel disease (IBD). This device and the data it collects will be used to improve the treatment of obesity and related metabolic disorders, such as type II diabetes, that cumulatively cost the US economy over $200 billion per year. Given the centrality of gut physiology to human health, there will likely be additional uses of the technology in monitoring human health, eventually making it as routine and informative as a blood test is today in the practice of medicine.This Small Business Innovation Research Phase I project will deliver a pill-sized device to the distal small intestine region of the human GI tract and trigger the collection of the luminal contents in that region. The device will need to accommodate tremendous variation in the physiology of the human gut. The sampling device will encounter a biochemical environment ranging from pH 1 to pH 8. The time required for normal peristalsis to deliver the sampling device to the desired region of the GI tract will vary from 3 to 10 hours. Furthermore, cost and safety constraints strongly favor the use of a passive device with no actively powered sensors or actuators. A multidisciplinary approach using mechanical and material science innovations can meet these challenges and make the proposed device a platform sampling technology for IBD, and GI disorders in general.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.