SBIR Phase I: A Medical Device to Protect and Stabilize Umbilical Catheters in the Neonatal Intensive Care Unit

这项小型企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是标准化脐带导管的固定和保护过程。这些导管被插入新生儿重症监护病房（NICU）的新生儿体内，用于直接向他们的血液中提供挽救生命的营养物质和药物。不幸的是，与这些导管相关的感染率是医疗保健系统中最高的。迫切需要一种能够降低感染风险的简单医疗装置。感染率的降低每年将为医院节省数十万美元，因为他们目前必须承担治疗这些感染的费用。最重要的是，降低脐带导管感染率将在任何医院环境中挽救新生儿的生命。拟议的项目将开发一种标准化设备，可靠地固定脐带导管，并保护导管插入部位免受各种感染源的影响。在美国NICU中固定这些导管的现行护理标准是一卷非无菌胶带，该胶带对导管插入部位没有保护屏障。这与与成人导管一起使用的医疗器械形成鲜明对比，有助于预防血流感染。研究目标包括评估不同的材料，测试导管的固定机制，测试细菌定植率，并评估设备？用于新生儿皮肤的生物安全性。这将使用定制的测试装置和协议来完成。我们预计成功开发出一种材料规格允许在NICU进行临床测试的器械。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to standardize the process of securing and protecting umbilical cord catheters. These catheters are inserted into newborn babies in the neonatal intensive care unit (NICU) and are used to provide life-saving nutrients and medication directly into their bloodstream. Unfortunately, the infection rate associated with these catheters is among the highest in the healthcare system. There is an important need for a simple medical device that reduces the risk of infection. A reduction in infection rate would save hospitals hundreds of thousands of dollars per year since they must currently absorb the cost of treating these infections. Most importantly, reducing umbilical catheter infection rates would save neonatal lives in any hospital setting.The proposed project will develop a standardized device that reliably secures umbilical cord catheters and protects the catheter insertion site from various sources of infection. The current standard of care for securing these catheters in NICUs across the United States is a roll of non-sterile tape that offers no protective barrier to the catheter insertion site. This is in stark contrast to medical devices that are used with adult catheters and help prevent bloodstream infections. The research objectives include evaluating different materials, testing the catheter securement mechanism, testing bacterial colonization rates, and evaluating the device?s biosafety for use on neonatal skin. This will be accomplished using custom-built testing rigs and protocols. We anticipate the successful development of a device with material specifications that allow for clinical testing in the NICU.