SBIR Phase I: Innovative Green Technology for Advanced, Patient-Centered Home Hemodialysis

这个小型企业创新研究(SBIR)第一阶段项目建议开发一种移动的、易于使用的、以患者为导向的先进的家庭血液透析(HD)系统，该系统最大限度地减少水和医疗废物的使用，重要的是，最大限度地减少营养物质的损失。终末期肾病(ESRD)是一种需要长期透析治疗的破坏性和致残性疾病，由于接受治疗所需的时间和精力，严重限制了ESRD患者及其照顾者的行动和生活质量(QOL)。在透析中心，标准的血液透析治疗使用大量高纯度的水，导致营养物质的显著损失。这一阶段项目的目标是设计和测试HD机器(HDM)的关键部件，在体外测试系统的有效性和安全性，并设计一个重量轻(~22 kg)、配备高精度组件的家用HD系统原型，用于体内研究。使用最小透析液(6L)，开发的家庭HD系统将实现充分的毒素清除，离子和血清白蛋白损失最少，通过允许在家中、工作中、学校或旅行期间进行有效和舒适的治疗，极大地改善终末期肾病患者及其家人的生活质量。该项目的更广泛影响/商业潜力包括减轻终末期肾病(ESRD)对患者和联邦医疗保健计划的经济负担。随着全球ESRD患者数量接近300万，通过大幅降低设施成本、治疗中水和能源的使用来降低这些患者的慢性透析治疗的成本和资源负担，并通过促进更大的治疗时间和地点的灵活性来提高患者的生活质量变得至关重要。拟议的半便携式血液透析机比目前可用的透析系统有许多优点。这种优势既基于高效的透析再生能力，也基于重量轻、配置和控制精确的机器。单是使用这种高清系统就能节省大量的原水成本。在世界上水费明显较高的其他地区(如德国、英国等)，节省的资金可能会更多。以及获得清洁水变得越来越困难的地方(如中国、印度、墨西哥等)。该系统将增强透析和吸附技术领域的科学和技术知识。

This Small Business Innovation Research (SBIR) Phase I project proposes to develop a mobile, easy-to-use, patient oriented, advanced Home Hemodialysis (HD) system that minimizes the use of water and medical wastes, and importantly, minimizes loss of nutrients. End-stage renal disease (ESRD) is a devastating and disabling disease requiring chronic dialysis treatment, which severely limits the mobility and quality of life (QOL) of ESRD patients and their caregivers due to the time and effort required to receive treatment. At dialysis centers, standard hemodialysis treatment, which utilizes massive amounts of highly purified water, results in a significant loss of nutrients. The objectives of this Phase I project are to design and test key units of an HD machine (HDM), to test the efficacy and safety of the system in vitro and to design a light weight (~22 kg) prototype home HD system equipped with high precision components for in vivo studies. Using minimum dialysate (6L), the developed home HD system will achieve adequate toxin clearance with minimal ion and serum albumin loss, greatly improving the QOL of ESRD patients and their families by allowing for effective and comfortable treatment at home, work, or school or during travel.The broader impact/commercial potential of this project includes reducing the economic burden of end-stage renal disease (ESRD) on patients and Federal healthcare programs. As the number of ESRD patients approaches 3 million globally, it is becoming critical to decrease the cost and resource burden of the chronic dialysis treatment of these patients by drastically decreasing facility costs, use of water and energy in treatment, and to increase patients' quality of life by facilitating greater flexibility in length and place of treatment. The proposed semi-portable hemodialysis machine offers many advantages over currently available dialysis systems. The advantages are based on both the highly efficient dialysis regeneration capability and the light-weight, precisely configured and controlled machine. The savings in raw water costs alone from use of this HD system would be significant. The savings could be even greater in other parts of the world where water costs are significantly higher (i.e. Germany, Great Britain, etc.) and where access to clean water is becoming increasingly difficult (i.e. China, India, Mexico, etc.). The system will enhance the scientific and technical knowledge in the fields of dialysis and sorbent technologies.