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

该小型企业创新研究（SBIR）二期项目的重点是进一步开发一种先进的、移动的、易于使用的、以患者为导向的先进家庭血液透析（HHD）系统，该系统可最大限度地减少水（少于6升）和医疗废物的使用，重要的是，最大限度地减少营养流失。终末期肾病（ESRD）是一种毁灭性的致残性疾病。由于在医院和透析中心进行血液透析（HD）治疗的时间和精力，许多ESRD患者及其家人的活动性和自由度受到严重限制。我们的最终目标是开发下一代轻型透析机（约22 kg），配备高精度组件和创新的透析液再生盒（DRC）。第二阶段计划的重点是建造一台配备必要功能和安全装置的原型HHD机器。 其智能优势在于由特定功能化吸附剂组成的高效选择性DRC，以及紧凑高效的HD机器，可实现配置良好且精确控制的透析治疗。这一发展将大大提高终末期肾病患者及其家人的生活质量，使他们能够在家中，甚至在工作或学校进行有效和舒适的治疗。 如果成功，该项目更广泛的影响/商业潜力是减少ESRD对患者和联邦医疗保健计划的经济负担。随着全球HD患者数量接近300万，通过大幅降低设施成本、治疗用水和能源来降低治疗这些患者的成本和资源负担变得至关重要。 第二个影响是通过促进治疗时间和地点（家庭、学校、工作）的更大灵活性来提高患者的生活质量。该系统还允许通过选择性吸附毒素对患者进行个性化透析治疗。所提出的移动的、半便携式HD机器与当前可用的透析系统相比具有许多优点，从而具有很高的商业潜力。 该系统将提高透析生物工程和吸附剂技术化学领域的科学和技术知识。由于透析治疗的灵活性，透析患者的生活质量将大大提高。 由于该产品同时实现了两个目标，即改善治疗和降低成本，因此与当今许多竞争产品相比具有显著优势。

This Small Business Innovation Research (SBIR) Phase II project focuses on the further development of an advanced, mobile, easy-to-use, patient-oriented, advanced Home Hemodialysis (HHD) system that minimizes the use of water (less than 6 liters) and medical waste, and importantly, minimizes nutrient loss. End-stage renal disease (ESRD) is a devastating, disabling disease. Many ESRD patients and their family members are severely limited in the mobility and freedom due to the time and effort of having hemodialysis (HD) treatments at hospitals and dialysis centers. Our ultimate goal is to develop a next generation lightweight HD machine (~22 kg) equipped with high precision components and an innovative dialysate regeneration cartridge (DRC). This Phase II program focuses on the construction of a prototype HHD machine that is fully equipped with necessary functions and safety devices. The intellectual merits are based on both the highly efficient and selective DRC composed of a specifically functionalized sorbent, and the compact and highly efficient HD machine that allows for a well-configured and accurately controlled dialysis treatment. This development would greatly improve quality of life for ESRD patients and their families by allowing for effective and comfortable treatment at home, or even at work or school. The broader impact/commercial potential of this project, if successful, is to reduce the economic burden of ESRD on both patients and Federal healthcare programs. As the number of HD patients approaches 3 million globally, it is becoming critical to decrease the cost and resource burden of treating these patients by drastically decreasing facility costs, use of water and energy in treatment. The second impact is to increase patients' quality of life by facilitating greater flexibility in the length and place of treatment (home, school, work). This system also allows for the personalized dialysis treatment of patients through selective adsorption of toxins. The proposed mobile, semi-portable HD machine offers many advantages over currently available dialysis systems, resulting in high commercial potential. The system will enhance the scientific and technical knowledge in the fields of bioengineering of dialysis and chemistry of sorbent technologies. Given the flexibility in dialysis treatment, the quality of life of dialysis patients will be greatly enhanced. Since this product achieves two goals simultaneously, namely improved treatment and reduced cost, it has a significant advantage over many of the competitive products available today.