Dialysate regeneration system based on photo-electrochemical urea oxidation and reactive adsorption to enable portable hemodialysis

项目摘要/摘要 目前，美国有超过40万名肾病患者正在接受透析。主要的治疗模式是 血液透析，在医院或私人诊所进行。目前的透析疗法需要一台大型设备 必须连续连接到反渗透(RO)系统。一次治疗需要超过 150L的AAMI透析液使便携式设备变得无法实现。库莱纳科技公司，与 透析创新中心(CDI)和华盛顿大学(UW)正在开发一种新技术 这将允许血液透析治疗，而不需要对他们的家进行管道改造。这个 设备设计目标是在标准滚动行李箱的尺寸范围内，使便携式能够 在房间之间移动，带到工作场所或旅行，这将扩大家庭血液透析(HDD)市场 意义重大。这项技术，光氧化尿素去除，或倾倒，系统将去除尿毒症毒素 从透析机的废透析液中回收干净的透析液回到透析机。 允许任何透析机在没有连续水连接的情况下进行操作，并且只使用少量的 几公升无菌袋装水。 Kuleana Technology于2020年在华盛顿州注册成立，该公司正在重新考虑今天的血液透析。这个 Kuleana特别关注便携式、非卧床透析(AKTIV，可移动肾脏以增加活力) 以及没有水连接或昂贵而笨重的尿素吸附剂的透析。威斯康星大学的CDI专注于 科学进步对便携式血液透析至关重要。疾病预防控制中心由西北肾脏中心资助 (NKC)，一家非营利性透析提供商，为他们的患者寻求更好的护理和结果。在备忘录中 NKC和华盛顿大学之间的协议，CDI、UW之间的IP流机制 Kuleana被指明(UW代表CDI提交了大量专利申请)。此外，NKC， 已经捐赠了充足的空间和其他资源来孵化Kuleana，为创业努力。空间就在里面 NKC的西雅图透析中心之一。医务人员和患者的紧密联系将增强HD 并为库列纳节省了相当大的费用。 CDI和UW将对倾倒进行必要的科学研究和开发 技术Hinds实验室将建造、测试和修改初始浇注技术。然后，Kuleana科技 将把这些原型移植到遵循必要的医学开发过程并完成 将浇注系统开发为透析再生模块，将提交FDA用于 510K批准。所有这些都符合FDA《联邦法规》所规定的必要的质量管理体系和DC。

PROJECT SUMMARY/ ABSTRACT Currently in the US there are over 400,000 kidney patients on dialysis. The primary therapy mode is hemodialysis and is performed in a hospital or private clinic. Current dialysis therapy requires a large device that must be continuously connected to a reverse osmosis (RO) system. A single treatment will require over 150L of AAMI dialysate making portable device unattainable. Kuleana Technology, Inc., in partnership with the Center for Dialysis Innovation (CDI) and the University of Washington (UW), is developing a new technology that will allow a hemodialysis therapy without the need for plumbing modifications to their home. The equipment design target is to fit within the dimensions of standard rolling suitcases, enabling portability to move between rooms, bring to the workplace or travel, which will expand the home hemodialysis (HDD) market significantly. This technology, the Photo Oxidation Urea Removal, or POUR, system will remove uremic toxins from the dialysis machine’s waste dialysate and recycle the clean dialysate back to the dialysis machine. Allowing any dialysis machine to perform without a continuous water connection and only priming with a few liters of sterile bagged water. Kuleana Technology, incorporated in the State of Washington in 2020, is rethinking today’s hemodialysis. The particular focus for Kuleana is portable, ambulatory dialysis (The AKTIV, ambulatory kidney to increase vitality) and dialysis without a water hook-up or expensive and bulky urea sorbents. The CDI at UW focuses on science advancements essential to portable hemodialysis. The CDI is funded by the Northwest Kidney Centers (NKC), a not-for-profit dialysis provider seeking better care and outcomes for their patients. In a memorandum of agreement between NKC and the University of Washington, a mechanism for IP flow between CDI, the UW and Kuleana is specified (the UW, on behalf of CDI, has filed numerous patent applications). In addition, NKC, has donated ample space and other resources to incubate Kuleana for the start-up effort. The space is within one of NKC’s Seattle dialysis centers. The close proximity of medical personnel and patients will enhance HD developments and save Kuleana considerable expense. The CDI and the UW will be performing the necessary scientific research and development of the POUR technology. The Hinds lab will build, test, and modify the initial POUR technology. Then, Kuleana Technology will migrate these prototypes to the follow the necessary medical development processes and complete the development of the POUR system into a Dialysis Regeneration Module which will be submitted to the FDA for 510k approval. All under the necessary QMS and DC as regulated by the FDA’s Code of Federal Regulation.