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

基于光电化学尿素氧化和反应吸附的透析液再生系统，可实现便携式血液透析

• 批准号: 10761594
• 负责人: Barry Fulkerson
• 金额: $ 29.96万
• 依托单位: KULEANA TECHNOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-22 至 2024-09-21
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10761594
• 关键词: Adsorption; Adult; Affect; Agreement; Air; American; Amino Acids; Anodes; Artificial Kidney; Award; Back; Benign; Blood; Carbon; Carbon Dioxide; Caring; Cathodes; Cattle; Cause of Death; Clinic; Clinical; Code; Development; Devices; Dialysis procedure; Dimensions; Economics; Effectiveness; Electrodes; End stage renal failure; Equipment Design; Excision; Exclusion; Family; Fatigue; Foundations; Funding; Future; Glucose; Grant; Health Personnel; Hemodialysis; Home; Home Hemodialysis; Hospitals; Hour; Human; Incubated; Journals; Kidney; Kidney Diseases; Kidney Failure; Kidney Transplantation; Legal patent; Lighting; Liquid substance; Marketing; Medical; Medical Device Designs; Membrane; Mission; Modification; Nanostructures; Natural regeneration; Nature; Nausea; Nephrology; Osmosis; Outcome; Outpatients; Patient-Focused Outcomes; Patients; Phase; Plumbing; Privatization; Prize; Process; Production; Provider; Pump; Quality of life; Recycling; Regulation; Renal function; Research; Resources; Rest; Science; Series; Societies; Source; Specific qualifier value; Sterility; Survival Rate; System; Technology; Testing; Therapeutic; Thinking; Toxin; Translating; Travel; United States Dept. of Health and Human Services; Universities; Urea; Uremia; Vision; Washington; Water; Whole Blood; Work; Workplace; clinically relevant; commercialization; design; improved; innovation; medically necessary care; migration; miniaturize; new technology; news; novel; oxidation; patient mobility; portability; prototype; public-private partnership; research and development; side effect; social; solute; symposium; technological innovation; titanium dioxide; virtual; wasting

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.

项目摘要/摘要 目前，在美国，透析有超过40万名肾脏患者。主要治疗模式是 血液透析并在医院或私人诊所进行。当前的透析治疗需要大型设备 必须连续连接到反渗透（RO）系统。单一治疗将需要结束 150升AAMI透析液使便携式设备无法实现。 Kuleana Technology，Inc。与 透析创新中心（CDI）和华盛顿大学（UW）正在开发一项新技术 这将允许血液透析治疗，而无需对其家进行管道修改。这 设备设计目标是适合标准滚动手提箱的尺寸，使可移植性 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 显著地。这项技术，照片氧化尿素去除或倒入系统将去除尿毒症毒素 从透析机的废物透析液，然后将干净的透析物回收回透析机。 允许任何透析机器都没有连续的水连接性能，只有几个 一升无菌袋装的水。 Kuleana Technology于2020年在华盛顿州成立，正在重新思考当今的血液透析。这 Kuleana的特别重点是便携式的，可容忍的透析（Aktiv，Absuratory肾脏以增加活力） 透析没有水钩或昂贵而笨重的尿素吸附剂。 UW的CDI专注于 科学进步对便携式血液透析至关重要。 CDI由西北肾脏中心资助 （NKC），一个非营利性透析提供者，为患者寻求更好的护理和结果。在备忘录中 NKC与华盛顿大学之间的一致性，UW CDI之间的IP流动机制 并指定了Kuleana（UW代表CDI提交了许多专利申请）。此外，NKC， 已经捐赠了足够的空间和其他资源，以孵化Kuleana进行启动工作。空间在 NKC的西雅图透析中心之一。医务人员和患者的近距离接近将增强高清 发展并节省Kuleana的大量费用。 CDI和UW将执行倾倒的必要科学研发 技术。 Hinds Lab将构建，测试和修改初始倒入技术。然后，Kuleana技术 将这些原型迁移到以下必要的医学发展过程，并完成 将倾倒系统的开发成透析的再生模块，该模块将提交给FDA 510k批准。根据《 FDA的联邦法规》的规定，所有这些都在必要的QM和DC下。