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.

项目概要/摘要 目前美国有超过40万名肾病患者接受透析。 血液透析是在医院或私人诊所进行的，需要大型设备。 必须连续连接到反渗透 (RO) 系统，单次处理需要超过 100 次。 150L 的 AAMI 透析液使便携式设备无法实现，与 Kuleana Technology, Inc. 合作。 透析创新中心 (CDI) 和华盛顿大学 (UW) 正在开发一项新技术 这将允许进行血液透析治疗，而无需对他们的家进行管道改造。 设备设计目标是适合标准拉杆箱的尺寸，从而实现便携性 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 这项技术，即光氧化尿素去除系统（POUR），可以去除尿毒症毒素。 从透析机的废透析液中分离出来，并将干净的透析液回收回透析机。 允许任何透析机在没有连续水连接的情况下运行，并且只需少量启动 升无菌袋装水。 Kuleana Technology 于 2020 年在华盛顿州注册成立，正在重新思考当今的血液透析。 Kuleana 特别关注的是便携式流动透析（AKTIV，流动肾脏以增加活力） 华盛顿大学 CDI 专注于无需水连接或昂贵且笨重的尿素吸附剂的透析。 便携式血液透析至关重要的科学进步由西北肾脏中心资助。 (NKC)，一家非营利性透析提供商，致力于为患者寻求更好的护理和结果。 NKC 与华盛顿大学之间的协议，CDI 与华盛顿大学之间的知识产权流机制 指定了 Kuleana（华盛顿大学代表 CDI 提交了许多专利申请）。 已捐赠充足的空间和其他资源来孵化 Kuleana 的启动工作。空间就在其中。 NKC 的西雅图透析中心之一，医务人员和患者距离很近，这将增强 HD 的效果。 开发并为 Kuleana 节省大量费用。 CDI 和华盛顿大学将进行 POUR 的必要科学研究和开发 Hinds 实验室将构建、测试和修改最初的 POUR 技术，然后是 Kuleana 技术。 将迁移这些原型以遵循必要的医疗开发流程并完成 将 POUR 系统开发为透析再生模块，该模块将提交给 FDA 510k 批准。全部符合 FDA 联邦法规规定的必要 QMS 和 DC。