Faraday, a Novel Automated Peritoneal Dialysis Device with Dialysate Customization

Faraday，一种具有透析液定制功能的新型自动化腹膜透析装置

• 批准号: 10441610
• 负责人: Steve J Lindo
• 金额: $ 83.96万
• 依托单位: SIMERGENT, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-20 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10441610
• 关键词: Admixture; Agreement; American; Architecture; Area; Blood; Blood Circulation; Blood Pressure; Cardiovascular system; Cessation of life; Chemicals; Clinical; Clinical Trials; Consumption; Custom; Development; Devices; Dialysis patients; Dialysis procedure; Diet; Elements; End stage renal failure; Endotoxins; Ensure; Equilibrium; Excision; Exposure to; Failure; Film; Filtration; Funding; Generations; Glucose; Goals; Grant; Guidelines; Health; Healthcare; Hemodialysis; Home; Housing; Hypertension; Industry Standard; Injections; Intake; Intuition; Investments; Kidney; Kidney Failure; Legal patent; Life; Lifting; Liquid substance; Measures; Mechanics; Medicare; Membrane; Outcome; Patient-Focused Outcomes; Patients; Peritoneal; Peritoneal Dialysis; Peritoneum; Phase; Privatization; Production; Pump; Recording of previous events; Regulatory Pathway; Risk Management; Safety; Shipping; Side; Small Business Innovation Research Grant; Sodium; Sterility; Sterilization; System; Techniques; Technology; Testing; Transplantation; Ultrasonics; Water; Water Purification; Water Supply; animation; base; commercialization; design; experience; flexibility; follow-up; hypertensive; improved; individualized medicine; innovation; interest; meetings; microbial; miniaturize; miniaturized device; novel; operation; personalized approach; portability; precision medicine; prototype; risk mitigation; therapy design; user-friendly; water quality

PROJECT SUMMARY Up to 80% of the over 326,000 patients on peritoneal dialysis (PD) around the globe have hypertension and 56% will die due to cardiovascular issues. Clinical outcomes are dictated largely by the dextrose and sodium concentrations used in each treatment. However, the flexibility of APD systems is woefully deficient. While the benefits of limiting glucose exposure to extend the life of the peritoneum are known, no APD device allows users to deliver a gradually decreasing dextrose concentration. Recent evidence shows that hypertensive PD patients could benefit from a currently unavailable reduced dialysate sodium admixture to remove excess sodium from the blood and improve blood pressure. The recently announced Advanced American Kidney Health Initiative (AAKHI) calls for 80% of new ESRD patients in 2025 to receive home dialysis or a transplant, which will result in an increase from 10% to ~50% of dialysis patients using PD. Our innovative Faraday™ APD technology created in a Phase I SBIR project enables admixing PD therapies that remove excess sodium in the bloodstream while minimizing dextrose exposure. We have developed a benchtop APD pumping engine prototype that accurately admixes custom solutions from five input fluids via a proprietary cassette and pneumatics. Our Phase II development will culminate in a fully functioning, commercializable, user-friendly APD device and tap water filtration system with custom therapies designed to drastically reduce cardiovascular deaths and early PD technique failure. Specific Aim 1: Develop regulatory pathway with FDA: Our goal is to develop design history file documents and meet with the FDA in a pre-sub meeting to ensure they agree with our predicate device, water sterilization requirements, product architecture, high-level risk mitigations, and safety systems. Specific Aim 2: Optimize current pumping engine:. The cassette and pneumatics manifold will be miniaturized, and a cassette-to-hardware door interface mechanism will be developed. Flow rate testing will confirm flow rates >190 ml/min Fill and >125 ml/min Drain with the optimized pumping engine. Specific Aim 3: Integrate pumping engine into fully functioning APD cycler: All hardware elements will be optimized in a table-top sized portable enclosure to create a device that admixes at 1.5% accuracy. We will develop a best-in-class UI with setup animations and intuitive therapy programming and operation. Specific Aim 4: Develop water purification system: We will design and build a water filtration and sterilization system to create injection-quality water to meet FDA requirements for sterility of TVC <0.1 CFU/ml, endotoxins <0.1 EU/ml (95% confidence), and chemical contaminants per ISO 23500 and USP <1231>. Our Phase II development will culminate in a commercializable, user-friendly tabletop APD device with sodium and dextrose tailoring APD therapies designed to reduce cardiovascular deaths and early PD technique failure.

项目摘要 在地球仪的326，000多名腹膜透析（PD）患者中，高达80%的患者患有高血压，56%的患者患有高血压。 会死于心血管疾病临床结果主要取决于葡萄糖和钠 每种处理中使用的浓度。然而，APD系统的灵活性非常不足。而 限制葡萄糖暴露以延长腹膜寿命的益处是已知的，没有APD装置允许 使用者输送逐渐降低的葡萄糖浓度。最近的证据表明，高血压PD 患者可以从目前不可用的减少透析液钠混合物中获益， 钠从血液和改善血压。最近宣布的先进的美国肾脏 健康倡议（AAKHI）呼吁到2025年，80%的新发ESRD患者接受家庭透析或移植， 这将导致使用PD的透析患者从10%增加到~50%。 我们在一期SBIR项目中创建的创新性法拉第™ APD技术能够混合PD治疗 去除血液中多余的钠同时减少葡萄糖的摄入。我们已经开发出一种 台式APD泵送发动机原型，可通过一个 专有的磁带和磁带。我们的第二阶段发展将最终在一个全面运作， 可商业化的、用户友好的APD设备和自来水过滤系统， 大大减少心血管死亡和早期PD技术失败。 具体目标1：与FDA一起制定监管途径：我们的目标是制定设计历史文件 并与FDA举行预提交会议，以确保他们同意我们的同品种器械，水灭菌 要求、产品体系结构、高级别风险缓解措施和安全系统。 具体目标2：优化当前泵送引擎：。卡匣和气动歧管将 小型化，并将开发一个盒式磁带到硬件门接口机制。流速测试将 使用优化的泵送引擎，确认流速>190 ml/min填充和>125 ml/min排出。 具体目标3：将泵送引擎集成到功能齐全的APD循环仪中： 在桌面大小的便携式外壳中进行了优化，以创建混合精度为1.5%的设备。我们将 开发具有设置动画和直观治疗编程和操作的一流UI。 具体目标4：开发水净化系统：我们将设计和建造一个水过滤和杀菌 该系统可生产注射用水，以满足FDA对TVC <0.1 CFU/ml、内毒素 &lt;0.1 EU/ml（95%置信度），化学污染物符合ISO 23500和USP<1231>。 我们的第二阶段开发将最终在一个商业化的，用户友好的桌面APD设备与钠 和葡萄糖定制APD疗法，旨在减少心血管死亡和早期PD技术失败。