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: 10325976
• 负责人: Steve J Lindo
• 金额: $ 83.11万
• 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 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10325976
• 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; improved; individualized medicine; innovation; interest; meetings; microbial; miniaturize; 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.

项目总结