Research Project
10325976
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.
