Faraday, a Novel Automated Peritoneal Dialysis Device with Dialysate Customization

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PROJECT SUMMARY There are currently over 326,000 patients on peritoneal dialysis (PD) around the globe. Clinical outcomes are dictated largely by the dextrose and sodium concentrations used in each session. However, the state of the art in APD systems is woefully deficient: clinicians must choose from only 3 dialysate dextrose concentrations available and have no choice for sodium concentration. While researchers have widely published the benefits of limiting glucose exposure to prolong the life of the peritoneal membrane, no APD device allows users to deliver an intermediate dextrose concentration. In addition, recent evidence suggests that hypertensive PD patients (up to 80% of the PD population) could benefit from a reduced dialysate sodium concentration to remove excess sodium from the bloodstream and improve blood pressure. To dramatically improve the clinical options for optimal PD therapy, Simergent proposes the Faraday™: an automated peritoneal dialysis (APD) device which can enable individualized glucose sparing and sodium adjustment therapies by creating on-demand custom solution concentrations needed to improve cardiac outcomes and prolong membrane function. In this Phase I SBIR project, we will develop an APD pumping engine prototype that will take the patient’s own home tap water, sterilize it, then accurately admix it with one to four additional sources. An enormous side benefit of our technology is that its use can reduce the shipping, storage, and lifting burden of dialysate bags by 92% by mixing concentrated dialysate solutions with sterile water generated at the patient’s home. Specific Aim 1: Create a prototype admixing disposable tubing set: Design and manufacture a disposable cassette and associated tubing set capable of admixing fluids from 5 sources and delivering to a mixing bag. Specific Aim 2: Manufacture and test working APD pumping engine prototype: Design and manufacture a functioning prototype hardware & software system to interface with the cassette and validate the volumetric accuracy is ≤1.5%. Specific Aim 3: Create customizable sodium concentrations: Design and demonstrate a mechanism which will accurately admix low-sodium dialysate and hypertonic saline (2 sources) to create sodium concentrations ranging from 100 to 170 mmol/l in increments of 10 mmol/l to support personalized sodium adjustment therapies. Specific Aim 4: Create customizable dextrose concentrations: Design and demonstrate a mechanism which will accurately admix 5 sources: concentrated dialysate solution (2 dextrose concentrations), buffer solution, saline, and sterile water to create solutions ranging from 1.0% to 4.5% dextrose in increments of 0.25%. Our Phase I feasibility results will culminate in a revolutionary prototype demonstration subsystem critical for admixing fluids from disparate sources. In Phase II, we will integrate this into a fully functioning APD device.