Simergent, LLC — Department of Health and Human Services SBIR Phase I: 400

Description

PROJECT SUMMARY There are currently over 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 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 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 by mixing concentrated dialysate solutions with sterile water generated at the patient s home Specific Aim Create a prototype admixing disposable tubing set Design and manufacture a disposable cassette and associated tubing set capable of admixing fluids from sources and delivering to a mixing bag Specific Aim Manufacture and test working APD pumping engine prototype Design and manufacture a functioning prototype hardware andamp software system to interface with the cassette and validate the volumetric accuracy is Specific Aim Create customizable sodium concentrations Design and demonstrate a mechanism which will accurately admix low sodium dialysate and hypertonic saline sources to create sodium concentrations ranging from to mmol l in increments of mmol l to support personalized sodium adjustment therapies Specific Aim Create customizable dextrose concentrations Design and demonstrate a mechanism which will accurately admix sources concentrated dialysate solution dextrose concentrations buffer solution saline and sterile water to create solutions ranging from to dextrose in increments of 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 PROJECT NARRATIVE Peritoneal dialysis devices and solutions have changed very little in the past years In this Phase I SBIR project Simergent proposes the development of an automated peritoneal dialysis device capable of admixing its own dialysate solution and allowing the nephrologist to customize the sodium and dextrose concentration to meet the patient s clinical needs If widely distributed ultimately the product would dramatically improve the cardiovascular outcomes of peritoneal dialysis patients