Exploring a New Management Option for Patients With Refractory Ascites: The PeriLeve Device

Abstract

Cirrhosis of the liver is often accompanied by refractory ascites, a condition characterized by fluid buildup in the peritoneal cavity that does not respond to diuretics or recurs shortly after therapeutic paracentesis. There are several management strategies in practice including large-volume paracentesis, transjugular intrahepatic portosystemic shunts, peritoneovenous shunting, and liver transplant. However, each of these options come with limitations such as high cost, poor efficacy, and increased risk of complications. This article explores a new management strategy with a novel biopowered shunt, the PeriLeve device, that moves fluid from the peritoneal cavity to the urinary bladder using natural changes in intra-abdominal pressure (IAP). By doing so, PeriLeve shifts the current paradigm of care from the hospital to the home which reduces costs to healthcare providers and patients while improving quality of life. The basic design of the pump consists of two check (i.e., one-way) valves on either side of a fluid filled cavity which is separated from an air cavity by an elastomeric membrane. This article presents benchtop testing results of a prototype PeriLeve pump. The performance of the pump was analyzed along six parameters: change in intra-abdominal pressure, valve opening pressure, membrane thickness, membrane stiffness, membrane surface area, and air cavity volume. Initial results indicate that, with future optimizations, the pump can ultimately move a clinically significant volume of fluid.