I-Corps: Medical device to treat liver failure

University Of Washington, Seattle WA

Investigators

Abstract

The broader impact/commercial potential of this I-Corps project is the development of an advanced multi-organ replacement system that initially focuses on treating liver failure. Currently, when the liver fails, liver transplants are the only option for survival, however, only one in ten people who need a liver transplantation receive it. Liver support systems aim to keep patients alive while waiting for their liver to recover or for an organ to become available. However, current liver support systems have not been able to extend life long enough to receive transplantation and survive. The proposed technology may provide treatment for previously untreatable liver and multi-organ failure patients, as well as preventing liver failure during other medical procedures such as gene therapy and surgery for cancerous tumor removal. The goal is to provide a bridge to transplantation, as well as reduce racial and gender disparities in determining who is selected for a transplant. In addition, the proposed technology also may provide support for patients excluded from transplantation. This includes people with insufficient social support for transplantation, or comorbidities such as mental illness or old age that make them poor transplant candidates. The proposed system may extend the potential range of conditions where treatment is possible and may provide transplant-ineligible patients with better healthcare access. This I-Corps project is based on the development of a medical device to treat liver failure by removing protein bound toxins and excess fluid from liver failure patients. The proposed technology uses a hemofiltration method to remove a greater quantity of excess fluid from the patient while using less dialysate. Existing hemofiltration systems are typically predilution, meaning that replacement fluid is added before the blood passes through the dialyzer. This process has the disadvantages of reducing the efficiency of excess fluid removal (because some of what is removed is the newly added replacement fluid) and reducing the efficiency of toxin removal. Post-dilution systems remove more toxin and excess fluid with less waste, but have a risk of coagulation. The proposed recirculation hemofiltration method recirculates a portion of the blood after post-dilution back to a pre-dilution port, which minimizes excessive fluid usage and coagulation risk. This system also includes methods to increase the efficiency of protein-bound toxin removal using albumin dialysis, charcoal, and a rinsing protocol. A prototype of the system achieved 80% 28-day survival in patients where 20% survival was expected due to critical illness. In addition, this may allow an increase in the efficiency of protein bound toxin removal, improving treatment outcomes and bridging patients to transplantation. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.