Implantable Roller Pump for Heart-Failure Induced Lymphedema

Abstract

Background: During heart failure-induced lymphedema, the volume transfer from the lymphatic system through the thoracic duct into the cardiovascular system becomes increasingly reduced due, in part, to the high back pressure in the venous system. No minimally invasive devices currently exist that could boost the rate of volume transfer as a long-term means to alleviate lymphatic congestion in decompensated heart failure. To address this unmet clinical need, we are developing a miniature roller pump that is the size of a pacemaker as an implantable device to treat lymphedema. The lymphatic pump is designed for periodic unloading and intermittent volume rates of up to 0.8 L/min and a pressure generation of 20-30 mmHg. Methods: In this study, we established the initial design of the device per engineering and clinical principles, constructed an initial prototype of the device using acrylic materials, and experimentally tested its performance using a lymph analog fluid in a hydraulic flow loop. Results: The prototype generated 1-69 mmHg of pressure rise for flow rates between 0.1-1.1 L/min at 400-600 RPM, meeting design requirements. The next phase of optimization will focus on improving pump performance, achieving additional size reduction, and designing the power supply system. Conclusion: The results of the study support the continued development of this new implantable device to alleviate lymphatic congestion, and thus ease the debilitating symptoms of congestive heart failure in pediatric patients with dysfunctional single ventricle physiology.