Development of Smaller Artificial Ventricles and Valves Made by Vacuum Forming

Abstract

Implantable prosthetic ventricles and trileaflet valves made by vacuum forming have been developed and implant tested. All components are made from Pellethane®. Recognizing the need for smaller as well as larger ventricles, designs with effective stroke volumes of 50, 85, 100 and 130 cc have been tested with several valve types. The pneumatically driven Utah ventricular assist device (UVAD) can be used as a total artificial heart (TAH) or ventricular assist device (VAD) by using the appropriate inflow and outflow adapters. In vitro durability testing has demonstrated ventricular lifetime beyond two years and valve lifetime to nearly one and one half years. The polymer valves have lower regurgitation than mechanical valves. Animal implantation experience includes 21 TAH implants and 16 left ventricular assist device (LVAD) implantations. TAH survival ranges from 2 to 210 days. LVAD animals have lived up to 116 days before elective termination. The animal were healthy and grew normally. The devices exhibit a “Starling's Law” response. One TAH animal survived 72 days before successful explantation followed by transplantation. At autopsy, this animal had no renal infarcts. Hematology data has demonstrated the existence of little or no intravascular hemolysis (PF Hb < 5 mg%). The “Philadelphia” version of the UVAD vacuum formed ventricles are small enough to be implanted without thrombus provoking connectors. Eight animals have received this TAH and survived up to 120 days. Vacuum forming offers a rapid and inexpensive way to produce reliable and effective total artificial hearts and valves for widespread, temporary clinical application in any size adult human.