We remodeled and tested our semisoft 20cc ventricle and made a new bileaflet flap inflow valve. Housings, bases, outflow valve, and a newly designed diaphragm were all made by vacuum forming and put together by radiofrequency welding or glue. In vitro, the ventricle produced a cardiac output of 2.5 to 3.0 L/min and showed reliable durability results. Hematological testing showed no important thrombogenicity of the new valve. Cardiac output was higher than expected for the volume of the ventricle, perhaps because of stretching or flow through. Animal experiments with the left ventricular assist device (LVAD) version was done at Ohio State University. Earlier in Utah, we did 20 cc total artificial heart (TAH) implantations and LVAD experiments in lambs and recently in calves with the 60cc TAH version. A soft ventricle is easy to implant and low in production costs.
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 existance of little or no intravascular hemolysis (PF Hb less than 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.
This study was designed to compare the relative merits of soft and rigid artificial ventricles. A cascade mock circulation was used to measure cardiac output under different circumstances. The data show that these soft air driven ventricles show a Starling's-like response over a wider range of filling pressures than identical, but rigid, ventricles. Compression of soft ventricles by high intrathoracic pressures was simulated in vitro. Air pressures up to + 20 mm Hg did not seriously affect soft ventricles. Cardiac tamponade was simulated by compressing the ventricle in a closed fluid compartment. Tamponade became severe when volume reduction of the ventricle rose to 60 ml. Hemolysis caused by soft and rigid ventrides was tested in a blood bag set-up and was ---I _
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