Abstract
The authors are developing an implantable centrifugal blood pump for short- and medium-term (1-6 months) left ventricular assist. They hypothesized that the application of result dependent modifications to this pump would lead to overall improved performance in long-term implantation studies. Essential requirements for pump operation, such as durability and resistance to clot formation, have been achieved through specialized fabrication techniques. The antithrombogenic character of the pump has been improved through coating at the cannula-housing interfaces and the baffle seal, and through changing the impeller blade material from polysulfone to pyrolytic carbon. The electronic components of the pump have been sealed for implantable use through specialized processes of dipping and potting, and the surfaces of the internal pump components have been treated to increase durability. The device has demonstrated efficacy in five chronic sheep implantation studies of 14, 10, 28, 35, and 154 day duration. Post mortem findings from the 14 day experiment showed stable fibrin entangled around the impeller shaft and blades. After pump modification, autopsy findings of the 10 day study showed no evidence of clot. Additionally, the results of the 28 day experiment showed only a small (2.0 mm) ring of fibrin at the shaft-seal interface. In the 35 and 154 day experiments, redesign of the stators have resulted in improved motor corrosion resistance. The 35 day study showed a small, 0.5 mm wide fibrin deposit at the lip seal, but no motor failure. In the 154 day experiment, the motor failed because of stator fluid corrosion, while the explanted pump was devoid of thrombus. Based on these findings, the authors believe that these pump refinements have contributed significantly to improvements in durability and resistance to clot formation.
Published Version
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