Initial in vivo evaluation of the newly developed axial flow turbo pump with hydrodynamic bearings

Abstract

An implantable, compact rotary blood pump has been newly developed using an axial flow turbo pump with hydrodynamic bearings. The rotating impeller, which is hydrodynamically levitated with the assistance of repulsive magnetic force, has no contact with the inner surface of the pump. To evaluate the hemodynamic performance and biocompatibility, the pump was installed into four calves for up to 90 days. The pump was installed in the left heart bypass fashion, and placed paracorporeally in the first two calves and in the thoracic cavity in the other two calves. All calves received anticoagulation and antiaggregation therapy during the study. Aortic pressure, heart rate and pump-operating parameters were continuously measured. Hematologic and biochemical tests to evaluate anemia, hepato-renal function and the extent of hemolysis were performed on schedule. Each calf was killed at the termination of the experiments, and pathological analysis for the biocompatibility of the pump system was performed, including the thrombi in the device, emboli in the systemic organs and signs of infection. The pump stably produced a flow of 5 l/min. Each calf was supported for 78, 50, 90 and 90 days, respectively, with no incidence of hemorrhage, organ failure or significant hemolysis. No thrombus formation or mechanical wearing was observed inside the pump. There was no evidence of heat injury around the pump. Device-related infections were observed, but the severity of infection was mild in the implant case compared to the paracorporeal case. The pump demonstrated acceptable hemodynamic performance and biocompatibility in the initial in vivo testing.