T. Nakazawa et al., A PIVOT BEARING-SUPPORTED CENTRIFUGAL PUMP FOR A LONG-TERM ASSIST HEART, International journal of artificial organs, 20(4), 1997, pp. 222-228
A pivot bearing-supported centrifugal blood pump has been developed it
is a compact, cost effective, and anti-thrombogenic pump with anatomi
cal compatibility. A preliminary evaluation of five paracorporeal left
ventricular assist studies were performed on pre-conditioned bovine (
70-100 kg), without cardiopulmonary bypass and aortic cross-clamping.
The inflow cannula was inserted into the left ventricle (LV) through t
he apex and the outflow cannula affixed with a Dacron vascular graft w
as anastomosed to the descending aorta, All pumps demonstrated trouble
free performance over a two-week screening period. Among these five s
tudies; three implantations were subjected for one month system valida
tion studies. All the devices were trouble free for longer than ir mon
th. (35, 34, and 31 days). After achieving one month studies, all expe
riments were terminated There was no evidence of device induced thromb
us formation inside the pump. The plasma free hemoglobin levels were w
ithin normal ranges throughout all experiments. As a consequence of th
ese studies a mass production model C1E3 of this pump was fabricated a
s a short-term assist pump This pump has a Normalized Index of Hemolys
is of 0.0007 mg/100L and the estimated wear life of the impeller beari
ngs is longer than 8 years. The C1E3 will meet the clinical requiremen
ts as a cardiopulmonary bypass pump. For the next step, a miniaturized
pivot bearing centrifugal blood pump Pl-601 has been developed for us
e as a permanently implantable device after design optimization. The e
volution from C1E3 to the Pl-601 converts this pivot bearing centrifug
al pump as a totally implantable centrifugal pump. A pivot bearing cen
trifugal pump will become an ideal assist pump for the patients with f
ailing heart.