title: A pivot bearing-supported centrifugal pump for a long-term assist heart.
abstract: A pivot bearing-supported centrifugal blood pump has been developed. It is a compact, cost effective, and anti-thrombogenic pump with anatomical 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 the apex and the outflow cannula affixed with a Dacron vascular graft was anastomosed to the descending aorta. All pumps demonstrated trouble free performance over a two-week screening period. Among these five studies, three implantations were subjected for one month system validation studies. All the devices were trouble free for longer than 1 month. (35, 34, and 31 days). After achieving one month studies, all experiments were terminated. There was no evidence of device induced thrombus formation inside the pump. The plasma free hemoglobin levels were within normal ranges throughout all experiments. As a consequence of these studies, a mass production model C1E3 of this pump was fabricated as a short-term assist pump. This pump has a Normalized Index of Hemolysis of 0.0007 mg/100L and the estimated wear life of the impeller bearings is longer than 8 years. The C1E3 will meet the clinical requirements as a cardiopulmonary bypass pump. For the next step, a miniaturized pivot bearing centrifugal blood pump P1-601 has been developed for use as a permanently implantable device after design optimization. The evolution from C1E3 to the PI-601 converts this pivot bearing centrifugal pump as a totally implantable centrifugal pump. A pivot bearing centrifugal pump will become an ideal assist pump for the patients with failing heart.
authors.affiliation: Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.
authors.forename: T
authors.initials: T
authors.lastname: Nakazawa
authors.forename: Y
authors.initials: Y
authors.lastname: Ohara
authors.forename: R
authors.initials: R
authors.lastname: Benkowski
authors.forename: K
authors.initials: K
authors.lastname: Makinouchi
authors.forename: Y
authors.initials: Y
authors.lastname: Takami
authors.forename: S
authors.initials: S
authors.lastname: Ohtsubo
authors.forename: K
authors.initials: K
authors.lastname: Kawahito
authors.forename: K
authors.initials: K
authors.lastname: Tasai
authors.forename: J
authors.initials: J
authors.lastname: Glueck
authors.forename: G P
authors.initials: GP
authors.lastname: Noon
authors.forename: A
authors.initials: A
authors.lastname: Sueoka
authors.forename: H
authors.initials: H
authors.lastname: Schmallegger
authors.forename: H
authors.initials: H
authors.lastname: Schima
authors.forename: E
authors.initials: E
authors.lastname: Wolner
authors.forename: Y
authors.initials: Y
authors.lastname: Nosé
mesh_terms: D000818:Animals; D002315:Cardiopulmonary Bypass / Q000295:instrumentation; D002417:Cattle; D002498:Centrifugation; D003362:Cost-Benefit Analysis; D005260:Female; D006333:Heart Failure / Q000628:therapy; D006353:Heart-Assist Devices; D006454:Hemoglobins / Q000032:analysis; D013927:Thrombosis / Q000517:prevention & control
chemical_list: D006454:Hemoglobins