Development of the Baylor Gyro permanently implantable centrifugal blood pump as a biventricular assist device. 2001

K Nonaka, and J Linneweber, and S Ichikawa, and M Yoshikawa, and S Kawahito, and M Mikami, and T Motomura, and H Ishitoya, and I Nishimura, and D Oestmann, and J Glueck, and H Schima, and E Wolner, and T Shinohara, and Y Nosé
Baylor College of Medicine, Michael E. DeBakey Department of Surgery, Houston, Texas, U.S.A. knonaka@bcm.tmc.edu

The Baylor Gyro permanently implantable centrifugal blood pump (Gyro PI pump) has been under development since 1995 at Baylor College of Medicine. Excellent results were achieved as a left ventricular assist device (LVAD) with survival up to 284 days. Based on these results, we are now focusing on the development of a biventricular assist device (BVAD) system, which requires 2 pumps to be implanted simultaneously in the preperitoneal space. Our hypothesis was that the Gyro PI pump would be an appropriate device for an implantable BVAD system. The Gyro PI 700 pump is fabricated from titanium alloy and has a 25 ml priming volume, pump weight of 204 g, height of 45 mm, and pump diameter of 65 mm. This pump can provide 5 L/min against 100 mm Hg at 2,000 rpm. In this study, 6 half-Dexter healthy calves have been used as the experimental model. The right pump was applied between the infundibular of the right ventricle and the main pulmonary artery. The left pump was applied between the apex of the left ventricle and the thoracic descending aorta. As for anticoagulation, heparin was administered at the first postoperative week and then converted to warfarin sodium from the second week after surgery. Both pump flow rates were controlled maintaining a pulmonary arterial flow of less than 160 ml/kg/min for the sake of avoidance of pulmonary congestion. Blood sampling was done to assess visceral organ function, and the data regarding pump performance were collected. After encountering the endpoint, which the study could not keep for any reasons, necropsy and histopathological examinations were performed. The first 2 cases were terminated within 1 week. Deterioration of the pump flow due to suction phenomenon was recognized in both cases. To avoid the suction phenomenon, a flexible conduit attached on the inlet conduit was designed and implanted. After using the flexible inflow conduit, the required power and the rotational speed were reduced. Furthermore, the suction phenomenon was not observed except for 1 case. There was no deterioration regarding visceral organ function, and pulmonary function was maintained within normal range except for 1 case. Even though the experimental animal survived up to 45 days with the flexible inflow conduit, an increase in power consumption due to thrombus formation behind the impeller became a problem. Lower rotational speed, which was probably produced by the effectiveness of the flexible inflow conduit, was speculated to be one of the reasons. And the minimum range of rotational speed was 1,950 rpm in these 6 BVAD cases and the previous 3 cases of LVAD. In conclusion, 6 cases of BVAD implantation were performed as in vivo animal studies and were observed up to 45 days. The flexible inflow conduit was applied in 4 of 6 cases, and it was effective in avoiding a suction phenomenon. The proper rotational speed of the Gyro PI 700 pump was detected from the viewpoint of antithrombogenicity, which is more than 1,950 rpm.

UI MeSH Term Description Entries
D008904 Miniaturization The design or construction of objects greatly reduced in scale. Miniaturisation,Miniaturisations,Miniaturizations
D012039 Regional Blood Flow The flow of BLOOD through or around an organ or region of the body. Blood Flow, Regional,Blood Flows, Regional,Flow, Regional Blood,Flows, Regional Blood,Regional Blood Flows
D002417 Cattle Domesticated bovine animals of the genus Bos, usually kept on a farm or ranch and used for the production of meat or dairy products or for heavy labor. Beef Cow,Bos grunniens,Bos indicus,Bos indicus Cattle,Bos taurus,Cow,Cow, Domestic,Dairy Cow,Holstein Cow,Indicine Cattle,Taurine Cattle,Taurus Cattle,Yak,Zebu,Beef Cows,Bos indicus Cattles,Cattle, Bos indicus,Cattle, Indicine,Cattle, Taurine,Cattle, Taurus,Cattles, Bos indicus,Cattles, Indicine,Cattles, Taurine,Cattles, Taurus,Cow, Beef,Cow, Dairy,Cow, Holstein,Cows,Dairy Cows,Domestic Cow,Domestic Cows,Indicine Cattles,Taurine Cattles,Taurus Cattles,Yaks,Zebus
D004867 Equipment Design Methods and patterns of fabricating machines and related hardware. Design, Equipment,Device Design,Medical Device Design,Design, Medical Device,Designs, Medical Device,Device Design, Medical,Device Designs, Medical,Medical Device Designs,Design, Device,Designs, Device,Designs, Equipment,Device Designs,Equipment Designs
D006353 Heart-Assist Devices Small pumps, often implantable, designed for temporarily assisting the heart, usually the LEFT VENTRICLE, to pump blood. They consist of a pumping chamber and a power source, which may be partially or totally external to the body and activated by electromagnetic motors. Artificial Ventricle,Heart Assist Device,Heart Ventricle, Artificial,Pumps, Heart-Assist,Vascular-Assist Device,Vascular-Assist Devices,Ventricle-Assist Device,Ventricular Assist Device,Artificial Heart Ventricle,Artificial Heart Ventricles,Artificial Ventricles,Assist Device, Heart,Assist Device, Ventricular,Assist Devices, Heart,Assist Devices, Ventricular,Device, Heart Assist,Device, Heart-Assist,Device, Vascular-Assist,Device, Ventricle-Assist,Device, Ventricular Assist,Devices, Heart Assist,Devices, Heart-Assist,Devices, Vascular-Assist,Devices, Ventricle-Assist,Devices, Ventricular Assist,Heart Assist Devices,Heart Ventricles, Artificial,Heart-Assist Device,Heart-Assist Pump,Heart-Assist Pumps,Pump, Heart-Assist,Pumps, Heart Assist,Vascular Assist Device,Vascular Assist Devices,Ventricle Assist Device,Ventricle, Artificial,Ventricle, Artificial Heart,Ventricle-Assist Devices,Ventricles, Artificial,Ventricles, Artificial Heart,Ventricular Assist Devices
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D014025 Titanium A dark-gray, metallic element of widespread distribution but occurring in small amounts with atomic number, 22, atomic weight, 47.867 and symbol, Ti; specific gravity, 4.5; used for fixation of fractures.
D020007 Implants, Experimental Artificial substitutes for body parts and materials inserted into organisms during experimental studies. Experimental Implant,Experimental Implants,Implant, Experimental

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