Development of a disposable maglev centrifugal blood pump intended for one-month support in bridge-to-bridge applications: in vitro and initial in vivo evaluation.
MedTech Dispo, a disposable maglev centrifugal blood pump with two degrees of freedom magnetic suspension and radial magnetic coupling rotation, has been developed for 1-month extracorporeal circulatory support. As the first stage of a two-stage in vivo evaluation, 2-week evaluation of a prototype MedTech Dispo was conducted. In in vitro study, the pump could produce 5 L/min against 800 mm Hg and the normalized index of hemolysis was 0.0054 +/- 0.0008 g/100 L. In in vivo study, the pump, with its blood-contacting surface coated with biocompatible 2-methacryloyloxyethyl phosphorylcholine polymer, was implanted in seven calves in left heart bypass. Pump performance was stable with a mean flow of 4.49 +/- 0.38 L/min at a mean speed of 2072.1 +/- 64.5 rpm. The maglev control revealed its stability in rotor position during normal activity by the calves. During 2 weeks of operation in two calves which survived the intended study period, no thrombus formation was seen inside the pump and levels of plasma free hemoglobin were maintained below 4 mg/dL. Although further experiments are required, the pump demonstrated the potential for sufficient and reliable performance and biocompatibility in meeting the requirements for cardiopulmonary bypass and 1-week circulatory support.
Someya
Takeshi
T
Department of Cardiothoracic Surgery, Graduate School of Medicine Tokyo Medical, Tokyo, Japan.
Kobayashi
Mariko
M
Waguri
Satoshi
S
Ushiyama
Tomohiro
T
Nagaoka
Eiki
E
Hijikata
Wataru
W
Shinshi
Tadahiko
T
Arai
Hirokuni
H
Takatani
Setsuo
S
D000818:Animals; D000831:Animals, Newborn; D001344:Autopsy; D015415:Biomarkers / Q000097:blood; D002417:Cattle; D002498:Centrifugation; D020099:Coated Materials, Biocompatible; D004209:Disposable Equipment; D004867:Equipment Design; D018611:Heart Bypass, Left / Q000009:adverse effects / Q000295:instrumentation*; D006353:Heart-Assist Devices / Q000009:adverse effects; D006439:Hemodynamics; D006461:Hemolysis; D008280:Magnetics; D008297:Male; D008422:Materials Testing; D008689:Methacrylates; D023421:Models, Animal; D010767:Phosphorylcholine / Q000031:analogs & derivatives*; D013927:Thrombosis / Q000097:blood / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D013997:Time Factors
D015415:Biomarkers; D020099:Coated Materials, Biocompatible; D008689:Methacrylates; D010767:Phosphorylcholine; C070638:2-methacryloyloxyethyl phosphorylcholine