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

Artif Organs. 2009 Sep;33(9):704-13. doi: 10.1111/j.1525-1594.2009.00900.x.

Abstract

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.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Animals, Newborn
  • Autopsy
  • Biomarkers / blood
  • Cattle
  • Centrifugation
  • Coated Materials, Biocompatible
  • Disposable Equipment*
  • Equipment Design
  • Heart Bypass, Left / adverse effects
  • Heart Bypass, Left / instrumentation*
  • Heart-Assist Devices* / adverse effects
  • Hemodynamics
  • Hemolysis
  • Magnetics
  • Male
  • Materials Testing
  • Methacrylates*
  • Models, Animal
  • Phosphorylcholine / analogs & derivatives*
  • Thrombosis / blood
  • Thrombosis / etiology
  • Thrombosis / physiopathology
  • Thrombosis / prevention & control*
  • Time Factors

Substances

  • Biomarkers
  • Coated Materials, Biocompatible
  • Methacrylates
  • Phosphorylcholine
  • 2-methacryloyloxyethyl phosphorylcholine