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 |
| |
Authors: | Takeshi Someya †Mariko Kobayashi †Satoshi Waguri Tomohiro Ushiyama Eiki Nagaoka ‡Wataru Hijikata §Tadahiko Shinshi Hirokuni Arai †Setsuo Takatani |
| |
Institution: | Department of Cardiothoracic Surgery, Graduate School of Medicine;;Department of Artificial Organs, Institute of Biomaterials and Bioengineering, Tokyo Medical and Dental University, Tokyo;;Interdisciplinary Graduate School of Science and Engineering;;Precision and Intelligence Laboratory, Tokyo Institute of Technology, Yokohama, Japan |
| |
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. |
| |
Keywords: | Antithrombogenicity Circulatory support Disposable centrifugal blood pump Hemolysis Magnetic levitation |
|
|