Search

Background: Mechanical circulatory support devices, such as left ventricular assist devices, have recently been used in patients with heart failure as destination therapy but the formation of thrombus in blood pumps remains a critical problem. In this study, we propose a mechanical antithrombogenic method by impeller excitation using a magnetically levitated (Maglev) centrifugal pump. Previous studies have shown that one‐directional excitation prevents thrombus; however, it is effective in only one direction. In this study, we aimed to obtain a better effect by vibrating it in a circular orbit to induce uniform changes in the shear‐rate field entirely around the impeller. Methods: The blood coagulation time was compared using porcine blood. (1) The flow rate was set to 1 L/min, and applied excitation was at a frequency of 280 Hz and amplitude of 3 μm. (2) Moreover, the effect was compared by varying the frequency, amplitude, and direction of the excitation. In this experiment, the flow rate was set to 0.3 L/min. Results: (1) The thrombus formation time was 77 min without excitation and 133 min with excitation, which was 1.7 times longer. (2) The results showed no difference between (280 Hz, 3 μm) and (50 Hz, 16 μm) circular orbital excitations, and no directional difference, with thrombus formation of 2.5 times longer under all conditions than that without excitation. Conclusion: In the case of simple reciprocating excitation, the time was approximately 1.2 times longer. This indicated that the circular orbital excitation is more effective. [ABSTRACT FROM AUTHOR]

Mechanical circulatory support devices have been used clinically for patients with heart failure for over 10 years. However, thrombus formation inside blood pumps remains a risk to patient life, causing pump failure and contributing to neurological damage through embolization. In this article, we propose a method for preventing thrombus formation by applying vibrational excitation to the impeller. We evaluate the ability of this method to enhance the antithrombogenic properties of a magnetically levitated centrifugal blood pump and ensure that the impeller vibration does not cause undue hemolysis. First, 3 vibrational conditions were compared using an isolated pump without a mock circulation loop; the vibrational excitation frequencies and amplitudes for the impeller were set to (a) 0 Hz‐0 μm, (b) 70 Hz‐10 μm, and (c) 300 Hz‐2.5 μm. The motor torque was measured to detect thrombus formation and obtain blood coagulation time by calculating the derivative of the torque. Upon thrombus detection, the pump was stopped and thrombi size were evaluated. The results showed an increase in the blood coagulation time and a decrease in the rate of thrombus formation in pumps with the impeller vibration. Second, an in vitro hemolysis test was performed for each vibrational condition to determine the effect of impeller vibration on hemolysis. The results revealed that there was no significant difference in hemolysis levels between each condition. Finally, the selected vibration based on the above test results and the non‐vibration as control were compared to investigate antithrombogenic properties under the continuous flow condition. The blood coagulation time and thrombi size were investigated. As a result, vibrational excitation of the impeller at a frequency of 300 Hz and amplitude of 2.5 μm was found to significantly lengthen clotting time, decreasing the rate of pump thrombus compared to the non‐vibration condition. We indicate the potential of impeller vibration as a novel mechanical antithrombogenic mechanism for rotary blood pumps. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]