Control of mechanical circulatory support pump output typically requires that pressure-regulating functions be accomplished by active control of the speed or geometry of the device, with feedback from pressure or flow sensors. This article presents a different design approach, with a pressure-regulating device as the core design feature, allowing the essential control function of regulating pressure to be directly programmed into the hydromechanical design. We show the step-by-step transformation of a pressure-regulating device into a continuous-flow total artificial heart that passively balances left and right circulations without the need for pressure and flow sensors. In addition, we discuss a ventricular assist device that prevents backflow in the event of power interruption and also dynamically interacts with residual ventricle function to preserve pulsatility.
From *R1 Engineering, Euclid, Ohio
†Department of Biomedical Engineering, Lerner Research Institute (LRI), Cleveland Clinic, Cleveland, Ohio
‡Electronics Core, Medical Device Solutions, LRI, Cleveland Clinic, Cleveland, Ohio
§Department of Thoracic and Cardiovascular Surgery, Miller Family Heart & Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
Submitted for consideration September 2017; accepted for publication in revised form December 2017.
Disclosure: David J. Horvath and Barry D. Kuban are inventors of the continuous-flow total artificial heart (CFTAH). The technology was licensed to Cleveland Heart, Inc., a Cleveland Clinic spin-off company. David J. Horvath, Barry D. Kuban, and Kiyotaka Fukamachi are inventors of the Advanced ventricular assist device (VAD). The other authors have no conflicts of interest to report.
These concepts and initial prototypes were created with internal Cleveland Clinic funding. Subsequent development was being supported with federal funding obtained from the National Heart, Lung and Blood Institute of the National Institutes of Health, under grants R01HL096619 and R21HL133871 (to K.F.).
David J. Horvath, formerly of the Department of Biomedical Engineering, recently retired. Nader Moazami is currently a Professor of Cardiothoracic Surgery at New York University’s Langone Health, New York, NY.
Correspondence: Kiyotaka Fukamachi, Cardiovascular Dynamics Laboratory, Department of Biomedical Engineering/ND20, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195. Email: email@example.com.