Cannula Tip with Integrated Volume and Pressor Sensors for Rotary Blood Pump Control

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Project Summary / Abstract The use of left ventricular assist devices (LVADs) has been a viable therapeutic option for end-stage heart failure patients. These devices are commonly used as bridge-to-transplant or destination therapy, and as the risk of adverse events has been reduced with improved device design, LVAD support is being considered as an option for class III heart failure patients as well. Recently, the use of continuous flow LVADs has become common due to their small size and improved reliability. However, control of these devices can be challenging as opposed to the previous generation of pulsatile devices. Current control systems operate the pump at a fixed speed set by the clinician. The speed is set high enough to provide adequate circulatory support but not too high as to cause suction and ventricular collapse. These control systems cannot increase flow in response to physiologic demand and therefore, patients with these devices have limited exercise capacity. As patients are now leaving the hospital and returning to their daily activities, a control system that responds to patient demand is necessary. The major impediment to control system development is the availability of implantable sensors capable of assessing ventricular unloading. The primary objective of the proposed research is to develop a “smart” cannula tip with integrated sensors for measuring the pressure and volume of the left ventricle. A control algorithm will be developed to adjust pump speed based on the sensor data obtained from the cannula tip. The control algorithm will adapt pump flow to changes in circulatory demand in order to maintain ventricular unloading, provide adequate blood flow, and prevent adverse suction events. The experience and expertise of the Penn State Division of Artificial Organs in the development of LVADs and implantable electronics will be utilized to develop and fabricate the proposed device. A prototype cannula tip and control system have been tested in acute ovine studies with the HeartMate II LVAD. We propose to evaluate the biocompatibility of the device, stability of the volume and pressure sensors, and functionality of the automatic control system in a series of acute and chronic ovine studies.