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

项目总结/摘要 左心室辅助装置（LVAD）的使用已成为终末期患者的可行治疗选择。 心力衰竭患者。这些设备通常用作移植桥或目的地治疗， 随着器械设计的改进，不良事件的风险降低， 也被认为是III级心力衰竭患者的一种选择。最近，使用连续流 LVAD由于其小尺寸和改进的可靠性而变得常见。然而，控制这些 与上一代脉动装置相反，这种装置可能具有挑战性。电流控制 系统以由临床医生设定的固定速度操作泵。速度设置得足够高， 足够的循环支持，但不能太高，以免引起抽吸和心室塌陷。这些控制 系统不能响应生理需求而增加流量，因此， 装置具有有限的运动能力。当病人们离开医院，回到他们的 在日常活动中，需要一个响应患者需求的控制系统。的主要障碍 控制系统的发展是可植入传感器能够评估心室 卸货拟议研究的主要目标是开发一种“智能”插管尖端， 用于测量左心室的压力和容积的集成传感器。控制算法将是 根据从插管尖端获得的传感器数据调整泵速。控制 算法将使泵流量适应循环需求的变化，以维持心室 卸载，提供足够的血流，并防止不良抽吸事件。的经验和 宾夕法尼亚州立大学人工器官部门在LVAD和植入式LVAD开发方面的专业知识 将利用电子学来开发和制造所提出的装置。原型插管尖端， 对照系统已在使用HeartMate II LVAD的急性绵羊研究中进行了测试。我们建议 评价器械的生物相容性、容量和压力传感器的稳定性以及功能性 自动控制系统在一系列急性和慢性绵羊研究中的应用。

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.