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

项目摘要/摘要 左心辅助装置的使用已经成为终末期的一种可行的治疗选择。 心力衰竭患者。这些设备通常被用作移植的桥梁或目的地疗法， 随着改进的设备设计降低了不良事件的风险，LVAD支持正在 也被认为是III级心力衰竭患者的一种选择。最近，连续流的使用 由于体积小和可靠性提高，LVAD已经变得很常见。然而，对这些的控制 与上一代脉动设备相比，设备可能具有挑战性。电流控制 系统以临床医生设定的固定速度运行泵。速度被设置得足够高，以提供 有足够的循环支持，但不能过高而导致吸气和脑室衰竭。这些控件 系统不能根据生理需求增加流量，因此，患有这些疾病的患者 设备的运动能力有限。因为病人们现在正在离开医院，回到他们的 在日常活动中，一个响应患者需求的控制系统是必要的。主要的障碍是 控制系统的开发是植入式传感器的可用性，能够评估脑室 正在卸货。这项拟议研究的主要目标是开发一种“智能”的插管尖端 用于测量左心室压力和容量的集成传感器。控制算法将是 开发用于根据从套管尖端获得的传感器数据来调整泵速。该控件 算法将使泵流量适应循环需求的变化，以维持心室 卸载，提供充足的血液流动，并防止不利的吸入事件。体验和 宾夕法尼亚州立大学人工器官分部在开发左心室和植入物方面的专业知识 电子学将被用来开发和制造拟议的设备。一个原型插管尖端和 控制系统已经在急性绵羊研究中使用HeartMate II LVAD进行了测试。我们建议 评估设备的生物兼容性、体积和压力传感器的稳定性以及功能 在一系列急性和慢性绵羊研究中对自动控制系统进行了研究。

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.