Physiological Adaptive COntrol of Continuous Flow Ventricular Assist Devices

连续流心室辅助装置的生理自适应控制

• 批准号: 8610345
• 负责人: GERSON ROSENBERG
• 金额: $ 22.49万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-02-01 至 2016-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8610345
• 关键词: Acute; Adverse event; Algorithms; Animal Testing; Artificial Organs; Blood; Blood flow; Cause of Death; Cessation of life; Chronic; Custom; Destinations; Detection; Device Designs; Device or Instrument Development; Devices; Event; Exercise; FDA approved; Feedback; Frequencies; Generations; Head; Heart; Heart Diseases; Heart failure; Hospitals; In Vitro; Left; Measurement; Measures; Myocardial; Operating System; Patients; Physiological; Pump; Research; Risk; Safety; Series; Sheep; Signal Transduction; Speed; Staging; Sturnus vulgaris; Suction; System; Testing; Therapeutic; Time; Transplantation; United States; Ventricular; Ventricular Arrhythmia; active control; base; blood pump; experience; hemodynamics; improved; pressure; prevent; public health relevance; response; sensor; ventricular assist device

DESCRIPTION (provided by applicant): 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 respond to patient demand is necessary. The primary objective of the proposed research is to develop a control system for continuous flow blood pumps that can reduce the risk of suction and adapt pump flow in response to circulatory demand. We have developed a pressure sensor that can be integrated to the inlet of a continuous flow LVAD and maintain a seamless blood interface. Using this pressure sensor, the following specific aims of the control system will be developed. (1) The onset of ventricular suction can be detected as a negative transient in the inlet pressure signal, and pump speed can be immediately reduced to resolve the suction event. (2) The peak-to-peak inlet pressure signal can be used in a feedback control loop to mimic the Frank-Starling mechanism and maintain adequate circulatory support in response to changes in ventricular preload. (3) The control system set point can be automatically adjusted based on the frequency of detected suction events in order to adapt to physiologic changes. The control system has been developed in vitro using the FDA approved HeartMate II axial flow pump, and tested in an initial acute sheep study. We propose to further develop and evaluate the control system in a series of acute and chronic sheep studies. The Penn State Division of Artificial Organs has extensive experience and expertise in LVAD development and large animal testing that we will utilize for the proposed research.

描述（由申请人提供）：使用左心室辅助设备（LVADS）一直是最终心力衰竭患者的可行治疗选择。这些设备通常被用作移植或目的地治疗的桥梁，并且随着设备设计的改进，不良事件的风险已降低，因此LVAD支持也被视为III类心力衰竭患者的一种选择。最近，由于其尺寸小和可靠性提高，连续流量LVAD的使用变得很普遍。但是，与上一代脉冲设备相比，对这些设备的控制可能是具有挑战性的。当前的控制系统以临床医生设定的固定速度操作泵。速度设置得足够高，可以提供足够的循环支撑，但不会太高，以引起吸力和心室塌陷。这些控制系统不能响应生理需求而增加流量，因此，具有这些设备的患者的运动能力有限。随着患者现在离开医院并返回日常活动，需要对患者需求做出响应的控制系统。拟议研究的主要目的是开发一个控制系统，用于连续流血泵，以响应循环需求而降低吸力和调整泵流的风险。我们已经开发了一个可以集成到连续流LVAD的入口并保持无缝血液界面的压力传感器。使用此压力传感器，将开发控制系统的以下特定目标。 （1）可以在入口压力信号中检测到心室吸力的发作，作为负瞬变，可以立即降低泵速度以解决吸力事件。 （2）可以在反馈控制回路中使用峰峰入口压力信号，以模仿坦率的储藏机构并维持足够的循环支持，以应对心室预紧力的变化。 （3）可以根据检测到的吸力事件的频率自动调整控制系统设置点，以适应生理变化。使用FDA认可的心伴侣II轴向流动泵在体外开发了控制系统，并在最初的急性绵羊研究中进行了测试。我们建议在一系列急性和慢性绵羊研究中进一步开发和评估控制系统。宾夕法尼亚州人造器官分部在LVAD开发和大型动物测试方面具有丰富的经验和专业知识，我们将用于拟议的研究。

项目成果

Cannula Tip With Integrated Volume Sensor for Rotary Blood Pump Control: Early-Stage Development.

带有集成容量传感器的插管尖端，用于旋转血泵控制：早期开发。

• DOI: 10.1097/mat.0000000000000818
• 发表时间: 2019
• 期刊: ASAIO journal (American Society for Artificial Internal Organs : 1992)
• 作者: Cysyk,Joshua;Newswanger,Ray;Popjes,Eric;Pae,Walter;Jhun,Choon-Sik;Izer,Jenelle;Weiss,William;Rosenberg,Gerson
• 通讯作者: Rosenberg,Gerson