Physiological Controller for Rotary Blood Pumps

旋转式血泵的生理控制器

• 批准号: 8126038
• 负责人: Gill B. Bearnson
• 金额: $ 55.45万
• 依托单位: WORLD HEART CORPORATION
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-08-15 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8126038
• 关键词: Algorithms; Animal Experiments; Animal Model; Animals; Applications Grants; Blood; Blood Pressure; Blood flow; Clinical; Clinical Markers; Clinical Protocols; Clinical Trials; Computer software; Computers; Conduct Clinical Trials; Detection; Development; Devices; Effectiveness; Evaluation; Event; Exercise; Funding; Future; Generations; Goals; Heart; Home environment; Homeostasis; Human; Human Resources; Life Style; Measurement; Measures; Mechanics; Patients; Performance; Phase; Physical activity; Physiological; Preclinical Testing; Private Sector; Probability; Protocols documentation; Pump; Quality of life; Recovery; Regulation; Risk; Safety; Series; Small Business Innovation Research Grant; Suction; System; Technology; Testing; Time; United States National Institutes of Health; Validation; Ventricular; base; blood pump; cost effective; experience; hemodynamics; improved; in vivo; meetings; neglect; physical conditioning; pre-clinical; pressure; programs; prototype; research clinical testing; response; standard of care; success; ventricular assist device

DESCRIPTION (provided by applicant): Competing Continuation Grant Application Physiologic Controller for Rotary Blood Pumps Rotary blood pumps are rapidly gaining favor in the field of mechanical circulatory support because of their small size, reliability, and energy efficiency. However the control of these pumps presents some difficulties because of their sensitivity to circulatory load and ability to draw blood under negative pressure. In a Phase I and Phase II effort, we have developed advanced algorithms to mimic the physiological control of blood flow and pressure by developing algorithms suitable for rotary ventricular assist devices, and specifically testing them on the WorldHeart Levacor" VAD system. At this juncture, additional verification testing and validation is required to meet regulatory requirements so that these control improvements may be provided to patients receiving VAD therapy. The specific aims for the grant application are as follows: 1) Implement the controller with the Levacor VAD" system. 2) Conduct preclinical animal studies. 3) Complete an Initial Clinical Trial. 4) Prepare submission to FDA for the Pivotal clinical trial. Preclinical tests are proposed in the grant application for six 30-day animal experiments that will prove safety and effectiveness of the controller in an animal model. Protocols for clinical tests are described to evaluate anti-suction control for false positive detection as well as affirmative response to suction events. Protocols for evaluation of patient recovery and for response to exercise are also proposed as part of the trial. Success of the trial will be demonstrated by, 1) a net decrease in risk to patients by implementation of the automatic control, 2) correlation of device measurements of recovery to independently measured clinical markers for recovery, and 3) improved quality of life for patients by enhanced response to exercise. PUBLIC HEALTH RELEVANCE: Physiologic Controller for Rotary Blood Pumps Physiologically responsive control software for an implantable rotary blood pump has been developed in Phase I and Phase II SBIR programs. The objective of this proposed program is to complete rigorous testing that is required for FDA approval, and begin use of the controller in people.

描述（由申请人提供）：竞争继续资助申请旋转血泵生理控制器旋转血泵由于其体积小，可靠性和能源效率，在机械循环支持领域迅速获得青睐。然而，这些泵的控制存在一些困难，因为它们对循环负荷的敏感性和在负压下抽取血液的能力。 在第一阶段和第二阶段的工作中，我们开发了先进的算法，通过开发适用于旋转心室辅助设备的算法来模拟血流和压力的生理控制，并专门在WorldHeart Levacor的VAD系统上测试它们。此时，需要进行额外的验证测试和确认以满足监管要求，以便为接受VAD治疗的患者提供这些控制改进。 本项目的具体目标如下：1）实现Levacor VAD系统的控制器。 2)进行临床前动物研究。 3)完成初步临床试验。 4)准备提交给FDA的临床试验申请。 在拨款申请中提出了六个30天的动物实验的临床前测试，将证明控制器在动物模型中的安全性和有效性。描述了用于临床测试的方案，以评价假阳性检测的反抽吸控制以及对抽吸事件的肯定响应。作为试验的一部分，还提出了评估患者恢复和运动反应的方案。 试验的成功将通过以下方面来证明：1）通过实施自动控制，患者风险净降低，2）器械恢复测量值与独立测量的恢复临床标志物的相关性，3）通过增强运动反应改善患者生活质量。 公共卫生相关性：用于旋转式血泵的生理控制器已在第I和第II阶段SBIR项目中开发了用于植入式旋转式血泵的生理响应控制软件。该计划的目标是完成FDA批准所需的严格测试，并开始在人体中使用控制器。