Counterpulsation Device with Integrated ECG Sensing

具有集成心电图传感功能的反搏装置

• 批准号: 7908461
• 负责人: Robert D. Dowling
• 金额: $ 23.85万
• 依托单位: SCR, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7908461
• 关键词: Acute; Anastomosis - action; Animals; Anterior; Blood; Blood Circulation; Bypass; Cardiac; Catheters; Cattle; Chest; Chronic; Clinical; Clinical Trials; Computer Simulation; Computer software; Congestive Heart Failure; Counterpulsation; Data; Detection; Development; Devices; Diastole; Electrocardiogram; Ensure; Exercise stress test; Functional disorder; Funding; Goals; Grant; Healthcare; Heart; Heart Transplantation; Heart failure; Implant; Infection; Infraclavicular region structure; Intra-Aortic Balloon Pumping; Ischemia; Lead; Left; Limb structure; Lung; Methods; Modeling; Motion; Muscle; Myocardial; Myocardial perfusion; Operative Surgical Procedures; Organ; Organ Donor; Pacemakers; Patients; Performance; Perfusion; Peripheral; Pharmacotherapy; Phase; Polyurethanes; Positioning Attribute; Preparation; Pump; Quality of life; Resources; Right-On; Safety; Signal Transduction; Small Business Innovation Research Grant; Staging; Sternotomy; Stroke Volume; Structure of subclavian artery; Surgical incisions; System; Systole; Testing; Time; Time Study; United States National Institutes of Health; Vascular Graft; Ventricular; Workload; base; blood pump; cost; design; effective therapy; implantation; in vivo; instrument; interest; novel; operation; outcome forecast; preclinical study; prototype; public health relevance; subcutaneous; ventricular assist device

DESCRIPTION (provided by applicant): Counterpulsation with an intra-aortic balloon pump has been widely and successfully used as a short term treatment for both acute and chronic cardiac dysfunction. SCR (Louisville, KY) is developing a novel chronic, implantable counterpulsation device (CPD) to treat late stage HF patients. The CPD is a 32-ml stroke volume polyurethane-lined blood chamber designed to fit comfortably in a subcutaneous pocket on the right anterior chest. The blood pumping chamber is connected to the systemic circulation by a short graft anastomosed to the subclavian artery. The CPD is connected to a small, wearable pneumatic driver via a percutaneous drive line. The CPD fills with blood during native heart systole lowering ventricular workload, and ejects during diastole augmenting myocardial and end-organ perfusion. Previous NIH funding has been received for development of both the blood pumping chamber and the portable driver. The timing of ejection from the pumping chamber was synchronized with EKG signals from epicardial leads, which complicated the surgical procedure. To simplify the implant operation, SCR has developed prototype CPD with integrated subcutaneous leads that are ready for in vivo testing. The objective of this proposal is to determine if the CPD with integrated EKG leads placed in the subcutaneous position will result in a robust, durable signal and allow for ideal timing of device filling and ejection. In Specific Aim 1, standard laparoscopic instruments will be used to place subcutaneous EKG leads. The main goals of this aim are twofold: 1) to demonstrate that we are able to deliver subcutaneous EKG leads and show that they do not migrate, 2) to determine which EKG lead configuration results in the best R wave detection. In Specific Aim 2, we will perform full system implants to evaluate the subcutaneous leads in a chronic bovine model. Lead position will be determined in Specific Aim 1. The data from the subcutaneous EKG leads will be used to time device ejection and compared to simultaneous data obtained from epicardial leads. Treadmill exercise testing will be performed to ensure that motion and muscular activity do not interfere with EKG signaling. Strict criteria for determining if the subcutaneous lead configurations are acceptable are outlined. If successful, in Phase 2 we will perform long-term GLP animal implants with the integrated system in preparation for a clinical investigational device exemption (IDE) study. PUBLIC HEALTH RELEVANCE: SCR, Inc. (Louisville, KY) is developing a long-term counterpulsation device (CPD) to treat early stage heart failure patients. The CPD has been developed for superficial implantation without the need to enter the chest and a portable pneumatic driver that the patient can carry restores mobility.

描述（由申请人提供）：主动脉内球囊泵反搏已被广泛并成功地用作急性和慢性心功能障碍的短期治疗。SCR （Louisville， KY）正在开发一种新型慢性植入式反搏装置（CPD）来治疗晚期心衰患者。CPD是一个32毫升的中风容积聚氨酯内衬血腔设计适合在右前胸皮下袋舒适。泵血室通过与锁骨下动脉吻合的短移植物与体循环相连。CPD通过经皮驱动线连接到一个小型可穿戴气动驱动器。CPD在心脏收缩期充血，降低心室负荷，在舒张期喷射，增加心肌和终末器官灌注。此前，美国国立卫生研究院已经收到了用于开发血液泵室和便携式驱动器的资金。抽血室的射血时间与心外膜导联的心电图信号同步，这使手术过程复杂化。为了简化植入操作，SCR已经开发出具有集成皮下导线的CPD原型，准备进行体内测试。本提案的目的是确定将集成心电图导联置于皮下位置的CPD是否会产生稳健、持久的信号，并允许理想的设备填充和弹出时间。在具体目标1中，标准腹腔镜器械将用于放置皮下心电图导联。这一目的的主要目标有两个：1)证明我们能够提供皮下心电图导联，并表明它们不会迁移，2)确定哪种心电图导联配置能产生最佳的R波检测。在具体目标2中，我们将执行全系统植入来评估慢性牛模型的皮下导联。领导位置将在具体目标1中确定。皮下心电图导联的数据将用于测定装置弹射的时间，并与心外膜导联同时获得的数据进行比较。将进行跑步机运动测试，以确保运动和肌肉活动不会干扰心电图信号。本文概述了确定皮下铅配置是否可接受的严格标准。如果成功，在第二阶段，我们将使用集成系统进行长期GLP动物植入，为临床研究器械豁免（IDE）研究做准备。