Counterpulsation Device with Integrated ECG Sensing

描述(申请人提供)：主动脉内球囊反搏已被广泛和成功地用作急性和慢性心功能不全的短期治疗。肯塔基州路易斯维尔的SCR公司正在开发一种新型的慢性植入式反搏器(CPD)，用于治疗晚期心力衰竭患者。CPD是一种32毫升的每搏量聚亚安酯内衬血腔，设计用于舒适地放置在右前胸的皮下口袋中。血泵腔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在自然心脏收缩时充满血液，降低心室负荷，在舒张期射血，增加心肌和末梢器官的血流灌注。之前NIH已经收到了用于血泵室和便携式驱动器开发的资金。从泵房射出的时间与心外膜导联的EKG信号同步，这使得手术过程变得复杂。为了简化植入操作，SCR开发了带有集成皮下导线的CPD原型，可用于体内测试。这项建议的目的是确定将集成的EKG导联放置在皮下位置的CPD是否会产生强大、持久的信号，并允许理想的设备充填和弹出时间。在具体目标1中，将使用标准的腹腔镜器械放置皮下EKG导联。这一目标的主要目的有两个：1)证明我们能够提供皮下EKG导联，并证明它们不会迁移；2)确定哪种EKG导联可以获得最佳的R波检测结果。在特定的目标2中，我们将实施完整的系统植入来评估慢性牛模型中的皮下导联。导联的位置将在特定的目标1中确定。皮下EKG导联的数据将被用来计算装置射出的时间，并与从心外膜导联获得的同步数据进行比较。将进行跑步机运动测试，以确保运动和肌肉活动不会干扰EKG信号。概述了确定皮下导联构型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的GLP动物植入，为临床研究设备豁免(IDE)研究做准备。 公共卫生意义：SCR公司(路易斯维尔，肯塔基州)正在开发一种长期反搏装置(CPD)，用于治疗早期心力衰竭患者。CPD是为表面植入而开发的，无需进入胸部，患者可以携带的便携式气动驱动器可以恢复活动能力。

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.