A counterpulsation device to promote myocardial recovery

促进心肌恢复的反搏装置

• 批准号: 7054951
• 负责人: Paul A Spence
• 金额: $ 17.27万
• 依托单位: SCR, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-02-20 至 2007-02-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7054951
• 关键词: aortic balloon pump; auxiliary heart prosthesis; bioengineering /biomedical engineering; biomaterial compatibility; biomedical equipment development; biomedical equipment safety; cardiovascular disorder therapy; carotid artery; congestive heart failure; cow; heart ventricle; hemodynamics; immature animal; medical implant science; medical rehabilitation related tag; miniature biomedical equipment; myocardium disorder; nonhuman therapy evaluation; rehabilitation; therapy design /development

DESCRIPTION (provided by applicant): The incidence of congestive heart failure (CHF) is increasing worldwide with over one million new cases diagnosed annually. Over the past 30 years, counterpulsation with an intra-aortic balloon pump (IABP) has been widely and successfully used as a short-term treatment for cardiac dysfunction. However, counterpulsation is limited by its location within the descending thoracic aorta to short durations of therapy, typically less than 14 days. To overcome this limitation, Superficial Counterpulsation Research (SCR), Inc. has invented a novel device for long-term application of counterpulsation therapy for heart failure. The counterpulsation device (CPD) is designed to be implanted via a surface operation in the shoulder area (pacemaker pocket) by attaching it to the subclavian artery. This approach would give the patient nearly complete mobility. The first prototype CPD developed was a 40-ml valveless sac that fills and empties with each cardiac cycle. In acute studies in a calf with diminished cardiac function (DCF), the 40-ml CPD successfully reduced ventricular workload and augmented myocardial perfusion. In a cadaver fit study a problem with proper fit of the device in patients was revealed. To solve this problem, a smaller, second generation device (30-ml CPD) was developed. The 30-ml CPD provides a better fit and more comfortable implantation in the shoulder area, but its stroke volume is reduced by 25%, and this change requires verification that it can provide sufficient hemodynamic support. This 30-ml CPD is ready for in vivo testing. The goal of this Phase 1 SBIR proposal is to compare the hemodynamic efficacy of the new, ergonomic 30- ml CPD to the 40-ml CPD prototype. We will also demonstrate that the 30-ml CPD will not damage the artery or blood. This will be accomplished by completing the following specific aims: Aim-1: Demonstrate the efficacy of the 30-ml CPD in reducing ventricular workload and augmenting diastolic perfusion to the heart and vasculature in acute experiments using the DCF calf model. Aim-2: Perform a safety evaluation of the 30-ml CPD by examining possible pathological and hematologic changes in the artery and blood (i.e. hemolysis). In Phase II, we will propose chronic in vivo testing (30-day and 90-day DCF calf model) to demonstrate long-term effectiveness of the 30-ml CPD.

描述（由申请人提供）：全世界充血性心力衰竭 (CHF) 的发病率正在增加，每年诊断出的新病例超过一百万例。在过去的 30 年里，主动脉内球囊反搏 (IABP) 已被广泛且成功地用作心功能障碍的短期治疗方法。然而，反搏因其在胸降主动脉内的位置而受到限制，治疗持续时间较短，通常少于 14 天。为了克服这一限制，浅层反搏研究（SCR）公司发明了一种用于长期应用反搏治疗心力衰竭的新型装置。反搏装置 (CPD) 设计为通过表面手术将其附着到锁骨下动脉，植入肩部区域（起搏器袋）。这种方法将使患者几乎完全活动。开发的第一个 CPD 原型是一个 40 毫升的无阀囊，每个心动周期都会填充和排空。在对心功能减弱 (DCF) 的小牛进行的急性研究中，40 毫升 CPD 成功减少了心室负荷并增加了心肌灌注。在一项尸体贴合研究中，揭示了该装置在患者体内的正确贴合问题。为了解决这个问题，开发了更小的第二代设备（30 毫升 CPD）。 30毫升CPD在肩部区域提供了更好的贴合性和更舒适的植入，但其每搏输出量减少了25%，这一变化需要验证其能否提供足够的血流动力学支持。该 30 毫升 CPD 可用于体内测试。该第一阶段 SBIR 提案的目标是比较新型符合人体工程学的 30 毫升 CPD 与 40 毫升 CPD 原型的血流动力学功效。我们还将证明 30 毫升 CPD 不会损害动脉或血液。这将通过完成以下具体目标来实现： 目标 1：在使用 DCF 小牛模型的急性实验中，证明 30 毫升 CPD 在减少心室工作负荷和增加心脏和脉管系统舒张期灌注方面的功效。目标 2：通过检查动脉和血液中可能的病理和血液学变化（即溶血）对 30 毫升 CPD 进行安全性评估。在第二阶段，我们将提出慢性体内测试（30天和90天DCF小牛模型）以证明30毫升CPD的长期有效性。

项目成果

Acute hemodynamic efficacy of a 32-ml subcutaneous counterpulsation device in a calf model of diminished cardiac function.

• DOI: 10.1097/mat.0b013e318186891f
• 发表时间: 2008-11
• 期刊: ASAIO journal (American Society for Artificial Internal Organs : 1992)
• 作者: Koenig SC;Litwak KN;Giridharan GA;Pantalos GM;Dowling RD;Prabhu SD;Slaughter MS;Sobieski MA;Spence PA
• 通讯作者: Spence PA