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）：充血性心力衰竭（CHF）的发病率在全球范围内增加，每年被诊断出100万个新病例。在过去的30年中，用可靠性气球内气球泵（IABP）的反抗被广泛地用作心脏功能障碍的短期治疗。然而，反抗受到其在降胸主动脉降低治疗持续时间的位置的限制，通常不到14天。为了克服这一局限性，表面反抗研究（SCR），Inc。发明了一种新颖的装置，用于长期应用反抗疗法用于心力衰竭。抗击装置（CPD）设计为通过将其连接到锁骨下动脉的肩部区域（起搏器袋）中植入。这种方法将使患者几乎完全流动。开发的第一个原型CPD是一个40毫升的valveless囊，每个心脏周期都填充和排空。在心脏功能降低（DCF）的小腿急性研究中，40 mL CPD成功降低了心室工作量并增强了心肌灌注。在尸体拟合研究中，揭示了患者适当拟合的问题。为了解决这个问题，开发了一个较小的第二代设备（30 mL CPD）。 30 mL CPD在肩部区域提供了更好的贴合性和更舒适的植入，但其中风量减少了25％，并且这种变化需要验证它可以提供足够的血液动力学支持。这个30 ml的CPD已准备好进行体内测试。该阶段1 SBIR提案的目的是将新的符合人体工程学30-ML CPD的血液动力学功效与40 mL CPD原型进行比较。我们还将证明30毫升CPD不会损害动脉或血液。这将通过完成以下特定目的来实现：AIM-1：在急性实验中使用DCF Calf模型在急性实验中证明30 ml CPD在减少心室工作量并增加心脏和脉管系统的功效。 AIM-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 mL CPD进行安全评估。在第二阶段，我们将提出慢性体内测试（30天和90天DCF CALF模型），以证明30 mL 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