A counterpulsation device to promote myocardial recovery

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不断增加，每年诊断的新病例超过100万例。在过去的30年里，主动脉内球囊反搏（IABP）已被广泛和成功地用作心功能不全的短期治疗。然而，反搏受限于其在降胸主动脉内的位置，治疗持续时间短，通常少于14天。为了克服这一局限性，浅表反搏研究（SCR），公司。发明了一种新型装置，用于长期应用反搏治疗心力衰竭。反搏装置（CPD）设计为通过将其连接到锁骨下动脉，通过肩部区域（起搏器囊袋）的表面手术植入。这种方法将使患者几乎完全移动。开发的第一个原型CPD是一个40 ml无瓣膜囊，随着每个心动周期填充和排空。在心功能减退（DCF）小牛的急性研究中，40 ml CPD成功降低了心室工作负荷并增加了心肌灌注。在一项尸体匹配研究中，发现器械在患者体内的适当匹配存在问题。为了解决这个问题，开发了一种更小的第二代设备（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，但其每搏输出量减少了25%，这一变化需要验证其能够提供足够的血流动力学支持。该30 ml CPD可用于体内试验。本1期SBIR提案的目标是比较新型人体工程学30 ml CPD与40 ml CPD原型的血流动力学疗效。我们还将证明30 ml CPD不会损伤动脉或血液。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 ml CPD在降低心室工作负荷和增加心脏和血管舒张灌注方面的有效性。目标二：通过检查动脉和血液中可能的病理学和血液学变化（即溶血），对30 ml CPD进行安全性评价。在II期，我们将提出慢性体内试验（30天和90天DCF小牛模型），以证明30 ml CPD的长期有效性。

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.