Portable pneumatic driver for counterpulsation therapy

用于反搏治疗的便携式气动驱动器

• 批准号: 7269728
• 负责人: Paul A Spence
• 金额: $ 26.88万
• 依托单位: SCR, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-01 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7269728
• 关键词: Acute; Anastomosis - action; Animal Experiments; Animals; Area; Arrhythmia; Blood; Blood Circulation; Cardiac; Catheters; Characteristics; Chronic; Clinical; Condition; Congestive Heart Failure; Coronary; Counterpulsation; Development; Devices; Diagnosis; Diastole; Early treatment; Economic Inflation; Effectiveness; Engineering; Evaluation; Functional disorder; Generations; Goals; Grant; Heart; Heart Rate; Heart failure; Hypertension; Hypotension; Implant; Incidence; Intra-Aortic Balloon Pumping; Invasive; Location; Longevity; Mechanics; Modification; Myocardial; Numbers; Operative Surgical Procedures; Organ; Pacemakers; Patients; Performance; Perfusion; Peripheral; Phase; Physiological; Pump; Range; Recovery; Research; Shoulder; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Staging; Standards of Weights and Measures; Sternotomy; Structure of subclavian artery; Surface; System; Systole; Testing; Thoracic aorta; Time; Ventricular; Week; Weight; Workload; biomaterial compatibility; clinically relevant; day; design; heart rhythm; hemodynamics; improved; in vivo; novel; prototype; response; size; therapy duration; ventricular assist device

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 system for extended application of counterpulsation therapy for heart failure. The system consists of a 32-ml counterpulsation device (CPD) that is designed to be implanted via a surface operation in the shoulder area (pacemaker pocket). The CPD, a blood sac, is anastamosed to the subclavian artery. A driver for controlling device inflation/deflation timing carried externally allowing complete patient mobility. Preliminary testing with a first generation prototype driver was conducted in mock circulation system and acute animal experiments to define driver performance characteristics. The driver was then re-designed to reduce size and weight, improve force of counterpulsation delivery, increase response to higher heart rates, and extend device longevity. The CPD driver is in fabrication and ready for in vivo testing. The goal of this Phase I SBIR proposal is to compare the hemodynamic efficacy of the 32-ml CPD system (device and driver) to a 40- ml IABP system (catheter and driver). We will also demonstrate that engineering specifications of the new driver are met. This will be accomplished by completing the following specific aim: Aim-1: To demonstrate the efficacy of a 32-ml CPD driver in reducing ventricular afterload and augmenting diastolic perfusion to the heart and vasculature under a variety of clinically-relevant conditions - hypertension, hypotension, and heart failure. Our hypothesis is that the performance of the CPD system will be similar to a standard clinically-available IABP system. If successful, in Phase II we will conduct driver reliability testing controller reliability testing and chronic in vivo testing to demonstrate the long-term effectiveness of the 32-ml CPD system. SCR, Inc. (Louisville, KY) is developing a novel mechanical device to treat early stage heart failure patients. The device can be implanted using a simple surgical procedure comparable to a pacemaker. Since comparable devices can only provide up to 2 weeks of support, SCR is proposing to develop a portable, pneumatic driver to provide up to two years of support.

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。发明了一种新的系统，用于心力衰竭的反搏治疗的扩展应用。该系统由一个32 ml反搏装置（CPD）组成，设计用于通过肩部区域（起搏器囊袋）的表面手术植入。CPD是一个血囊，与锁骨下动脉吻合。用于控制器械充盈/回缩定时的驱动器，外部携带，允许患者完全移动。在模拟循环系统和急性动物实验中进行了第一代原型驱动器的初步测试，以定义驱动器的性能特征。然后重新设计驱动器，以减小尺寸和重量，提高反搏输送力，增加对更高心率的响应，并延长器械寿命。CPD驱动器正在制造中，并准备进行体内测试。本I期SBIR提案的目标是比较32 ml CPD系统（器械和驱动器）与40 ml IABP系统（导管和驱动器）的血流动力学有效性。我们还将证明新驱动程序符合工程规范。这将通过完成以下具体目标来实现：目标-1：证明32 ml CPD驱动器在各种临床相关疾病（高血压、低血压和心力衰竭）下降低心室后负荷和增加心脏和血管舒张期灌注的有效性。我们的假设是CPD系统的性能与标准临床可用IABP系统相似。如果成功，在第二阶段，我们将进行驱动器可靠性测试、控制器可靠性测试和慢性体内测试，以证明32 ml CPD系统的长期有效性。SCR，Inc.（Louisville，KY）正在开发一种新的机械装置来治疗早期心力衰竭患者。该装置可以使用与起搏器相当的简单外科手术植入。由于同类设备只能提供长达2周的支持，SCR建议开发一种便携式气动驱动器，以提供长达两年的支持。