Novel device for improving standard CPR outcomes

描述（由申请人提供）：本次SBIR二期申请的目标是继续开发和评估一种旨在提高人工心肺复苏术效率的新型设备。这种名为ErgoPad的轻便手持式设备有助于在心肺复苏术期间将胸腔转变为波纹管，从而使救援人员能够手动执行主动压缩减压（ACD）心肺复苏术。与单纯手工CPR相比，ACD CPR与吸气阻抗阈值装置（ITD）联合使用可使流向心脏和大脑的血流量增加四倍。该过渡段由申请人发明，最近已商业化。ErgoPad和ITD技术协同工作，降低减压阶段的胸内压力，在胸腔内创造相对于身体其他部位的真空，从而a)增强胸腔的血液回流，b)增强大脑的血液回流，c)向救援人员提供实时反馈，以保持高质量的心肺复苏，d)提高心肺复苏的整体效率。ErgoPad旨在为家庭和专业救援人员使用，以增加心脏骤停后有意义的生存机会。在第一阶段的研究中，ErgoPad已经被证明比目前ACD CPR设备的吸盘版本要好得多，因为它重量更轻，更好地附着在胸部，让救援者的手更靠近胸部，不摇晃，从而更有效地传递动能，更容易使用，有一个更友好的压力表来指导按压和减压，需要更少的工作，具有更大的压缩表面以优化压缩力的分散，更容易与除颤器一起存储在小盒子中，并且更适合于适应皮肤电极用于生理监测或除颤。I期概念验证研究还表明，ErgoPad和ITD的联合使用提高了猪心脏骤停模型的神经完整存活率，在该模型中，我们将无心肺复苏的骤停时间延长至8.5分钟，并使90%的动物复苏。SBIR II期研究的主要目的是进一步开发ErgoPad和ITD的组合：a)增加几个关键功能，包括音频和视觉线索，以指导救援人员心肺复苏术的最佳性能，以便在家庭和救护车环境中轻松实施；b)为非专业救援人员创建和评估一个易于理解的培训计划；c)测量ErgoPad在心脏骤停患者中的临床表现。一旦II期研究完成，ErgoPad和ITD将准备进入家庭和专业市场商业化。这项SBIR二期研究的主要目的是进一步开发一种手动主动压缩减压心肺复苏（ACD CPR）装置，该装置可以被外行和专业救援人员轻松使用，从而可以在家庭和救护车环境中实施，为外行救援人员创建和评估易于理解的培训计划，并衡量心脏骤停患者的设备性能。如果这个项目成功，新的复苏系统有可能使美国每年40万例院外心脏性猝死患者中的5万多例患者复苏。这一估计没有考虑到每年在医院发生的几乎相同数量的心源性猝死患者。随着家用体外除颤器等重要救生技术的日益普及，这种新型复苏系统是非专业救援人员在家中使用的理想技术。

DESCRIPTION (provided by applicant): The goal of this SBIR Phase II application is to continue the development and evaluation of a novel device designed to increase the efficiency of manual CPR. This hand-held lightweight device, termed the ErgoPad, helps to transform the thorax into a bellows during CPR, thereby enabling the rescuer to manually perform active compression decompression (ACD) CPR. The combination of ACD CPR and the inspiratory impedance threshold device (ITD) quadruples blood flow to the heart and brain compared with manual CPR alone. The ITD was invented by the applicant and recently commercialized. The ErgoPad and ITD technologies work synergistically to decrease the decompression phase intrathoracic pressure, creating a vacuum within the thorax relative to the rest of the body, thereby a) enhancing blood return to the thorax, b) enhancing blood return to the brain, c) providing real-time feedback to rescuers to maintain high quality CPR, and d) improving overall CPR efficiency. The ErgoPad is intended for home and professional rescuer use to increase the chances for meaningful survival after cardiac arrest. The ErgoPad has been shown in Phase I studies to be significantly better than the current suction cup version of the ACD CPR device as it is lighter in weight, adheres better to the chest, allows the rescuer's hands to be closer to the chest, does not wobble and thereby transfers kinetic energy more efficiently, is easier to use, has a more user-friendly gauge to guide compressions and decompressions, requires less work, has a larger compression surface to optimize dispersion of compression forces, is easier to store in a small box with a defibrillator, and is more amenable to adapt to a skin electrode for physiological monitoring or defibrillation. Phase I proof of concept studies also demonstrated that the combination of the ErgoPad and ITD increased neurologically intact survival in a well established porcine model of cardiac arrest, in which we extended arrest without CPR time to 8.5 minutes and resuscitated >90% of the animals. The SBIR Phase II research is primarily intended to further develop the ErgoPad and ITD combination by a) adding several key features including audio and visual cues to guide rescuers on the optimal performance of CPR so that it can be easily implemented into the home and ambulance setting, b) creating and evaluating an easy to understand training program for the lay rescuer, and c) measuring the clinical performance of the ErgoPad in patients in cardiac arrest. Once Phase II studies are completed, the ErgoPad and ITD will be ready for commercialization into the home and professional markets. This SBIR Phase 2 research is primarily intended to further develop a manual active compression decompression cardiopulmonary resuscitation (ACD CPR) device that can be easily used by lay and professional rescuers so that it can be implemented into the home and ambulance setting, to create and evaluate an easy to understand training program for the lay rescuer, and to measure device performance in patients in cardiac arrest. If this program is successful, the new resuscitation system has the potential to resuscitate approximately 50,000 more patients of the 400,000 sudden cardiac deaths that occur outside the hospital each year in the United States. This estimation does not take into account a nearly equal number of patients with sudden cardiac death that occur in-hospital each year. With the increasing trend of vital life saving technologies such as external defibrillators being bought for home use, this new resuscitation system is an ideal technology for the lay rescuer to use at home.