Novel device for improving standard CPR outcomes

描述(由申请人提供)：这项SBIR第二阶段申请的目标是继续开发和评估一种旨在提高手动CPR效率的新设备。这种名为ErgoPad的手持式轻型设备有助于在CPR过程中将胸部转变为波纹管，从而使救援人员能够手动执行主动按压减压(ACD)CPR。与手工CPR相比，ACD CPR和吸气阻抗阈值装置(ITD)的结合使流向心脏和大脑的血流量增加了四倍。ITD是申请者发明的，最近商业化了。ErgoPad和ITD技术协同工作，降低减压阶段的胸腔内压，在胸腔内形成相对于身体其他部位的真空，从而a)增强血液回流到胸腔，b)增强血液回流到大脑，c)向救援人员提供实时反馈，以维持高质量的CPR，以及d)提高整体CPR效率。ErgoPad旨在供家庭和专业救援人员使用，以增加心脏骤停后有意义的存活机会。在第一阶段的研究中，ErgoPad已经被证明比目前ACD CPR设备的吸杯版本要好得多，因为它重量更轻，对胸部的粘附性更好，允许救援者的手更靠近胸部，不会摇晃，从而更有效地传递动能，更容易使用，具有更易操作的量规来指导按压和减压，所需工作更少，具有更大的压缩表面以优化压力分散，更容易存储在带有除颤器的小盒子中，并且更适合用于生理监测或除颤的皮肤电极。第一阶段概念验证研究还表明，ErgoPad和ITD的结合提高了已建立的猪心脏骤停模型的神经学完整存活率，在该模型中，我们将不进行CPR的心脏骤停时间延长至8.5分钟，并复苏了90%的动物。SBIR第二阶段研究的主要目的是进一步开发ErgoPad和ITD的组合，方法是a)增加几个关键功能，包括音频和视频提示，以指导救援人员进行CPR的最佳操作，以便可以轻松地在家庭和救护车环境中实施；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；以及c)测量ErgoPad在心脏骤停患者的临床表现。一旦第二阶段研究完成，ErgoPad和ITD将准备好在家庭和专业市场进行商业化。这项SBIR第二阶段研究的主要目的是进一步开发一种便于外行和专业救援者使用的手动主动按压减压心肺复苏(ACD CPR)设备，以便将其实施到家庭和救护车环境中，为外行救援者创建和评估易于理解的培训计划，并测量心脏骤停患者的设备性能。如果这一计划成功，新的复苏系统有可能再抢救美国每年发生在医院外的40万名心脏性猝死患者中的大约5万名患者。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脏性猝死患者。随着体外除颤器等重要救生技术越来越多地被购买用于家庭使用，这种新的复苏系统是业馀救援者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.