A Multimodal Integrated System For Improved Cardiopulmonary Resuscitation

摘要 CPR治疗公司正在开发第一个多模式自动化系统， 复苏（CPR）。该技术集成和扩展了多个泵机构， 除颤，并将成为第一个设备，以改善患者的结果在心脏骤停与数量所需的- 商业成功的预测。它将在提高患者和供应商安全性的同时做到这一点。在全国范围内， 每年约有65万人心脏骤停。心肺复苏术问世50年后， 存活率通常低于10%，并且很大一部分复苏的患者留下神经系统疾病。 损伤值得注意的是，护理标准仍然是由救援人员进行手动胸外按压， 手中据估计，仅与院外心脏骤停相关的社会成本可能是 在美国每年超过330亿美元毫无疑问，心肺复苏术的临床有效改善是其中之一， 最大的未满足的医疗需求以前所有有效的心肺复苏装置的尝试都：1）只集中在一个 2）在随机试验中结果令人失望，3）在大多数情况下导致骨骼损伤， 患者，以及4）与手动CPR相比没有提供益处。在一系列试点研究中，CPR Therapeutics证明， 心输出量和静脉回流增强技术的组合可以提供额外的，甚至 对血液动力学的协同益处。正如设想的那样，公司的多功能系统是基于 多个CPR泵机制的概念，结合除颤和无脉同步 电活动（PEA）CPR将协同血液动力学和电生理学。这些方法 应该能显著改善临床效果在这个直接进入第二阶段的项目中， 将：1）设计并建立一个第三代猪实验台，能够高保真毫秒控制的， 多模式CPR泵机构，2）优化猪体内的系统配置和部件设计 室颤模型，以及3）在设计控制下设计和构建人类临床原型， 质量管理体系（QMS）。该器械将在以下时间接受结构和功能台架测试： 期待申请FDA IDE。除了技术的发展，该项目的范围- 这项工作将大大增加我们对心肺复苏泵机制之间相互作用的基础科学知识， 和患者部件同步。

Abstract CPR Therapeutics Inc. is developing the first multimodal automated system for cardiopulmonary resuscitation (CPR). This technology integrates and synchronizes multiple pump-mechanisms with enhanced defibrillation, and will be the first device to improve outcomes of patients in cardiac arrest with a number-needed- to-treat predictive of commercial success. It will do this while enhancing patient and provider safety. Nationally, approximately 650,000 individuals suffer cardiac arrest each year. Fifty years after the description of CPR, survival is generally below 10%, and a significant fraction of resuscitated patients are left with neurologic impairment. Remarkably, the standard-of-care remains manual chest compressions performed by rescuers with their hands. It has been estimated that the societal costs related to out-of-hospital cardiac arrest alone may be in excess of $33 billion a year in the US. Without question, clinically effective improvements in CPR are among the greatest unmet medical needs. All previous attempts at effective CPR devices have: 1) focused on only one enhancement at a time, 2) had disappointing outcomes in randomized trials, 3) cause skeletal injuries in most patients, and 4) provide no benefit over manual CPR. In a series of pilot studies, CPR Therapeutics demonstrated that combinations of cardiac output- and venous return-enhancing techniques may offer additive or even synergistic benefits to hemodynamics. As envisioned, the Company’s multifunctional system is based on the concept that multiple CPR pump mechanisms, combined with synchronization of defibrillation and pulseless electrical activity (PEA) CPR, will synergize both the hemodynamics and electrophysiology. These approach should significantly improve real-world clinical outcomes. In this Direct-to-Phase II project, CPR Therapeutics will: 1) Design and build a 3rd generation porcine test-bed capable of high-fidelity millisecond control of the multimodal CPR pump-mechanisms, 2) Optimize the system configuration and component designs in a porcine model of ventricular fibrillation, and 3) Design and build a human clinical prototype under a design-control and Quality Management System (QMS). This device will be subjected to structural and functional bench testing in anticipation of filing for an FDA IDE. In addition to the development of the technology, the project’s scope-of- work will add significantly to our basic science knowledge of the interactions between CPR pump-mechanisms and patient-component synchronizations.