Non-invasive Extra-Corporeal Circulator for Prolonged Resuscitation

用于长时间复苏的无创体外循环器

• 批准号: 7746747
• 负责人: KEITH G LURIE
• 金额: $ 19.49万
• 依托单位: ADVANCED CIRCULATORY SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2011-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7746747
• 关键词: Accounting; Animal Model; Animals; Applications Grants; Assisted Circulation; Blood Circulation; Blood Pressure; Blood flow; Brain; Cardiac; Cardiopulmonary Resuscitation; Caring; Cerebrum; Chest; Clinical; Complex; Coronary; Coronary Circulation; Counterpulsation; Coupled; Data; Development; Device or Instrument Development; Devices; Disease; Electric Countershock; Emergency Situation; Environmental air flow; Family member; Family suidae; Goals; Heart; Heart Arrest; Home environment; Hospitals; Hour; Human; Injury; Intracranial Pressure; Intrinsic factor; Investigation; Laboratories; Life; Link; Lower Extremity; Manuals; Mechanics; Medical; Modeling; Myocardial Ischemia; Nervous System Physiology; Neurologic; Organ; Outcome; Outcome Study; Patients; Perfusion; Phase; Principal Investigator; Pump; Regulation; Research Proposals; Resistance; Resuscitation; Shock; Small Business Innovation Research Grant; Survival Rate; System; Techniques; Technology; Testing; Time; United States; Vasoconstrictor Agents; Venous; base; design; improved; indexing; innovation; new technology; novel; novel strategies; pressure; programs; prototype; public health relevance; sudden cardiac death

DESCRIPTION (provided by applicant): Based upon newly discovered mechanisms to enhance circulation during CPR, the goal of this SBIR phase 1 application is to develop a comprehensive and novel non-invasive extracorporeal automated circulatory assist device to normalize blood flow during cardiac arrest and to provide adequate circulation for prolonged periods of time allowing for transport of patients to the hospital where they can receive more definite therapies. The device is designed to harness both the intrathoracic pump mechanism during CPR to provide sufficient forward flow, to refill the heart to maintain normal blood pressures, to lower intracranial pressures, and to further augment venous return and direct diastolic flow to the heart and brain by using synchronized lower extremity couterpulsation. The novel approach is also designed to reduce or eliminate the need for potentially harmful exogenous vasopressor therapies. To provide prolonged effective prolonged resuscitation, three core technologies will be combined into one device. They are: i) Active compression decompression (ACD) CPR with a pneumatic sternal compression device. ii) A means to provide intrathoracic pressure regulation coupled with a means to provide positive pressure ventilation. iii) Lower extremity counterpulsations (LECP) with a pneumatically driven shock-trousers-like device linked to the ACD CPR device. The LECP will be synchronized to inflate and compress the lower limbs during the decompression phase of the chest compression - decompression cycle. These 3 core technologies will be coordinated and controlled electronically to enhance cardiac preload, forward blood flow to the brain, and minimize intracranial resistance to cerebral perfusion. This unique combination of non-invasive mechanisms promises to provide a means to provide prolonged normal blood circulation until definitive care, such as coronary revascularization, can be provided in a controlled manner. The three specific aims of this research proposal are: 1) design and build a prototype non-invasive circulatory support device for the treatment of cardiac arrest to provide normal circulation to the heart and brain, 2) coordinate and test the different configurations of the CPR device system components in an animal model to maximize vital organ perfusion pressures and blood flow, and 3) demonstrate proof of concept that use of the novel CPR device will result in normal circulation for at least one hour of prolonged CPR, effective defibrillation, and 24-hour neurological-intact survival. Data from the sponsor's laboratory and from other laboratories have shown that prolonged CPR is feasible if circulation to the heart and brain during CPR and post-resuscitation care are optimized. The proposed device development and the proposed paradigm shift promises to provide a fundamental change in our understanding and ultimately clinical approach for the vast majority of patients, both young and old, who cannot be resuscitated with current basic and advanced life support techniques. PUBLIC HEALTH RELEVANCE: The goal of this SBIR phase 1 application is to further develop a comprehensive and novel extracorporeal circulatory assist device to normalize blood flow during cardiac arrest and to non- invasively provide adequate circulation for prolonged periods of time allowing for transport of patients to the hospital where they can receive more definite therapies. The device is designed to harness the intrathoracic pump mechanism during CPR to provide sufficient forward flow, to refill the heart to maintain normal blood pressures, and to lower intracranial pressures in the absence of exogenous vasopressor therapy. To provide prolonged effective prolonged resuscitation, three core technologies will be combined into one device. They are: i) Active compression decompression (ACD) CPR with a pneumatic sternal compression device. ii) A means to provide intrathoracic pressure regulation coupled with a means to provide positive pressure ventilation. iii) Lower extremity counterpulsations (LECP) with a pneumatically driven shock-trousers-like device linked to the ACD CPR device. The LECP will be synchronized to inflate and compress the lower limbs during the decompression phase of the chest compression - decompression cycle. These 3 core technologies will be coordinated and controlled electronically to enhance cardiac preload, forward blood flow to the brain, and minimize intracranial resistance to cerebral perfusion. This unique combination of non-invasive mechanisms promises to provide a means to provide prolonged normal blood circulation until definitive care, such as coronary revascularization, can be provided in a controlled manner. 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.

描述（由申请人提供）：基于新发现的在CPR期间增强循环的机制，该SBIR第1阶段应用的目的是开发一种全面且新颖的非侵入性的非体外自动化循环辅助装置，以使心脏骤停过程中的血液正常化，并在患者的时间内延长医院的时间，以提供足够的循环，以便为您提供更多的住院时间。该设备旨在利用心肺复苏期间的胸内泵机制来提供足够的向前流动，以补充心脏以保持正常的血压，以降低颅内压力，并通过使用同步的下肢同步下肢Couterpulsation来进一步增加静脉回流并将舒张期引向心脏和大脑。这种新型方法还旨在减少或消除对潜在有害外源加压剂疗法的需求。为了提供延长有效的长时间复苏，将三个核心技术合并为一个设备。它们是：i）具有气动胸骨压缩装置的主动压缩减压（ACD）CPR。 ii）一种提供胸前压力调节以及提供正压通气的方法的方法。 iii）下肢反抗（LECP），其带有气动驱动的冲击式工具的设备与ACD CPR设备相关。在胸部压缩 - 减压周期的减压阶段，LECP将同步以膨胀和压缩下肢。这3种核心技术将通过电子方式进行协调和控制，以增强心脏预紧力，向前流向大脑，并最大程度地减少颅内耐药性对脑灌注。这种非侵入性机制的独特组合有望提供一种提供长时间正常血液循环的方法，直到可以控制的方式提供最终的护理，例如冠状动脉血运重建。 The three specific aims of this research proposal are: 1) design and build a prototype non-invasive circulatory support device for the treatment of cardiac arrest to provide normal circulation to the heart and brain, 2) coordinate and test the different configurations of the CPR device system components in an animal model to maximize vital organ perfusion pressures and blood flow, and 3) demonstrate proof of concept that use of the novel CPR device will result in normal circulation for at least one hour of长时间的CPR，有效​​的除颤和24小时神经系统的生存。发起人的实验室和其他实验室的数据表明，如果在心肺复苏术和令人震惊的后护理期间对心脏和大脑的循环进行了优化，则可以进行长时间的CPR。拟议的设备开发和拟议的范式转变有望为我们的理解和最终的临床方法提供根本性的变化，并为年轻和老年人的绝大多数患者提供了临床方法，他们无法通过当前的基本和先进的生命支持技术复苏。公共卫生相关性：该SBIR第1阶段应用的目的是进一步开发一种全面的新型体外循环辅助装置，以使心脏骤停期间的血液正常化，并非侵入性地提供足够的循环，以延长时间，以便将患者运输到医院，以便他们可以接受更多确定的治疗疗法。该设备的设计目的是利用心肺复苏术期间的胸腔泵机制，以提供足够的前向流动，以补充心脏以保持正常的血压，并在没有外源加压剂治疗的情况下降低颅内压力。为了提供延长有效的长时间复苏，将三个核心技术合并为一个设备。它们是：i）具有气动胸骨压缩装置的主动压缩减压（ACD）CPR。 ii）一种提供胸前压力调节以及提供正压通气的方法的方法。 iii）下肢反抗（LECP），其带有气动驱动的冲击式工具的设备与ACD CPR设备相关。在胸部压缩 - 减压周期的减压阶段，LECP将同步以膨胀和压缩下肢。这3种核心技术将通过电子方式进行协调和控制，以增强心脏预紧力，向前流向大脑，并最大程度地减少颅内耐药性对脑灌注。这种非侵入性机制的独特组合有望提供一种提供长时间正常血液循环的方法，直到可以控制的方式提供最终的护理，例如冠状动脉血运重建。如果该计划成功，新的复苏系统有可能使每年在美国医院外发生的400,000例猝死患者复苏。该估计并未考虑到每年内部发生心脏猝死的患者数量几乎相等的。