Novel non-invasive device for treatment of elevated intracranial pressures

描述（由申请人提供）：尽管在休克和头部损伤患者的治疗方面取得了进展，但创伤性脑损伤和出血性休克的组合是儿童和成人在其最具生产力的年龄死亡和残疾的主要原因。据估计，美国每年有160万人头部受伤。仅在美国，这些严重伤害在生产力损失和医疗费用方面的经济后果估计每年超过1000亿美元。虽然过去二十年的研究已经导致了对多发性创伤后导致继发性神经元损伤的生理事件的更好理解，但迫切需要治疗进展。本SBIR第1阶段应用的目标是开发和评价一种新型器械，即胸内压力调节器（ITPR），旨在减少创伤性头部损伤和休克后继发性脑损伤的有害影响。该SBIR申请基于申请人的发现，即使用ITPR降低胸内压可降低颅内压，同时增加心输出量和血压。新设备被插入到患者和患者呼吸装置之间的标准呼吸回路中。它的功能是降低病人的胸内压。胸内压的降低在胸腔内相对于身体的其余部分产生真空，从而增强血液返回心脏，同时降低颅内压。本1期研究建议：a）建立一种新型胸内压力调节阀在颅内压升高和失血性休克动物中是一种有用且有效的复苏技术的概念证明，以及B）为胸内压力调节器（ITPR）系统添加一个定制的可变速率真空调节器和一个显示监视器原型。如果成功，2期研究将探讨ITPR在多发性创伤（包括创伤性脑损伤）患者中的潜在临床疗效。创伤性脑损伤每年影响数十万美国人，造成多达60，000人死亡，估计有70，000至90，000名患者患有永久性神经残疾。根据动物研究中观察到的心脏和大脑血流量增加和颅内压降低，预计使用ITPR可显著改善患者结局。如果临床效益显著，ITPR可能成为出血性休克和创伤性脑损伤患者的标准设备和治疗方法。

DESCRIPTION (provided by applicant): Despite advances in the treatment of patients with shock and head injuries, the combination of traumatic brain injury and hemorrhagic shock is the leading cause of death and disability in children and adults in their most productive years. An estimated 1.6 million head injuries occur every year in the United States. The economic consequence of these grave injuries in terms of both lost productivity and the cost of medical care is estimated at over 100 billion dollars annually in the United States alone. While the last two decades of research has resulted in a greater understanding of the physiologic events leading to secondary neuronal injury following polytrauma, therapeutic advances are desperately needed. The goal of this Phase 1 SBIR application is to develop and evaluate a novel device, the intrathoracic pressure regulator (ITPR), intended to decrease the detrimental effects of secondary brain injury following traumatic head injury and shock. This SBIR application is based upon the discovery by the applicants that decreasing intrathoracic pressures with the ITPR lowers intracranial pressures while concurrently increasing cardiac output and blood pressure. The new device is inserted into a standard respiratory circuit between the patient and a means to ventilate the patient. It functions by decreasing a patient's intrathoracic pressure. The decrease in intrathoracic pressure creates a vacuum within the thorax relative to the rest of the body, thereby enhancing blood return to the heart while simultaneously decreasing intracranial pressures. This phase 1 investigation proposes to a) establish proof of concept that a novel intrathoracic pressure regulator valve is a useful and effective resuscitation technology in animals with elevated intracranial pressures and hemorrhagic shock, and b) add a custom variable rate vacuum regulator and prototype a display monitor for the intrathoracic pressure regulator (ITPR) system. If successful, Phase 2 studies will address the potential clinical efficacy of the ITPR in patients with polytrauma including traumatic brain injury. Traumatic brain injury affects hundreds of thousands of Americans each year, accounting for as many as 60,000 deaths and an estimated 70,000 to 90,000 patients with permanent neurologic disabilities. Use of the ITPR is expected to significantly improve patient outcomes, based upon the increase in blood flow to the heart and brain and the lowering of intracranial pressures observed in animal studies. If a significant clinical benefit is demonstrated, the ITPR could become a standard piece of equipment and treatment for patients with hemorrhagic shock and traumatic brain injury.