Mechanical Airway Support Device to Treat Obstructive Sleep Disordered Breathing

描述（由申请人提供）：本研究的长期目标是开发和商业化一种新型设备，提供机械气道支持来治疗阻塞性睡眠呼吸障碍（SBD）。研究人员发明并制造了一种不需要电力的机器，并承诺为许多SDB患者降低气道正压的成本。机器储存来自呼气的动能作为势能对抗阻力，并将其转换回动能和吸入时的持续压力。在探索了许多设计之后，一种全新而独特的方法展示了这种颠覆性技术的前景，但也突出了需要额外工程的关键领域。现在提出的工作将把一个引人注目的理论机会转化为一个有效的原型，可以在人类志愿者身上进行测试。百分之几的成年人受到SDB的影响，它会导致白天嗜睡、认知功能受损、车祸、中风、高血压和心力衰竭。持续气道正压通气（CPAP）目前是一种有效但昂贵的治疗方法，在美国和世界上欠发达地区的某些情况下，对电源插座的需求也限制了CPAP的使用。自供电机械装置的潜在影响是显著的，因为CPAP的全球市场在2009年超过20亿美元，预计将增长，如果机器可供许多无法负担现有技术的患者和国家使用，可能会增长得更快。建议的设备至少针对SDB患者的相当大的子集，这些患者将受益于5至12厘米水的气道正压。这个第一阶段的应用集中在工程和台架测试上。虽然目前的原型已经产生了适当的呼气PAP，但第一个目标是优化吸入过程中稳定返回充分加压的空气。成功将被定义为足够的吸气压力从吸气持续时间的65%（目前）扩展到100%。平均吸气压力至少为平均呼气压力的70%。第二个目标是最大限度地减少多个所需阀门的压力降，目前每个阀门的平均吸入压力降低了0.5厘米。成功的定义是每个阀门的压降小于0.5厘米。第三个目标是开发一种面罩，最大限度地减少泄漏和死区，并为任何过高或负压提供安全阀。成功的定义是在实验室测试中基本上为零泄漏，并将增加的死区减少到20ml或更少。这些目标将证明可行性，这是SBIR第一阶段拨款的关键目标，并在SBIR第二阶段申请中产生一个准备进行人体测试的原型。鉴于SDB在全球范围内的流行、后果和治疗挑战，该项目具有巨大的潜在影响。这项正在申请专利的技术是完全新颖和高度创新的。研究团队在呼吸生物医学创新、睡眠医学和商业化方面具有专业知识，是成功执行该项目的理想人选。

DESCRIPTION (provided by applicant): The long range goal of this research is to develop and commercialize a novel device that provides mechanical airway support to treat obstructive sleep disordered breathing (SBD). The investigators invented and fabricated a machine that requires no electricity and promises to reduce the cost of positive airway pressure for many SDB patients. The machine stores kinetic energy from exhalation against resistance as potential energy, and converts this back to kinetic energy and continued pressure during inhalation. After exploration of many designs, a totally new and unique approach demonstrates the promise of this disruptive technology but also highlights areas of critical need for additional engineering. The work now proposed will translate a compelling theoretical opportunity into an effective prototype that can be tested with human volunteers. Several percent of adults are affected by SDB, which can lead to daytime sleepiness, impaired cognitive functioning, automobile accidents, stroke, hypertension, and heart failure. Continuous positive airway pressure (CPAP) is currently an effective but expensive treatment, and the need for an electric outlet also limits use of CPAP in some situations in the U.S., and in less developed areas of the world. The potential impact of a self-powered mechanical device is significant, as the global market for CPAP was over $2 billion in 2009, is expected to grow, and potentially could grow faster if a machine were available for the many patients and countries that cannot afford current technology. The proposed device targets at minimum the sizeable subset of SDB patients who would benefit from positive airway pressure at 5 to 12 cm of water. This Phase I application focuses on engineering and bench testing. Although appropriate expiratory PAP is already generated by the current prototype, the first aim is to optimize steady return of adequately pressurized air during inhalation. Success will be defined by extension of adequate inspiratory pressure from 65% (currently) to 100% of the duration of inspiration. Average inspiratory pressure will be at least 70% of average expiratory pressure. The second aim is to minimize pressure drops across multiple required valves that presently reduce average inspiratory pressure by 0.5 cm of water per valve. Success will be defined by a pressure drop that is less than 0.5 cm of water per valve. The third aim is to develop a mask that minimizes leaks and dead space, and provides safety valves for any excessive or negative pressure. Success will be defined by essentially zero leak in laboratory testing, and by reduction of added dead space to 20 mL or less. These aims will prove feasibility, the key objective for an SBIR Phase I grant, and produce a prototype ready for human testing in a Phase II SBIR application. This project offers substantial potential impact given the prevalence, consequences, and treatment challenges posed by SDB worldwide. The patent-pending technology to be employed is completely novel and highly innovative. The investigative team, with demonstrated expertise in respiratory biomedical innovation, sleep medicine, and commercialization, is ideally positioned to execute this project successfully.