Non-Invasive Pneumothorax Detector

描述（由申请人提供）：气胸是胸膜腔内的空气积聚，通常是钝性创伤导致肺部分塌陷的结果。虽然气胸是很容易治疗的，但如果没有在早期发现，它可能会危及生命。目前用于诊断气胸的方法（胸部X射线、胸部CT扫描）对于急救队或战场医务人员是不可能的，并且对于重症监护患者的长期监测是不实用的。当考虑进行气升后送时，对于急救人员来说，正确诊断和治疗气胸尤其重要，因为减压可能导致气胸扩大和死亡。因此，便宜、准确和非侵入性的便携式手持式气胸检测器将是一个很大的好处。BIOMEC与劳伦斯利弗莫尔国家实验室合作，开发了基于专利微功率脉冲雷达（MIR）技术的气胸检测设备原型。该设备发射非常低功率的射频脉冲，具有非常高的频率和广泛的频谱（1-4 GHz）。由此产生的回波由极高速电路收集，并由专有软件算法进行分析。部分由第一阶段和第二阶段NIH SBIR计划资助，我们已经证明了这些设备能够准确检测两个底特律大都会医院急诊科40多名患者是否存在疑似气胸。虽然最初基于笔记本电脑进行数据收集和分析，但BIOMEC目前正在对电子设备进行集成，并将该设备与手持PDA完全连接。该器械商业化的下一步是完成小型化和与PDA的集成，完成临床研究，并向FDA申请510（k）上市许可。在这些努力的同时，BIOMEC将申请额外的专利覆盖范围，开始生产规模扩大，并确定适当的市场渠道。该设备的市场包括民用应急小组（EMT和ER工作人员）以及军事战场医务人员。长期市场包括持续监测气胸，例如心脏手术后的重症监护室。BIOMEC与民用和军用市场的医生和支持人员进行了重要的讨论，并收到了关于该设备价值和需求的非常积极的反馈。现在需要一名全职业务开发人员来开发这些渠道，以支持该器械在这些市场的商业化。手持式廉价气胸检测器将是商业上有吸引力的紧急医疗人员和创伤临床医生沿着战场医务人员。此外，它将是有用的病人监测在心胸ICU或重症监护病房。这些应用的综合市场相当大。随着进一步的发展，该设备可能能够检测其他创伤情况，如血肿和出血性中风。

DESCRIPTION (provided by applicant): Pneumothorax is an accumulation of air in the pleural cavity, often as the result of a blunt trauma causing a partial collapse of the lung. While a pneumothorax is easily treatable, it can become life threatening if not detected at an early stage. Current methods for diagnosing pneumothorax (chest x-ray, chest CT scan) are not possible for emergency squads or battlefield medics and not practical for long-term monitoring of critical care patients. It is especially important for first responders to properly diagnose and treat a pneumothorax when an airlift evacuation is considered, as the reduced pressures could result in an expansion of the pneumothorax and death. A portable handheld pneumothorax detector that is inexpensive, accurate, and non-invasive therefore would be a great benefit. Working with Lawrence Livermore National Labs, BIOMEC has developed prototype pneumothorax detection devices based on patented Micropower Impulse Radar (MIR) technology. This device emits very low power radio frequency impulses of a very high frequency and broad spectrum (1-4 GHz). The resultant echoes are collected by extremely high-speed circuitry and analyzed by a proprietary software algorithm. Funded in part by the Phase I and Phase II NIH SBIR program, we have demonstrated the ability of these devices to accurately detect the presence or absence of a suspected pneumothorax in over 40 patients at two metro-Detroit hospital emergency departments. While originally based on a laptop computer for data collection and analysis, BIOMEC is currently in the process of miniaturizing the electronics and completely interfacing the device with a handheld PDA. The next steps in commercialization of this device are to complete the miniaturization and integration with the PDA, complete the clinical study, and apply to the FDA for 510(k) clearance to market. In parallel to these efforts, BIOMEC will apply for additional patent coverage, begin manufacturing scale-up, and identify the appropriate market channels. The markets for this device include both the civilian emergency response teams (EMTs and ER staff) as well as military battlefield medics. Longer-term markets include continuous monitoring for pneumothorax, for example in an intensive care unit after cardiac surgery. BIOMEC has had significant discussions with physicians and support staff in both the civilian and military markets and received extremely positive feedback regarding the value and need for this device. A full time business development person is now required to develop these channels to support the commercialization of this device into these markets. A handheld inexpensive pneumothorax detector will be commercially attractive to emergency medical personnel and trauma clinicians along with battlefield medics. Also, it would be useful for patient monitoring in a cardio-thoracic ICU or critical care units. The combined market for these applications is quite large. With further development, the device may be able to detect other trauma conditions, such as hematoma and hemorrhagic stroke.