Non-Invasive Pneumothorax Detector

Period of Performance: 05/01/2009 - 04/30/2011

$782K

Phase 2 SBIR

Recipient Firm

Electrosonics Medical Inc.
1771 E 30TH ST, 1771 E 30TH ST
Cleveland, OH 44114
Principal Investigator

Abstract

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.