SBIR-STTR Award

Non-Invasive Pneumothorax Detector
Award last edited on: 6/22/12

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$4,008,045
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Frank P Difilippo

Company Information

Electrosonics Medical Inc (AKA: Biomec Inc~PneumoSonics Inc)

1771 East 30th Street
Cleveland, OH 44114
   (216) 357-3310
   info@elecsonmed.com
   www.elecsonmed.com
Location: Multiple
Congr. District: 11
County: Cuyahoga

Phase I

Contract Number: 1R43HL065125-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2000
Phase I Amount
$121,424
Pneumothorax, while easily treatable, can become life-threatening if not detected at an early stage. Current devices for diagnosing pneumothorax (chest x-ray, chest CT scan, and stethoscope) are impractical for emergency squads or chaotic trauma care situations. A portable handheld pneumothorax detector that is inexpensive, accurate, and non-invasive would be very attractive commercially. We propose in Phase I to build and test such a prototype device based on micropower impulse radar (MIR) technology. A MlR device fulfills the above technical requirements for trauma care environments and would be ideal as a pneumothorax detector. In Phase I, we will test the device using phantom models and animal models to verify its efficacy. We will also investigate human factors to develop an appropriate design for field use, and we will evaluate the operating characteristics of the device. In Phase II, we will build an optimized handheld device and validate the technique on human subjects. Proposed Commercial Applications: A handheld inexpensive pneumothorax detector will be commercially attractive to emergency medical personnel and trauma clinicians. With further development, the device may be tuned to detect other trauma conditions, such as hematoma and hemorrhagic stroke.

Phase II

Contract Number: 2R44HL065125-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2002
(last award dollars: 2009)
Phase II Amount
$3,886,621

Pneumothorax, while easily treatable, can become life threatening if not detected at any early stage. Current methods for diagnosing pneumothorax (chest x-ray, chest CT scan) are not possible for emergency squads and not practical for long-term monitoring of critical care patients. A portable handheld pneumothorax detector that is inexpensive, accurate, and non-invasive therefore would be very attractive. In Phase I, we investigated the feasibility of such a device, based on micropower impulse radar (MIR) technology. In animal studies (swine model), we are determined that pneumothorax as small as 30 ml were clearly detectable by the MIR device. This level of detection is important for the feasibility, since it is below the threshold of clinical significance. In Phase II, we propose to further optimize the MIR characteristics of the device and the signal algorithms. We will then acquire scans on human subjects to confirm the correlation of the MIR measure to the chest x-ray, which is the present standard of care. After finalizing the device parameters, we will continue with device development, miniaturization, and packaging. This research will result in a design ready for commercialization that fulfills the need for a non- invasive pneumothorax detector. PROPOSED COMMERCIAL APPLICATIONS: A handheld inexpensive pneumothorax will be commercially attractive to emergency medical personnel and trauma clinicians. Also, it would be useful for patient monitoring in critical care units. The combined market for these applications if very large. With further development, the device may be tunable to detect other trauma conditions, such as hemotoma and hemorrhagic stroke.

Thesaurus Terms:
biomedical equipment development, diagnosis design /evaluation, noninvasive diagnosis, pneumography, pneumothorax disorder, radiowave radiation, respiratory disorder diagnosis diagnosis quality /standard, miniature biomedical equipment, patient monitoring device, portable biomedical equipment clinical research, human subject