Development of an automated Needle Decompression Device

Tension pneumothorax (PTX) is the presence of air between the parietal pleural and visceral pleural, and most often occurs as a result of blunt or penetrating thoracic trauma. Left untreated, the accumulation of air in the pleural cavity shifts the mediastinum leading to an immediate and life?threatening emergency. Creare is developing a self-contained device that significantly simplifies diagnosis and treatment of a PTX by reliably and rapidly automating needle decompression. Our approach leverages an array of Creare?developed technologies and off?the?shelf products to form an integrated system. In Phase II, we developed a prototype system and successfully evaluated the effectiveness of our diagnostic PTX algorithms and the automated needle decompression features of our device. In the proposed sequential Phase II, we will refine the device for human use, finalize our diagnostic algorithms, and will evaluate their effectiveness. In Phase III, we will commercialize the technology and obtain FDA clearance.