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. We propose 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 I, we developed a preliminary design for a prototype system and demonstrated overall feasibility. In Phase II, we will develop a prototype system and will evaluate its effectiveness. In Phase III, we will validate the technology through clinical trials and will use that data to obtain FDA clearance.