Project Description: 

Excess fluid can fill the pericardial sac – a fibrous, protective membrane around the heart – due to a multitude of diseases, including viral infections, autoimmune diseases, and cancer. This condition is known as a pericardial effusion, and in severe cases can prevent the heart from beating as in the case of cardiac tamponade. Physicians can perform a pericardiocentesis by inserting a large 18-gauge needle through the patient’s chest and into the pericardial space to drain this fluid. However, in up to 50% of pericardiocentesis procedures, the needle unintentionally perforates the vascular heart, and 1 in 4 people die due to this complication. Complications due to myocardial perforations can extend a patient’s hospital stay by seventeen days on average, costing tens of millions of dollars in excess costs to the US healthcare system. Team Five of Hearts devised the SafeCentesis, a novel approach that allows physicians to safely access the pericardial space by mechanically entering the pericardium no more than 1cm, engaging a half-coiled needle tip for parallel insertion into the heart to reduce risk of puncture, and providing real-time feedback to signal the needle’s relative position to the heart. Our device presents a vast opportunity to save lives and create value in a market of $64 million in the United States alone. With the help of SafeCentesis, Team Five of Hearts can save weeks of prolonged, painful hospital stays and reduce costs by over $50,000 per puncture. Our device offers to save over 10,000 patients annually, which not only creates a safer environment for patients but also increases physician confidence and enables further, more advanced treatments in the pericardial space and treating other anatomical access cases.