Project Description: 

Each year thousands of individuals are affected by gallstone disease in the USA. Stones originating from the gallbladder will sometimes travel out and obstruct the bile duct, causing severe inflammation and pain. Management of these stones are typically done in one of two ways: endoscopic retrograde cholangiopancreatography (ERCP) or laparoscopic common bile duct exploration (lap CBDE). In lap CBDE, an incision is made in the cystic duct and the stones are extracted retrograde or flushed through into the small intestine. In ERCP, a long endoscopic tube is passed into the mouth to the small intestine where the stones are then pulled out. Recently, there has been a trend in performing the ERCP due to its higher success rate because, unlike lap CBDE, the sphincter is widened, allowing for the retrieval of larger stones. The problem with ERCP is that it requires a second operation to remove the gallbladder and a gastroenterologist specialist, whose availability varies greatly depending on the hospital. This indicates a major opportunity to improve lap CBDE, which is where our team, the Rolling (gall)Stones comes in. Building off the standard balloon catheter, we have developed a multi-lumen dual balloon catheter, called the McJagger, that can dilate the sphincter and occlude the bile duct to increase the success of gallstone removal. In the USA, roughly 400,000 individuals need treatment for gallstones, and this market is expected to grow at a compound annual growth rate of 6.5%. We also expect greater revenue to be generated due to the baseline cost for lap CBDE being ~$800 versus the ~$500 for ERCP. Ultimately, this device would be a substantial asset to both surgeons and patients by accomplishing its goal to remove stones at a high success rate while eliminating the need for a second operation.