SBIR Phase II: A Medical Device to Treat Gallstone Disease

This Small Business Innovation Research (SBIR) Phase II project seeks to develop a novel technology that will enable non-surgical treatment of gallstone disease. Symptomatic gallstone disease occurs when gallstones obstruct the outlet of the gallbladder and prevent the flow of bile. Obstruction can result in significant pain and if left untreated can lead to dangerous infections. The most common and effective treatment for gallstone disease today is surgical removal of the gallbladder, or cholecystectomy. Unfortunately, many patients are not eligible for surgery due to other complicating medical conditions or very old age, and the surgery itself can have complications. This project will develop a catheter-implanted device contained within the gallbladder to prevent stones from reaching the outlet. The procedure is quick and requires only local anesthesia, making it safe for elderly and sick patients. This project will finalize the design of the device, evaluate its safety in an animal study, evaluate its biocompatibility with biologic, chemical, and mechanical tests, and transfer the design to a manufacturable product. The broader impact/commercial potential of this project includes helping gallstone disease patients who are not eligible for surgery, providing an alternative for patients who prefer not to have surgery, and significantly decreasing overall healthcare costs. While gallbladder surgery is currently the standard of care for symptomatic gallstone disease, surgery is not without risks ? complications can occur from general anesthesia or the surgical procedure, and post-operative pain and digestive disorders are common. The new proposed procedure is expected to be faster and safer than the current standard of care. In addition, the proposed device enables patients to keep their gallbladders, maintaining normal digestive function. Considering the large population of patients with symptomatic gallstone disease (approximately 1.3 million annually in the U.S.), the decreased procedure time, recovery time, and overall healthcare costs could be very significant.