This Small Business Innovation Phase I Research project will support development and testing of a novel medical technology to replace gallbladder surgery with a minimally invasive solution. Gallstone disease affects over 20 million Americans and carries a direct cost of more than $6 billion. Surgical removal of the organ is currently the only definitive treatment for symptomatic gallstone disease and many patients are unwilling or unfit for surgery. If successful, this project will result in a validated device ready for use in animal studies in SBIR Phase II as a critical step towards clinical studies in human subjects.
The broader impact/commercial potential of this project is in addressing a critical and unmet need in management of gallstone disease ? preventing recurrent attacks without the need for general anesthesia and surgery while preserving organ function. Symptomatic gallstone disease presents acutely and often requires urgent if not emergent intervention. Patients are referred for surgery from their primary care provider or the emergency room. With such a large referral base, scheduling logistics and medical co-morbidities delay or prevent surgery in many patients. Without definitive treatment, recurrence is common and especially dangerous in cases of acute cholecystitis or pancreatitis. Commercialization of this novel percutaneous device will also provide a significant economic benefit to the healthcare system by reducing the number of surgical procedures, the number of repeat admissions in patients who cannot have surgery, and increasing the quality of life of patients.
The gallbladder stores bile produced by the liver which is released into the small intestine to aid in the digestion of fats. Gallstones form as cholesterol and other solids precipitate out of the concentrated bile stored in the gallbladder. 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 surgery is not without risks – complications can occur from general anesthesia or the surgical procedure, and post-operative pain and digestive disorders are common. We have invented an implantable device contained within the gallbladder to prevent stones from reaching the outlet. The outlet and duct remain patent and bile flow is unrestricted. The device is delivered to the gallbladder through a catheter passed through the skin and abdomen using medical imaging. The procedure is quick and requires only local anesthesia, making it safe for elderly and sick patients. With support from a NSF SBIR Phase I award, we developed prototype devices which fit in a catheter less than 2 mm in diameter and can anchor the implant securely inside the gallbladder. Preliminary testing has shown that the device is both biocompatible and mechanically durable. Phase I development has been an important and exciting step towards helping a large population of patients with symptomatic gallstone disease (approximately 1.3 million annually in the U.S.) who cannot tolerate or prefer to avoid surgery.
