Applicator for endoscopic treatment of biliary disease

#The invention described in this patent application addresses challenges confronted in the treatment of biliary disease. Biliary disease includes conditions affecting the gallbladder, cystic duct, and common bile duct.

#Biliary System Function and Anatomy:

#Bile is a greenish-brown digestive fluid produced by the liver 10 illustrated in FIG. 1, and is vital for the digestion of fatty foods. Bile is secreted by liver cells and collected by a network of ducts that converge at the common hepatic duct 12. While a small quantity of bile drains directly into the lumen of the duodenum 30 (the section of small intestine immediately downstream of the stomach), most travels through the common hepatic duct 12 and accumulates in the lumen of the gallbladder 14. Healthy gallbladders are pear-shaped sacs with a muscular wall that, on average, measure 10 cm in length and can store approximately 50 ml of fluid within its lumen. When fatty foods are ingested, the hormone cholecystokinin is released, which causes the gallbladder 14 to contract. Contraction of the gallbladder 14 forces bile to flow from the gallbladder 14, through the cystic duct 16, into the common bile duct 18, out the papilla 28, and finally into the duodenum 30 of the small intestine. Here, it mixes and reacts with the food that exits the stomach. The Sphincter of Oddi 26 controls secretions from the liver, pancreas 24, and gallbladder 14 into the duodenum 30 of the small intestine. The opening on the inside of the descending duodenum 30 after the Sphincter of Oddi 26 is called the major duodenal papilla 28 (of Vater). Together, the biliary ducts, the gallbladder 14, the cystic duct 16 and the common bile duct 18 comprise the biliary system (FIG. 1).

#The novel features of the invention will be set forth with particularity in any claims presented based on this application. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

#FIG. 1 illustrates an overview of the biliary system;

#FIG. 2 illustrates the biliary system with gallstones;

#Devices, systems, methods and kits provided herewith can obviate the need for a plurality of procedures, including, for example: 1) percutaneous cholecystostomy, 2) cholecystectomy, 3) percutaneous trans-hepatic cholangiography (PTHC), and 4) endoscopic retrograde cholangiopancreatography (ERCP). Additionally, disclosed treatment modalities enable treatment of a distal common bile duct 18 obstruction, e.g. secondary to pancreatic carcinoma, cholangiocarcinoma, and/or ampullary carcinoma. As will be appreciated by those skilled in the art, the conventional standard of care for treating biliary disease has been surgical removal of the gallbladder 14 and closure of the cystic duct 16. While this has proven to be an effective mechanism for permanently eliminating biliary disease and its recurrence, the present invention seeks to accomplish the same end in a less invasive and less costly way. This may be achieved by treating biliary disease without requiring the removal of the gallbladder 14. Methods and apparatus are described in this application that are intended to effectively treat biliary disease with the gallbladder 14 and cystic duct 16 left in situ by defunctionalizing the gallbladder.

#Defunctionalization of the Gallbladder:

#By treating the gallbladder in situ in such a way that the biliary disease necessitating treatment is addressed and the likelihood of recurrence is low or altogether eliminated, the need for additional treatment, e.g. cholecystectomy, may be obviated. One method for achieving these goals may be defunctionalization of the gallbladder. A gallbladder that is treated and remains in situ but is otherwise non-functional may lead to the desired result. Alternatively, for example, this goal may be achieved by altering the configuration of the gallbladder 14 in such a way that the underlying condition is addressed and prevented from recurring. The gallbladder can be accessed by any suitable mechanism including, percutaneously, endoscopically, laparoscopically, and the like. Moreover, any of the materials and substances delivered to the gallbladder can be delivered concurrently or sequentially. Delivery of substances can occur sequentially in time or the sequence of delivery can be separated by seconds, minutes, or hours.