Method and Apparatus for Electrical Stimulation of the Pancreatico-Biliary System

Abstract

The present invention is directed to a method and apparatus for electrical stimulation of the pancreatico-biliary system. Electrode sets are placed in the pancreatico-biliary system in an arrangement that induce contractions or relaxation of the portion or whole of the pancreatico-biliary system by electrical stimulation of the surrounding tissue, muscles and nerves. The electrical stimulus is applied for periods of varying duration and varying frequency so as to produce the desired therapeutic effect, including inhibiting fat digestion or fat absorption by a patient and inducing satiety in the patient.

We claim: 
     
         1 . A method for treating a biological condition, comprising the steps of:
 arranging at least one electrode on at least one of a pancreas, a pancreatic duct, a pancreatic sphincter, a bile duct, a cystic duct, a gall bladder, a biliary sphincter, or autonomic nerves supplying the pancreas and the biliary system, and activating said electrode to provide an electrical stimulus thereto.   
     
     
         2 . The method of  claim 1  wherein said electrical stimulus modulates the secretion of pancreatic juices into the small intestine. 
     
     
         3 . The method of  claim 1  wherein said electrical stimulus modulates the secretion of bile juices into the small intestine. 
     
     
         4 . The method of  claim 1  wherein said electrical stimulus causes contraction of at least one of the pancreas, the pancreatic duct, the pancreatic sphincter, the bile duct, the cystic duct, the gall bladder, or the biliary sphincter. 
     
     
         5 . The method of  claim 1  wherein said electrical stimulus relaxes at least one of the pancreas, the pancreatic duct, the pancreatic sphincter, the bile duct, the cystic duct, the gall bladder, or the biliary sphincter. 
     
     
         6 . The method of  claim 1  wherein said electrical stimulus increases tone of at least one of the pancreas, the pancreatic duct, the pancreatic sphincter, the bile duct, the gall bladder, or the biliary sphincter. 
     
     
         7 . The method according to  claim 1  wherein the electrical stimulus is provided by a pulse generator. 
     
     
         8 . The method according to  claim 7  wherein the electrical stimulus has a frequency in the range of approximately of 1 mHz to 1 MHz. 
     
     
         9 . The method of  claim 1 , further incorporating the step of arranging at least one sensing electrode to detect a change in one or more physiological parameters. 
     
     
         10 . The method of  claim 9  wherein the physiological parameter is selected from the group consisting of esophageal peristalsis, esophageal pH, esophageal impedence, esophageal pressure, esophageal electrical activity, LES pressure, LES electrical activity, gastric peristalsis, gastric electrical activity, gastric chemical activity, gastric hormonal activity, gastric temperature, gastric pressure, gastric impedence, gastric pH, duodenal peristalsis, duodenal electrical activity, duodenal chemical activity, duodenal hormonal activity, duodenal temperature, duodenal pressure, duodenal impedence, duodenal pH, blood activity, chemical activity, hormonal activity, vagal activity, gastrointestinal neural activity, salivary chemical activity, biliary pressure, biliary electrical activity, biliary chemical activity, pancreatic pressure, pancreatic electrical activity, pancreatic chemical activity, pancreatic sphincter pressure, pancreatic sphincter electrical activity, biliary sphincter pressure, and biliary sphincter electrical activity. 
     
     
         11 . A method for treating obesity in a patient, comprising the steps of:
 arranging at least one electrode on at least one of a pancreas, a pancreatic duct, a pancreatic sphincter, a bile duct, a cystic duct, a gall bladder, a biliary sphincter, or autonomic nerves supplying the pancreas and biliary system, and activating said electrode to provide an electrical stimulus thereto, wherein said electrical stimulus is effective to inhibit at least one of fat digestion or fat absorption by said patient.   
     
     
         12 . The method of  claim 11  wherein said electrical stimulus modulates the secretion of pancreatic juices into the small intestine. 
     
     
         13 . The method of  claim 11  wherein said electrical stimulus modulates the secretion of bile juices into the small intestine. 
     
     
         14 . The method of  claim 11  wherein said electrical stimulus causes contraction of at least one of the pancreas, the pancreatic duct, the pancreatic sphincter, the bile duct, the cystic duct, the gall bladder, or the biliary sphincter. 
     
     
         15 . The method according to  claim 11  wherein the electrical stimulus is provided by a pulse generator. 
     
     
         16 . The method according to  claim 15  wherein the electrical stimulus has a frequency in the range of approximately of 1 mHz to 1 MHz and a power range of 1 mAmp to 10 Amp. 
     
     
         17 . The method of  claim 11 , further incorporating the step of arranging at least one sensing electrode to detect a change in one or more physiological parameters. 
     
     
         18 . The method of  claim 17  wherein the physiological parameter is selected from the group consisting of esophageal peristalsis, esophageal pH, esophageal impedence, esophageal pressure, esophageal electrical activity, LES pressure, LES electrical activity, gastric peristalsis, gastric electrical activity, gastric chemical activity, gastric hormonal activity, gastric temperature, gastric pressure, gastric impedence, gastric pH, duodenal peristalsis, duodenal electrical activity, duodenal chemical activity, duodenal hormonal activity, duodenal temperature, duodenal pressure, duodenal impedence, duodenal pH, blood activity, chemical activity, hormonal activity, vagal activity, gastrointestinal neural activity, salivary chemical activity, biliary pressure, biliary electrical activity, biliary chemical activity, pancreatic pressure, pancreatic electrical activity, pancreatic chemical activity, pancreatic sphincter pressure, pancreatic sphincter electrical activity, biliary sphincter pressure, and biliary sphincter electrical activity. 
     
     
         19 . The method of  claim 11  wherein said electrical stimulus increases tone of at least one of the pancreas, the pancreatic duct, the pancreatic sphincter, the bile duct, the cystic duct, the gall bladder, or the biliary sphincter. 
     
     
         20 . A device for electrical stimulation, comprising: a) a pulse generator; and
 b) at least one electrode set connected to the pulse generator wherein the electrode sets are arranged on at least one of a pancreas, a pancreatic duct, a pancreatic sphincter, a bile duct, a gall bladder, a biliary sphincter, or autonomic nerves supplying the pancreas and biliary system, such that activating said electrode is effective to modulate secretions of biliary or pancreatic juices.