Systems and methods for treating obesity and other gastrointestinal conditions

Abstract

Systems and methods affect tightening of the pyloric sphincter and/or serve to mediate or moderate receptive relaxation of muscles in the stomach, to treat or mitigate various physiologic conditions, such as obesity, biliary reflex, GERD, and/or Barrett's esophagus. The systems and methods may be used as either a primary treatment modality, or applied as a supplementary treatment before, during or after a primary intervention.

1 - 4 . (canceled) 
     
     
         5 . A system to treat obesity by tightening a pyloric sphincter to slow or meter the emptying of a patient's stomach, the system comprising an operative device adapted and configured, in use, to be deployed adjacent to a tissue region, at, or near the pyloric sphincter, the operative device including an expandable structure and a tissue piercing element movable from a retracted position within the expandable structure and an extended position extending outwardly from the expandable structure, and a source of treatment agent coupled to the operative element to apply the treatment agent into contact with the tissue region, the treatment agent injectable through the tissue piercing element at or near the pyloric sphincter to thereby tighten the pyloric sphincter to slow or meter emptying of the patient's stomach. 
     
     
         6 . The system according to  claim 5 , wherein the treatment agent includes at least one cytokine and/or vanilloid compound and/or tissue bulking agent. 
     
     
         7 - 8 . (canceled) 
     
     
         9 . A system to treat biliary reflux by tightening a pyloric sphincter to restrict or meter the backflow of fluids through the pyloric sphincter, the system comprising an operative device adapted and configured, in use, to be deployed adjacent to a tissue region, at or near the pyloric sphincter, the operative device including an expandable structure and a tissue piercing element movable from a retracted position within the expandable structure and an extended position extending outwardly from the expandable structure, and a source of treatment agent coupled to the operative element to apply the treatment agent into contact with the tissue region, the treatment agent injectable through the tissue piercing element at or near the pyloric sphincter to restrict or meter the backflow of fluids through the pyloric sphincter. 
     
     
         10 . The system according to  claim 9 , wherein the treatment agent includes at least one cytokine and/or vanilloid compound and/or tissue bulking agent. 
     
     
         11 - 30 . (canceled) 
     
     
         31 . The system of  claim 5 , wherein the expandable structure includes a spine with an opening formed therein for passage of the tissue piercing element. 
     
     
         32 . The system of  claim 31 , further comprising a generator for applying energy to the pyloric sphincter via the at least one tissue piercing element to create one or more lesions to thereby tighten the pyloric sphincter. 
     
     
         33 . The system of  claim 5 , further comprising a treatment agent delivery apparatus connectable to the operative device. 
     
     
         34 . The system of  claim 5 , wherein the operative device is configured for insertion through a lumen of an endoscope. 
     
     
         35 . The system of  claim 5 , further comprising multiple tissue piercing elements retractable and extendable with respect to the expandable structure. 
     
     
         36 . The system of  claim 35 , wherein the expandable structure includes a spine having a plurality of openings formed therein for passage of the tissue piercing elements. 
     
     
         37 . The system of  claim 9 , wherein the expandable structure includes a spine with an opening formed therein for passage of the tissue piercing element. 
     
     
         38 . The system of  claim 37 , further comprising a generator for applying energy to the pyloric sphincter via the at least one tissue piercing element to create one or more lesions to thereby tighten the pyloric sphincter. 
     
     
         39 . The system of  claim 9 , further comprising a treatment agent delivery apparatus connectable to the operative device. 
     
     
         40 . The system of  claim 9 , wherein the operative device is configured for insertion through a lumen of an endoscope. 
     
     
         41 . The system of  claim 9 , further comprising multiple tissue piercing elements retractable and extendable with respect to the expandable structure. 
     
     
         42 . The system of  claim 41 , wherein the expandable structure includes a spine having a plurality of openings formed therein for passage of the tissue piercing elements. 
     
     
         43 . A system to treat obesity by tightening a pyloric sphincter to slow or meter the emptying of a patient's stomach, the system comprising an operative device adapted and configured, in use, to be deployed adjacent to a tissue region, at, or near the pyloric sphincter, the operative device including a tissue piercing electrode movable from a retracted position within the expandable structure and an extended position extending outwardly from the expandable structure to apply energy to the pyloric sphincter, a generator for applying energy to the tissue piercing electrode, and a source of treatment agent coupled to the operative element to apply the treatment agent into contact with the tissue region, the treatment agent injectable through the tissue piercing element at or near the pyloric sphincter to thereby in conjunction with lesions formed by the electrode tighten the pyloric sphincter to slow or meter emptying of the patient's stomach. 
     
     
         44 . The system of  claim 43 , further comprising a plurality of tissue piercing electrodes extendable through openings in the expandable structure. 
     
     
         45 . The system of  claim 43 , further comprising a controller to govern power levels and govern the delivery of the treatment agent.