Endoluminal sleeve gastroplasty

Abstract

Devices and methods of endolumenal formation of gastric sleeves are described. Some embodiments allow templating of a gastric sleeve by a gastric bougie, exposing a selected amount of tissue for suturing access, while maintaining sufficient internal working space for suturing within the template lumen.

What is claimed is: 
     
         1 . A system for gastric reshaping including:
 a bougie for shaping a portion of a stomach to receive sutures, said bougie comprising:
 a flexible wall sized and shaped to define a gastric passageway for food; 
 a plurality of spaced wall fenestrations longitudinally distributed along the flexible wall, wherein said plurality of fenestrations are configured such that vacuum applied to said fenestrations cause collapse of the stomach portion onto said bougie; 
   at least one sensor configured to sense a leak in the stomach; and   circuitry configured to receive a signal from said sensor and configured to generate an alert when a leak in the stomach is indicated by said sensor.   
     
     
         2 . The system of  claim 1 , wherein said at least one sensor is configured to detect leakage within a range of about ±0.001 bar. 
     
     
         3 . The system of  claim 1 , wherein said at least one sensor is configured to detect leakage within a range of about ±0.005 bar. 
     
     
         4 . The system of  claim 1 , wherein said sensor is configured to detect a change in one or more properties of the vacuum. 
     
     
         5 . The system of  claim 1 , wherein the change in one or more properties of the vacuum indicates a penetration through a wall of the stomach. 
     
     
         6 . The system of  claim 1 , wherein said sensor is configured to detect a change in vacuum pressure in said bougie. 
     
     
         7 . The system of  claim 6 , wherein said change in vacuum pressure indicates a potential leak in said bougie. 
     
     
         8 . The system of  claim 1 , wherein said bougie is provided with a pyloric region seal and an esophageal/cardia region seal configured to stabilize a vacuum pressure within said bougie. 
     
     
         9 . The system of  claim 1 , wherein at least one of a leak, a sudden change in pressure, and a sudden change in flow is detectable by said at least one sensor. 
     
     
         10 . The system of  claim 9 , wherein said sensor is coupled to at least one of a vacuum source and to a line to said bougie. 
     
     
         11 . The system of  claim 1 , wherein said system is configured to monitor vacuum pressure within said bougie and to send an alert indicating a change in pressure. 
     
     
         12 . The system of  claim 1 , wherein pressure in said bougie is maintainable by feedback, wherein a change in pressure and/or flow in said bougie is detectable and wherein said feedback includes transmission of an alert. 
     
     
         13 . The system of  claim 1  including a leak indicator. 
     
     
         14 . A method for gastric reshaping, said method including:
 inserting a bougie into a stomach;   applying vacuum through the bougie to collapse a portion of a stomach wall onto the bougie;   one of detecting a leak in the stomach and detecting a penetration through the stomach wall;   transmitting a signal from the sensor to indicate at least one of a leak in the stomach, a penetration through the stomach wall, and a change in the vacuum;   receiving the signal by circuitry and generating an alert if at least one of a leak in the stomach, a penetration through the stomach wall, and a change in the vacuum is indicated by the signal.   
     
     
         15 . The method according to  claim 14 , wherein said applying vacuum includes applying vacuum through a plurality of fenestrations in a wall of the bougie and receiving tissue of the stomach wall in the plurality of fenestrations. 
     
     
         16 . The method according to  claim 15 , wherein said receiving tissue includes drawing tissue from opposing sides of the stomach to the bougie wall such that the tissue wraps around the bougie and partially intrudes into the fenestrations. 
     
     
         17 . The method according to  claim 16 , including suturing the drawn tissue from the opposing sides to each other. 
     
     
         18 . The method according to  claim 17 , wherein said suturing includes piercing the drawn tissue in a non-penetrating manner which does not exit the stomach. 
     
     
         19 . The method according to  claim 17 , including viewing the tissue from within the bougie prior to said suturing.