Flanged gastrointestinal devices and methods of use thereof

Abstract

The present invention provides gastrointestinal devices for limiting transfer and contact of material across luminal walls along a segment of the gastrointestinal tract (e.g., at the duodenum and/or upper jejunum). Devices of the invention include a gastrointestinal sleeve, an anchor, and a flange for attachment to a luminal wall proximal to the pyloric orifice. The invention also provides methods of use associated with such gastrointestinal devices, including methods for delivery, removal, and treatment of metabolic disorders, such as type 2 diabetes, non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, obesity, and related comorbidities thereof by implanting gastrointestinal devices.

1 - 30 . (canceled) 
     
     
         31 . A method of implanting a gastrointestinal device, the method comprising:
 (a) providing a gastrointestinal device comprising:
 (i) a sleeve configured to carry fluid from its proximal end to its distal end, wherein its proximal end is configured to be at or proximal to a subjects pyloric orifice and its distal end is configured to be at or distal to the subjects duodenum; 
 (ii) an anchor connected to the sleeve, the anchor configured to be retained within a duodenal bulb; and 
 (iii) a flange positioned proximal to the anchor, the flange configured to resist distal migration of the gastrointestinal device; and 
   (b) attaching the flange to a proximally oriented luminal surface proximal to the pyloric orifice.   
     
     
         32 . A method of treating a metabolic disorder, the method comprising:
 (a) providing a gastrointestinal device comprising:
 (i) a sleeve configured to carry fluid from its proximal end to its distal end, wherein its proximal end is configured to be at or proximal to a subjects pyloric orifice and its distal end is configured to be at or distal to the subjects duodenum; 
 (ii) an anchor connected to the sleeve, the anchor configured to be retained within a duodenal bulb; and 
 (iii) a flange positioned proximal to the anchor, the flange configured to resist distal migration of the gastrointestinal device; and 
   (b) attaching the flange to a proximally oriented luminal surface proximal to the pyloric orifice.   
     
     
         33 . The method of  claim 32 , wherein the metabolic disorder is type 2 diabetes. 
     
     
         34 . The method of  claim 32 , wherein the metabolic disorder is non-alcoholic steatohepatitis (NASH). 
     
     
         35 . The method of  claim 32 , wherein the metabolic disorder is non-alcoholic fatty liver disease (NAFLD). 
     
     
         36 . The method of  claim 32 , wherein the metabolic disorder is obesity. 
     
     
         37 . The method of  claim 31 , wherein the proximally oriented luminal surface is a proximal surface of the pyloric sphincter. 
     
     
         38 . The method of  claim 31 , wherein the proximally oriented luminal surface is an antral surface of the stomach. 
     
     
         39 . The method of  claim 31 , wherein the attaching is performed endoscopically. 
     
     
         40 . The method of  claim 31 , wherein the attaching comprises transmission of a distal force from an attachment element to the proximally oriented luminal surface. 
     
     
         41 . The method of  claim 40 , wherein the attaching comprises puncturing a gastrointestinal wall. 
     
     
         42 . The method of  claim 41 , wherein the attachment element comprises a suture. 
     
     
         43 . The method of  claim 40 , wherein the attachment element comprises a staple. 
     
     
         44 . A method of removing the gastrointestinal device of  claim 31 , the method comprising:
 (a) disengaging the flange from a proximally oriented luminal surface proximal to the pyloric orifice;   (b) pulling a drawstring attached to the anchor, the drawstring configured to exert an inward radial force on a proximal portion of the anchor when pulled proximally; and   (c) retracting the anchor into a retrieval catheter.   
     
     
         45 . A method of removing the gastrointestinal device of  claim 32 , the method comprising disengaging the flange from a proximally oriented luminal surface proximal to the pyloric orifice.