Intragastric device for treating obesity

Abstract

An apparatus and method comprising at least one intragastric member or artificial bezoar made of a digestive-resistant or substantially indigestible material that is introduced into a gastric lumen of a mammal for the treatment of obesity. The intragastric member or artificial bezoar is typically at inserted into the gastric lumen in a partially compacted configuration, whereby it is then manipulated into, or allowed to assume, a second expanded configuration sufficiently large to remain within the reservoir of the stomach during normal activities and not be passed through the pylorus into the intestines. In animals, the present invention has been found to be effective in achieving weight loss over a several month period, while being easy to place and retrieve.

1 . An intragastric device for the treatment of obesity, the intragastric device comprising a digestive-resistant material that is expandable from a first configuration to a second configuration, the first configuration being sufficiently small to permit introduction of said intragastric device into a gastric lumen of a mammal, the second configuration being sufficiently large to prevent said intragastric device from passing through the mammal's pylorus, wherein said intragastric device is configured to function as an artificial bezoar, and further wherein said digestive-resistant material has been one of folded, gathered, bundled, tied, collected, manipulated and organized to form a volume displacing mass in the second configuration.  
   
   
       2 . The intragastric device according to  claim 1  wherein said digestive-resistive material comprises one or more elements selected from the group consisting of plastic, nylon, polyesters, polyurethanes, polyethylenes, polyamides, silicone and biocompatible polymers to which food will generally not adhere.  
   
   
       3 . The intragastric device according to  claim 1  wherein said digestive-resistive material comprises one or more elements selected from the group consisting of high-density polyethylene, low-density polyethylene, fluorinated ethylene propylene and ethylene vinyl acetate copolymer.  
   
   
       4 . The intragastric device according to  claim 1  wherein the digestive-resistant material has a resilience which is biased towards the second configuration.  
   
   
       5 . The intragastric device according to  claim 1  wherein said digestive-resistant material comprises a continuous strip of material that has been folded to form a plurality of loops, said plurality of loops being connected together in the second configuration to form the volume displacing mass, the mass having a shape suggestive of a butterfly or bow-tie.  
   
   
       6 . The intragastric device according to  claim 5  wherein the continuous strip of material is folded to form a plurality of bundles in the first configuration, each of said bundles comprising a plurality of loops connected together to form a shape suggestive of a butterfly or bow-tie, and wherein said plurality of bundles are connected together in the second configuration to form the volume displacing mass.  
   
   
       7 . The intragastric device according to  claim 6  wherein each of the bundles is introduced into the gastric lumen of the mammal separately.  
   
   
       8 . (canceled)  
   
   
       9 . (canceled)  
   
   
       10 . (canceled)  
   
   
       11 . (canceled)  
   
   
       12 . The intragastric device according to  claim 1  wherein said digestive-resistant material comprises a plurality of strips of material that have been connected together in the second configuration to form the volume displacing mass, the mass having a shape suggestive of a butterfly or bow-tie.  
   
   
       13 . The intragastric device according to  claim 12  wherein the plurality of strips of material have been connected together to form a plurality of bundles in the first configuration, each of said bundles comprising a plurality of strips of material connected together to form a shape suggestive of a butterfly or bow-tie, and wherein said plurality of bundles are connected together in the second configuration to form the volume displacing mass.  
   
   
       14 . The intragastric device according to  claim 13  wherein each of the bundles is introduced into the gastric lumen of the mammal separately.  
   
   
       15 . (canceled)  
   
   
       16 . (canceled)  
   
   
       17 . (canceled)  
   
   
       18 . (canceled)  
   
   
       19 . The intragastric device according to  claim 1  wherein said digestive-resistant material comprises a sheet of material that has been folded or pleated in the second configuration to form the volume displacing mass, the mass having a shape suggestive of a butterfly or bow-tie.  
   
   
       20 . (canceled)  
   
   
       21 . The intragastric device according to  claim 1  wherein said digestive-resistant material comprises a continuous thread of nylon that has tied in the second configuration to form a ball-like volume displacing mass.  
   
   
       22 . The intragastric device according to  claim 21  wherein the continuous thread of nylon is tied to form a plurality of ball-like masses in the first configuration, and wherein said plurality of ball-like masses are connected together in the second configuration to form the volume displacing mass.  
   
   
       23 . The intragastric device according to  claim 22  wherein each of said bundles is introduced into the gastric lumen separately.  
   
   
       24 . (canceled)  
   
   
       25 . (canceled)  
   
   
       26 . (canceled)  
   
   
       27 . (canceled)  
   
   
       28 . (canceled)  
   
   
       29 . (canceled)  
   
   
       30 . (canceled)  
   
   
       31 . (canceled)  
   
   
       32 . The intragastric device according to  claim 1  wherein the digestive-resistant material is distributed throughout the mass in the second configuration.  
   
   
       33 . The intragastric device according to  claim 32  wherein void spaces are distributed throughout the mass in the second configuration, the void spaces allowing the passage of gastric fluid into or through the intragastric device.  
   
   
       34 . The intragastric device according to  claim 32  wherein the mass comprises a substantially homogeneous cross-section.  
   
   
       35 . The intragastric device according to  claim 1  wherein the digestive-resistant material comprises a surface having a first contact point and a second contact point, the first contact point being spaced apart from the second contact point in the first configuration, the first contact point being in contact with the second contact point in the second configuration.  
   
   
       36 . The intragastric device according to  claim 1  wherein the digestive-resistant material comprises a substantially planar material.  
   
   
       37 . The intragastric device according to  claim 1  wherein the digestive-resistant material comprises an elongate material having a length that is substantially longer than its width or thickness.  
   
   
       38 . The intragastric device according to  claim 1  wherein the volume displacing mass comprises a flexible or dynamic shape that conforms to the gastric lumen of the mammal.  
   
   
       39 . The intragastric device according to  claim 1  wherein the volume displacing mass is free-floating within the gastric lumen of the mammal.  
   
   
       40 . The intragastric device according to  claim 1  wherein the digestive-resistant material is substantially non-elastic.  
   
   
       41 . The intragastric device according to  claim 1  wherein the digestive-resistant material is substantially non-expandable.  
   
   
       42 . The intragastric device according to  claim 1  wherein the digestive-resistant material is substantially non-inflatable.  
   
   
       43 . The intragastric device according to  claim 1  wherein a coupling mechanism is provided to one of fold, gather, bundle, tie and organize the digestive-resistant material to form the volume displacing mass in the second configuration.  
   
   
       44 . The intragastric device according to  claim 43  wherein the coupling mechanism comprises a suture, the suture binding the digestive-resistant material together to form the volume displacing mass in the second configuration.  
   
   
       45 . The intragastric device according to  claim 1  wherein the digestive-resistant material is reconfigurable from the second configuration to a third configuration while in the gastric lumen of the mammal, the third configuration having a size and shape permitting removal of digestive-resistant material from the gastric lumen of the mammal.  
   
   
       46 . The intragastric device according to  claim 45  wherein a coupling mechanism is provided to one of fold, gather, bundle, tie and organize the digestive-resistant material to form the volume displacing mass in the second configuration, and further wherein the coupling mechanism is adapted to facilitate reconfiguration of the digestive-resistant material from the second configuration to the third configuration.  
   
   
       47 . The intragastric device according to  claim 46  wherein the coupling mechanism comprises a suture, the suture binding the digestive-resistant material together to form the volume displacing mass in the second configuration, the suture being severable to facilitate reconfiguration of the digestive-resistant material from the second configuration to the third configuration.  
   
   
       48 . An intragastric device for the treatment of obesity, the intragastric device comprising a digestive-resistant non-fluid material that is manipulated from a first configuration to a second configuration, the first configuration being sufficiently small to permit introduction of said intragastric device into a gastric lumen of a mammal, the second configuration being sufficiently large to prevent said intragastric device from passing through the mammal's pylorus, wherein said digestive-resistant material is manipulated to form a three-dimensional volume in the second configuration, further wherein the digestive-resistant material is substantially distributed throughout the three-dimensional volume in the second configuration.  
   
   
       49 . An intragastric device for the treatment of obesity, the intragastric device being manipulated from a first configuration to a second configuration, the first configuration permitting introduction of said intragastric device into a gastric lumen of a mammal, the second configuration preventing said intragastric device from passing through the mammal's pylorus, wherein said intragastric device is configured to function as an artificial bezoar when in the second configuration, further wherein the intragastric device comprises a digestive-resistant material that is manipulated from the first configuration to the second configuration, the digestive-resistant material being distributed to form a volume-displacing substantially homogeneous mass in the second configuration.  
   
   
       50 . An intragastric device for the treatment of obesity, the intragastric device being manipulated from a first configuration to a second configuration, the first configuration comprising a first shape that is sufficient to permit introduction of said intragastric device into a gastric lumen of a mammal, the second configuration comprising a second shape that is sufficient to prevent said intragastric device from passing through the mammal's pylorus, wherein said intragastric device is configured to function as an artificial bezoar when in the second configuration, further wherein the intragastric device comprises a digestive-resistant non-fluid material that is gathered upon itself in the second configuration to form a volume-displacing mass, the mass comprising a distribution of said digestive-resistant non-fluid material.  
   
   
       51 . An intragastric device for the treatment of obesity, the intragastric device comprising one or more intragastric members comprising a digestive-resistant material and being deployable in a first configuration sized for introduction into the stomach of a mammal, wherein said one or more intragastric members are organizable upon deployment within said stomach to form a mass of said digestive-resistant material having a second configuration defining a volume effective to substantially reduce the available reservoir within said stomach, said mass of digestive-resistant material being further configured to prevent passage through the pylorus of said mammal.  
   
   
       52 . The intragastric device according to  claim 51  wherein said mass of digestive-resistant material includes adaptations for facilitating a third configuration of said mass while within said stomach, said third configuration having a size and shape permitting removal of digestive-resistant material from said stomach.  
   
   
       53 . The intragastric device according to  claim 52  wherein said adaptations comprises a suture that binds said mass of digestive-resistant material in the second configuration, further wherein said suture is severed to facilitate the third configuration of said mass.