Devices and systems for gastric volume control

Abstract

A gastric balloon includes a scaffold structure, one or more internal inflatable compartments within the scaffold structure, and one or more inflatable bladders formed over the space-filling compartment. The gastric balloon may be deployed transesophageally using a gastroscope and is inflated in situ, preferably using a combination of liquid and gas inflation media.

1 . A gastric balloon positionable within the gastric cavity above the pylorus, said balloon having a constrained configuration that can be introduced into the gastric cavity and a deployed configuration that assumes an overall space-filling geometry with a curved longitudinal axis to maintain the distended shape of the gastric cavity in the feeding state, said balloon comprising:
 two or more inflatable compartments held in place adjacent to each other and together defining the space-filling geometry of the balloon in the deployed configuration, and   a valve structure coupled to one or more of said inflatable compartments, said valve structure allowing fluids to enter the compartment(s) and preventing said fluids from exiting such compartment(s); and   one or more filling tubes detachably coupled to one or more said valve structures through which fluids are delivered into the compartments from outside the body for deployment, and   wherein each of said compartments has an individual volume such that, after the deflation of any single compartment, the collective volume and dimensions of the balloon including the remaining inflated compartments and the valve structures prevent the balloon from passing through the pylorus.   
   
   
       2 . A gastric balloon as in  claim 1 , wherein the geometry of the balloon in the constrained configuration can be introduced transorally into the gastric cavity. 
   
   
       3 . A gastric balloon as in  claim 1 , wherein at least one of the filling tubes is coupled to a single valve structure and its associated compartment and fluid is delivered through the said filling tube only to such compartment. 
   
   
       4 . A gastric balloon as in  claim 1 , wherein at least two of the said valve structures are components of a joint filling assembly which couples a single filling tube to the plurality of said compartments. 
   
   
       5 . A gastric balloon as in  claim 4 , wherein the said filling assembly coupled to a single filling tube permits a user to selectively inflate at least two compartments. 
   
   
       6 . A gastric balloon as in  claim 1 , wherein the said compartments are held in place adjacent to each other and attached to another by at least one structure external to the compartments. 
   
   
       7 . A gastric balloon as in  claim 6 , wherein the said structure comprises a tubular structure. 
   
   
       8 . A gastric balloon as in  claim 7 , wherein the tubular structure comprises at least a portion of a filling assembly or a portion of a valve structure. 
   
   
       9 . A gastric balloon as in  claim 6 , wherein the said structure encloses an interior, wherein the at least two inflatable structures are constrained within the enclosed interior. 
   
   
       10 . A gastric balloon as in  claim 6 , wherein the said structure is flexible. 
   
   
       11 . A gastric balloon as in  claim 6 , wherein the said structure is formed from a mesh or fabric. 
   
   
       12 . A gastric balloon as in  claim 6 , wherein at least a portion of the said structure is non-collapsible in order to prevent passage through the pylorus. 
   
   
       13 . A gastric balloon as in  claim 1 , wherein the said compartments are held in place adjacent to each other by sharing at least part of a common wall. 
   
   
       14 . A gastric balloon as in  claim 1 , wherein the said compartments are held in place adjacent to each other by fastening the wall of a compartment to another at one or more points. 
   
   
       15 . A gastric balloon as in  claim 1 , wherein the said compartments are filled with two or more compressible and incompressible fluids. 
   
   
       16 . A gastric balloon having a deployed configuration that is positionable in the stomach above the pylorus, said balloon comprising:
 at least two compartments, each said compartment being at least partly filled with a compressible or incompressible fluid in the deployed configuration, and   one or more markers disposed within at least two of the said compartments, wherein each of the said markers provides a detectable signal upon a compromise of structural integrity of the compartment,   wherein in the event of a structural failure of a compartment with a marker, such a compartment breach can be detected and in the event of the structural failure of two or more compartments with different markers, more than one compartment breach can be detected.   
   
   
       17 . A gastric balloon as in  claim 16 , wherein each of said compartments having individual volumes such that, after the deflation of any single compartment, the collective volume and dimensions of the balloon prevents it from passing through the pylorus. 
   
   
       18 . A gastric balloon as in  claim 16 , wherein a marker is an electrical sensor which is capable of transmitting a detectable electronic or wireless signal. 
   
   
       19 . A gastric balloon as in  claim 16 , wherein a marker is a chemical substance detectable upon excretion, secretion, exhalation, or regurgitation. 
   
   
       20 . A gastric balloon as in  claim 16 , wherein the chemical markers are different for each compartment. 
   
   
       21 . A gastric balloon as in claim  116 , wherein the chemical markers are the same but different in composition or concentration. 
   
   
       22 . A gastric balloon as in  claim 16 , wherein the said marker is disposed in the interior of the compartment. 
   
   
       23 . A gastric balloon as in  claim 16 , wherein the said marker is disposed in a structure surrounding the compartment. 
   
   
       24 . A method to diagnose the integrity of a gastric balloon by examining at least two components of the balloon subject to structural failure, each marker being indicative of the nature, location, or extent of a failure, said method comprising:
 providing a gastric balloon having one or more markers disposed within each of the said components, each of the said markers is capable of providing a detectable signal upon a breach of structural integrity of such component distinguishable from the signal of the marker disposed within another component, and   detecting one or more signals as an indication of the failure, impending failure, or the extent of failure of the balloon.   
   
   
       25 . A method as in  claim 24 , wherein the said marker is capable of transmitting a detectable electronic or wireless signal. 
   
   
       26 . A method as in  claim 24 , wherein the said marker is exposed upon a breach of structural failure to the surrounding environment and its signal is detectable upon excretion, secretion, exhalation, or regurgitation. 
   
   
       27 . A method as in  claim 24 , wherein the said marker is released upon a breach of structural failure and its signal is detectable upon excretion, secretion, exhalation, or regurgitation. 
   
   
       28 . A method as in  claim 24 , wherein the said marker is disposed in a space that can be filled with a fluid. 
   
   
       29 . A method as in  claim 24 , wherein the said marker is disposed in a physical structure of the balloon. 
   
   
       30 . A method as in  claim 29 , wherein the said marker is disposed in the wall of a structure enclosing a space or potential space. 
   
   
       31 . A method as in  claim 29 , wherein the said marker is disposed in a valve structure. 
   
   
       32 . A method as in  claim 24 , wherein the breach of a said component is a greater compromise than that of another component to the integrity of the balloon and a signal from the marker coupled to such component indicates a greater extent of failure than that of the other component. 
   
   
       33 . A method as in  claim 32 , wherein the breach of a said component is dependent on the breach of another component.