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 . (canceled) 
     
     
         2 . A method for deploying a gastric balloon structure in a patient, comprising:
 introducing the gastric balloon structure to a gastric cavity of the patient, the gastric balloon structure including
 a plurality of isolated chambers, and 
 a flexible central spine fixedly attached to both a first chamber of the plurality of isolated chambers and a second chamber of the plurality of isolated chambers and spanning a gap between the first chamber and the second chamber, wherein
 the first chamber is spaced apart from the second chamber within the gastric cavity along a curved longitudinal axis of the gastric balloon structure, and 
 each chamber of the plurality of isolated chambers has a respective fill state volume such that a collective volume of the plurality of isolated chambers remaining inflated after deflation of any single chamber of the plurality of isolated chambers prevents the gastric balloon structure from passing through the pyloric valve of the gastric cavity; 
 
   connecting an inflation lumen to the flexible central spine;   at least partially filling each chamber of the plurality of isolated chambers of the gastric balloon structure with the inflation lumen enclosed by the flexible central spine; and   after at least partially filling, disconnecting the inflation lumen from the flexible central spine, wherein the inflation lumen remains separated from the gastric balloon structure at least until removal of the gastric balloon structure from the patient;   wherein the central spine is designed to flexibly form, upon at least partially filling the chambers, the gastric balloon structure to a curved shape conforming to the natural three-dimensional kidney shape of the gastric cavity such that an outer surface of the gastric balloon structure aligns against greater and lesser curvatures of the gastric cavity.   
     
     
         3 . The method of  claim 2 , wherein the gastric balloon structure comprises a scaffold, the method further comprising expanding, while at least partially filling the plurality of isolated chambers, the scaffold to provide a fixed support geometry in the natural three-dimensional kidney shape of the gastric cavity. 
     
     
         4 . The method of  claim 3 , wherein each chamber of the plurality of isolated chambers comprises a respective inner layer, and a respective outer exoskeleton layer; and
 the respective outer exoskeleton layers of the plurality of isolated chambers in combination with the flexible central spine, form the scaffold.   
     
     
         5 . The method of  claim 4 , wherein, for each chamber of the plurality of isolated chambers, the respective inner layer is attached and adjacent to the respective outer exoskeleton layer. 
     
     
         6 . The method of  claim 4 , wherein the outer exoskeleton layers of the plurality of isolated chambers are silicone material. 
     
     
         7 . The method of  claim 2 , wherein the gastric balloon structure comprises a valve system for at least partly filling the plurality of isolated chambers, wherein
 the flexible central spine is in fluid communication with the valve system, and   the valve system comprises a respective valve structure for introducing fluid into each chamber of the plurality of isolated chambers.   
     
     
         8 . The method of  claim 7 , wherein, each respective valve structure includes at least a first valve in series with a second valve. 
     
     
         9 . The method of  claim 2 , wherein at least partially filling each chamber comprises at least partially filling each chamber with the same type of fluid. 
     
     
         10 . The method of  claim 2 , wherein the gastric balloon structure, upon inflation, rests within the gastric cavity without exerting pressure against the gastric cavity at any particular point sufficient to cause trauma to the gastric cavity lining. 
     
     
         11 . method of  claim 10 , wherein at least one of i) a type of the fluid, and ii) the respective volume of each of the plurality of isolated chambers is selected to avoid exerting pressure against the gastric cavity at any particular point sufficient to cause trauma to the gastric cavity lining. 
     
     
         12 . The method of  claim 2 , wherein at least two isolated chambers of the plurality of isolated chambers form, when in an inflated state, a cavity therebetween through which food may pass. 
     
     
         13 . The method of  claim 2 , wherein the gastric balloon structure is untethered in the gastric cavity after at least partly filling the plurality of isolated chambers. 
     
     
         14 . The method of  claim 2 , further comprising, after treating the obesity:
 deflating, within the gastric cavity, each chamber of the plurality of isolated chambers; and   removing the gastric balloon structure from the gastric cavity.   
     
     
         15 . The method of  claim 14 , wherein deflating each chamber comprises penetrating each chamber to release the fluid. 
     
     
         16 . The method of  claim 2 , wherein the gastric balloon structure is configured to provide for modulated passage of food through the gastric cavity upon inflation. 
     
     
         17 . The method of  claim 16 , wherein the gastric balloon structure is configured to leave, upon aligning the outer surface of the gastric balloon structure against greater and lesser curvatures of the gastric cavity, a) a first residual volume in the gastric cavity unoccupied by the gastric balloon structure and proximal to the gastric balloon structure for the collection of ingested food, and b) a second residual volume in the gastric cavity unoccupied by the gastric balloon structure and distal to the gastric balloon structure for active digestion. 
     
     
         18 . An obesity treatment device for deploying in a gastric cavity of a patient, comprising:
 a plurality of isolated chambers, each chamber configured for inflation by receiving a fluid through a respective valve mechanism, wherein
 the plurality of isolated chambers are non-concentric and adjacent, and 
 each chamber of the plurality of isolated chambers has a respective fill state volume such that a collective volume of the plurality of isolated chambers remaining inflated after deflation of any single chamber of the plurality of isolated chambers prevents the obesity treatment device from passing through a pyloric valve of the gastric cavity; 
   a valve system for introducing fluid into each chamber of the plurality of isolated chambers and for retaining, upon inflation, fluid in the plurality of isolated chambers, wherein the valve system comprises a respective valve structure for introducing fluid into each chamber of the plurality of isolated chambers; and   a flexible central spine fixedly attached to both a first chamber of the plurality of isolated chambers and a second chamber of the plurality of isolated chambers spanning a gap between the first chamber and the second chamber, wherein the first chamber is spaced apart from the second chamber thereby forming a cavity between the first chamber and the second chamber through which food may pass;   wherein the central spine is designed to flexibly form, upon at least partially filling the chambers, the obesity treatment device to a curved shape conforming to the natural three-dimensional kidney shape of the gastric cavity such that an outer surface of the obesity treatment device aligns against the walls of the gastric cavity.   
     
     
         19 . The obesity treatment device of  claim 18 , further comprising a scaffold configured to provide, upon inflation of the obesity treatment device, a fixed support geometry in the natural three-dimensional kidney shape of the gastric cavity. 
     
     
         20 . The obesity treatment device of  claim 19 , wherein:
 each chamber of the plurality of isolated chambers comprises a respective inner layer, and a respective outer exoskeleton layer; and   the respective outer exoskeleton layers of the plurality of isolated chambers in combination with the flexible central spine form the scaffold.   
     
     
         21 . The obesity treatment device of  claim 20 , wherein, for each chamber of the plurality of isolated chambers, the respective inner layer is attached and adjacent to the respective outer exoskeleton layer. 
     
     
         22 . The obesity treatment device of  claim 20 , wherein the outer exoskeleton layers of the plurality of isolated chambers are silicone material. 
     
     
         23 . The obesity treatment device of  claim 18 , wherein the flexible central spine is in fluid communication with the valve system. 
     
     
         24 . The obesity treatment device of  claim 18 , wherein:
 the flexible central spine is configured to releasably receive an inflation tube; and   introducing fluid into each chamber of the plurality of isolated chambers comprises delivering the fluid to the respective chamber through the inflation tube.   
     
     
         25 . The obesity treatment device of  claim 24 , wherein the flexible central spine at least partially encloses the inflation tube. 
     
     
         26 . The obesity treatment device of  claim 18 , wherein each respective valve structure comprises a first one-way valve in series with a second one-way valve. 
     
     
         27 . The obesity treatment device of  claim 18 , wherein each of the plurality of isolated chambers receives the same type of fluid. 
     
     
         28 . The obesity treatment device of  claim 18 , wherein the obesity treatment device is configured to float freely in the gastric cavity after inflation of the plurality of isolated chambers. 
     
     
         29 . The obesity treatment device of  claim 18 , wherein a diameter of the obesity treatment device is no larger than 2 centimeters prior to inflation. 
     
     
         30 . The obesity treatment device of  claim 18 , wherein the obesity treatment device is configured to leave, after at least partly filling the plurality of isolated chambers, a residual volume in the gastric cavity unoccupied by the obesity treatment device during a resting state of the gastric cavity, and wherein the residual volume is 10 ml to 100 ml. 
     
     
         31 . The obesity treatment device of  claim 18 , wherein the obesity treatment device is designed to maintain the introduced volume of fluid during obesity treatment without controlled adjustment.