Methods, devices, and systems for obesity treatment
In one aspect, a gastric balloon structure includes multiple isolated non-concentric inflatable chambers and a valve system for introducing fluid into each chamber, where the structure assumes, upon inflating, a curved shape conforming to a natural three-dimensional kidney shape of the gastric cavity.
1. An obesity treatment system comprising:
two expandable balloons, wherein each balloon of the two expandable balloons comprises
an inflation valve for inflating the respective balloon with one or more gasses, and
a wall comprising at least two layers, wherein a first layer of the at least two layers includes an elastic material,
the obesity treatment system is configured for delivery via an esophagus of a patient in an uninflated state and inflation via an inflation catheter while situated in a stomach of the patient, and
upon inflation, each balloon of the two expandable balloons is configured to occupy a respective volume in the stomach of the patient;
wherein, after inflating each balloon of the two expandable balloons with the one or more gasses,
the obesity treatment system is configured to float freely within the stomach of the patient without exerting pressure at any point in the stomach sufficient to cause ulceration and without occupying a volume immediately surrounding a pyloric valve such that the obesity treatment system leaves the pyloric valve unobstructed, and
the two expandable balloons are configured to be arranged adjacent one another aligned in a manner conforming to a natural three-dimensional geometry of the stomach such that each of the two expandable balloons abuts a wall of at least one of a greater and a lesser curvature of the stomach and the obesity treatment system abuts the wall of each of the greater and the lesser curvature of the stomach.
2. The obesity treatment system of claim 1 , wherein a respective fluid volume for filling each balloon of the two expandable balloons leaves in the stomach a residual volume proximal to the obesity treatment system unoccupied by the obesity treatment system during a resting state of the stomach, wherein
the residual volume is 10 ml to 100 ml.
3. The obesity treatment system of claim 2 , wherein a first gas of the one or more gasses is nitrogen.
4. The obesity treatment system of claim 1 , wherein each of the two expandable balloons is removable through the esophagus of the patient after deflation.
5. The obesity treatment system of claim 1 , wherein the obesity treatment system is configured to maintain an inflated state volume of each of the two expandable balloons while deployed in the stomach of the patient without controlled adjustment.
6. The obesity treatment system of claim 1 , wherein each balloon of the two expandable balloons has a major dimension, not including connection of the inflation catheter, no larger than two centimeters prior to inflation.
7. The obesity treatment system of claim 1 , wherein the inflation valve comprises a self-sealing one-way valve.
8. A space-occupying balloon system for obesity treatment, comprising:
two inflatable gastric balloons and, each balloon of the two inflatable gastric balloons comprising
a wall including two or more layers, wherein a first layer of the two or more layers is formed from an elastic material, and
a respective inflation lumen, wherein,
prior to the inflation via the inflation lumen, each balloon of the two inflatable gastric balloons has a major dimension no larger than two centimeters, and
after the inflation, the two inflatable gastric balloons are configured to be arranged along the gastric cavity to abut against a wall of one of a greater and a lesser curvature of the gastric cavity of a patient such that the space-occupying balloon system abuts the wall of each of the greater and the lesser curvature of the stomach;
wherein the space-occupying balloon system is configured for delivery via an esophagus of the patient and inflation with at least one gas after placement within the gastric cavity of the patient; and
wherein each balloon of the two inflatable gastric balloons is configured to float untethered within the gastric cavity of the patient within a first volume of the gastric cavity distal of a second volume of the gastric cavity proximal a pyloric valve such that the space-occupying balloon system leaves the pyloric valve unobstructed.
9. The space-occupying balloon system of claim 8 , wherein the two are more layers of the wall are bonded to one another.
10. The space-occupying balloon system of claim 8 , wherein a first layer of the two or more layers of the wall comprises a polyethylene material.
11. The space-occupying balloon system of claim 8 , wherein the at least one gas comprises nitrogen.
12. The space-occupying balloon system of claim 8 , wherein the two inflatable gastric balloons are removable through the esophagus of the patient after deflation.
13. The space-occupying balloon system of claim 8 , wherein each inflation lumen comprises a self-sealing one-way valve.
14. An obesity treatment system, comprising:
two expandable balloons, each balloon of the two expandable balloons comprising
a means for receiving and retaining one or more gasses delivered via an inflation catheter from an external pressurized fluid source, and
a wall including two or more layers, wherein a first layer of the two or more layers is formed from an elastic material; and
a means for conforming the obesity treatment system, in an inflated state, to a curvature of a natural three-dimensional geometry of a stomach of a patient;
wherein the obesity treatment system is configured for delivery via an esophagus of a patient in an uninflated state, wherein,
upon inflation, each balloon of the two expandable balloons is configured to occupy a respective volume in the stomach of the patient while avoiding a volume proximate a pyloric valve such that the obesity treatment system is configured to leave the pyloric valve unobstructed, wherein
each balloon of the two expandable balloons is filled with a same gas composition comprising the one or more gasses, and
after inflation, the obesity treatment system is configured to float freely within the stomach of the patient without exerting pressure at any point in the stomach sufficient to cause ulceration, wherein
the one or more gasses of the external pressurized fluid source are selected to provide buoyancy to the obesity treatment system within the stomach, and
the two expandable balloons are configured to align adjacent one another in the stomach, such that each of the two expandable balloons abuts a wall of at least one of a greater and a lesser curvature of the stomach and the obesity treatment system abuts the wall of each of the greater and the lesser curvature of the stomach.
15. The system of claim 14 , wherein the means for receiving and retaining the one or more gasses comprises a self-sealing one-way valve.
16. The system of claim 14 , wherein a first gas of the one or more gasses is nitrogen.
17. The system of claim 14 , wherein the obesity treatment system is configured to maintain an inflated state volume of each of the two expandable balloons while deployed in the stomach of the patient without controlled adjustment.
18. The system of claim 14 , wherein each balloon of the two expandable balloons has a major dimension no larger than two centimeters prior to inflation.