Methods for gastric volume control

• US 20050267595A1
• Filed: 05/03/2005
• Published: 12/01/2005
• Est. Priority Date: 05/03/2004
• Status: Active Grant

• Current Assignee: Fulfillium, Inc.
• Original Assignee: Fulfillium, Inc.
• Inventors: Chen, Richard, Jones, Christopher S., Johanson, Craig A., Dauskardt, Reinhold H.
• Granted Patent: US 8,066,780 B2
• Time in Patent Office: Days
• US Class Current: 623/23.650
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0033 with more than one chamber
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2210/1053 Stomach

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.

Claims

1. A method for treating obesity in a patient, said method comprising:

introducing a gastric balloon structure comprising a scaffold and at least one inflatable space-filling compartment to the patient'"'"'s stomach;

expanding the scaffold to provide a fixed support geometry; and

at least partly filling the space-filling compartment(s) of the balloon with a compressible and/or incompressible fluid.

2. A method as in claim 1, further comprising determining the size of the stomach and selecting a gastric balloon of a proper size.

3. A method as in claim 2, wherein determining comprises visually examining the gastric cavity of the stomach through a gastroscope, externally scanning with X-rays, or externally scanning with ultrasound.

4. A method as in claim 2, wherein the size is determined while the stomach is filled with a biocompatible medium.

5. A method as in claim 4, wherein the balloon size is selected to leave an unobstructed stomach volume surrounding the sides of the device in the range from 10 cm³ to 100 cm³ after the balloon is inflated.

6. A method as in claim 1, wherein introducing comprises passing the gastric balloon in a deflated configuration into the stomach through a gastroscope or using an orogastric or nasogastric tube.

7. A method as in claim 1, wherein the balloon and/or the scaffold is/are configured so that the balloon will inflate with a curved geometry conforming to the curve of the gastric cavity.

8. A method as in claim 1, wherein the space-filling compartment(s) is/are inflated through an inflation tube removably attached to the balloon.

9. A method as in claim 8, wherein at least two separate inflatable space-filling compartments are inflated by the inflation tube.

10. A method as in claim 9, further comprising selectively inflating each of the compartments by manipulating a valve structure which directs inflation fluid to a selected compartment.

11. A method as in claim 4, wherein the space-filling compartments are filled with a mixture of compressible and incompressible fluid to control the buoyancy of the gastric balloon in the stomach.

12. A method as in claim 11, wherein the mixture of compressible and incompressible fluids is selected to provide a generally neutral buoyancy in the stomach.

13. A method as in claim 1, further comprising filling one or more external bladders attached to or over the outer surfaces of the space-filling compartments at least partially with a compressible and/or incompressible fluid.

14. A method as in claim 1, further comprising deflating all of the component structures and removing the deflated balloon from the stomach.

15. A method as in claim 4, wherein deflating comprises breaching one or more walls of each space-filling compartment(s).

16. A method as in claim 15, wherein breaching comprises severing a common wall portion of two or more space-filling compartments so that all deflate simultaneously.

17. A method as in claim 1, further comprising adjusting the fill volume of at least one space-filling compartment after filling has been completed.

18. A method as in claim 17, wherein fill volume adjusting comprises reattaching an inflation tube to one or more space-filling compartments, and filling or removing inflation fluid through the reattached inflation tube.

19. A method for deploying a gastric balloon in a patient, said method comprising:

introducing the balloon to the patient'"'"'s stomach; and

separately inflating a plurality of isolated chambers within the balloon, wherein the chambers have individual volumes such that the collective volume of the chambers remaining inflated after the deflation of any single chamber is such that the balloon is prevented from passing through the pyloric valve.

20. A method as in claim 19, further comprising detecting a substance which is released into the stomach by a partially or fully ruptured balloon chamber and is excreted, secreted, exhaled, or regurgitated by the patient.

21. A method as in claim 20, wherein the substance is selected from the group consisting of dyes, scented materials, symptom-inducing agents, and detectable reactants.

22. A method as in claim 19, wherein at least some portions of the balloon are inflated in situ by inducing a gas-generating reaction within the balloon.

23. A method for selecting a gastric balloon, said method comprising:

determining an internal volume of a patient'"'"'s stomach while filled with a biocompatible filling medium; and

selecting a balloon having a filling volume less than the determined volume by a preselected amount.

24. A method as in claim 23, wherein the preselected amount is in the range from 10 cm³ to 100 cm³.

25. A method as in claim 23, wherein the biocompatible filling medium comprises liquid or solid food.

26. A method as in claim 23, wherein the internal volume is measured by external X-ray, external ultrasound, or by internal endoscopic measurement.