Methods for gastric volume control

• US 8,066,780 B2
• Filed: 05/03/2005
• Issued: 11/29/2011
• Est. Priority Date: 05/03/2004
• Status: Expired due to Fees

• Current Assignee: Fulfillium, Inc.
• Original Assignee: Fulfillium, Inc.
• Inventors: Chen, Richard, Johanson, Craig A., Dauskardt, Reinhold H., Jones, Christopher S.
• Primary Examiner(s): Jackson; Gary
• Assistant Examiner(s): MENDOZA, MICHAEL G
• Application Number:
  US11/122,315
• Publication Number:
  US 20050267595A1
• Time in Patent Office: 2,401 Days
• Field of Search: 606/192, 606/195, 606/191, 623/23.65, 623/23.67, 623/23.68, 600/37, 600/116
• US Class Current: 623/23.65
• 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 two inflatable space-filling compartments to the inside of the patient'"'"'s stomach;

expanding the scaffold to provide a fixed support geometry within the stomach; and

at least partly filling the at least two space-filling compartments of the balloon with a compressible and/or incompressible fluid such that the compartments are constrained by the scaffold after filling.

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 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.

7. A method as in claim 6, wherein the mixture of compressible and incompressible fluids is selected to provide a generally neutral buoyancy in the stomach.

8. 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.

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

10. A method as in claim 1, wherein the at least two space-filling compartments are inflated through an inflation tube removably attached to the balloon.

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

12. 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.

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

14. A method as in claim 13, wherein deflating comprises breaching one or more walls of each space-filling compartment.

15. A method as in claim 14, wherein breaching comprises severing a common wall portion between two or more space-filling compartments so that both deflate simultaneously.

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

17. A method as in claim 16, 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.

18. A method as in claim 1, wherein said scaffold structure has an interior and said space-filling compartments are constrained within the interior.

19. A method as in claim 1, wherein the gastric balloon structure floats free in the stomach after the scaffold is expanded and the space-filling compartments are filled.

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

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

filling a scaffold structure to provide a fixed support geometry; and

separately filling a plurality of isolated chambers within the scaffold structure, 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.

21. A method as in claim 20, 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.

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

23. A method as in claim 20, wherein at least some portions of the balloon are inflated in situ by inducing a gas-generating reaction within the balloon.

24. A method as in claim 20, wherein the scaffold structure has an interior and said isolated chambers are constrained within the interior after filling.

25. A method as in claim 20, wherein the gastric balloon structure floats free in the stomach after the scaffold is expanded and the space-filling compartments are filled.