Devices and systems for gastric volume control

• US 20050267596A1
• Filed: 05/03/2005
• Published: 12/01/2005
• Est. Priority Date: 05/03/2004
• Status: Abandoned Application

• Current Assignee: Fulfillium, Inc.
• Original Assignee: Fulfillium, Inc.
• Inventors: Jones, Christopher S., Taub, Marc B., Dauskardt, Reinhold H., Chen, Richard D.Y.
• Application Number:
  US11/121,704
• Publication Number:
  US 20050267596A1
• Time in Patent Office: Days
• US Class Current: 623/23.670
• 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 gastric balloon comprising:

a scaffold having a constrained configuration and a deployed, wherein the scaffold can be introduced into a gastric cavity in the constrained configuration; and

at least one inflatable space-filling compartment secured to the scaffold, said compartment assuming a space-filling configuration when inflated at least partly with a compressible or incompressible fluid.

2. A gastric balloon as in claim 1, wherein the space-filling compartment(s) have a generally crescent shape when at least partly inflated with the fluid.

3. A gastric balloon as in claim 2, wherein the scaffold is a resilient structure which conforms to the crescent shape of the space-filling compartment when the scaffold is deployed.

4. A gastric balloon as in claim 2, wherein the scaffold is an inflatable structure which conforms to the crescent shape of the space-filling compartment when the scaffold is deployed by inflation.

5. A gastric balloon as in claim 2, wherein the scaffold is inflatable with a compressible or an incompressible fluid.

6. A gastric balloon as in claim 1, wherein the scaffold forms a plurality of longitudinal channels, and the inflatable space-filling compartment(s) is (are) disposed in at least some of the channels, to occupy at least a portion thereof when inflated.

7. A gastric balloon as in claim 1, wherein the scaffold has an X-shaped cross-section to define channels in four quadrants and the inflatable space-filling compartment includes at least one section in each of the quadrants.

8. A gastric balloon as in claim 1, comprising a plurality of separately inflatable space-filling compartments.

9. A gastric balloon as in claim 8, comprising at least three separately inflatable space-filling compartments.

10. A gastric balloon as in claim 9, comprising at least four separately inflatable space-filling compartments.

11. A gastric balloon as in claim 1, further comprising at least one inflation tube removably connected to the space-filling compartment(s).

12. A gastric balloon as in claim 11, wherein a separate inflation tube is connected to each of the space-filling compartments.

13. A gastric balloon as in claim 11, wherein a single inflation tube is commonly connected to all of the space-filling compartments.

14. A gastric balloon as in claim 13, wherein the gastric balloon comprises a plurality of inflatable compartments, further comprising a valve structure which connects the single inflation tube to the plurality of inflatable compartments and which permits a user to selectively inflate each inflatable compartment.

15. A gastric balloon as in claim 1, further comprising at least one separately inflatable external bladder formed over the space-filling compartment(s), wherein the bladder shapes the outside of the balloon when inflated at least partly with a compressible or incompressible fluid.

16. A gastric balloon as in claim 15, further comprising at least one inflation tube removably connected to the external bladder.

17. A gastric balloon as in claim 1, further comprising at least one substance disposed within the wall or interior of at least one of the inflatable space-filling compartment(s), wherein the substance is detectable upon release from the balloon due to breach and secretion, excretion, exhalation, and/or regurgitation by the patient.

18. A gastric balloon as in claim 11, further comprising a wireless breach detection system, incorporated into a wall of at least one space-filling compartment, wherein said system is adapted to emit a detectable signal if the wall is at least partially breached.

19. A gastric balloon as in claim 1, wherein at least a portion of the inflatable space-filling compartments are coated with or impregnated by an anti-microbial and/or adhesion-resistant agent.

20. A gastric balloon as in claim 19, wherein all exposed surfaces of the gastric balloon are coated with the agent(s).

21. An improved gastric balloon of the type having an inflatable chamber, wherein the improvement comprises having a plurality of inflatable compartments, wherein the compartments 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.

22. An improved gastric balloon as in claim 21, further comprising a substance disposed within at least some of the inflatable compartments or walls of the inflatable compartments, wherein the substance is detectable upon excretion, secretion, exhalation, or regurgitation by a patient.

23. An improved gastric balloon as in claim 21, further comprising a wireless breach detection system incorporated into at least one wall of one inflatable compartment.

24. An improved gastric balloon of the type including at least one inflatable space-filling compartment, further comprising a self-expanding scaffold which has a size or geometry which prevents the balloon from passing through the pyloric valve after accidental deflation of the inflatable compartments.

25. An improved gastric balloon as in claim 24, further comprising a substance disposed within at least some of the inflatable compartments or walls of the inflatable compartments, wherein the substance is detectable upon excretion, secretion, exhalation, or regurgitation by a patient.

26. An improved gastric balloon as in claim 24, further comprising a wireless breach detection system incorporated into at least one wall of one inflatable compartment.

27. An improved gastric balloon of the type comprising an inflatable compartment having a wall subject to breach, said improvement comprising:

a wall formed from at least two layers, wherein each layer has different physical and/or mechanical properties.

28. An improved balloon as in claim 27, wherein the properties are selected from the group consisting of stiffness, durability, biocompatibility, chemical resistance, and permeability.

29. An improved balloon as in claim 27, further comprising a detectable material present between said layers so that the material is released in the event the wall is breached.

30. An improved gastric balloon of the type comprising an inflatable compartment having a wall subject to breach, said improvement comprising:

a detectable material present in the wall such that the material is released if the wall is breached.

31. An improved gastric balloon as in claim 30, wherein the detectable material is dispersed within the wall.

32. An improved gastric balloon as in claim 30, wherein the detectable material is disposed between two layers of the wall.

33. An improved gastric balloon of the type comprising an inflatable compartment having a wall subject to breach, said improvement comprising:

a wireless detection system including two probes, wherein the probes are arranged so that the probes are exposed to stomach contents only upon breach of the wall; and

a transmitter which is connected to the probes and powered when the probes are exposed to stomach contents.

34. An improved balloon as in claim 33, wherein at least one of the probes is a mesh embedded in the wall and the other probe is external to the wall.