Intragastric balloon with improved valve locating means

• US 5,084,061 A
• Filed: 08/16/1989
• Issued: 01/28/1992
• Est. Priority Date: 09/25/1987
• Status: Expired due to Term

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Inamed Development Corp. (Abbvie Incorporated)
• Inventors: Hancock, John C., Gau, Fred C.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): Maglione, Corrine
• Application Number:
  US07/394,545
• Time in Patent Office: 895 Days
• Field of Search: 128/344, 128/303 R, 604/96-103
• US Class Current: 606/195
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices

Abstract

An intragastric balloon has an ellipsoid or like configuration so that the balloon implanted in the stomach tends to rotate or rock only about one axis when a surgeon attempts to manipulate the balloon, for example, for the purpose of finding a filler valve and inserting a filler tube into it. For easy location, the filler valve is disposed on the equator. A retrieval tab is mounted to the exterior of the balloon, to permit capturing of the balloon and retrieval from the stomach, after the balloon has been deflated and is no longer desired for weight control purposes. Visual and X-ray opaque markers are located in the proximity of the valve and of the retrieval tab to facilitate their visualization with an endoscopic light when the balloon is in the stomach.

Claims

1. An inflatable intragastric balloon useful for facilitating weight reduction when implanted into the stomach of obese patients, comprising:

an inflatable shell, the shell having a smooth continuously convex exterior and a configuration such that when inflated the shell has a unique axis of greatest symmetry whereby when the inflated shell is placed into the interior of the stomach and disturbed while in the stomach, spinning of the shell about its axis of greatest symmetry causes minimum displacement of the walls of the stomach, and

a self-sealing valve affixed to the shell at a predetermined location with respect to the axis of greatest symmetry, the balloon being inflatable through the valve by introduction of fluid into the balloon through the valve.

2. The intragastric balloon of claim 1 wherein the inflatable shell comprises a silicone elastomer.

3. The intragastric balloon of claim 2 wherein the silicone elastomer comprises high phenyl silicone.

4. The intragastric balloon of claim 1 wherein the valve is located on the periphery of the shell substantially on a plane which is orthogonal to the axis of greatest symmetry and substantially cuts the axis of greatest symmetry into two equal halves.

5. The intragastric balloon of claim 1 further comprising means located on the outer periphery of the shell for allowing capturing of the balloon to facilitate removal thereof from the stomach.

6. The intragastric balloon of claim 5 wherein the means for allowing includes an optical marker comprising a substantially non-reflective body.

7. The intragastric balloon of claim 5 wherein the means for allowing comprises a tab.

8. The intragastric balloon of claim 7 wherein the tab includes a black marker.

9. The intragastric balloon of claim 7 wherein the tab includes a narrow section for facilitating being captured for removal of the balloon from the stomach.

10. The intragastric balloon of claim 7 wherein the tab is reinforced.

11. The intragastric balloon of claim 1 wherein the means for allowing is located on the periphery of the shell substantially centered on the axis of greatest symmetry of the balloon.

12. The intragastric balloon of claim 1 wherein the interior surface of the shell is reinforced at least at one location adapted to receive a stylette introduced through the valve, said reinforcement comprising means for preventing accidental puncture of the shell by the stylette.

13. The intragastric balloon of claim 1 wherein the self-sealing valve comprises a tubular member having a flange at a first end, an interior passage and a substantially elastic membrane blocking the interior passage, and a collapsible tube mounted to the second end of the tubular member, the flange being affixed to the interior of the inflatable shell to align with an opening in the inflatable shell, the tubular member having larger internal diameter than the exterior diameter of a filler tube which is introduced through the valve for the purpose of introducing fluid into the balloon, the membrane having a substantially central opening which is significantly smaller in diameter than the filler tube and which nevertheless allows passage of the filler tube by expansion of the central opening.

14. The intragastric balloon of claim 13 wherein the self-sealing valve further includes a reinforcing member affixed to the exterior of the inflatable shell, the reinforcing member having a slot which is aligned with the opening in the inflatable shell.

15. The intragastric balloon of claim 14 wherein the slot of the reinforcing member is X-shaped.

16. An inflatable intragastric balloon useful for facilitating weight reduction when implanted into the stomach of obese patients, comprising:

an inflatable elastomeric shell, the shell having a smooth continuously convex exterior and a configuration such that when inflated the shell has a single unique axis of greatest symmetry whereby when the inflated shell is placed into the interior of the stomach and disturbed while in the stomach, spinning of the shell about its axis of greatest symmetry involves minimum displacement of the walls of the stomach, and

a self-sealing valve affixed to the shell at a location which is substantially on a plane orthogonal to the axis of greatest symmetry, which plane substantially cuts the axis of greatest symmetry into two equal halves, the balloon being inflatable through the valve by introduction of fluid into the balloon through the valve.

17. The intragastric balloon of claim 16 wherein the shell comprises a silicone elastomer.

18. The intragastric balloon of claim 16 further comprising means located on the exterior of the shell for allowing capturing of the balloon to facilitate removal thereof from the stomach.

19. The intragastric balloon of claim 18 having optically visible marker means located on the shell comprising substantially non-reflective material for facilitating identification of the positioning of the balloon with an endoscope when the balloon is in the stomach.

20. The intragastric balloon of claim 19 wherein the marker means are located adjacent to the valve.

21. The intragastric balloon of claim 16 having optically visible marker means located on the shell, comprising substantially non-reflective material for facilitating identification of the positioning of the balloon with an endoscope when the balloon is in the stomach.

22. The intragastric balloon of claim 21 wherein the marker means are located adjacent to the valve.

23. The intragastric balloon of claim 16 further comprising marker means located on the shell comprising substantially x-ray opaque material for facilitating identification of the positioning of the balloon when the balloon is in the stomach.

24. The intragastric balloon of claim 16 wherein the self-sealing valve comprises a reinforcing member affixed to the exterior of the inflatable shell and having a slot which registers with an opening in the inflatable shell, a tubular member having a flange at a first end, an interior passage and a substantially elastic membrane blocking the interior passage, and a collapsible tube mounted to the second end of the tubular member, the flange being affixed to the interior of the inflatable shell to register the interior passage with the opening in the inflatable shell, the tubular member having larger internal diameter than the exterior diameter of a filler tube which is introduced through the valve for the purpose of introducing fluid into the balloon, the membrane having a substantially central opening which is significantly smaller in diameter than the filler tube and which nevertheless allows passage of the filler tube by expansion of the central opening.

25. The intragastric balloon of claim 24 wherein the slot of the reinforcing member is X-shaped.

26. An inflatable intragastric balloon used for facilitating weight reduction when implanted into the stomach of obese patients, comprising:

an inflatable elastomer shell, the shell having a configuration such that when inflated the shell becomes substantially an ellipsoid having a smooth continuously convex exterior surface, whereby when the inflated shell is placed into the interior of the stomach and disturbed while in the stomach, spinning of the shell about its shortest axis involves minimum displacement of the walls of the stomach;

a self-sealing valve affixed to the shell substantially on the equator of the ellipsoid, the balloon being inflatable through the valve by introduction of fluid into the balloon through the valve, and

a tab affixed to the external periphery of the shell, the tab comprising means for allowing the capturing of the balloon for removal of the balloon from the stomach.

27. The intragastric balloon of claim 26 wherein the tab is located substantially on the pole of the ellipsoid.

28. The intragastric balloon of claim 27 having optically visible marker means located on the shell comprising substantially non-reflective material for facilitating identification of the positioning of the balloon with an endoscope when the balloon is in the stomach.

29. The intragastric balloon of claim 28 wherein the marker means are located adjacent to the valve.

30. The intragastric balloon of claim 29 wherein the marker means are also located on the tab.

31. The intragastric balloon of claim 30 wherein the shell comprises silicone elastomer.

32. The intragastric balloon of claim 31 wherein the shell comprises high phenyl silicone elastomer.

33. The intragastric balloon of claim 31 wherein the interior surface of the shell is reinforced at least at one location adapted to receive a stylette introduced through the valve, said reinforcement comprising means for preventing accidental puncture of the shell by the stylette.

34. The intragastric balloon of claim 31 wherein the tab and the area of the shell immediately adjacent to the tab is reinforced.

35. The intragastric balloon of claim 31 further comprising marker means located on the shell comprising substantially x-ray opaque material for facilitating identification of the positioning of the balloon when the balloon is in the stomach.

36. The intragastric balloon of claim 31, wherein the optically visible marker means are also opaque to x-ray.

37. The intragastric balloon of claim 26 wherein the self-sealing valve comprises an opening in the inflatable shell, a tubular member having a flange at a first end, an interior passage and a substantially elastic membrane blocking the interior passage, and a collapsible tube mounted to the second end of the tubular member, the flange being affixed to the interior of the inflatable shell to register the interior passage with the opening in the inflatable shell, the tubular member having larger internal diameter than the exterior diameter of a filler tube which is introduced through the valve for the purpose of introducing fluid into the balloon, the membrane having a substantially central opening which is significantly smaller in diameter than the filler tube and which nevertheless allows passage of the filler tube by expansion of the central opening.

38. The intragastric balloon of claim 37 wherein the self-sealing valve further comprises a reinforcing member affixed to the exterior of the inflatable shell and having a slot which registers with the opening in the inflatable shell.

39. The intragastric balloon of claim 38 wherein the slot of the reinforcing member is X-shaped.

40. The intragastric balloon of claim 26 wherein a visible marker is present substantially along the equator of the ellipsoid.

41. The intragastric balloon of claim 26 wherein the visible marker present substantially along the equator of the ellipsoid is also x-ray opaque.