Gastro-occlusive device

• US 20050267405A1
• Filed: 05/26/2004
• Published: 12/01/2005
• Est. Priority Date: 05/26/2004
• Status: Active Grant

• Current Assignee: Polyzen Incorporated (Compagnie Generale DES Etablissements Michelin SCA)
• Original Assignee: Tilak M. Shah
• Inventors: Shah, Tilak M.
• Granted Patent: US 7,112,186 B2
• Time in Patent Office: Days
• US Class Current: 604/96.10
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/004 remotely adjustable
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A gastro-occlusive device, comprising a balloon disposable in a stomach cavity of a patient, and inflatable therein to occlude a portion of the volume of the stomach cavity, a gas flow tube coupled at a distal end thereof with the balloon and extending outwardly through a stomach wall for coupling with a gas source for selectively inflating the balloon, to occlude at least a portion of the volume of the stomach cavity. The gastro-occlusive device may be employed in combination with a feeding tube unit, a drain unit or other ancillary apparatus, and is useful for treatment of morbid obesity and various eating disorders.

Claims

1. A gastro-occlusive device, comprising a balloon disposable in a stomach cavity of a patient, and inflatable therein to occlude a portion of the volume of the stomach cavity, a gas flow tube coupled at a distal end thereof with the balloon and extending through a stomach wall to a proximal end that is at or in interior proximity to a dermal wall of the patient'"'"'s body or extends exteriorly out of the dermal wall of the patient'"'"'s body, and means for selectively inflating the balloon, coupled to the gas flow tube at the proximal end thereof and arranged to flow inflation gas to the balloon in the patient'"'"'s stomach cavity, for said inflation therein to occlude at least a portion of the volume of the stomach cavity, wherein the dermal wall and the stomach wall are in spaced relationship to one another, and wherein the gas tube is positionally anchored at both the stomach wall and the dermal wall of the patient.

2. The gastro-occlusive device of claim 1, wherein said balloon is formed of a thin film polymeric material.

3. The gastro-occlusive device of claim 1, wherein said polymeric material comprises polyurethane.

4. The gastro-occlusive device of claim 1, wherein said polymeric material comprises silicone.

6. The gastro-occlusive device of claim 1, wherein the proximal end of the gas flow tube is joined to a cap at the surface of the patient'"'"'s body, and said cap includes coupling members to which the means for selectively inflating the balloon are connected.

7. The gastro-occlusive device of claim 1, wherein the proximal end of the gas flow tube is coupled exteriorly of the patient'"'"'s body to said means for selectively inflating the balloon.

8. The gastro-occlusive device of claim 1, wherein the means for selectively inflating the balloon comprise a manually operable squeeze bulb.

9. The gastro-occlusive device of claim 1, wherein the means for selectively inflating the balloon comprise a pressurized gas supply.

10. The gastro-occlusive device of claim 1, wherein the means for selectively inflating the balloon are arranged for selectively deflating the balloon subsequent to selectively inflating it.

13. The gastro-occlusive device of claim 1, in combination with a feeding tube unit.

14. The gastro-occlusive device of claim 13, wherein the feeding tube unit comprises a nutritive fluid supply coupled with a feeding tube, and the feeding tube is arranged with its distal end disposed in the stomach cavity of the patient.

15. The gastro-occlusive device of claim 14, wherein the feeding tube is arranged for flowing nutritive fluid to the stomach cavity when the balloon is deflated.

16. The gastro-occlusive device of claim 14, wherein the feeding tube is arranged for flowing nutritive fluid to the stomach cavity when the balloon is inflated.

17. The gastro-occlusive device of claim 14, wherein a pump is coupled to the feeding tube at an intermediate position between the nutritive fluid supply and the patient.

18. The gastro-occlusive device of claim 17, wherein the pump is reversible.

19. The gastro-occlusive device of claim 14, wherein the feeding tube is interiorly disposed in the gas flow tube with the body of a patient.

20. The gastro-occlusive device of claim 14, wherein the feeding tube is connected to and enters a side wall of the gas flow tube.

21. The gastro-occlusive device of claim 1, wherein the balloon when inflated occupies at least 50% of total volume of the stomach cavity of a patient.

22. The gastro-occlusive device of claim 1, wherein the balloon when inflated occupies at least 75% of total volume of the stomach cavity of a patient

23. The gastro-occlusive device of claim 1, wherein the balloon when inflated occupies at least 95% of total volume of the stomach cavity of a patient.

24. The gastro-occlusive device of claim 1, wherein the balloon when inflated occupies 100% of volume ofthe stomach cavity of a patient.

25. The gastro-occlusive device of claim 1, further comprising means for monitoring pressure in the balloon.

5. A gastro-occlusive device, comprising a balloon disposable in a stomach cavity of a patient and inflatable therein to occlude a portion of the volume of the stomach cavity, a gas flow tube coupled at a distal end thereof with the balloon and extending through a stomach wall to a proximal end that is at or in interior proximity to a surface of the patient'"'"'s body, and means for selectively inflating the balloon, coupled to the gas flow tube at the proximal end thereof and arranged to flow inflation gas to the balloon in the patient'"'"'s stomach cavity, for said inflation therein to occlude at least a portion of the volume of the stomach cavity, wherein the proximal end of the gas flow tube is coupled to a subcutaneous sealable membrane and port assembly that is subcutaneously engageable with an injector of inflation gas for inflation of the balloon.

11. The gastro-occlusive device of claim 5, further comprising members positionally anchoring the gas tube at the stomach wall of the patient.

12. The gastro-occlusive device of claim 5, further comprising members positionally anchoring the gas tube at the dermal wall of the patient.

26. A method of treating a subject in need of treatment for an eating disorder or overweight condition, said method comprising disposing in the stomach of the subject a balloon that is inflatable to occlude at least a portion of interior volume of the stomach, wherein the balloon is coupled by a gas flow passage to an actuatable source of inflation gas, and actuating the source of inflation gas to flow gas into the balloon for inflation thereof to occlude at least a portion of the interior volume of the stomach, to an extent producing satiety with reduced intake of nutrition, relative to a corresponding subject lacking the inflated balloon in the subject'"'"'s stomach, wherein the stomach is defined by a stomach wall, said gas flow passage is at or in interior proximity to a dermal wall of the subject'"'"'s body or extends exteriorly out of the dermal wall of the subject'"'"'s body, said dermal wall and the stomach wall are in spaced relationship to one another, and said gas flow passage is positionally anchored at both the stomach wall and the dermal wall of the subject.

27. The method of claim 26, wherein the balloon is inflated to occlude at least 50% of total volume of the subject'"'"'s stomach.

28. The method of claim 26, wherein the balloon is inflated to occlude at least 75% of total volume of the subject'"'"'s stomach.

29. The method of claim 26, wherein the balloon is inflated to occlude at least 95% of total volume of the subject'"'"'s stomach.

30. The method of claim 26, wherein the balloon is inflated to occlude 100% of total volume of the subject'"'"'s stomach.

31. The method of claim 26, wherein the subject'"'"'s stomach is supplied by a feeding tube with nutrition.

32. The method of claim 31, wherein the nutrition is supplied when the balloon is in a deflated state.

33. The method of claim 31, wherein the nutrition is supplied when the balloon is in an inflated state.

34. A gastro-occlusive device, comprising a balloon disposable in a stomach cavity of a patient, and inflatable therein to occlude a portion of the volume of the stomach cavity, a gas flow tube coupled at a distal end thereof with the balloon and extending through a stomach wall to a proximal end that is at or in interior proximity to a surface of the patient'"'"'s body or extends exteriorly out of a dermal wall of the patient'"'"'s body, and means for selectively inflating the balloon, coupled to the gas flow tube at the proximal end thereof and arranged to flow inflation gas to the balloon in the patient'"'"'s stomach cavity, for said inflation therein to occlude at least a portion of the volume of the stomach cavity, wherein the gas flow tube is a single lumen tube.

35. A gastro-occlusive device, comprising a balloon disposable in a stomach cavity of a patient, and inflatable therein to occlude a portion of the volume of the stomach cavity, a gas flow tube coupled at a distal end thereof with the balloon and extending through a stomach wall to a proximal end that extends exteriorly out of a dermal wall of the patient'"'"'s body, and means for selectively inflating the balloons coupled to the gas flow tube at the proximal end thereof and arranged to flow inflation gas to the balloon in the patient'"'"'s stomach cavity, for said inflation therein to occlude at least a portion of the volume of the stomach cavity, wherein the gas flow tube extending through the stomach wall is retained in position by a first exterior flange member and a first interior flange member, and wherein the gas flow tube extending through the dermal wall is retained in position by a second exterior flange member and a second interior flange member.