Resistive anti-obesity devices

• US 7,819,836 B2
• Filed: 07/12/2007
• Issued: 10/26/2010
• Est. Priority Date: 06/23/2006
• Status: Active Grant

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Melanson, David A., Lamport, Ronald B., Levine, Andy H., Randle, Stuart A., Fishman, Ezra S.
• Primary Examiner(s): Deak; Leslie R
• Application Number:
  US11/827,674
• Publication Number:
  US 20080071383A1
• Time in Patent Office: 1,202 Days
• Field of Search: 604/8, 604/9, 606/37, 623/23.68
• US Class Current: 604/9
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves

Abstract

A patient is provided with an increased sense of satiety by increasing resistance to the outflow of food from the stomach and through the intestines. Stomach emptying may be slowed with devices implantable within the gastrointestinal tract below the stomach. Implants are preferably removable and can include artificial strictures or apertures that may be adjustable or elastic to vary the rate of stomach emptying. Slowing gastric emptying may induce satiety for a longer period and may therefore reduce food consumption. Many of the embodiments include intestinal sleeves or sleeves, but they need not. The resistor concept may be applied to a simple anchor and resistor without a long sleeve.

Claims

1. A gastrointestinal implant device comprising:

an anchor adapted to be retained in the pyloric orifice or distal to the pylorus; and

a restrictive aperture attached to the anchor, adapted to retard the outflow of chyme from the stomach, the aperture expanding substantially at a pressure of 50 inches of water or more, the diameter of the aperture being about 5 mm or below, when the water pressure is between 0 and 50 inches of water.

2. The gastrointestinal implant device of claim 1, wherein the aperture ranges in diameter from 1 to 10 millimeters over a range of water pressures.

3. The gastrointestinal implant device of claim 1, wherein the diameter of the aperture is about 4 mm or below, when the water pressure is between 0 inches and 50 inches of water.

4. The gastrointestinal implant device of claim 1, wherein the diameter of the aperture opens to greater than 4 mm when the water pressure is above 50 inches of water.

5. The gastrointestinal implant device of claim 1, wherein the aperture is made of silicone.

6. The gastrointestinal implant device of claim 1, further comprising a flexible and floppy sleeve that is in communication with the anchor.

7. The gastrointestinal implant device of claim 6, wherein the aperture is within the sleeve.

8. The gastrointestinal implant device of claim 6, wherein the sleeve is at least one foot in length to extend into the intestine.

9. A gastrointestinal implant device comprising:

an anchor adapted to be retained in the pyloric orifice or distal to the pylorus;

a flexible, floppy sleeve, a proximal end of the sleeve attached to the anchor, the sleeve to extend into the intestine, the sleeve defining a lumen through which chyme passes; and

a restricting aperture within the sleeve, the aperture adapted to retard the outflow of chyme from the stomach, the aperture expanding substantially at a pressure of 50 inches of water or more, the diameter of the aperture being about 5 mm or below, when the water pressure is between 0 and 50 inches of water.

10. The gastrointestinal implant device of claim 9, wherein the aperture ranges in diameter from 1 to 10 millimeters over a range of water pressure.

11. The gastrointestinal implant device of claim 9, wherein the diameter of the aperture is about 4 mm or below, when the water pressure is between 0 inches and 50 inches of water.

12. The gastrointestinal implant device of claim 9, wherein the diameter of the aperture opens to greater than 4 mm when the water pressure is above 50 inches of water.

13. The gastrointestinal implant device of claim 9, wherein the aperture is made of silicone.

14. The gastrointestinal implant device of claim 9, wherein the sleeve encapsulates the anchor and the aperture.

15. The gastrointestinal implant device of claim 9, wherein the sleeve is at least one foot in length to extend into the intestine.

16. A method for treating obesity comprising:

implanting a device within a gastrointestinal tract of an animal at or distal to the pylorus; and

with the implanted device, resisting the outflow of chyme from the stomach with a restrictive aperture, the aperture expanding substantially at a pressure of 50 inches of water or more, the diameter of the aperture being about 5 mm or below, when the water pressure is between 0 and 50 inches of water.

17. The method of claim 16, wherein the aperture ranges in diameter from 1 to 10 millimeters over a range of water pressures.

18. The method of claim 16, wherein the diameter of the aperture is about 4 mm or below, when the water pressure is between 0 inches and 50 inches of water.

19. The method of claim 16, wherein the diameter of the aperture opens to greater than 4 mm when the water pressure is above 50 inches of water.

20. The method of claim 16, wherein the aperture is made of silicone.

21. The method of claim 16, further comprising a flexible and floppy sleeve that is in communication with the anchor.

22. The method of claim 21, wherein the aperture is within the sleeve.

23. The method of claim 22, wherein the sleeve is at least one foot in length to extend into the intestine.

24. A method of treating obesity comprising:

anchoring a flexible, floppy sleeve with an anchor in the intestine, the sleeve extending into the intestine, the sleeve defining a lumen through which chyme passes; and

restricting the outflow of chyme from the stomach with a restrictive aperture within the sleeve, the aperture expanding substantially at a pressure of 50 inches of water or more, the diameter of the aperture being about 5 mm or below, when the water pressure is between 0 and 50 inches of water.

25. The method of claim 24, wherein the aperture ranges in diameter from 1 to 10 millimeters over a range of water pressure.

26. The method of claim 24, wherein the diameter of the aperture is about 4 mm or below, when the water pressure is between 0 inches and 50 inches of water.

27. The method of claim 24, wherein the diameter of the aperture opens to greater than 4 mm when the water pressure is above 50 inches of water.

28. The method of claim 24, wherein the aperture is made of silicone.

29. The method of claim 24, wherein the sleeve encapsulates the anchor and the aperture.

30. The method of claim 24, wherein the sleeve is at least one foot in length to extend into the intestine.

31. The method of claim 24, wherein the anchor is retained within the pyloric orifice.

32. The method of claim 24, wherein the anchor is retained distal to the pylorus.

33. The method of claim 24, wherein the implanting step comprises removably anchoring the device within the gastrointestinal tract.

34. A gastrointestinal implant for treating obesity comprising:

aperture means for increasing within the intestine resistance to the outflow of chyme from the stomach, the aperture expanding substantially at a pressure of 50 inches of water or more, the diameter of the aperture being about 5 mm or below, when the water pressure is between 0 and 50 inches of water; and

anchoring means for anchoring within a gastrointestinal tract of an animal and at the pyloric orifice or distal to the pylorus the aperture means.

35. The gastrointestinal implant of claim 34 further comprising flexible, floppy sleeve means attached to the anchor, the sleeve means to extend into the intestine, and the sleeve means defining a lumen through which chyme passes.