GASTRIC SPACE OCCUPIER SYSTEMS AND METHODS OF USE

• US 20090171383A1
• Filed: 11/13/2008
• Published: 07/02/2009
• Est. Priority Date: 12/31/2007
• Status: Abandoned Application

• Current Assignee: Barosense, Inc. (Boston Scientific Scimed Incorporated)
• Original Assignee: Barosense, Inc. (Boston Scientific Scimed Incorporated)
• Inventors: Cole, David, Smith, Andrew, Lunsford, John, Balbierz, Daniel J., Swope, Bretton, Crews, Samuel T.
• Application Number:
  US12/270,607
• Publication Number:
  US 20090171383A1
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices

Abstract

Systems for controlling obesity utilize a number of space occupiers positioned in the stomach to reduce the effective volume of the stomach. Such arrangements provides sufficient stomach volume consumption to induce weight loss, but enable use of space occupiers that are proportioned to minimize the threat of obstruction even if they should migrate into the intestine. In general, numerous small volume space occupiers are placed in the stomach such that the total volume equals or exceeds the single volume of prior art single unit space occupiers. However, each individual space occupier is proportioned so that it will pass without obstruction if it moves into the intestine.

Claims

1. A gastric space occupier, comprising:

a tubular balloon having a tubular wall comprising an outer tubular layer and an inner layer tubular disposed within the outer tubular layer, the inner and outer tubular layers having a space therebetween, the wall defining an elongate lumen extending through the balloon; and

a fluid in the space between the inner and outer tubular layers.

2. The gastric space occupier of claim 1, wherein the inner and outer tubular layers are slidable relative to one another in opposite directions.

3. The gastric space occupier of claim 2, wherein the inner and outer tubular layers are slidable from a first arrangement in which the inner tubular layer is disposed within the outer tubular layer, and a second arrangement in which the outer tubular layer is disposed within the inner tubular layer.

4. The gastric space occupier of claim 3, wherein the inner and outer tubular layers are movable between the first and second arrangements in response to radially inward pressure against an outer surface of the tubular balloon.

5. The gastric space occupier of claim 1, wherein the tubular wall is formed of an elongate tube having first and second ends, the first and second ends sealed together to form the tubular inner and outer layers and the space between the inner and outer tubular layers.

6. The gastric space occupier of claim 1, further including a valve fluidly coupled to the space.

7. The gastric space occupier of claim 1, wherein the gastric space occupier includes a plurality of the tubular balloons.

8. A method of treating obesity in a patient, comprising:

placing a tubular balloon into a stomach, the tubular balloon including a tubular wall comprising an outer tubular layer and an inner layer tubular disposed within the outer tubular layer, and a space between the inner and outer tubular layers;

filling the space between the inner and outer tubular layers with a fluid such that the fluid is contained within the tubular wall.

9. The method of claim 8, wherein the method further includes;

in the event the tubular balloon advances from the stomach into contact with walls of a lumen of the stomach or intestine that is sufficiently narrow to impart radially inward pressure against the tubular balloon, allowing the inner and outer tubular layers to slide relative to one another in the opposite directions, causing the tubular balloon to move proximally within the stomach.

10. The method of claim 8, wherein filling the space includes filling the space prior to placing the tubular balloon into the stomach.

11. The method of claim 8, wherein filling the space includes filling the space after placing the tubular balloon into the stomach.

12. The method of claim 8, wherein the method includes placing a plurality of the tubular balloons into the stomach.

13. The method of claim 12, further including monitoring a rate of weight loss by the patent, and removing at least one tubular balloons from the stomach to decrease the rate of weight loss.

14. The method of claim 8, further including monitoring a rate of weight loss by the patent, and placing additional tubular balloons into the stomach to increase the rate of weight loss.

15. The method of claim 8, wherein the tubular balloon reduces the effective volume of the stomach by an amount sufficient to cause the patient to lose weight.

16. A gastric space occupier system comprising:

an elongate member having first and second end portions, the elongate member movable between a first generally streamlined position in which the elongate member is shaped for passage through the esophagus into the stomach, and a second position in which the elongate member is incapable of passage from the stomach into the intestine; and

a fastener positioned to couple the first and second end portions together to retain the elongate member in the second position.

17. The gastric space occupier system of claim 16, wherein first and second end portions have first and second ends, respectively, and wherein the fastener is positioned to couple the first end to the second end.

18. The gastric space occupier system of claim 17, wherein the elongate member in the second position bounds a central opening.

19. The gastric space occupier system of claim 18, wherein the elongate member in the second position has a generally annular shape.

20. The gastric space occupier system of claim 18, wherein the elongate member in the second position defines a generally triangular shape.

21. The gastric space occupier system of claim 20, wherein the elongate member includes a pair of bend regions, and wherein the elongate member is bendable at the bend regions to move the elongate member from the first position to the second position.

22. The gastric space occupier system of claim 17, further including an element coupled to the first end and slidably coupled to the second end such that application of tension to the element moves the first end towards the second end.

23. The gastric space occupier system of claim 16, further including a plurality of the elongate members independently introducible through the esophagus into the stomach, and each movable to a second position incapable of passage from the stomach into the intestine.

25. The method according to claim 23, wherein the method further includes:

placing a plurality of the elongate members in the second position in the stomach.

26. The method according to claim 25, wherein the elongate members reduce the effective volume of the stomach by an amount sufficient to cause the patient to lose weight.

24. A method of treating obesity in a patient, comprising:

introducing an elongate member in a streamlined first position through an esophagus into a stomach;

moving first and second end portions of the elongate member relatively towards one another to position the elongate member in a second position in which the elongate member is incapable of passage from the stomach into the intestine; and

coupling the first and second end portions together to retain the elongate member in the second position.

27. A method of treating obesity in a patient using a gastric implant, comprising:

introducing a plurality of gastric balloons within the stomach, each gastric balloon having a volume in the range of approximately 50-200 cc, wherein the plurality of gastric balloons reduce the effective volume of the stomach by an amount sufficient to cause the patient to lose weight.

28. The method of claim 27, wherein each gastric balloon has a volume in the range of approximately 75-125 cc.

29. The method of claim 27, further including monitoring a rate of weight loss by the patent, and removing at least one gastric balloon from the stomach to decrease the rate of weight loss.

30. The method of claim 27, further including monitoring a rate of weight loss by the patent, and placing additional gastric balloons into the stomach to increase the rate of weight loss.

31. The method of claim 27, wherein the gastric balloons collectively occupy at least approximately 300 cc of stomach volume.