Gastric Space Occupier Systems And Methods Of Use

• US 20110319924A1
• Filed: 09/01/2011
• Published: 12/29/2011
• Est. Priority Date: 12/31/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Barosense, Inc. (Boston Scientific Corporation)
• Inventors: Cole, David, Crews, Samuel T., Swope, Bretton, Smith, Andrew, Lunsford, John, Balbierz, Daniel J.
• Granted Patent: US 8,945,167 B2
• 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 moveable 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 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.

17. The method of claim 16, wherein each gastric balloon has a volume in the range of approximately 75-125 cc.

18. The method of claim 16, 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.

19. The method of claim 16, 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.

20. The method of claim 16, wherein the gastric balloons collectively occupy at least approximately 300 cc of stomach volume.