Intragastric device for treating obesity

• US 20030078611A1
• Filed: 05/17/2002
• Published: 04/24/2003
• Est. Priority Date: 05/17/2001
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Hashiba, Kiyoshi, Surti, Vihar C.
• Granted Patent: US 7,066,945 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• CPC Class Codes: A61F 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61F 5/0036 Intragastrical devices

Abstract

An apparatus and method comprising at least one intragastric member or artificial bezoar made of a digestive-resistant or substantially indigestible material that is introduced into a gastric lumen of a mammal for the treatment of obesity. The intragastric member or artificial bezoar is typically at inserted into the gastric lumen in a partially compacted configuration, whereby it is then manipulated into, or allowed to assume, a second expanded configuration sufficiently large to remain within the reservoir of the stomach during normal activities and not be passed through the pylorus into the intestines. In animals, the present invention has been found to be effective in achieving weight loss over a several month period, while being easy to place and retrieve.

Claims

1. An intragastric device for the treatment of obesity, the intragastric device comprising a digestive-resistant material that is expandable from a first configuration to a second configuration, the first configuration being sufficiently small to permit introduction of said intragastric device into a gastric lumen of a mammal, the second configuration being sufficiently large to prevent said intragastric device from passing through the mammal'"'"'s pylorus, wherein said intragastric device is configured to function as an artificial bezoar.

2. The intragastric device according to claim 1 wherein said digestive-resistive material comprises one or more elements selected from the group consisting of plastic, nylon, polyesters, polyurethanes, polyethylenes, polyamides, silicone and biocompatible polymers to which food will generally not adhere.

3. The intragastric device according to claim 1 wherein said digestive-resistive material comprises one or more elements selected from the group consisting of high-density polyethylene, low-density polyethylene, fluorinated ethylene propylene and ethylene vinyl acetate copolymer.

4. The intragastric device according to claim 1 wherein the digestive-resistant material has a resilience which is biased towards the second configuration.

5. The intragastric device according to claim 1 wherein said digestive-resistant material comprises a continuous strip of material that has been folded to form a plurality of loops, said plurality of loops being connected together to form a shape suggestive of a butterfly or bow-tie.

6. The intragastric device according to claim 5 wherein the continuous strip of material is folded to form a plurality of bundles in the first configuration, each of said bundles comprising a plurality of loops connected together to form a shape suggestive of a butterfly or bow-tie, and wherein said plurality of bundles are connected together in the second configuration.

7. The intragastric device according to claim 6 wherein each of the bundles is introduced into the gastric lumen of the mammal separately.

8. The intragastric device according to claim 5 wherein the plurality of loops are connected together with a nylon thread that passes through an aperture in each loop.

9. The intragastric device according to claim 5 wherein the continuous strip of material comprises a flattened tube of material.

10. The intragastric device according to claim 5 wherein the continuous strip of material comprises a folded strip of material.

11. The intragastric device according to claim 5 wherein the continuous strip of material comprises a pair of folded strips of material, one strip being nested inside the other.

12. The intragastric device according to claim 1 wherein said digestive-resistant material comprises a plurality of strips of material that have been connected together to form a device having a shape suggestive of a butterfly or bow-tie.

13. The intragastric device according to claim 12 wherein the plurality of strips of material have been connected together to form a plurality of bundles in the first configuration, each of said bundles comprising a plurality of strips of material connected together to form a shape suggestive of a butterfly or bow-tie, and wherein said plurality of bundles are connected together in the second configuration.

14. The intragastric device according to claim 13 wherein each of the bundles is introduced into the gastric lumen of the mammal separately.

15. The intragastric device according to claim 12 wherein the plurality of strips of material are connected together with a nylon thread that passes through an aperture in each strip.

16. The intragastric device according to claim 12 wherein the plurality of strips of material each comprise a flattened tube of material.

17. The intragastric device according to claim 12 wherein the plurality of strips of material each comprise a folded strip of material.

18. The intragastric device according to claim 12 wherein the plurality of strips of material each comprise a pair of folded strips of material, one strip being nested inside the other.

19. The intragastric device according to claim 1 wherein said digestive-resistant material comprises a sheet of material that has been folded or pleated to form a shape suggestive of a butterfly or bow-tie.

20. The intragastric device according to claim 19 wherein a nylon thread passes through a plurality of apertures in the sheet of material and is tied so as to form the shape suggestive of a butterfly or bow-tie.

21. The intragastric device according to claim 1 wherein said digestive-resistant material comprises a continuous thread of nylon that has tied to form a ball-like mass.

22. The intragastric device according to claim 21 wherein the continuous thread of nylon is tied to form a plurality of ball-like masses in the first configuration, and wherein said plurality of ball-like masses are connected together in the second configuration.

23. The intragastric device according to claim 22 wherein each of said bundles is introduced into the gastric lumen separately.

24. The intragastric device according to claim 1 wherein the intragastric device has been introduced into the gastric lumen of the mammal with an endoscopic device.

25. The intragastric device according to claim 1 wherein the intragastric device has been introduced into the gastric lumen of the mammal in stages, wherein a sub-component of the intragastric device is introduced into the gastric lumen in each stage, said sub-components being combined with each other in the gastric lumen to form a single intragastric device.

26. The intragastric device according to claim 1 wherein the intragastric device is contained within a delivery catheter when in the first configuration, and is pushed out of the delivery catheter and allowed to expand to form the second configuration.

27. The intragastric device according to claim 1 wherein the intragastric device is contained within a delivery sheath when in the first configuration, and is removed from the delivery sheath and allowed to expand to form the second configuration.

28. The intragastric device according to claim 27 wherein the delivery sheath comprises an outer wrapping that may be split by an operator to permit the intragastric device to expand to form the second configuration.

29. The intragastric device according to claim 27 wherein the delivery sheath comprises an dissolvable material that will dissolve in the gastric lumen to permit the intragastric device to expand to form the second configuration.

30. A method for the treatment of obesity in mammals, said method comprising the steps of:

a) introducing an intragastric device into a gastric lumen of the mammal, said intragastric device comprising a digestive-resistant material that has been compacted into a first configuration that is sufficiently small to permit introduction of said intragastric device into a gastric lumen of the mammal;

b) expanding the intragastric device into a second configuration that is sufficiently large to prevent said intragastric device from passing through the mammal'"'"'s pylorus; and

c) permitting said intragastric device to function as an artificial bezoar.

31. A method for the treatment of obesity in mammals, said method comprising the steps of:

a) introducing a plurality of sub-components of an intragastric device into a gastric lumen of the mammal, each sub-component of the intragastric device comprising a digestive-resistant material that is formed into a first configuration that is sufficiently small to permit introduction of said subcomponent into a gastric lumen of the mammal;

b) connecting the plurality of sub-components together to form a unitary intragastric device having a second configuration that is sufficiently large to prevent said intragastric device from passing through the mammal'"'"'s pylorus; and

c) permitting said unitary intragastric device to function as an artificial bezoar.