Method and apparatus for reducing obesity

• US 20050192614A1
• Filed: 11/30/2004
• Published: 09/01/2005
• Est. Priority Date: 02/26/2004
• Status: Active Grant

• Current Assignee: Endosphere, Inc
• Original Assignee: Endosphere, Inc
• Inventors: Binmoeller, Kenneth F.
• Granted Patent: US 7,931,693 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 5/0013 Implantable devices or invasive measures
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

Method and apparatus for treatment of morbid obesity by placement of a series of flow reduction elements in the small intestine to induce satiety are disclosed. The flow reduction elements restrict the movement of partially digested food and reduce the flow rate through the small intestine which causes the emptying of the stomach and the duodenum to occur slower. The flow reduction elements are attached to an elongated tube and are constructed from various shapes and configurations. The flow reduction elements may be inflated with fluid or may be constructed from self-expandable materials. The device is anchored in the antrum of the stomach with an anchoring member. The transoral gastric device can be inserted with a delivery catheter through the working lumen of an endoscope or alongside an endoscope and may be removed with the aid of an endoscope if desired.

Claims

1. A duodenal/small intestinal insert for treating obesity in humans by reducing the desire for eating, comprising:

an elongated member, said elongated member having a proximal end and a distal end;

an anchoring member engaged with said elongated member;

and at least one flow reduction element positioned within the small intestine.

2. A duodenal/small intestinal insert of claim 1, wherein a portion of the elongated member between the anchoring member and the flow reduction element is rigid.

3. A duodenal/small intestinal insert of claim 1, wherein a portion of the elongated member between the anchoring member and the flow reduction element is flexible.

4. A duodenal/small intestinal insert of claim 1, wherein the elongated member is formed from shape memory materials.

5. A duodenal/small intestinal insert of claim 1, wherein the elongated member contains shape memory materials.

6. A duodenal/small intestinal insert of claim 1, wherein the elongated member is formed from a spring material.

7. A duodenal/small intestinal insert of claim 1, wherein the flow reduction element is concentric with the elongated member.

8. A duodenal/small intestinal insert of claim 1, wherein the flow reduction element is eccentric to the elongated member.

9. A duodenal/small intestinal insert of claim 1, wherein the elongated member is a tube.

10. A duodenal/small intestinal insert of claim 9, wherein the flow reduction element can be inflated from a first volume to a second volume with a fluid introduced into the proximal end of the elongated member.

11. A duodenal/small intestinal insert of claim 10, wherein the fluid is a gas.

12. A duodenal/small intestinal insert of claim 1, wherein the flow reduction element occupies about 30-80% of the small intestine diameter.

13. A duodenal/small intestinal insert of claim 1, wherein the flow reduction element occupies about 40-60% of the small intestine diameter.

14. A duodenal/small intestinal insert of claim 1, wherein the flow reduction element is sized to restrict but not occlude the movement of digested food through the small intestine.

15. A duodenal/small intestinal insert of claim 1, wherein the flow reduction element contains a spring.

16. A duodenal/small intestinal insert of claim 1, wherein the flow reduction element self expands from a first volume to a second volume when unrestrained.

17. A duodenal/small intestinal insert of claim 16, wherein the flow reduction element is formed from open or closed cell foam.

18. A duodenal/small intestinal insert of claim 17, wherein the flow reduction element is impregnated with pharmacologics, biochemicals, alimentary lipids, alimentary peptides or metabolic substances.

19. A duodenal/small intestinal insert of claim 18, wherein the pharmacologics, biochemicals, alimentary lipids, alimentary peptides or metabolic substances are released into the small intestine over time.

20. A duodenal/small intestinal insert of claim 1, wherein the anchoring member is configured to reside in the antrum and when fully deployed restrict distal migration of the elongated member.

21. A duodenal/small intestinal insert of claim 20 wherein the anchoring member comprises two or more balloons eccentrically arranged on the proximal end of the elongated member.

22. A duodenal/small intestinal insert of claim 21, wherein the balloons are inflatable and their combined diameter is larger than the opening of the pylorus.

23. A duodenal/small intestinal insert of claim 20, wherein the anchoring member comprises two or more volume occupying members that self expand from a first volume to a second volume when unrestrained and their combined diameter is larger than the opening to into the pylorus.

24. A duodenal/small intestinal insert of claim 20, wherein the anchoring member comprises:

a collapsible, umbrella cage with a closed end and an open end, said closed end connected to the proximal end of the elongated member, the open end oriented toward the pylorus, and the open end of the umbrella cage is attached to a toroid.

25. The anchoring member of claim 24, wherein the umbrella cage is constructed from a shape memory material.

26. The anchoring member of claim 24, wherein, wherein the umbrella cage is constructed from a spring material.

27. A duodenal/small intestinal according to claim 1, wherein a self sealing valve is positioned at the proximal opening of the elongated member, said valve adapted to control the amount of fluid introduced or released from said elongated member.

28. A duodenal/small intestinal insert of claim 1, wherein the elongated member is flexible and conforms to the angulations of the duodenum and the small intestine.

29. A duodenal/small intestinal insert of claim 1, wherein the elongated member is formed with a configuration that conforms to the angulations of the duodenum and assists in restricting distal migration of the elongated member.

30. The intestinal insert described in claim 29 wherein the elongated member can be straightened for introduction into the duodenum and then return to a configuration that conforms to the angulations of the duodenum.

31. A method for treating obesity in humans by reducing the desire for eating, comprising:

providing, an elongated member, said elongated member having at least one central lumen, a proximal end and a distal end;

at least one flow reduction element connected to the elongated member and placeable within the small intestine;

at least one anchoring member engaged with said elongated member proximal to the flow reduction element, the anchoring member being configured for placement in the stomach to prevent migration of the elongated member distally into the small intestine;

collapsing at least one of;

the anchoring member, and the flow reduction element along a longitudinal axis of the insert;

advancing the elongated member into the patient until the anchoring member is disposed in the stomach and the flow reduction element is disposed in the small intestine;

injecting fluid into at least one central lumen to expand the anchoring member and flow reduction element.

32. A method for treating obesity in humans by reducing the desire for eating, comprising:

providing an elongated member with at least one flow reduction element connected to the elongated member, the flow reduction element placeable within the small intestine;

at least one anchoring member engaged with the elongated member proximal to the flow reduction element, the anchoring member being configured for placement in the stomach to prevent migration of the elongated member distally in the small intestine; and

collapsing at least one of;

the anchoring member, and the flow reduction element along a longitudinal axis of the elongated member by application of a collapsing force;

advancing the elongated member into the patient until the anchoring member is disposed in the stomach and the flow reduction element is disposed in the small intestine;

releasing the collapsing force to cause at least one of;

the anchoring member, and the flow reduction element to return to its original shape and size.

33. A method for treating obesity in humans by reducing the desire for eating, comprising:

providing, a duodenal/small intestinal insert having at least one flow reduction element positioned on an elongated member, the flow reduction element sized for placement within the small intestine;

the flow reduction element reducing the flow rate of partially digested food through the small intestine and maintaining a volume of food in the stomach to produce a feeling of satiety.

34. A method for treating obesity in humans by reducing the desire for eating, comprising:

providing, an insert having at least one flow reduction element positioned on an elongated member, the flow reduction element sized for placement within the small intestine;

said elongated member having a proximal end and a distal end;

said flow reduction element reducing the flow rate of food through small intestine.

35. A method for treating obesity in a human patient, comprising the acts of:

disposing at least one flow reduction element in the small intestine of the patient;

disposing at least one anchoring member coupled to the flow reduction element in the stomach of the patient, wherein the anchoring member cannot pass out of the stomach into the small intestine,

thereby preventing migration of the flow reduction element out of the small intestine into the large intestine.