Satiation devices and methods

• US 20040138761A1
• Filed: 01/05/2004
• Published: 07/15/2004
• Est. Priority Date: 08/27/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Barosense, Inc. (Boston Scientific Scimed Incorporated)
• Inventors: Williams, Michael S., Glenn, Richard A., Stack, Richard S., Athas, William L.
• Granted Patent: US 7,981,162 B2
• Time in Patent Office: Days
• US Class Current: 623/23.65
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal

Abstract

A device for inducing weight loss in a patient includes a tubular prosthesis positionable at the gastro-esophageal junction region, preferably below the z-line. In a method for inducing weight loss, the prosthesis is placed such that an opening at its proximal end receives masticated food from the esophagus, and such that the masticated food passes through the pouch and into the stomach via an opening in its distal end.

Claims

1. A method for inducing weight loss in a patient, comprising the steps of:

providing a pouch having a proximal opening and a distal opening;

positioning at least a portion of the pouch within the stomach of a patient;

securing the proximal portion of the pouch within the gastro-esophageal junction region such that the proximal opening receives food from the esophagus and such that the distal opening is positioned within the stomach; and

causing food ingested by the patient to flow from the esophagus into the proximal opening, and out the distal opening into the stomach.

2. The method of claim 1 wherein the proximal opening has a diameter that is larger than the diameter of the distal opening.

3. The method of claim 2 wherein the pouch has an approximate funnel shape.

4. The method of claim 1 wherein the securing step includes securing the proximal portion to tissue below the Z-line of the gastro-esophageal junction region.

5. The method of claim 1 wherein the securing step includes securing the proximal portion to tissue above the Z-line of the gastro-esophageal junction region.

6. The method of claim 1 wherein the proximal portion is secured using sutures.

7. The method of claim 1 wherein the proximal portion is secured using clips.

8. The method of claim 1 wherein the proximal portion is secured using biological adhesive.

9. The method of claim 1 wherein the pouch includes a neck and wherein the proximal opening is formed in the neck.

10. The method of claim 9, wherein the securing step includes securing the neck within the esophagus.

11. The method of claim 1 wherein the pouch is expandable from a collapsed position to an expanded position, and wherein the method includes passing the pouch into the stomach in the collapsed position, and expanding the pouch to the expanded position.

12. The method of claim 11 wherein the pouch is self-expandable from the collapsed to the expanded position.

13. The method of claim 1 wherein the positioning step includes extending a sheath through a patient'"'"'s esophagus to the gastro-esophageal junction region, and passing the pouch through the sheath and into the stomach.

14. The method of claim 13 wherein the passing step includes pushing the pouch through the sheath using a pushing tool.

15. The method of claim 1 wherein the positioning step includes grasping the pouch using jaw members of a grasper, inserting a sheath through a patient'"'"'s esophagus to the gastro-esophageal junction region, and carrying the pouch through the sheath and into the stomach using the grasper.

16. The method of claim 1 wherein the distal opening has a diameter and wherein the method includes the step of adjusting the diameter of the distal opening.

17. The method of claim 16 wherein the adjusting step is performed prior to the securing step.

18. The method of claim 17 wherein the adjusting step is performed after the securing step.

19. The method of claim 1, further including the step of leaving the pouch within the stomach for a desired period of time, and then removing the pouch from the stomach.

20. The method of claim 19 wherein the removing step includes passing a sheath through the esophagus, grasping the pouch using a grasping device extended through the sheath, and withdrawing the pouch into the sheath.

21. The method of claim 20 wherein the removing step further includes clipping sutures extending between the sheath and the stomach prior to withdrawing the pouch.

22. An apparatus for inducing weight loss in a patient, the apparatus comprising:

a pouch having a proximal opening and a distal opening, the pouch proportioned such that when the proximal opening is positioned at the gastro-esophageal junction region of a patient, the distal opening opens into the stomach such that food from the esophagus passes directly into the proximal opening, passes through the pouch and then into the stomach.

23. The apparatus of claim 22 wherein the proximal opening has a diameter that is larger than the diameter of the distal opening.

24. The apparatus of claim 23 wherein the pouch has an approximate funnel shape.

25. The apparatus of claim 22 wherein the pouch is self-expandable from a collapsed position to an expanded position.

26. The apparatus of claim 25 wherein the pouch includes at least one structural element.

27. The apparatus of claim 26 wherein the structural element is formed of a shape memory material.

28. The apparatus of claim 27 wherein the shape memory material is nitinol.

29. The apparatus of claim 27 wherein the shape memory material is a shape memory polymer.

30. The apparatus of claim 26 wherein the structural element is formed of a coil.

31. The apparatus of claim 26 wherein the structural element is formed of mesh.

32. The apparatus of claim 22 wherein the proximal portion of the pouch includes a sewing region.

33. The apparatus of claim 22 further including a cage positionable within the proximal region of the stomach, the pouch attachable to the proximal portion of the cage such that the distal opening extends into the interior of the cage.

34. The apparatus of claim 22 further including an alignment tube positionable within the distal region of the esophagus, the alignment tube including a distal end attachable to the proximal end of the pouch.

35. The apparatus of claim 34 further including a cage positionable within the proximal region of the stomach, the pouch attachable to the proximal portion of the cage such that the distal opening extends into the interior of the cage.

36. The apparatus of claim 22 further including a neck attached to a proximal portion of the pouch, the neck positionable within the esophagus.

37. The apparatus of claim 22, further including a collar at the distal portion of the pouch, the collar compressible to a first diameter and expandable to a second diameter to alter a diameter of the distal opening.

38. The apparatus of claim 22, further including a one-way valve at the distal opening, the valve oriented such that when the device is implanted, the valve prevents reflux from the stomach into the pouch.

39. The apparatus of claim 22 wherein the distal portion of the pouch is formed of elastic material.

40. The apparatus of claim 22 wherein the pouch is formed of bio-absorbable material.