Satiation devices and methods

• US 20040117031A1
• Filed: 01/16/2003
• Published: 06/17/2004
• Est. Priority Date: 08/27/2001
• Status: Abandoned Application

• Current Assignee: Barosense, Inc. (Boston Scientific Corporation)
• Original Assignee: Barosense, Inc. (Boston Scientific Corporation)
• Inventors: Williams, Michael S., Glenn, Richard A., Stack, Richard S., Athas, William L., Moody, Trevor J., Silverstein, Fred E., Every, Nathan
• Application Number:
  US10/345,914
• Publication Number:
  US 20040117031A1
• 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 satiation device is described which includes a sheath or liner extending from the proximal or middle stomach to the distal antrum. Food ingested by the patient passes through the sheath or liner, thereby minimizing contact between the ingested food and the stomach. It is believed that over time, reduced contact between food and the stomach will result in decreased Ghrelin production by the patient and a consequent decrease in appetite. In some embodiments, the satiation device may also include a proximal pouch and/or a distal bypass tube.

Claims

1. A method for inducing weight loss in a patient having a stomach, an antrum, and a pylorus, the method comprising the steps of:

positioning a prosthesis within a patient'"'"'s stomach, the prosthesis having a proximal opening and a distal opening and a passage extending between the proximal and distal openings;

causing the patient to ingest food material, at least a portion of the food material passing through the proximal opening into the prosthesis;

allowing food material to exit the prosthesis and to flow into the pylorus; and

allowing gastric secretions of the stomach to flow around at least a portion of the prosthesis and into the pylorus.

2. The method of claim 1, wherein the causing and allowing steps reduce the amount of food material absorbed by an interior surface of the stomach.

3. The method of claim 1, further including the steps of repeating the causing and allowing steps multiple times, resulting in a decrease of Ghrelin secretion by the stomach and thereby reducing sensations of hunger in the patient.

4. The method of claim 1, wherein the causing step reduces contact between ingested food material and an interior surface of the antrum.

5. The method of claim 1, wherein the stomach includes a fundus and wherein the causing step reduces contact between ingested food material and an interior surface of the fundus.

6. The method of claim 1, wherein the step of allowing gastric secretions to flow into the pylorus includes allowing the gastric secretions to flow from the stomach into the prosthesis.

7. The method of claim 6, wherein the gastric secretions flow into the prosthesis through an opening in the proximal portion of the prosthesis.

8. The method of claim 6, wherein the gastric secretions flow into the prosthesis through one or more openings in a wall of the prosthesis.

9. The method of claim 8, wherein the one or more openings are proportioned to permit flow of gastric secretions into the prosthesis while substantially preventing ingested food material from passing through the one or more openings.

10. The method of claim 1, wherein at least a portion of the gastric secretions flow into the pylorus without passing through the prosthesis.

11. The method of claim 1, wherein the positioning step includes securing a proximal portion of the prosthesis within the gastro-esophageal junction region such that the proximal opening receives food directly from the esophagus.

12. The method of claim 11, wherein the securing step includes securing the proximal portion to tissue below the Z-line of the gastro-esophageal junction region.

13. The method of claim 1, wherein the positioning step includes securing the distal portion of the prosthesis within the distal portion of the stomach.

14. The method of claim 1, wherein the prosthesis is expandable from a collapsed position in which the prosthesis has a first diameter to an expanded position in which the prosthesis has a second, larger, diameter, and wherein the positioning step includes the steps of:

with the prosthesis in the collapsed position, inserting the prosthesis into the stomach; and

expanding the prosthesis from the collapsed to the expanded position.

15. The method of claim 14, wherein the prosthesis self-expands to the expanded position.

16. The method of claim 1, wherein the proximal opening of the prosthesis is smaller than the distal opening.

17. The method of claim 1, further including the steps of:

positioning a tubular pouch in the gastro-esophageal junction region of the stomach, the pouch including a proximal opening and a distal opening;

causing food ingested by the patient to pass from the esophagus into the proximal opening of the pouch, and to pass from the pouch through the distal opening and into the tubular prosthesis.

18. The method of claim 17, wherein the proximal opening of the pouch is smaller than the distal opening.

19. The method of claim 17, wherein the pouch is tapered from a proximal portion of the pouch to a more distal portion of the pouch.

20. The method of claim 18, wherein a distal portion of the pouch includes an elongate chute, and wherein the distal opening is in the chute.

21. The method of claim 20, wherein a one-way valve is provided between the chute and the pouch, and wherein the method includes preventing flow of food material from the chute into the pouch.

22. The method of claim 17, wherein food material passing into the pouch causes the pouch to distend and impart pressure against a portion of the stomach, causing the patient to experience sensations of fullness.

23. The method of claim 17, wherein the positioning step includes securing the pouch to tissue below the Z-line of the gastro-esophageal junction region.

24. The method of claim 17, wherein at least a portion of the pouch is disposed within the prosthesis.

25. The method of claim 17, wherein the prosthesis extends from a distal portion of the pouch.

26. The method of claim 1, wherein the positioning step positions the proximal opening of the prosthesis at a position between a fundus of the stomach and the pylorus

27. The method of claim 1, wherein the positioning step positions the proximal opening of the prosthesis adjacent to the esophagus and positions the distal opening of the prosthesis adjacent to the pyloric sphincter.

28. The method of claim 1, wherein the prosthesis includes a distal tube, and wherein the positioning step includes positioning the distal tube through the pylorus, and wherein the method includes causing food material to pass from the prosthesis into the distal tube.

29. The method of claim 1, wherein the distal tube includes a first portion, a second portion, and a tether connecting the first and second portions, and wherein the positioning step includes positioning the distal tube such that the tether is adjacent the ampulla vader.

31. The apparatus of claim 29, wherein the prosthesis includes a wall formed of a material that prevents passage of food material through the wall.

32. The apparatus of claim 31, wherein at least a portion of the wall is fluid permeable to permit gastric secretions to pass through the sidewall and into the prosthesis.

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

a prosthesis having a proximal opening and a distal opening and a passage between the proximal and distal openings, at least a portion of the prosthesis positionable within a patient'"'"'s stomach, the proximal opening proportioned to receive at least a portion of food material ingested by the patient, and the distal opening proportioned to permit said food material to exit the prosthesis and to flow into the pylorus, the prosthesis configured to permit gastric secretions of the stomach to flow around at least a portion of the prosthesis and into the pylorus

33. The apparatus of claim 30, wherein the prosthesis is positionable in the stomach to permit a least a portion of gastric secretions of the stomach to flow into the pylorus without passing through the prosthesis.

34. The apparatus of claim 30, further including securing means for securing the proximal portion of the prosthesis at the gastro-esophageal junction region such that food from the esophagus passes directly into the proximal opening.

35. The apparatus of claim 34, wherein the securing means include sutures.

36. The apparatus of claim 34, wherein the securing means include clips.

37. The apparatus of claim 34, wherein the securing means include adhesives.

38. The apparatus of claim 34, wherein the securing means includes a structure expandable from a streamlined positioned for insertion into the stomach to an expanded position for contact with the walls of the stomach.

39. The apparatus of claim 30, further including securing means for securing the distal portion of the prosthesis within the stomach.

40. The apparatus of claim 39, wherein the securing means include clips.

41. The apparatus of claim 39, wherein the securing means include adhesives.

42. The apparatus of claim 39, wherein the securing means includes a structure expandable from a streamlined positioned for insertion into the stomach to an expanded position for contact with the walls of the stomach.

43. The apparatus of claim 30, further including a pouch, the pouch including a proximal opening and a distal opening, the pouch positionable in the gastro-esophageal junction region of the stomach such that food ingested by the patient passes from the esophagus into the proximal opening of the pouch, and from the pouch through the distal opening and into the prosthesis.

44. The apparatus of claim 43, wherein the proximal opening of the pouch is smaller than the distal opening of the pouch.

45. The apparatus of claim 44, wherein the pouch is tapered from a proximal portion of the pouch to a more distal portion of the pouch.

46. The apparatus of claim 44, wherein a distal portion of the pouch includes an elongate chute, and wherein the distal opening is in the chute.

47. The apparatus of claim 46, further including a one-way valve between the chute and the pouch.

48. The apparatus of claim 43, wherein the pouch is formed of an expandable material such that food material passing into the pouch causes the pouch to distend and impart pressure against a portion of the stomach, causing the patient to experience sensations of fullness.

49. The apparatus of claim 43, wherein at least a portion of the pouch is disposed within the prosthesis.

50. The apparatus of claim 43, wherein the prosthesis extends from a distal portion of the pouch.

51. The apparatus of claim 30, wherein the prosthesis includes a tail section proportioned to extend from the antrum into the small intestine.

52. The apparatus of claim 30, wherein the tail section includes a pair of tubes and a tether extending between the tubes.

53. The apparatus of claim 30, wherein the distal opening is smaller than the proximal opening.

54. The apparatus of claim 30, wherein the prosthesis is proportioned to reduce contact between ingested food material and an interior surface of the antrum.

55. The apparatus of claim 30, wherein the prosthesis is proportioned to reduce contact between ingested food material and an interior surface of the fundus.