Bariatric device and method

• US 7,846,174 B2
• Filed: 08/08/2006
• Issued: 12/07/2010
• Est. Priority Date: 10/15/2004
• Status: Active Grant

• Current Assignee: BFKW, LLC
• Original Assignee: BFKW, LLC
• Inventors: Baker, Randal S., Kemmeter, Paul R., Foote, James A.
• Primary Examiner(s): Mendez; Manuel A
• Application Number:
  US11/463,192
• Publication Number:
  US 20070293716A1
• Time in Patent Office: 1,582 Days
• Field of Search: 128/898, 623/1.1, 623/11.11, 623/23.64, 623/23.65, 600/97, 606213-219, 606/139, 606/192, 606/191, 604104-109, 604/99.01, 604/500
• US Class Current: 606/191
• 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 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• 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 5/0013 Implantable devices or invasive measures
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/004 remotely adjustable
• CPC Class Codes: A61F 5/0043 using injection ports
• CPC Class Codes: A61F 5/0069 in the wall of the stomach
• 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 bariatric device includes a body having a wall defining a lumen, the wall configured to generally conform to the shape and size of at least one chosen from i) the abdominal portion of the esophagus, ii) the esophageal-gastric junction, and iii) the proximal cardiac portion of the stomach, with the wall adapted to exert pressure on the at least one chosen from i) the abdominal portion of the esophagus, ii) the esophageal-gastric junction, and iii) the proximal cardiac portion of the stomach, thereby influencing a neurohormonal feedback mechanism of the patient to cause at least partial satiety by augmenting fullness caused by food and simulating fullness in the absence of food.

Claims

1. A bariatric device comprising:

a body having at least two wall portions, each of said wall portions defining a portion of a lumen, said lumen extending through said body;

one of said wall portions defining an esophageal member sized to conform to an abdominal portion of the esophagus;

another of said wall portions defining a cardiac member sized to conform to a proximal cardiac portion of the stomach; and

at least one tension member extending between said esophageal member and said cardiac member;

wherein said cardiac member is tapered outwardly from a proximal portion with respect to the gastrointestinal tract to a more distal portion with respect to the gastrointestinal tract and is adapted to exert a force on the cardiac portion of the stomach;

wherein the force exerted by said cardiac member on the cardiac portion of the stomach influences a neurohormonal feedback mechanism of a patient to cause at least partial satiety by augmenting fullness caused by food and simulating fullness in the absence of food.

2. The bariatric device as claimed in claim 1, wherein at least a portion of said body is radially non-symmetrical with respect to said longitudinal axis.

3. The bariatric device as claimed in claim 1, wherein said esophageal member being generally cylindrical.

4. The bariatric device as claimed in claim 1 further comprising at least one fixation mechanism that is adapted to resist distal migration of said body.

5. The bariatric device as claimed in claim 4, wherein said fixation mechanism includes at least a portion of said body being adapted to facilitate tissue ingrowth.

6. The bariatric device as claimed in claim 1, wherein said lumen is free of any substantial restrictions.

7. The bariatric device as claimed in claim 1, wherein said lumen has a length that is less than 9 cm.

8. The bariatric device as claimed in claim 1, wherein at least a portion of said wall is adapted to facilitate tissue ingrowth.

9. The bariatric device according to claim 8, wherein said lumen has a length less than 9 cm.

10. The bariatric device according to claim 1, wherein at least one of said wall portions is adapted to allow cell ingrowth.

11. The bariatric device according to claim 1, wherein at least one of said wall portions is adapted to exert a variable force on the abdominal portion of the esophagus and/or the proximal cardiac portion of the stomach.

12. The bariatric device as claimed in claim 11 including a control, said control is adapted to control an amount of force exerted by said at least one of said wall portions.

13. The bariatric device as claimed in claim 12, wherein said control is adapted to temporarily adjust an amount of force exerted by said at least one of said wall portions.

14. The bariatric device as claimed in claim 12, wherein said control comprises a remote control.

15. The bariatric device as claimed in claim 1 wherein said body is made at least in part from an absorbable material.

16. The bariatric device as claimed in claim 1 wherein said at least one tension member comprises a plurality of tension members spaced around the perimeter of said body.

17. The bariatric device as claimed in claim 1 wherein an entrance to said body is flared outwardly to bear against the esophagus.

18. The bariatric device as claimed in claim 1 wherein said at least one tension member is made from a fibrous material.

19. The bariatric device as claimed in claim 1 wherein said cardiac member is self-expanding.

20. The bariatric device as claimed in claim 1 wherein said esophageal member is self-expanding.

21. A method of causing at least partial satiety in a recipient comprising:

providing a body having a wall defining a lumen, said wall tapered outwardly from a proximal portion with respect to the gastrointestinal tract to a more distal portion with respect to the gastrointestinal tract;

positioning said body at a proximal cardiac portion of the stomach; and

exerting force with said wall on the proximal cardiac portion of the stomach, wherein the force influences a neurohormonal feedback mechanism of the recipient to cause at least partial satiety by augmenting fullness caused by food and simulating fullness in the absence of food.

22. The method as claimed in claim 21, wherein said body further includes a portion that is adapted to be positioned at the abdominal portion of the esophagus and a portion that is adapted to be positioned at the esophageal-gastric junction and wherein said positioning includes positioning said body at the abdominal portion of the esophagus, the esophageal-gastric junction and the proximal cardiac portion of the stomach.

23. The method as claimed in claim 22, wherein said portion that is adapted to be positioned at the esophageal-gastric junction comprises a substantially non-self-expanding portion of said body, and positioning said substantially non-self-expanding portion at the gastro esophageal sphincter to reduce interference with the anti-reflux mechanism of the recipient.

24. The method as claimed in claim 21 including fixing said body to the recipient to resist migration of said body.

25. The method as claimed in claim 24, wherein said fixing includes facilitating ingrowth of tissue through said wall.

26. The method as claimed in claim 21, wherein said exerting force includes exerting an adjustable force.

27. The method as claimed in claim 26, wherein said exerting an adjustable force includes adjusting the force endoscopically.

28. The method as claimed in claim 26, wherein said exerting an adjustable force includes adjusting the force with a control at least partially positioned at the recipient.

29. The method as claimed in claim 28 including administering anti-nausea medication to the recipient at least during initial deployment of said body.

30. The method as claimed in claim 28 including administering nutritional supplements to the recipient.

31. The method as claimed in claim 21 including monitoring the recipient'"'"'s satiety to determine whether an appropriate level of satiety is achieved with the force exerted by the wall.

32. The method according to claim 31, further comprising adjusting the force exerted by the wall if it is determined that the appropriate level of satiety has not been achieved.

33. The method according to claim 32, wherein said adjusting includes replacing the body with another body of a different size.

34. The method according to claim 32, wherein said adjusting is achieved by adjusting the amount of force exerted by the wall at the at least one of i) the recipient'"'"'s abdominal portion of the esophagus and ii) the recipient'"'"'s esophageal-gastric junction.

35. The method according to claim 31, wherein said monitoring includes monitoring the hypothalamus.

36. The method according to claim 35, wherein said monitoring includes monitoring the hypothalamus during deployment of the body in the recipient.

37. The method as claimed in claim 31, wherein said exerting an adjustable force includes adjusting the force according to a temporal parameter.

38. The method as claimed in claim 37, wherein said adjusting the force according to a temporal parameter includes decreasing the force during expected sleeping periods.

39. The method as claimed in claim 31 including selecting a force as a function of said monitoring.