BARIATRIC DEVICE AND METHOD

• US 20070293716A1
• Filed: 08/08/2006
• Published: 12/20/2007
• 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.
• Granted Patent: US 7,846,174 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• 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 a wall defining a lumen, said 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, said wall adapted to exert force 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.

2. The bariatric device as claimed in claim 1, wherein said body is elongated along a longitudinal axis and wherein said body is longitudinally non-symmetrical with respect to said longitudinal axis.

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

4. The bariatric device as claimed in claim 1, wherein said wall is sized to generally conform to the size and shape of the abdominal portion of the esophagus, the esophageal-gastric junction and the proximal cardiac portion of the stomach, and said wall being adapted to exert force at least on the abdominal portion of the esophagus and the proximal cardiac portion of the stomach.

5. The bariatric device as claimed in claim 4, wherein said body has first and second geometrical portions, said first geometrical portion being generally cylindrical, and said second geometrical portion being flared.

6. The bariatric device as claimed in claim 1, wherein said wall includes a self-expanding portion that is adapted to exert force and a substantially non-self-expanding portion that is adapted to not exert force.

7. 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.

8. The bariatric device as claimed in claim 7, wherein said fixation mechanism includes at least a portion of said body being adapted to facilitate tissue ingrowth.

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

10. The bariatric device as claimed in claim 4 including a restriction to resist egress from said lumen.

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

12. A bariatric device comprising:

a body having a wall defining a lumen, said wall being sized to generally conform to one chosen from an abdominal portion of the esophagus and a proximal cardiac portion of the stomach;

at least a portion of said wall adapted to facilitate tissue ingrowth; and

at least a portion of said wall adapted to exert force on said one chosen from an abdominal portion of the esophagus and a proximal cardiac portion of the stomach wherein the force 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.

13. The bariatric device according to claim 12, wherein said wall is sized to conform to the shape and size of the abdominal portion of the esophagus.

14. The bariatric device according to claim 13, wherein said lumen has a length less than 9 cm.

15. The bariatric device according to claim 12, wherein said wall is configured to generally conform to the shape and size of the proximal cardiac portion of the stomach.

16. The bariatric device according to claim 15, wherein said wall is flared to thereby conform to the cardiac notch of the proximal cardiac portion of the stomach.

17. The bariatric device according to claim 15, wherein said lumen is free of any restriction.

18. A bariatric device comprising:

a body having a wall defining a lumen, said body being free of any restrictions in said lumen, said wall being sized to generally conform to one chosen from an abdominal portion of the esophagus and a proximal cardiac portion of the stomach; and

at least a portion of said wall adapted to exert force to said one chosen from an abdominal portion of the esophagus and a proximal cardiac portion of the stomach, wherein said lumen is less than 9 cm in length.

19. The bariatric device as claimed in claim 18, wherein said lumen has a length that is in the range of between approximately 6 cm and approximately 7 cm.

20. The bariatric device according to claim 18, wherein said portion of said wall is adapted to conform to the abdominal portion of the esophagus and exerts force on said abdominal portion of the esophagus.

21. The bariatric device according to claim 20, wherein said wall includes a chamber, said chamber including a fluid, said fluid applying the force on the abdominal portion of the esophagus.

22. The bariatric device according to claim 21, wherein another portion of said wall is adapted to generally conform to the esophageal-gastric junction and comprises a non-force exerting portion.

23. The bariatric device according to claim 18, wherein said portion of said wall is adapted to conform to the proximal cardiac portion of the stomach.

24. The bariatric device according to claim 23, wherein another portion of said wall is adapted to conform to the abdominal portion of the esophagus.

25. The bariatric device according to claim 24, wherein a third portion of said wall is further adapted to conform to the esophageal-gastric junction.

26. The bariatric device according to claim 25, wherein the portions of the wall that are adapted to conform to the abdominal portion of the esophagus and to the proximal cardiac portion of the stomach comprise self-expanding portions, and the portion of the wall conforming to the esophageal-gastric junction comprising a non-self-expanding portion.

27. The bariatric device according to claim 26, wherein said non-self-expanding portion comprises a flaccid portion.

28. The bariatric device as claimed in claim 18 including at least one fixation mechanism that is adapted to resist migration of said body.

29. The bariatric device as claimed in claim 28, wherein said fixation mechanism includes at least a portion of said body being adapted to facilitate tissue ingrowth.

30. A bariatric device comprising:

a body having a wall, said wall defining a lumen, said lumen extending through said body, said wall having a portion sized to conform to an abdominal portion of the esophagus, a portion sized to conform to an esophageal-gastric junction, and a portion sized to conform to said a proximal cardiac portion of the stomach;

said wall adapted to exert force on the patient'"'"'s abdominal portion of the esophagus and the proximal cardiac portion of the stomach; and

said portion of said wall sized to conform to the esophageal-gastric junction having a substantially non-self-expanding portion for positioning at the gastro esophageal sphincter wherein said non-self-expanding portion does not apply significant force to the gastro esophageal sphincter.

31. The bariatric device according to claim 30, wherein said non-self-expanding portion comprises a flaccid portion.

32. The bariatric device according to claim 30, wherein said lumen is less than 9 cm in length.

33. The bariatric device according to claim 30, further comprising at least one fixation mechanism to resist migration of said body in the patient.

34. The bariatric device according to claim 33, wherein at least a portion of said wall is adapted to allow cell ingrowth.

35. The bariatric device according to claim 30, wherein said wall is adapted to exert a variable force on the abdominal portion of the esophagus and/or the proximal cardiac portion of the stomach.

36. The bariatric device according to claim 35, wherein said portion sized to conform to the proximal cardiac portion of the stomach is flared.

37. A bariatric device comprising:

a body having a wall defining a lumen, said 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, said wall adapted to exert an adjustable force 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, wherein the adjustable force influences a neurohormonal feedback mechanism of a patient when the bariatric device is positioned in the at least one chosen from i) the abdominal portion of the esophagus, ii) the esophagus-gastric junction, and iii) the proximal cardiac portion of the stomach to cause at least partial satiety by augmenting fullness caused by food and simulating fullness in the absence of food.

38. The bariatric device as claimed in claim 37, wherein said wall defines a chamber wherein an amount of fluid in said chamber adjusts the force exerted by said wall.

39. The bariatric device as claimed in claim 38 including a port providing external access to said chamber.

40. The bariatric device as claimed in claim 37 including a control, said control is adapted to control an amount of force exerted by said wall.

41. The bariatric device as claimed in claim 40, wherein said control is adapted to temporarily adjust an amount of force exerted by said wall.

42. The bariatric device as claimed in claim 40, wherein said control comprises remote control.

43. A method of causing at least partial satiety in a patient comprising:

providing a body having a wall defining a lumen;

positioning said body at at least one chosen from i) an abdominal portion of the esophagus, ii) an esophageal-gastric junction and (iii) a proximal cardiac portion of the stomach; and

exerting force with said wall 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.

44. The method as claimed in claim 43, wherein positioning includes positioning said body at the abdominal portion of the esophagus, the esophageal-gastric junction and the proximal cardiac portion of the stomach and wherein said exerting includes exerting force with said wall at least on the abdominal portion of the esophagus.

45. The method as claimed in claim 44 including providing a substantially flaccid portion of said wall, and positioning said substantially flaccid portion at the gastro esophageal sphincter to reduce interference with the anti-reflux mechanism of the patient.

46. The method as claimed in claim 43 including fixing said body to the patient to resist migration of said body.

47. The method as claimed in claim 46, wherein said fixing includes facilitating ingrowth of tissue through said wall.

48. The method as claimed in claim 43, wherein said exerting pressure includes exerting an adjustable force.

49. The method as claimed in claim 48, wherein said exerting an adjustable force includes adjusting the force endoscopically.

50. The method as claimed in claim 48, wherein said exerting an adjustable force includes adjusting the force with a control at least partially positioned at the patient.

51. The method as claimed in claim 50 including administering anti-nausea medication to the patient at least during initial deployment of said body.

52. The method as claimed in claim 50 including administering nutritional supplements to the patient.

53. A method of causing at least partial satiety in a patient, said method comprising:

providing a body having a wall defining a lumen;

positioning the body at at least one chosen from i) an abdominal portion of the esophagus, ii) an esophageal-gastric junction and (iii) a proximal cardiac portion of the stomach;

exerting force with the wall at the at least one of i) the abdominal portion of the esophagus, and (ii) the proximal cardiac portion of the stomach; and

monitoring the patient'"'"'s satiety to determine whether an appropriate level of satiety is achieved with the force exerted by the wall.

54. The method according to claim 53, further comprising adjusting the force exerted by the wall if it is determined that the appropriate level of satiety has not been achieved.

55. The method according to claim 54, wherein said adjusting includes replacing the body with another body of a different size.

56. The method according to claim 54, wherein said adjusting is achieved by adjusting the amount of force exerted by the wall at the at least one of i) the patient'"'"'s abdominal portion of the esophagus and ii) the patient'"'"'s esophageal-gastric junction.

57. The method according to claim 53, wherein said monitoring includes monitoring the hypothalamus.

58. The method according to claim 57, wherein said monitoring includes monitoring the hypothalamus during deployment of the body in the patient.

59. The method as claimed in claim 53, wherein said exerting an adjustable force includes adjusting the force according to a temporal parameter.

60. The method as claimed in claim 59, wherein said adjusting the force according to a temporal parameter includes decreasing the force during expected sleeping periods.

61. The method as claimed in claim 53 including selecting a force as a function of said monitoring.