Bariatric sleeve

• US 20050075622A1
• Filed: 11/30/2004
• Published: 04/07/2005
• Est. Priority Date: 12/02/2002
• Status: Active Grant

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Cvinar, John, Levine, Andy H., Meade, John, Melanson, Dave
• Granted Patent: US 7,267,694 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/00238 Type of minimally invasive operation A61B2017/00805 takes precedence
• CPC Class Codes: A61B 2017/0084 low friction A61B2017/00853 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/061 hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• 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 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 : provided on at least one of the ends
• CPC Class Codes: A61F 2002/9528 : for retrieval of stents
• CPC Class Codes: A61F 2210/0076 : multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• 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

Method and apparatus for limiting absorption of food products in specific parts of the digestive system is presented. A gastrointestinal implant device is anchored in the stomach and extends beyond the ligament of Treitz. All food exiting the stomach is funneled through the device. The gastrointestinal device includes an anchor for anchoring the device to the stomach and a flexible sleeve to limit absorption of nutrients in the duodenum. The anchor is collapsible for endoscopic delivery and removal.

Claims

1. A gastrointestinal implant device comprising:

a flexible, floppy sleeve, open at both ends, and adapted to extend within the intestine; and

a stent, comprising a network of struts, coupled to a proximal portion of the sleeve, and adapted to anchor the sleeve in the digestive system.

2. The gastrointestinal implant device of claim 1, wherein the stent is adapted to be retained distal to the pylorus.

3. The gastrointestinal implant device of claim 1, wherein the stent is adapted to be retained within the pyloric orifice.

4. The gastrointestinal implant device of claim 1, wherein the stent is collapsible.

5. The gastrointestinal implant device of claim 1, wherein the stent is covered by a proximal portion of the sleeve.

6. The gastrointestinal implant device of claim 5, wherein the stent is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve.

7. The gastrointestinal implant device of claim 1, wherein the sleeve is of a length that chyme exiting the stomach funneled through the proximal end of the sleeve exits the sleeve through the distal end below the ligament of Treitz.

8. The gastrointestinal implant device of claim 1, wherein the sleeve material has a coefficient of friction of less than 0.2.

9. The gastrointestinal implant device of claim 1, wherein the sleeve is formed of a fluoropolymer.

10. The gastrointestinal implant device of claim 9, wherein the fluoropolymer is expanded polytetrafluoroethylene.

11. The gastrointestinal implant device of claim 10, wherein the sleeve is coated with silicone.

12. The gastrointestinal implant device of claim 10, wherein the sleeve is coated with polyurethane.

13. The gastrointestinal implant device of claim 1, wherein the sleeve is formed of polyethylene.

14. The gastrointestinal implant device of claim 1, wherein the distal end of the sleeve is directionally textured.

15. The gastrointestinal implant device of claim 1, further comprising barbs extending from the exterior surface of the stent, the barbs being adapted to anchor the proximal portion of the sleeve in the digestive system.

16. The gastrointestinal implant device of claim 15, wherein the barbs are bi-directional.

17. The gastrointestinal implant device of claim 16 wherein the barbs anchor the flexible sleeve to the pyloric muscle in the stomach.

18. The gastrointestinal implant device of claim 1, further comprising barbs extending from the exterior surface of the stent, the barbs being adapted to anchor the proximal portion of the sleeve to muscle.

19. The gastrointestinal implant device of claim 1, further comprising an anti-buckling device coupled to the sleeve to reduce buckling of the sleeve.

20. The gastrointestinal implant device of claim 19, wherein the anti-buckling device extends from below the stent to the distal end of the flexible sleeve.

21. The gastrointestinal implant device of claim 19, wherein the anti-buckling device is adapted to reduce twisting of the sleeve.

22. The gastrointestinal implant device of claim 1, wherein the sleeve is adapted to cause enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

23. The gastrointestinal implant device of claim 1 in combination with a catheter to insert the flexible sleeve.

24. The gastrointestinal implant device of claim 1 in combination with a removal device to remove the flexible sleeve.

25. The gastrointestinal implant device of claim 1, wherein the stent is adapted for anchoring within the stomach.

26. A gastrointestinal implant device comprising:

a flexible sleeve, open at both ends, and adapted to extend within the intestine; and

a collapsible sleeve anchor coupled to a proximal end of the sleeve, the sleeve anchor comprising barbs for insertion into tissue as the sleeve anchor expands to anchor the proximal portion of the sleeve.

27. The gastrointestinal implant of claim 26, wherein the sleeve anchor is a stent.

28. The gastrointestinal implant of claim 26, wherein the sleeve anchor is a ring.

29. The gastrointestinal implant device of claim 26, wherein the tissue comprises muscle.

30. The gastrointestinal implant device of claim 26, wherein the sleeve anchor is adapted to be retained distal to the pylorus.

31. The gastrointestinal implant device of claim 26, wherein the sleeve anchor is adapted to be retained within the pyloric orifice.

32. The gastrointestinal implant device of claim 26, wherein the sleeve anchor is covered by a proximal portion of the sleeve.

33. The gastrointestinal implant device of claim 32, wherein the sleeve anchor is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve.

34. The gastrointestinal implant device of claim 26, wherein the sleeve is of a length that chyme exiting the stomach funneled through the proximal end of the sleeve exits the sleeve through the distal end below the ligament of Treitz.

35. The gastrointestinal implant device of claim 26, wherein the sleeve material has a coefficient of friction of less than 0.2.

36. The gastrointestinal implant device of claim 26, wherein the sleeve is formed of a fluoropolymer.

37. The gastrointestinal implant device of claim 36, wherein the fluoropolymer is expanded polytetrafluoroethylene.

38. The gastrointestinal implant device of claim 37, wherein the sleeve is coated with silicone.

39. The gastrointestinal implant device of claim 37, wherein the sleeve is coated with polyurethane.

40. The gastrointestinal implant device of claim 26, wherein the sleeve is formed of polyethylene.

41. The gastrointestinal implant device of claim 26, wherein the distal end of the sleeve is directionally textured.

42. The gastrointestinal implant device of claim 26, wherein the barbs are bi-directional.

43. The gastrointestinal implant device of claim 26, wherein the barbs are adapted to anchor the flexible sleeve to the pyloric muscle in the stomach.

44. The gastrointestinal implant device of claim 26, further comprising an anti-buckling device coupled to the sleeve to reduce buckling of the sleeve.

45. The gastrointestinal implant device of claim 44, wherein the anti-buckling device extends from below the anchor to the distal end of the flexible sleeve.

46. The gastrointestinal implant device of claim 43, wherein the anti-buckling device is adapted to reduce twisting of the sleeve.

47. The gastrointestinal implant device of claim 26, wherein the sleeve is adapted to cause enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

48. The gastrointestinal implant device of claim 26 in combination with a catheter to insert the flexible sleeve.

49. The gastrointestinal implant device of claim 26 in combination with a removal device to remove the flexible sleeve.

50. The gastrointestinal implant device of claim 26, wherein the collapsible sleeve anchor is adapted to be implanted distal to the pylorus.

51. The gastrointestinal implant device of claim 26, wherein the flexible sleeve is adapted to extend into the duodenum.

52. The gastrointestinal implant device of claim 26, wherein the flexible sleeve is floppy.

53. The gastrointestinal implant device of claim 26, wherein the stent is adapted for anchoring within the stomach.

54. A gastrointestinal implant device comprising:

a collapsible, floppy sleeve, open at both ends, and adapted to extend within the intestine; and

a stent, comprising a network of struts, coupled to a proximal portion of the sleeve, and adapted to retain the sleeve in the digestive system.

55. The gastrointestinal implant device of claim 54, wherein the sleeve is formed of a fluoropolymer.

56. The gastrointestinal implant device of claim 54, wherein the sleeve is adapted to be retained distal to the pylorus.

57. A gastrointestinal implant device comprising a collapsible sleeve, open at both ends, and adapted to extend within the intestine to limit absorption of nutrients in the intestine, the sleeve material having a coefficient of friction of less than 0.2.

58. The gastrointestinal implant device of claim 57, further comprising a stent, comprising a network of struts, coupled to a proximal portion of the sleeve, and adapted to anchor the sleeve in the digestive system.

59. The gastrointestinal implant device of claim 58, wherein the collapsible sleeve is adapted to extend within the duodenum.

60. The gastrointestinal implant device of claim 57, wherein the collapsible sleeve is floppy.

61. The gastrointestinal implant device of claim 57, wherein the sleeve is formed of a fluoropolymer.

62. The gastrointestinal implant device of claim 61, wherein the fluoropolymer is expanded polytetrafluoroethylene.

63. The gastrointestinal implant device of claim 57, further comprising a collapsible anchor coupled to a proximal end of the sleeve.

64. The gastrointestinal implant device of claim 63, wherein the sleeve is formed of expanded polytetrafluoroethylene.

65. The gastrointestinal implant device of claim 57, wherein the sleeve is adapted to be retained distal to the pylorus.

66. A gastrointestinal implant device comprising a collapsible sleeve formed of expanded polytetrafluoroethylene, open at both ends, and adapted to be anchored within the digestive system and positioned to extend through a portion of the intestine.

67. The gastrointestinal implant device of claim 66, further comprising a collapsible sleeve anchor coupled to a proximal portion of the sleeve, the sleeve anchor being adapted to anchor the sleeve within the digestive system.

68. The gastrointestinal implant device of claim 66, further comprising a stent, comprising a network of struts, coupled to a proximal portion of the sleeve, and adapted to retain the sleeve in the digestive system.

69. The gastrointestinal implant device of claim 66, wherein the collapsible sleeve is adapted to extend into the duodenum.

70. The gastrointestinal implant device of claim 66, wherein the collapsible sleeve is floppy.

71. The gastrointestinal implant device of claim 66, wherein the collapsible sleeve is adapted to be anchored distal to the pylorus.

72. The gastrointestinal implant device of claim 66, wherein the fluoropolymer is expanded polytetrafluoroethylene.