Methods of treatment using a bariatric sleeve

• US 20050080395A1
• Filed: 11/30/2004
• Published: 04/14/2005
• 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.
• Granted Patent: US 7,347,875 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 method of treatment comprising the steps of:

anchoring a stent within the digestive system, the stent comprising a network of struts and coupled to a proximal portion of a flexible, floppy sleeve, open at both ends; and

extending the flexible sleeve within the intestine.

2. The method of treatment of claim 1, wherein the flexible sleeve is anchored in the stomach.

3. The method of treatment of claim 1, wherein the flexible sleeve is anchored distal to the pylorus.

4. The method of treatment of claim 1, wherein the anchoring step comprises anchoring a stent comprising a network of struts within the pyloric orifice, the stent coupled to a proximal portion of a flexible sleeve.

5. The method of treatment of claim 1, wherein the stent is collapsible.

6. The method of treatment of claim 1, wherein the stent is covered by a proximal portion of the sleeve.

7. The method of treatment of claim 6, wherein the stent is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve.

8. The method of treatment 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.

9. The method of treatment of claim 1, wherein the sleeve is formed of a fluoropolymer.

10. The method of treatment of claim 1, wherein the fluoropolymer is expanded polytetrafluoroethylene.

11. The method of treatment of claim 10, wherein the sleeve is coated with silicone.

12. The method of treatment of claim 10, wherein the sleeve is coated with polyurethane.

13. The method of treatment of claim 1, wherein the sleeve is formed of polyethylene.

14. The method of treatment of claim 1, wherein the distal end of the sleeve is directionally textured.

15. The method of treatment of claim 1, further comprising anchoring the proximal portion of the sleeve with barbs extending from the exterior surface of the stent.

16. The method of treatment of claim 15, wherein the barbs are bi-directional.

17. The method of treatment of claim 16, wherein the barbs anchor the flexible sleeve to the pyloric muscle in the stomach.

18. The method of treatment of claim 15, wherein a first plurality of barbs are oriented in a proximal direction and a second plurality of barbs are oriented in a distal direction.

19. The method of treatment of claim 1, further comprising anchoring the proximal portion of the sleeve with barbs extending from the exterior surface of the stent the barbs anchoring the flexible sleeve to muscle.

20. The method of treatment of claim 1, further comprising coupling an anti-buckling device to the sleeve to reduce buckling of the sleeve.

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

22. The method of claim 20, wherein the anti-buckling device reduces twisting of the sleeve.

23. The method of treatment of claim 1, further comprising causing enzymes secreted in the duodenum to pass through the duodenum outside of the extended sleeve.

24. The method of treatment of claim 1, wherein the flexible sleeve and stent are delivered to the intestine using an esophageal catheter.

25. The method of treatment of claim 1, wherein the flexible sleeve and stent are removed through the esophagus.

26. The method of treatment of claim 1, wherein the flexible sleeve extends into the duodenum.

27. The method of treatment of claim 1, wherein the sleeve has a coefficient of friction of less than 0.2.

28. The method of treatment of claim 1, wherein the anchoring step further comprises:

placing the stent within the pyloric orifice; and

holding the pylorus open using the stent.

49. The method of treatment of claim 28, further comprising coupling an anti-buckling device to the sleeve to reduce buckling of the sleeve.

50. The method of treatment of claim 49, wherein the anti-buckling device extends from below the sleeve anchor to the distal end of the flexible sleeve.

51. The method of claim 49, wherein the anti-buckling device reduces twisting of the sleeve.

29. A method of treatment comprising the steps of:

anchoring within the digestive system a proximal portion of a flexible sleeve, open at both ends, and coupled to a collapsible sleeve anchor, the sleeve anchor comprising barbs for insertion into tissue as the sleeve anchor expands to anchor the proximal portion of the sleeve; and

extending the flexible sleeve within the intestine.

30. The method of treatment of claim 29, wherein the sleeve anchor is a stent.

31. The method of treatment of claim 29, wherein the sleeve anchor is a ring.

32. The method of treatment of claim 29, wherein the flexible sleeve is anchored in the stomach.

33. The method of treatment of claim 29, wherein the flexible sleeve is anchored distal to the pylorus.

34. The method of treatment of claim 29, wherein the anchoring step further comprises:

placing the collapsible sleeve anchor within the pyloric orifice; and

holding the pylorus open using the collapsible sleeve anchor.

35. The method of treatment of claim 29, wherein the sleeve anchor is covered by a proximal portion of the sleeve.

36. The method of treatment of claim 35, wherein the sleeve anchor is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve.

37. The method of treatment of claim 29, 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.

38. The method of treatment of claim 29, wherein the sleeve material has a coefficient of friction of less than 0.2.

39. The method of treatment of claim 29, wherein the sleeve is formed of a fluoropolymer.

40. The method of treatment of claim 29, wherein the fluoropolymer is expanded polytetrafluoroethylene.

41. The method of treatment of claim 40, wherein the sleeve is coated with silicone.

42. The method of treatment of claim 40, wherein the sleeve is coated with polyurethane.

43. The method of treatment of claim 29, wherein the sleeve is formed of polyethylene.

44. The method of treatment of claim 29, wherein the distal end of the sleeve is directionally textured.

45. The method of treatment of claim 29, wherein the barbs anchor the flexible sleeve to the pyloric muscle in the stomach.

46. The method of treatment of claim 29, wherein the barbs anchor the flexible sleeve to muscle.

47. The method of treatment of claim 29, wherein the barbs are bi-directional.

48. The method of treatment of claim 29, wherein a first plurality of barbs are oriented in a proximal direction and a second plurality of barbs are oriented in a distal direction.

52. The method of treatment of claim 29, wherein the sleeve causes enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

53. The method of treatment of claim 29, wherein the flexible sleeve and sleeve anchor are delivered to the intestine using an esophageal catheter.

54. The method of treatment of claim 29, wherein the flexible sleeve and sleeve anchor are removed through the esophagus.

55. The method of treatment of claim 29, wherein the flexible sleeve extends into the duodenum.

56. The method of claim 29, wherein the flexible sleeve is floppy.

57. A method of treating type 2 diabetes comprising:

anchoring a flexible sleeve, open at both ends; and

extending the flexible sleeve into the duodenum.

58. The method of claim 57, wherein the flexible sleeve is anchored in the stomach.

59. The method of claim 57, wherein the flexible sleeve is anchored distal to the pylorus.

60. The method of claim 57, wherein the flexible sleeve is floppy.

61. The method of claim 57, 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.

62. The method of claim 57, wherein the sleeve is formed of a fluoropolymer.

63. The method of claim 57, wherein the fluoropolymer is expanded polytetrafluoroethylene.

64. The method of claim 63, wherein the sleeve is coated with silicone.

65. The method of claim 63, wherein the sleeve is coated with polyurethane.

66. The method of claim 57, wherein the sleeve is formed of polyethylene.

67. The method of claim 57, wherein the distal end of the sleeve is directionally textured.

68. The method of claim 57, further comprising coupling barbs to a collapsible sleeve anchor, the barbs extending from the exterior surface of the sleeve for anchoring the proximal portion of the sleeve.

69. The method of claim 68, wherein the barbs are configured for anchoring the proximal portion of the sleeve to the stomach.

70. The method of claim 68, wherein the barbs are configured for anchoring the proximal portion of the sleeve distal to the pylorus.

71. The method of claim 68, wherein the barbs are bi-directional.

72. The method of claim 71, wherein the barbs anchor the flexible sleeve to the pyloric muscle in the stomach.

73. The method of treatment of claim 68, wherein a first plurality of barbs are oriented in a proximal direction and a second plurality of barbs are oriented in a distal direction.

74. The method of claim 68, wherein the barbs are configured to anchor the flexible sleeve to muscle.

75. The method of claim 57, further comprising coupling an anti-buckling device to the sleeve to reduce buckling of the sleeve.

76. The method of treatment of claim 75, wherein the anti-buckling device extends substantially from the proximal end to the distal end of the flexible sleeve.

77. The method of claim 75, wherein the anti-buckling device reduces twisting of the sleeve.

78. The method of claim 57, wherein the sleeve causes enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

79. The method of claim 57, in combination with a catheter to insert the flexible sleeve.

80. The method of claim 57, in combination with a removal device to remove the flexible sleeve.

81. The method of treatment of claim 57, wherein the sleeve has a coefficient of friction of less than 0.2.

82. A method of treatment comprising the steps of:

anchoring within the gastrointestinal tract a flexible sleeve, open at both ends; and

extending the flexible sleeve into the intestine, the sleeve having a coefficient of friction of less than about 0.2.

83. The method of claim 82, wherein the extended sleeve limits absorption of nutrients in the duodenum.

84. The method of treatment of claim 82, wherein the anchoring step comprises anchoring a stent comprising a network of struts within the pyloric orifice, the stent coupled to a proximal portion of a flexible sleeve.

85. The method of treatment of claim 82, wherein the sleeve is formed of a fluoropolymer.

86. The method of treatment of claim 82, wherein the fluoropolymer is expanded polytetrafluoroethylene.