Bariatric sleeve

• US 20040107004A1
• Filed: 01/09/2003
• Published: 06/03/2004
• Est. Priority Date: 12/02/2002
• Status: Active Grant

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: Seedling Enterprises, LLC
• Inventors: Cvinar, John, Levine, Andy H., Meade, John, Melanson, Dave
• Granted Patent: US 7,025,791 B2
• Time in Patent Office: Days
• US Class Current: 623/23.64
• 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
• 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
• CPC Class Codes: A61B 2017/061 hollow or tubular
• 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 sleeve, open at both ends, and adapted to extend into the duodenum to limit absorption of nutrients in the duodenum; and

a stent, comprising a network of struts, coupled to a proximal portion of the sleeve, and adapted to be retained within the stomach.

2. The gastrointestinal implant device of claim 1 wherein the stent is retained within the pyloric orifice to hold the pylorus open.

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

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

5. The gastrointestinal implant device of claim 4 wherein the stent is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve.

6. 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.

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

8. The gastrointestinal implant device of claim 1 wherein the sleeve is formed of expanded polytetrafluoroethylene.

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

10. The gastrointestinal implant device of claim 8 wherein the sleeve is coated with silicone.

11. The gastrointestinal implant device of claim 8 wherein the sleeve is coated with polyurethane.

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

13. The gastrointestinal implant device of claim 1 further comprising barbs extending from the exterior surface of the stent for anchoring the proximal portion of the sleeve to the stomach.

14. The gastrointestinal implant device of claim 13 wherein the barbs are bi-directional.

15. The gastrointestinal implant device of claim 14 wherein the barbs anchor the flexible sleeve to the pyloric muscle in the stomach.

16. The gastrointestinal implant device of claim 1 further comprising:

an anti-buckling device coupled to the sleeve and extending from below the stent to the distal end of the flexible sleeve to reduce buckling of the sleeve.

17. The gastrointestinal implant device of claim 1 wherein the sleeve allows enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

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

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

35. The gastrointestinal implant device of claim 18 in combination with a catheter to insert the flexible sleeve.

36. The gastrointestinal implant device of claim 18 in combination with a removal device to remove the flexible sleeve.

20. A gastrointestinal implant device comprising:

a flexible sleeve, open at both ends, and adapted to extend into the duodenum to limit absorption of nutrients in the duodenum; and

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

21. The gastrointestinal implant device of claim 20 wherein the anchor is retained within the pyloric orifice to hold the pylorus open.

22. The gastrointestinal implant device of claim 20 wherein the anchor is covered by a proximal portion of the sleeve.

23. The gastrointestinal implant device of claim 22 wherein the anchor is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve.

24. The gastrointestinal implant device of claim 20 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.

25. The gastrointestinal implant device of claim 20 wherein the sleeve material has a coefficient of friction of less than 0.2.

26. The gastrointestinal implant device of claim 20 wherein the sleeve is formed of expanded polytetrafloureothylene.

27. The gastrointestinal implant device of claim 20 wherein the sleeve is formed of polyethylene.

28. The gastrointestinal implant device of claim 26 wherein the sleeve is coated with silicone.

29. The gastrointestinal implant device of claim 26 wherein the sleeve is coated with polyurethane.

30. The gastrointestinal implant device of claim 20 wherein the distal end of the sleeve is directionally textured.

31. The gastrointestinal implant device of claim 20 wherein the barbs are bi-directional.

32. The gastrointestinal implant device of claim 20 wherein the barbs anchor the flexible sleeve to the pyloric muscle in the stomach.

33. The gastrointestinal implant device of claim 20 further comprising:

an anti-buckling device coupled to the sleeve and extending from below the anchor to the distal end of the flexible sleeve to reduce twisting of the sleeve.

34. The gastrointestinal implant device of claim 20 wherein the sleeve allows enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

66. The method of treatment of claim 20 wherein the barbs anchor the flexible sleeve to the pyloric muscle in the stomach.

37. A method of treatment comprising the steps of:

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

extending the flexible sleeve into the duodenum to limit absorption of nutrients.

38. The method of treatment of claim 37 wherein the stent is retained within the pyloric orifice to hold the pylorus open.

39. The method of treatment of claim 37 wherein the stent is collapsible.

40. The method of treatment of claim 37 wherein the stent is covered by a proximal portion of the sleeve.

41. The method of treatment of claim 40 wherein the stent is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve.

42. The method of treatment of claim 37 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.

43. The method of treatment of claim 37 wherein the sleeve is formed of expanded polytetraflouroethylene.

44. The method of treatment of claim 37 wherein the sleeve is formed of polyethylene.

45. The method of treatment of claim 43 wherein the sleeve is coated with silicone.

46. The method of treatment of claim 43 wherein the sleeve is coated with polyurethane.

47. The method of treatment of claim 37 wherein the distal end of the sleeve is directionally textured.

48. The method of treatment of claim 37 further comprising:

anchoring the proximal portion of the sleeve to the stomach with barbs extending from the exterior surface of the stent.

49. The method of treatment of claim 48 wherein the barbs are bi-directional.

50. The method of treatment of claim 49 wherein the barbs anchor the flexible sleeve to the pyloric muscle in the stomach.

51. The method of treatment of claim 37 further comprising:

coupling an anti-buckling device to the sleeve, the anti-buckling device extending from below the stent to the distal end of the flexible sleeve to reduce twisting of the sleeve.

52. The method of treatment of claim 37 wherein the sleeve allows enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

53. The method of treatment of claim 37 wherein the flexible sleeve and anchor are applied to the stomach and taken from an esophageal catheter.

54. The method of treatment of claim 37 wherein the flexible sleeve and stent are removed through the esophogus.

55. A method of treatment comprising the steps of:

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

extending the flexible sleeve into the duodenum to limit absorption of nutrients.

56. The method of treatment of claim 55 wherein the anchor is retained within the pyloric orifice to hold the pylorus open.

57. The method of treatment of claim 55 wherein the anchor is covered by a proximal portion of the sleeve.

58. The method of treatment of claim 57 wherein the anchor is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve.

59. The method of treatment of claim 55 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.

60. The method of treatment of claim 55 wherein the sleeve material has a coefficient of friction of less than 0.2.

61. The method of treatment of claim 55 wherein the sleeve is formed of expanded polytetraflouroethylene.

62. The method of treatment of claim 55 wherein the sleeve is formed of polyethylene.

63. The method of treatment of claim 61 wherein the sleeve is coated with silicone.

64. The method of treatment of claim 61 wherein the sleeve is coated with polyurethane.

65. The method of treatment of claim 55 wherein the distal end of the sleeve is directionally textured.

67. The method of treatment of claim 55 wherein the barbs are bi-directional.

68. The method of treatment of claim 55 further comprising:

coupling an anti-buckling device to the sleeve, the anti-buckling device extending from below the anchor to the distal end of the flexible sleeve to reduce twisting of the sleeve.

69. The method of treatment of claim 55 wherein the sleeve allows enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

70. The method of treatment of claim 55 wherein the flexible sleeve and anchor are applied to the stomach and broken from an esophageal catheter.

71. The method of treatment of claim 55 wherein the flexible sleeve and stent are removed through the esophagus.

72. A method of treating type 2 diabetes comprising:

anchoring a flexible sleeve, open at both ends, in the stomach; and

extending the flexible sleeve into the duodenum to limit absorption of nutrients in the duodenum.

73. The method of claim 72 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.

74. The method of claim 72 wherein the sleeve is formed of expanded polytetraflouroethylene.

75. The method of claim 72 wherein the sleeve is formed of polyethylene.

76. The method of claim 74 wherein the sleeve is coated with silicone.

77. The method of claim 74 wherein the sleeve is coated with polyurethane.

78. The method of claim 72 wherein the distal end of the sleeve is directionally textured.

79. The method of claim 72 further comprising:

coupling barbs to a collapsible anchor, the barbs extending from the exterior surface of the sleeve for anchoring the proximal portion of the sleeve to the stomach.

80. The method of claim 79 wherein the barbs are bi-directional.

81. The method of claim 80 wherein the barbs anchor the flexible sleeve to the pyloric muscle in the stomach.

82. The method of claim 72 further comprising:

coupling an anti-buckling device to the sleeve, the anti-buckling device extending to the distal end of the flexible sleeve to reduce twisting of the sleeve.

83. The method of claim 72 wherein the sleeve allows enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

84. The method of claim 72 in combination with a catheter to insert the flexible sleeve.

85. The method of claim 72 in combination with a removal device to remove the flexible sleeve.

86. A delivery system for placing a gastrointestinal implant device in a body comprising:

an outer sheath in the proximal portion of the delivery system for storing a proximal portion of the gastrointestinal implant device, the proximal portion of the gastrointestinal implant device including a self-expanding stent for anchoring the device in the stomach

an inner sheath within the outer sheath, the inner sheath extending beyond the outer sheath toward the distal end of the delivery system, a first lumen within the inner sheath for passing the outer sheath over a guidewire and a second lumen within the inner sheath for moving a moveable element to secure the distal end of a sleeve coupled to the stent to the inner sheath;

a stent release mechanism to release the stent from the outer sheath; and

a sleeve release mechanism coupled to the moveable element for releasing the distal end of the sleeve.

87. The delivery system of claim 86 wherein the moveable element is a sleeve retention wire, the sleeve which exits the second lumen and pierces the distal end of the sleeve.

88. The delivery system of claim 86 wherein the moveable element is a snare wire which captures the distal end of the sleeve.

89. The delivery system of claim 86 wherein the stent release mechanism pulls the outer sheath toward the proximal end of the delivery system to remove the outer sheath from the stent.

90. The delivery system of claim 89 wherein the sleeve release mechanism pulls the moveable element toward the proximal end of the delivery system to release the distal end of the sleeve after the stent has been released.

91. A removal device for removing a gastrointestinal implant device from the body comprising:

an outer sheath for storing a proximal portion of the gastrointestinal implant device, the proximal portion of the gastrointestinal implant device including a self-expanding stent for anchoring the device in the stomach; and

an inner sheath within the outer sheath, a plurality of fingers extending from the distal end of the inner sheath, the fingers collapsing the proximal end of the stent to allow the stent to be drawn into the outer sheath.

92. The removal device of claim 91 wherein the fingers collapse the stent by engaging the stent and pulling radially inward on the proximal end of the stent.

93. The removal device of claim 92 wherein the fingers pull radially inward as the inner sheath is moved over the fingers.