Bariatric sleeve

• US 7,267,694 B2
• Filed: 11/30/2004
• Issued: 09/11/2007
• Est. Priority Date: 12/02/2002
• Status: Expired due to Fees

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Cvinar, John, Meade, John C., Levine, Andy H., Melanson, Dave
• Primary Examiner(s): Stewart; Alvin J.
• Application Number:
  US11/000,099
• Publication Number:
  US 20050075622A1
• Time in Patent Office: 1,015 Days
• Field of Search: 623/23.64, 623/23.65, 623/1.15, 623/1.36, 623/23.66, 623/23.7, 623/1.35, 623/1.11, 623/1.13, 623/1.23
• US Class Current: 623/23.7
• 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, the sleeve being at least twelve inches in length to extend within the intestine, the sleeve being thin and conformable so that it collapses in the intestine to a small volume;

a self expanding stent, comprising a network of struts, coupled to a proximal portion of the sleeve, the stent being sized to anchor the sleeve at or distal to the pylorus in the digestive system, the sleeve being unsupported at a distal end, the sleeve including two layers of material at least at the proximal end, a first outer layer covering the exterior surface of the stent and a second inner layer covering the interior surface of the stent; and

members coupled to the stent, the members being structured and arranged to penetrate muscle, the members being barbs extending from an exterior surface of the stent.

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

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

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

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

8. The gastrointestinal implant device of claim 7, wherein the fluoropolymer is expanded polytetrafluoroethylene.

9. The gastrointestinal implant device of claim 8, wherein the sleeve is coated with a coat of silicone.

10. The gastrointestinal implant device of claim 8, wherein the sleeve is coated with a coat of polyurethane.

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

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, wherein the barbs comprise pairs of barbs that are directed outwardly and in opposite, axial directions.

14. The gastrointestinal implant device of claim 13, wherein the barbs are sized to anchor the flexible sleeve to the pyloric muscle in the stomach.

15. The implant device of claim 13, wherein the pairs of barbs are at a proximal end of the stent.

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

17. The gastrointestinal implant device of claim 16, wherein the anti-buckling device extends from below the stent to the distal end of the flexible sleeve.

18. The gastrointestinal implant device of claim 16, wherein the anti-buckling device reduces twisting of the sleeve.

19. The gastrointestinal implant device of claim 1, wherein the sleeve causes enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

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

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

22. A gastrointestinal implant device comprising:

a flexible, floppy sleeve, open at both ends, the sleeve being at least twelve inches in length to extend within the intestine, the sleeve being thin and conformable so that it collapses in the intestine to a small volume; and

a self expanding and collapsible sleeve anchor coupled to a proximal end of the sleeve, the sleeve anchor comprising barbs extending from the exterior surface of the anchor and structured, directed, and arranged for insertion into muscle as the sleeve anchor expands to anchor the proximal portion of the sleeve at or distal to the pylorus, the sleeve being unsupported at a distal end, and the sleeve including two layers of material at least at the proximal end, a first outer layer covering the exterior surface of the anchor and a second inner layer covering the interior surface of the anchor.

23. The gastrointestinal implant of claim 22, wherein the sleeve anchor is a stent.

24. The gastrointestinal implant device of claim 22, wherein the sleeve anchor is sized to be retained distal to the pylorus.

25. The gastrointestinal implant device of claim 22, wherein the sleeve anchor is sized to be retained within the pyloric orifice.

26. The gastrointestinal implant device of claim 22, 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.

27. The gastrointestinal implant device of claim 22, wherein the sleeve material has a coefficient of friction of less than 0.2.

28. The gastrointestinal implant device of claim 22, wherein the sleeve is formed of a fluoropolymer.

29. The gastrointestinal implant device of claim 28, wherein the fluoropolymer is expanded polytetrafluoroethylene.

30. The gastrointestinal implant device of claim 29, wherein the sleeve is coated with a coat of silicone.

31. The gastrointestinal implant device of claim 29, wherein the sleeve is coated with a coat of polyurethane.

32. The gastrointestinal implant device of claim 22, wherein the sleeve is formed of polyethylene.

33. The gastrointestinal implant device of claim 22, wherein the distal end of the sleeve is directionally textured.

34. The gastrointestinal implant device of claim 22, wherein the barbs comprise pairs of barbs that are directed outwardly and in opposite, axial directions.

35. The implant device of claim 34, wherein the pairs of barbs are at a proximal end of the anchor.

36. The gastrointestinal implant device of claim 22, wherein the barbs are sized to anchor the flexible sleeve to the pyloric muscle in the stomach.

37. The gastrointestinal implant device of claim 36, wherein the anti-buckling device reduces twisting of the sleeve.

38. The gastrointestinal implant device of claim 22, further comprising an anti-buckling device coupled to the sleeve to reduce buckling of the sleeve.

39. The gastrointestinal implant device of claim 38, wherein the anti-buckling device extends from below the anchor to the distal end of the flexible sleeve.

40. The gastrointestinal implant device of claim 22, wherein the sleeve causes enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

41. The gastrointestinal implant device of claim 22 in combination with a catheter to insert the flexible sleeve.

42. The gastrointestinal implant device of claim 22 in combination with a removal device to remove the flexible sleeve.

43. The gastrointestinal implant device of claim 22, wherein the collapsible sleeve anchor is sized to be implanted distal to the pylorus.

44. The gastrointestinal implant device of claim 22, wherein the stent is sized for anchoring within the stomach.

45. A gastrointestinal implant device comprising:

a collapsible, floppy sleeve, the sleeve being at least twelve inches in length, and open at both ends to extend within the intestine, the sleeve being thin and conformable so that it collapses in the intestine to a small volume;

a self-expanding stent, comprising a network of struts, coupled to a proximal portion of the sleeve, the stent being sized to retain the sleeve at or distal to the pylorus in the digestive system, the sleeve being unsupported at a distal end, and the sleeve including two layers of material at least at the proximal end, a first outer layer covering the exterior surface of the stent and a second inner layer covering the interior surface of the stent; and

members coupled to the stent, the members being barbs and extending from the exterior surface of the stent, the members being structured and arranged to penetrate muscle.

46. The gastrointestinal implant device of claim 45, wherein the sleeve is formed of a fluoropolymer.

47. The gastrointestinal implant device of claim 45, wherein the sleeve is sized to be retained distal to the pylorus.

48. A gastrointestinal implant device comprising:

a flexible, floppy sleeve, open at both ends, the sleeve being at least twelve inches in length to extend within the intestine, the sleeve being unsupported at a distal end, and the sleeve being formed of expanded polytetrafluoroethylene, the sleeve being thin and conformable so that it collapses in the intestine to a small volume;

a stent, comprising a network of struts, coupled to a proximal portion of the sleeve to anchor the sleeve distal to the pylorus, the sleeve including two layers of material at least at the proximal end, a first outer layer covering the exterior surface of the stent and a second inner layer covering the interior surface of the stent; and

barbs extending from the exterior surface of the stent and sized to anchor a proximal portion of the sleeve to muscle in the digestive system.

49. A gastrointestinal implant device comprising:

sleeve means for extending within the intestine, the sleeve means comprising a flexible, floppy sleeve open at both ends and at least twelve inches in length, the sleeve being thin and conformable so that it collapses in the intestine to a small volume; and

anchoring means for anchoring a proximal end of the sleeve, the anchoring means being collapsible and self-expanding and comprising barb means on the exterior surface of the stent means for insertion into muscle as the anchoring means expands to anchor the proximal portion of the sleeve, the sleeve being unsupported at a distal end, and the sleeve including two layers of material at least at the proximal end, a first outer layer covering the exterior surface of the anchoring means and a second inner layer covering the interior surface of the anchoring means.

50. A gastrointestinal implant device comprising:

sleeve means for extending within the intestine, the sleeve means comprising a flexible, floppy sleeve open at both ends, the sleeve being at least twelve inches in length, the sleeve being unsupported at a distal end, and the sleeve being formed of expanded polytetrafluoroethylene, the sleeve being thin and conformable so that it collapses in the intestine to a small volume; and

anchoring means for anchoring the sleeve distal to the pylorus comprising a network of struts and coupled to a proximal portion of the sleeve, the anchoring means being self-expanding, the anchoring means comprising barb means for anchoring a proximal portion of the sleeve to muscle, the barb means extending from the exterior of the struts, and the sleeve including two layers of material at least at the proximal end, a first outer layer covering the exterior surface of the anchoring means and a second inner layer covering the interior surface of the anchoring means.