Intestinal sleeve

• US 7,682,330 B2
• Filed: 07/26/2006
• Issued: 03/23/2010
• Est. Priority Date: 12/09/2003
• Status: Expired due to Fees

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Melanson, David A., Meade, John C., Levine, Andy H., Cvinar, John F.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/493,487
• Publication Number:
  US 20060265082A1
• Time in Patent Office: 1,336 Days
• Field of Search: 623 2363- 237, 604/8
• US Class Current: 604/8
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• 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: 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 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics

Abstract

A gastrointestinal implant device is anchored in the duodenum and extends beyond the ligament of Treitz. All food exiting the stomach is funneled through the device. The gastrointestinal device includes an anchor for attaching the device to the duodenum and an unsupported flexible sleeve. The anchor can include a stent and/or a wave anchor and is collapsible for catheter-based delivery and removal.

Claims

1. A method of treatment comprising the steps of:

with an anchor in the duodenum, anchoring a proximal portion of an unsupported flexible sleeve, open at both ends, the anchor being covered by a proximal portion of the sleeve; and

extending the unsupported flexible sleeve distally into the duodenum.

2. The method of treatment of claim 1, wherein the anchor is retained within the duodenal bulb.

3. The method of treatment of claim 1, wherein the anchor has a relaxed diameter of at least about 40 millimeters.

4. The method of treatment of claim 3, wherein the anchor has a relaxed diameter of at least about 45 millimeters.

5. The method of treatment of claim 1, wherein a relaxed length of the anchor is between one and two inches.

6. The method of treatment of claim 1, wherein the sleeve length is equal to or greater than one foot.

7. The method of treatment of claim 6, wherein the sleeve length is less than or equal to five feet.

8. The method of treatment of claim 1, wherein the anchor is collapsible.

9. The method of treatment of claim 1, wherein the anchor is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve.

10. The method of treatment of claim 1, wherein the anchor comprises a stent including a network of struts.

11. The method of treatment of claim 1, wherein the anchor comprises a compliant wave anchor.

12. The method of treatment of claim 1, wherein the anchor is a collapsible anchor comprising barbs for insertion into tissue as the anchor expands to anchor the proximal portion of the sleeve in the duodenum.

13. 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.

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

18. The method of treatment of claim 1, further comprising:

anchoring the proximal portion of the sleeve to the duodenum with barbs extending from the exterior surface of the anchor.

19. The method of treatment of claim 18, wherein the barbs are bi-directional.

20. The method of treatment of claim 18, wherein the barbs anchor the unsupported flexible sleeve to muscular tissue of the duodenum.

21. The method of treatment of claim 1, wherein the sleeve allows enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

22. The method of treatment of claim 1, wherein the unsupported flexible sleeve and anchor are applied to the duodenum and taken from an esophageal catheter.

23. The method of treatment of claim 1, wherein the unsupported flexible sleeve and the anchor are removed through the esophagus.

41. The method of claim 1,

at least a portion of the sleeve being impregnated with an active compound.

42. The method of claim 41, wherein the active compound comprises a drug that reduces inflammation.

43. The method of claim 42, further comprising extending the unsupported flexible sleeve into the jejunum.

44. The method of claim 41, wherein the active compound comprises a anti-hunger hormones.

45. The method of treatment of claim 41, wherein the anchor has a relaxed diameter of at least about 40 millimeters.

46. The method of treatment of claim 45, wherein the anchor has a relaxed diameter of at least about 45 millimeters.

47. The method of treatment of claim 41, wherein a relaxed length of the anchor is between one and two inches.

48. The method of treatment of claim 41, wherein the sleeve length is equal to or greater than one foot.

49. The method of treatment of claim 48, wherein the sleeve length is less than or equal to five feet.

51. The method of claim 1, wherein the sleeve is extended prior to anchoring the sleeve.

14. A method of treatment comprising the steps of:

with an anchor in the duodenum, anchoring a proximal portion of an unsupported flexible sleeve, open at both ends; and

extending the unsupported flexible sleeve distally into the duodenum,

wherein the sleeve is coated with silicone.

15. A method of treatment comprising the steps of:

with an anchor in the duodenum, anchoring a proximal portion of an unsupported flexible sleeve, open at both ends; and

extending the unsupported flexible sleeve distally into the duodenum,

wherein the sleeve is coated with polyurethane.

17. A method of treatment comprising the steps of:

with an anchor in the duodenum, anchoring a proximal portion of an unsupported flexible sleeve, open at both ends; and

extending the unsupported flexible sleeve distally into the duodenum,

wherein the distal end of the sleeve is directionally textured.

24. A method of treating Type-2 diabetes comprising:

with an anchor in the duodenum of a diabetic patient, anchoring a proximal portion of an unsupported flexible sleeve, open at both ends, the anchor being collapsible and including barbs coupled to the anchor, the barbs extending from the exterior surface of the sleeve for anchoring the proximal portion of the sleeve to the duodenum; and

extending the unsupported flexible sleeve into the duodenum to have a therapeutic effect on diabetes.

25. The method of claim 24, wherein the anchor is retained within the duodenal bulb.

26. The method of treatment of claim 24, wherein the anchor has a relaxed diameter of at least about 40 millimeters.

27. The method of treatment of claim 26, wherein the anchor has a relaxed diameter of at least about 45 millimeters.

28. The method of treatment of claim 24, wherein a relaxed length of the anchor is between one and two inches.

29. The method of treatment of claim 24, wherein the sleeve length is equal to or greater than one foot.

30. The method of treatment of claim 29, wherein the sleeve length is less than or equal to five feet.

31. The method of claim 24, wherein the anchor comprises a stent including a network of struts.

32. The method of claim 24, wherein the anchor comprises a compliant wave anchor.

33. The method of claim 24, 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.

34. The method of claim 24 wherein the sleeve is coated with silicone.

36. The method of claim 24, wherein the barbs are bi-directional.

37. The method of claim 24, wherein the barbs anchor the unsupported flexible sleeve to the muscular tissue of the duodenum.

38. The method of claim 24, wherein the sleeve allows enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

39. The method of claim 24 further comprising inserting the unsupported flexible sleeve with a catheter.

50. The method of claim 24, wherein the diabetic patient is non-obese.

52. The method of claim 24, wherein the sleeve is extended prior to anchoring the sleeve.

35. A method of treating Type-2 diabetes comprising:

with an anchor in the duodenum of a diabetic patient, anchoring a proximal portion of an unsupported flexible sleeve, open at both ends; and

extending the unsupported flexible sleeve into the duodenum to have a therapeutic effect on diabetes,

wherein the sleeve is coated with polyurethane.

40. A method of treating Type -2 diabetes comprising:

with an anchor in the duodenum of a diabetic patient, anchoring a proximal portion of an unsupported flexible sleeve, open at both ends;

extending the unsupported flexible sleeve into the duodenum to have a therapeutic effect on diabetes; and

removing the unsupported flexible sleeve with a removal device.