Intestinal sleeve

• US 7,476,256 B2
• Filed: 06/01/2004
• Issued: 01/13/2009
• Est. Priority Date: 12/09/2003
• Status: Active Grant

• 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:
  US10/858,851
• Publication Number:
  US 20050125075A1
• Time in Patent Office: 1,687 Days
• Field of Search: 623 2364- 2368
• 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 17/0482 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
• 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

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 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 to limit absorption of nutrients in the duodenum. The anchor can include a stent and/or a wave anchor and is collapsible for catheter-based delivery and removal.

Claims

1. A gastrointestinal implant device comprising:

a flexible sleeve, open at both ends, and adapted to extend into the duodenum, the sleeve being at least one foot in length and being unsupported at a distal end, the sleeve being noncompliant and having a coefficient of friction less than 0.2, the sleeve having a maximum thickness of 0.001 inches in thickness and collapsing in the intestine to a small volume, and the sleeve being and conformable to the intestine; and

an anchor coupled to a proximal portion of the sleeve and adapted to be retained within the duodenum, the anchor having a relaxed diameter greater than 40 millimeters.

2. The gastrointestinal implant device of claim 1, wherein the anchor has a minimal relaxed diameter of at least about 45 millimeters.

3. The gastrointestinal implant device of claim 1, wherein the anchor, when implanted, has a diameter of about 30 to 35 millimeters.

4. The gastrointestinal implant device of claim 1, wherein the anchor defines a length and a diameter, when implanted, having a ratio of length-to-diameter of about one.

5. The gastrointestinal implant device of claim 1, wherein the anchor is adapted to be retained within the duodenal bulb.

6. The gastrointestinal implant device of claim 1, wherein the anchor is collapsible.

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

8. The gastrointestinal implant device of claim 7, wherein the anchor is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve.

9. gastrointestinal implant device of claim 1, wherein the anchor comprises a compliant wave anchor.

10. The gastrointestinal implant device of claim 1, wherein the anchor is a collapsible anchor comprising barbs for insertion into tissue.

11. 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.

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

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

14. The gastrointestinal implant device of claim 13, wherein the fluoropolymer is expanded polytetrafluoroethylene.

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

16. The gastrointestinal implant device of claim 14, wherein the sleeve is coated with silicone.

17. The gastrointestinal implant device of claim 14, wherein the sleeve is coated with polyurethane.

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

19. The gastrointestinal implant device of claim 1, further comprising means for attaching to secure the anchor to muscular tissue of the duodenum.

20. The gastrointestinal implant device of claim 19, wherein the attaching means include barbs extending from the exterior surface of the anchor for attaching the proximal portion of the sleeve to the duodenum.

21. The gastrointestinal implant device of claim 20 wherein the barbs are bi-directional, and wherein the barbs comprise pairs of barbs that are directed outwardly and in opposite, axial directions.

22. The gastrointestinal implant device of claim 21, wherein the barbs anchor the unsupported flexible sleeve to muscular tissue of the duodenum.

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

24. The gastrointestinal implant device of claim 1, wherein the relaxed length of the anchor is between one and two inches.

25. The gastrointestinal implant device of claim 1, wherein the sleeve length is less than or equal to five feet.

26. The gastrointestinal implant device of claim 1, wherein the anchor has a minimal relaxed diameter of at least about 45 millimeters, the relaxed length of the anchor is between one and two inches, and the sleeve length is between one and five feet.

27. The gastrointestinal implant device of claim 1, wherein the anchor comprises a stent including a network of struts.

28. The gastrointestinal implant device of claim 1 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 buckling of the sleeve.

29. The gastrointestinal implant device of claim 1, in combination with a catheter to insert the gastrointestinal implant device.

30. The gastrointestinal implant device of claim 1, in combination with a removal device to remove the gastrointestinal implant device.

31. The gastrointestinal implant device of claim 1, further comprising a drawstring configured to facilitate removal of the anchor.

32. The gastrointestinal implant device of claim 31, wherein the drawstring resides along a proximal portion of the anchor, reducing the proximal diameter of the anchor when drawn.

33. A gastrointestinal implant device comprising;

flexible sleeve means for extending distally into the duodenum, the flexible sleeve means being at least one foot in length and being unsupported at a distal end, the flexible sleeve means being noncompliant and having a coefficient of friction less than 0.2, the sleeve having a maximum thickness of 001 inches and collapsing in the intestine to a small volume, and the sleeve being conformable to the intestine; and

anchoring means for anchoring a proximal portion of the flexible sleeve means open at both ends, within the duodenum, the anchoring means having a relaxed diameter of at least 40 mm.