Intestinal sleeve

• US 9,237,944 B2
• Filed: 06/16/2014
• Issued: 01/19/2016
• Est. Priority Date: 12/09/2003
• Status: Expired due to Fees

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Meade, John C., Levine, Andy H., Melanson, David A., Cvinar, John F.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US14/305,518
• Publication Number:
  US 20140303543A1
• Time in Patent Office: 582 Days
• Field of Search: 623234- 237, 623 2365- 237
• US Class Current: 1/1
• 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 gastrointestinal implant device comprising:

a unsupported flexible sleeve configured to carry chyme from a proximal end of the sleeve to a distal end of the sleeve and adapted to extend into the duodenum; and

a collapsible self-expanding anchor coupled to the proximal end of the sleeve and adapted to be retained substantially entirely within the duodenal bulb, the anchor having a relaxed diameter of at least about 40 millimeters, a length of the anchor from a proximal end of the device to the proximal end of the sleeve being from about 1 inch to about 1.5 inches.

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

3. The gastrointestinal implant device of claim 1, wherein the anchor, when implanted, preferably 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 covered by a proximal portion of the sleeve.

7. The gastrointestinal implant device of claim 6, wherein the anchor is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve.

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

9. The 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 as the anchor expands to anchor the proximal portion of the sleeve in the duodenum.

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 14, wherein the sleeve is coated with silicone.

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

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

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 attaching means adapted 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.

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 in combination with a catheter to insert the unsupported flexible sleeve.

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

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

27. The gastrointestinal implant device of claim 26, wherein the drawstring resides along a proximal portion of the anchor, reducing the proximal diameter when drawn.