Intestinal sleeve
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.
1. A gastrointestinal implant device comprising:
a 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 within the duodenal bulb, the anchor having a relaxed diameter of at least about 40 millimeters, the anchor having a shape configured to engage a substantial length of the duodenal bulb, the anchor comprising a perimeter allowing flexure such that the perimeter self-expands to substantially engage the duodenal bulb when the anchor is implanted, 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 and configured to reside substantially within the duodenal bulb, the proximal end of the device being distal to the pylorus.
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 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 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.