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 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.
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.
16. The method of treatment of claim 1 , wherein the sleeve is formed of polyethylene.
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.
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.
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.
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.
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.
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.
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.
50. The method of claim 24 , wherein the diabetic patient is non-obese.
51. The method of claim 1 , wherein the sleeve is extended prior to anchoring the sleeve.
52. The method of claim 24 , wherein the sleeve is extended prior to anchoring the sleeve.