Transpyloric anchoring
A gastrointestinal implant device ( 2800 ) comprises a planar proximal element ( 220 ) configured to reside in a stomach to resist distal migration, a distal element ( 222 ) configured to reside in an intestine to resist proximal migration and one or more tethers ( 224 ) coupling the planar proximal element to the distal element.
1. A gastrointestinal device comprising:
(a) a conformable, collapsible sleeve through which chyme can pass from a proximal end of the sleeve to a distal end of the sleeve; and
(b) a transpyloric anchor comprising a wave anchor and a proximal element, wherein:
(i) the wave anchor is connected to the proximal portion of the sleeve and is configured to form a seal against the duodenal wall, and
(ii) the proximal element is configured to reside in an antrum of a stomach and resist distal migration across a pyloric sphincter;
wherein, when implanted in a patient, a first dimension of the proximal element is larger than the diameter of the pylorus of the stomach and a second dimension of the proximal element is smaller than the diameter of the pylorus, wherein the second dimension is orthogonal to the first dimension.
2. The gastrointestinal device of claim 1 , wherein the distal end of the sleeve is unsupported.
3. The gastrointestinal device of claim 1 , wherein the distal end of the sleeve is configured to reside in the jejunum, when implanted in a patient.
4. The gastrointestinal device of claim 1 , wherein the proximal end of the sleeve is contoured to the wave anchor.
5. The gastrointestinal device of claim 1 , wherein the proximal element is between 40 mm and 100 mm in size in a first dimension and between 0.5 mm and 15 mm in size in a second dimension.
6. The gastrointestinal device of claim 1 , wherein the wave anchor is between 30 mm and 40 mm in diameter.
7. The gastrointestinal device of claim 1 , wherein the wave anchor comprises a length to diameter ratio of at least one.
8. The gastrointestinal device of claim 1 , wherein the wave anchor is covered in an atraumatic material.
9. The gastrointestinal device of claim 1 , wherein the proximal element and/or the sleeve comprises a polymer.
10. The gastrointestinal device of claim 1 , wherein the polymer comprises at least one material selected from the group consisting of silicone, polytetrafluoroethylene, polyethylene, and polypropylene.
11. The gastrointestinal device of claim 1 , wherein the wave anchor comprises a metal.
12. The gastrointestinal device of claim 1 , wherein the metal is nitinol.
13. The gastrointestinal device of claim 1 , wherein the gastrointestinal device is configured to be collapsible into a container for endoscopic delivery into a gastrointestinal tract.
14. The gastrointestinal device of claim 1 , further comprising a removal drawstring.
15. A method of treatment comprising:
(a) providing the gastrointestinal device of claim 1 ;
(b) sealing the wave anchor to the tissue of the intestine; and
(c) positioning the proximal element in the antrum of the stomach, thereby securing the gastrointestinal device across the pylorus of a patient.
16. The method of claim 15 , wherein the method is for the treatment of Type-2 diabetes.
17. The method of claim 15 , wherein the gastrointestinal device is delivered into the gastrointestinal tract endoscopically.
18. The method of claim 15 , wherein the distal end of the sleeve is unsupported.
19. The method of claim 15 , wherein the proximal end of the sleeve is contoured to the wave anchor.
20. The method of claim 15 , wherein the wave anchor is between 30 mm and 40 mm in diameter and/or comprises a length to diameter ratio of at least one.