Surgical device for controlled anchoring in the intestine
A surgical anchor device for being anchored on the mucous membrane of the inner wall of the intestine, the device having a temporary anchor element presenting anchoring that can be modified in a controlled manner and having a first substantially cylindrical multiply-perforated wall presenting properties of radial elasticity whereby the first wall presents an outer diameter that can be varied in controlled manner, wherein a portion of the inner surface of the first wall is lined with an independent leakproof inner sheath having only its longitudinal ends fastened to the anchor element to define a suction chamber between the inner sheath and the first wall, the temporary anchor element being coupled to a flexible or semi-rigid tube extending outside the anchor element, an open end of the injection-suction tube opening out into the suction chamber enabling air to be injected into or sucked out from the suction chamber.
1. A method of protecting an anastomosis in an intestine during healing, the method comprising:
introducing a device into the intestine through an anal orifice of a patient, the device comprising a negative pressure anchor coupled to a sheath;
routing the negative pressure anchor to an anchor site in the intestine upstream of the anastomosis; and
applying negative pressure to a suction chamber of the negative pressure anchor to suck an intestinal wall against an outer surface of the negative pressure anchor, such that the device is anchored to the intestinal wall and the sheath extends downstream from the negative pressure anchor and across the anastomosis, thereby protecting the anastomosis,
wherein applying the negative pressure causes the negative pressure anchor to stay in place at the anchor site in the intestine upstream of the anastomosis during peristalsis.
2. The method of claim 1 , wherein the negative pressure anchor comprises radial expansion properties such that the outer surface is configured to continue to contact the intestinal wall in a leaktight sealed configuration during peristalsis.
3. The method of claim 1 , wherein the negative pressure anchor comprises a downstream region and an upstream region each configured to inhibit migration of the negative pressure anchor from the anchor site.
4. The method of claim 3 , wherein the downstream and the upstream regions each comprise a collar configured to create a leaktight seal with the intestinal wall.
5. The method of claim 3 , wherein the downstream and upstream regions each comprise a flared extension having an orientation directed away from a longitudinal axis of the negative pressure anchor.
6. The method of claim 3 , wherein the downstream and upstream regions each comprise a circular profile about a longitudinal axis of the negative pressure anchor.
7. The method of claim 3 , further comprising expanding the negative pressure anchor from a collapsed delivery state to an expanded deployed state at the anchor site.
8. The method of claim 7 , wherein, in the expanded deployed state, the downstream and upstream regions each comprise a maximum outer diameter that is larger than a maximum outer diameter of a central region of the negative pressure anchor.
9. The method of claim 3 , wherein the suction chamber of the negative pressure anchor is defined by the outer surface of the negative pressure anchor and the intestinal wall between the downstream and upstream regions.
10. The method of claim 3 , wherein applying the negative pressure comprises applying negative pressure via a suction lumen in fluid communication with the suction chamber, and wherein an opening of the suction lumen opens out into the suction chamber.
11. The method of claim 10 , wherein applying the negative pressure via the suction lumen comprises applying negative pressure via a tube comprising the suction lumen which extends past the downstream region and opens into the suction chamber.
12. The method of claim 11 , wherein the tube is coupled to a connection endpiece comprising a valve.
13. The method of claim 1 , wherein the sheath extends from an upstream end of the negative pressure anchor to out the anal orifice to define a lumen for fecal matter flowing through the device.
14. The method of claim 1 , wherein the negative pressure anchor and the sheath comprise at least one of an elastomer or polymer.
15. The method of claim 14 , wherein the elastomer comprises at least one of silicone or polyurethane.
16. The method of claim 1 , wherein the device further comprises a tube in fluid communication with the suction chamber such that applying the negative pressure comprises applying the negative pressure to the suction chamber via the tube to suck the intestinal wall against the outer surface of the negative pressure anchor.
17. The method of claim 1 , wherein introducing the device into the intestine through the anal orifice of the patient is conducted using a delivery system comprising a pusher tube, a distal end of the pusher tube configured to abut the negative pressure anchor at the anchor site in the intestine upstream of the anastomosis.
18. The method of claim 17 , wherein the delivery system comprises an outer shell configured to contain the negative pressure anchor therein.
19. The method of claim 1 , wherein the device comprises a covering disposed on the outer surface of the negative pressure anchor.
20. The method of claim 1 , wherein protecting the anastomosis comprises temporarily protecting the anastomosis, the method further comprising removing the device from the intestine via the anal orifice upon healing of the anastomosis.
21. The method of claim 1 , wherein the sheath comprises a length such that the sheath extends from the anchor site to beyond the anal orifice.
22. The method of claim 1 , wherein the negative pressure anchor comprises a length of at least 30 mm.
23. The method of claim 1 , further comprising delivering fluid to the negative pressure anchor to modify or eliminate the suction effect of the negative pressure applied to the negative pressure anchor.
24. The method of claim 1 , wherein the device, during peristalsis, continues to contact the inner wall of the intestine for anchoring in a leaktight sealed configuration.
25. The method of claim 1 , further comprising, after a digestive process has restarted, releasing the device from the intestine to cause the device to migrate from the intestine via the anal orifice.
26. The method of claim 1 , further comprising, after healing of the anastomosis, using a lasso of the device to release the negative pressure anchor from the anchor site for removal of the device from the intestine via the anal orifice.
27. The method of claim 1 , further comprising, after healing of the anastomosis, injecting gas or liquid into the suction chamber of the negative pressure anchor using a tube coupled to the suction chamber to release the negative pressure anchor from the anchor site for removal of the device from the intestine via the anal orifice.
28. The method of claim 1 , wherein the negative pressure anchor comprises a mesh of spiral-wound metal wires made of nitinol for anchoring the device at the anchor site.
29. The method of claim 1 , wherein the negative pressure anchor comprises a second stent arranged coaxially inside a first stent for anchoring the device at the anchor site.
30. The method of claim 1 , further comprising leaving the device in the intestine for at least three days; and
after the at least three days, removing the device from the intestine.