Systems and methods for introducing a device for protecting an anastomosis
The present invention relates to a complex surgical device for carrying out an anastomosis in the intestine including: a—a protective device ( 5 ) comprising an anchor element consisting of a stent ( 1 ) and a flexible outer sheath ( 2 ), and b—an introducer ( 10 ) comprising at least a first deformable guide tube ( 12 ), characterized in that the downstream end of said outer sheath is connected to said first guide tube ( 12 ) or to a first connecting piece ( 11 ), said outer sheath ( 2 ) being folded inside said first deformable guide tube ( 12 ), said stent being held in radial compression inside said first deformable guide tube.
1. A system for protecting an anastomosis site in an intestine during healing, the system comprising:
an implantable device comprising an anchor coupled to a sheath, the implantable device configured to transition from a radially compressed state to an expanded state; and
an introducer device configured to deliver the implantable device to a position upstream of the anastomosis site in the intestine, the introducer device comprising a first guide tube configured to hold the implantable device therein in the radially compressed state for delivery, a second guide tube positioned downstream from the first guide tube, a stop between the first guide tube and the second guide tube, and a handle positioned, in a delivery state, downstream from the second guide tube, the stop having a diameter larger than that of the first guide tube and the second guide tube,
wherein a distal end of the first guide tube is configured to be introduced through an anal orifice into the intestine to the position upstream of the anastomosis site, and a distance between the first guide tube and the handle is configured to be reduced to cause the implantable device to be released from the first guide tube at the position upstream of the anastomosis site to transition to the expanded state for anchoring in the intestine such that the sheath extends across the anastomosis site for protecting the anastomosis site.
2. The system of claim 1 , wherein the second guide tube is configured to be moved into the handle when the distance between the first guide tube and the handle is reduced.
3. The system of claim 1 , wherein the second guide tube comprises a guide groove configured to control translation.
4. The system of claim 1 , wherein the distal end of the first guide tube comprises cut-out tabs configured to block the distal end of the first guide tube.
5. The system of claim 4 , wherein the cut-out tabs are elastically deformable to permit the implantable device to be deployed therethrough.
6. The system of claim 5 , wherein the cut-out tabs form a tulip configuration.
7. The system of claim 1 , wherein the handle comprises an actuator configured to control longitudinal translation.
8. The system of claim 7 , wherein the actuator comprises a button on the handle.
9. The system of claim 1 , wherein the introducer device further comprises a pusher disposed within the first guide tube, the pusher configured to cause the implantable device to be released out of the distal end of the first guide tube when the distance between the first guide tube and the handle is reduced.
10. The system of claim 1 , wherein the introducer device is configured to introduce the implantable device before an anastomosis is carried out at the anastomosis site.
11. The system of claim 1 , wherein the sheath extends within the anchor along an inner wall.
12. The system of claim 11 , wherein the implantable device defines a vacuum chamber at the sheath within the anchor.
13. The system of claim 12 , wherein the implantable device comprises at least one suction tube configured to permit application of suction at the vacuum chamber to increase anchoring force.
14. The system of claim 13 , wherein the at least one suction tube comprises two suction tubes, each suction tube being connected to the vacuum chamber for maintaining vacuum in the vacuum chamber.
15. The system of claim 1 , wherein the anchor comprises a stent.
16. The system of claim 15 , wherein the stent comprises spiral meshing of nitinol metal wires.
17. The system of claim 1 , wherein the distance between the first guide tube and the handle is configured to be reduced until the stop is positioned at or near the handle.
18. The system of claim 1 , wherein the implantable device is configured to be delivered via the introducer device after performing the anastomosis with a stapler and an anvil.
19. The system of claim 1 , wherein the sheath is configured to be cut from the introducer device after implantation.
20. The system of claim 1 , wherein the sheath is configured to extend downstream from the anchor and out the anal orifice.