Complex surgical device for carrying out and 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 device for introducing an implantable device into an intestine to protect an anastomosis site, the device comprising:
a first guide tube configured to hold the implantable device therein in a radially compressed state, the first guide tube comprising a distal end configured to be introduced through an anal orifice into the intestine to a position upstream of the anastomosis site;
a second guide tube positioned proximal to the first guide tube;
a stop between the first guide tube and the second guide tube, the stop having a diameter larger than that of the first guide tube and the second guide tube; and
a handle positioned, in a delivery state, proximal to the second guide tube, wherein a distance between the first guide tube and the handle is configured to be reduced to release the implantable device out of the distal end of the first guide tube at the position upstream of the anastomosis site for implanting the implantable device for protecting the anastomosis site.
2. The device 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 device of claim 1 , wherein the second guide tube comprises a guide groove configured to control translation.
4. The device 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 device of claim 4 , wherein the cut-out tabs are elastically deformable to permit the implantable device to be deployed therethrough.
6. The device of claim 5 , wherein the cut-out tabs form a tulip configuration.
7. The device of claim 1 , wherein the handle comprises an actuator configured to control longitudinal translation.
8. The device of claim 7 , wherein the actuator comprises a button on the handle.
9. The device of claim 1 , further comprising 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 device of claim 1 , wherein the implantable device comprises a stent coupled to a sheath, the stent configured to expand upon release from the distal end of the first guide tube to anchor the implantable device at the position upstream of the anastomosis site such that the sheath protects the anastomosis site.
11. The device of claim 10 , wherein the implantable device comprises at least one suction tube configured to permit application of suction at the stent to increase anchoring force at the stent.
12. The device of claim 11 , wherein the at least one suction tube comprises two suction tubes, each suction tube being connected to a vacuum chamber between the stent and the sheath for maintaining vacuum in the vacuum chamber.
13. The device of claim 1 , wherein the device is configured to introduce the implantable device before an anastomosis is carried out at the anastomosis site.
14. The device 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.
15. A method for introducing an implantable device into an intestine to protect an anastomosis site, the method comprising:
introducing a distal end of a first guide tube of an introducer device through an anal orifice into the intestine to a position upstream of the anastomosis site, the first guide tube having the implantable device disposed therein, the introducer device comprising a second guide tube positioned proximal to the first guide tube and a stop between the first guide tube and the second guide tube, the stop having a diameter larger than that of the first guide tube and the second guide tube; and
using a handle to reduce a distance between the first guide tube and the handle to release the implantable device out the distal end of the first guide tube at the position upstream of the anastomosis site for implanting the implantable device for protecting the anastomosis site.
16. The method of claim 15 , further comprising applying and maintaining suction to the implantable device at the position upstream of the anastomosis site to anchor the implantable device within the intestine.
17. The method of claim 15 , wherein the implantable device comprises a stent coupled to a sheath, and
wherein the stent expands upon deployment from the distal end of the first guide tube to contact an intestine wall at the position for anchoring.
18. The method of claim 15 , wherein using the handle comprises actuating an actuator at the handle to control longitudinal translation.
19. The method of claim 15 , wherein reducing the distance between the first guide tube and the handle causes the second guide tube to move into the handle.
20. The method of claim 15 , wherein releasing the implantable device comprises elastically deforming cut-out tabs at the distal end of the first guide tube to permit the implantable device to be deployed therethrough.