Complex surgical device for carrying out and protecting an anastomosis

1. A surgical device that is a ready-to-use assembly for performing an anastomosis in the intestine with an anvil and a circular stapler and protecting said anastomosis in the intestine, the device comprising:

(a) a protective device comprising an anchor element consisting of at least one stent capable of being temporarily anchored to the inner wall of the intestine upstream of the anastomosis and a flexible sheath, at least the upstream end of which is fixed to said stent, said sheath being capable of extending downstream of said anchor element and downstream of said anastomosis in order to allow said anastomosis to be protected, and

(b) at least a first tube, called first guide tube, said stent being held in radial compression inside said first guide tube, at a distal end of said first guide tube, said first guide tube being part of a guide tube of an introducer device, or being reversibly attachable to an introducer device, said first guide tube being deformable in curvature with respect to its longitudinal axis,

wherein said flexible sheath is folded inside said first guide tube, the downstream end of said sheath being connected to said first guide tube, or to a first connection piece independent of said first guide tube, said sheath being able to be deployed downstream of said stent by withdrawing the proximal end of said first guide tube or to said first connection piece to which it is fixed, and

wherein said first guide tube, or said first connecting piece, comprises a reversible fixing means to enable the proximal end to be reversibly fixed to said anvil.

2. The surgical device as claimed in claim 1 , wherein the protective device comprises at least one suction tube, said at least one suction tube being capable of extending outside said stent downstream thereof, an open end of said at least one suction tube opening inside the stent into a vacuum chamber defined between the inner wall of the stent and an inner film covering the inner wall of the stent, said film constituting an extension of said flexible sheath, and

wherein said at least one suction tube is arranged inside said first guide tube, the downstream end of said at least one suction tube being connected to said first guide tube or to said first connecting piece, said at least one suction tube being adapted to be deployed downstream of said stent by the withdrawal of said anvil reversibly fixed to the proximal end of said first guide tube or respectively to said first connecting piece.

3. The surgical device as claimed in claim 2 , wherein the downstream end of said sheath, and the downstream end of said at least one suction tube are connected to the distal end of said first guide tube, the proximal end of said first guide tube comprising a second connecting piece capable of being fixed in a reversible manner to the distal end of a second rigid guide tube of an introducer device for the introduction of the protective device upstream of the anastomosis site, and capable of being fixed in a reversible manner to said anvil for carrying out the anastomosis.

4. The surgical device as claimed in claim 3 , wherein the downstream end of said sheath, and the downstream end of said at least one suction tube are connected to the distal end of said first guide tube by bonding, or by a thread.

5. The surgical device as claimed in claim 3 , wherein said second connecting piece is fixed, or capable of being fixed, in a reversible manner to an adapter, said adapter being capable of being fixed in a reversible manner to said stapler anvil.

6. The surgical device as claimed in claim 3 , wherein said second connecting piece is fixed, or is capable of being fixed, in a reversible manner by screwing, gluing, clamping, or magnetic connection to an adapter which is capable of being fixed in a reversible manner to said anvil, by gluing, screwing, clamping, or magnetic connection.

7. The surgical device as claimed in claim 3 , wherein said second connecting piece comprises a threaded element capable of cooperating by screwing with:

a first complementary threaded element located at the distal end of said second rigid guide tube, and

a second complementary threaded element located at the distal end of said adapter.

8. The surgical device as claimed in claim 1 , wherein the downstream end of said sheath and the downstream end of said at least one suction tube, are connected to said first connecting piece, of which at least one proximal end is disposed outside the downstream end of said stent.

9. The surgical device as claimed in claim 8 , wherein the downstream end of said flexible sheath and the downstream end of said at least one suction tube are connected to a distal portion of said first connecting piece independent of said first guide tube, a tubular distal portion arranged, or capable of being arranged, inside the downstream end of said stent, and a proximal portion of said first connecting piece arranged outside and at the downstream end of said stent having a flat proximal face of larger diameter than said tubular distal portion.

10. The surgical device as claimed in claim 8 , wherein the downstream end of said flexible sheath, and the downstream end of said at least one suction tube are bonded to said first connecting piece by gluing, or by a thread.

11. The surgical device as claimed in claim 9 , wherein said first connecting piece is capable of being reversibly fixed to a stop of a pusher rod inside said first guide tube when the protective device is introduced upstream of the anastomosis site.

12. The surgical device as claimed in claim 8 , wherein said first connecting piece is adapted to be reversibly fixed directly to said anvil by a member selected from the group consisting of gluing, screwing, clamping, and magnetic bonding.

13. The surgical device as claimed in claim 1 , wherein the distal end of said first guide tube is closed by a flexible retaining element capable of retaining said protective device inside said first guide tube in the absence of a thrust inside said first guide tube by a pusher rod stop, said retaining element being capable of deforming elastically, and allowing the exit of said protective device under the effect of said thrust by said pusher rod stop.

14. The surgical device as claimed in claim 1 , wherein said introducer device comprises a handle fixed and/or capable of cooperating with the following two parts of the introducer device:

said first guide tube within which said stent is held in radial compression near the distal end of said first guide tube, the proximal end of said first guide tube being fixed to a second rigid guide tube integral with said handle, and

a pusher comprising a pusher rod deformable in curvature with respect to its longitudinal axis, and said pusher stop at the distal end of the pusher rod, extending from the handle inside said second rigid guide tube and said first guide tube, the proximal end of said pusher rod being adapted to cooperate with said handle by manually controlling a relative translation of said pusher rod with respect to the first guide tube.

15. The surgical device as claimed in claim 14 , wherein the pusher rod is a spiral rod formed of a steel wire wound helically along a virtual longitudinal axis with coaxial contiguous turns of the same diameter, the diameter of the contiguous turns forming a deformable rod capable of being deformed in curvature with respect to said longitudinal axis to allow it to adopt a curvature to form a 90° bend.

16. The surgical device as claimed in claim 2 , wherein said at least one suction tube is folded or wound helically inside said first guide tube.

17. The surgical device as claimed in claim 11 , wherein said first connecting piece is reversibly fixed by gluing, screwing, clamping, or magnetic bonding.

18. The surgical device as claimed in claim 1 , wherein the first guide tube, or said first connecting piece, comprises a reversible fixing means, such that said proximal end is capable of being fixed in a reversible manner to said anvil.