Anastomosis system and method for controlling a tissue site

• US 20010021857A1
• Filed: 04/27/2001
• Published: 09/13/2001
• Est. Priority Date: 07/28/1999
• Status: Active Grant

• Current Assignee: Aesculap AG (B. Braun Holding GmbH & Co. KG)
• Original Assignee: Cardica Incorporated
• Inventors: Yencho, Stephen A., Hausen, Bernard A., Hendricksen, Michael, Donohoe, Brendan, Vargas, Jaime, Nielsen, Jamey
• Granted Patent: US 6,478,804 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 17/1152 applying the staples on the outside of the lumen
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/07214 Stapler heads
• CPC Class Codes: A61B 2017/07278 characterised by its sled or its staple holder
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11

Abstract

An anastomosis system and method uses an anvil to control and support a tissue site during an anastomosis procedure. The anvil is particularly useful for supporting a wall of a coronary artery during attachment of a graft vessel to the coronary artery because the wall of the coronary artery is very thin, difficult to grasp, and susceptible to tearing. In one method, the anvil is inserted into a pressurized or unpressurized target vessel and is pulled against an inner wall of the target vessel causing tenting of the thin tissue of the vessel wall. A graft vessel is then advanced to the anastomosis site and an end of the graft vessel is positioned adjacent and exterior of the target vessel. Staples are inserted through the tissue of the graft vessel and the target vessel by pivoting the arms of a staple holder towards the anvil. When the ends of the staples engage staple bending features on the anvil, the ends of the staples bend over securing the graft vessel and target vessel together. After stapling is complete, an incision is formed in the wall of the target vessel to allow blood flow between the target vessel and the graft vessel.

Claims

1. A method of controlling a tissue site during an anastomosis procedure, the method comprising:

inserting an anvil into a pressurized vessel at an intended anastomosis site;

supporting a wall of the pressurized vessel at the intended anastomosis site with the anvil positioned adjacent an interior of the wall;

performing anastomosis; and

removing the anvil.

2. The method of

claim 1

, further comprising a step of forming an incision in the wall of the pressurized vessel after the step of performing the anastomosis to allow blood flow between the pressurized vessel and a graft vessel.

3. The method of

claim 2

, wherein the incision extends along the anvil from a puncture in the vessel where the anvil was inserted.

4. The method of

claim 2

, wherein the incision is made while removing the anvil.

5. The method of

claim 2

, wherein the incision is made before removing the anvil.

6. The method of

claim 1

, wherein the step of performing anastomosis includes inserting staples through a graft vessel and a target vessel and bending ends of the staples against the anvil.

7. The method of

claim 1

, wherein the step of performing anastomosis includes suturing a graft vessel and the pressurized vessel together.

8. The method of

claim 1

, further comprising a step of clamping a wall of the pressurized vessel between the anvil and a clamp, and forming an incision in the wall of the pressurized vessel before the step of performing the anastomosis.

9. The method of

claim 1

, wherein the anvil is an elongated member having substantially parallel features for supporting tissue of the pressurized vessel while puncturing the tissue during anastomosis.

10. A method of controlling a tissue site during an anastomosis procedure, the method comprising:

inserting an anvil into a target vessel at an intended anastomosis site;

supporting a wall of the target vessel at the intended anastomosis site with the anvil positioned adjacent an interior of the wall;

performing anastomosis between a graft vessel and the target vessel; and

making an incision in the wall of the target vessel to allow blood flow between the graft vessel and the target vessel.

11. The method of

claim 10

, wherein the anastomosis is performed on a pressurized target vessel.

12. The method of

claim 10

, wherein the incision is made while removing the anvil from the target vessel.

13. The method of

claim 10

, wherein the incision is made before removing the anvil from the target vessel.

14. An anastomosis system for connecting a graft vessel to a target vessel, the anastomosis system comprising:

an elongated anvil having substantially parallel staple bending features for bending the ends of staples;

at least one staple with staple ends configured to be received by the staple bending features; and

a staple holder for holding the at least one staple while puncturing tissue.

15. The anastomosis device of

claim 14

, wherein the two substantially parallel staple bending features are formed along opposite sides of the anvil arm.

16. The anastomosis device of

claim 14

, wherein the at least one staple comprises a plurality of U-shaped staples.

17. The anastomosis device of

claim 16

, wherein the plurality of U-shaped staples are mounted on two staple holding strips which are received in the staple holder.

18. The anastomosis device of

claim 17

, wherein a frangible portion is provided between the plurality of U-shaped staples and the staple holding strips allowing the staples to be separated from the staple strips.

19. The anastomosis device according to

claim 17

, wherein the staple holder includes two arms movably connected to a handle, each of the arms configured to receive one of the staple holding strips.

20. The anastomosis device of

claim 14

, wherein the two substantially parallel staple bending features are both formed on a top side of the anvil.

21. The anastomosis device of

claim 14

, wherein the at least one staple comprises a staple body and a plurality of tissue puncturing staple ends extending from the staple body and configured to be received by the substantially parallel staple bending features.

22. The method of

claim 21

, wherein the staple body is formed from a plurality of struts.

23. The anastomosis device of

claim 14

, further comprising a clamp which is movable with respect to the anvil arm to trap tissue between the anvil and the clamp.

24. The anastomosis device of

claim 23

, wherein the clamp is elongated in shape to correspond to the elongated shape of the anvil and has an opening for receiving the at least one staple.

25. The anastomosis device of

claim 14

, wherein the substantially parallel staple bending features each include a plurality of recesses.

26. The anastomosis device of

claim 14

, wherein the substantially parallel staple bending features are grooves extending along the elongated anvil.

27. A method of performing anastomosis comprising:

providing an elongated anvil having two substantially parallel rows of staple bending features bending the ends of staples;

inserting the elongated anvil through the wall of a target blood vessel and positioning the elongated anvil along an interior of the target blood vessel wall;

positioning a graft vessel adjacent an exterior of the target blood vessel wall;

inserting the ends of at least one staple through the graft vessel and the target vessel;

bending the ends of the at least one staple by advancing the ends against the staple bending features of the elongated anvil to secure the graft vessel to the target vessel; and

making an opening in the target vessel to allow blood to flow between the target vessel and the graft vessel.

28. The method of

claim 27

, wherein the opening is made in the target vessel after the graft vessel has been secured to the target vessel.

29. The method of

claim 27

, wherein edges of the opening in the target vessel are held by a clamp and the opening is made in the target vessel before the graft vessel has been secured to the target vessel.

30. An anvil for use in performing anastomosis between a graft vessel and a target vessel, the anvil comprising:

a handle; and

an elongated anvil arm extending from the handle, the anvil arm having substantially parallel staple bending grooves or recesses for bending the ends of anastomosis staples, wherein the elongated anvil arm is configured to be inserted into the target vessel at an intended anastomosis site through a small incision which allows pressurization of the vessel to be maintained.

31. A stapling system for use in performing anastomosis between a graft vessel and a target vessel, the stapling system comprising:

a plurality of staples having ends configured to be inserted through tissue and bent over to secure the tissue; and

an expandable backbone supporting the plurality of staples for insertion, the backbone having an expandable configuration allowing a spacing between the plurality of staples to be changed.

32. The stapling system of

claim 31

, wherein the staples are connected to the backbone by frangible portions.

33. The stapling system of

claim 31

, wherein the expandable backbone is formed as a single piece.

34. A method of performing anastomosis comprising:

providing a plurality of interconnected staples;

selecting a graft vessel;

expanding a spacing between the interconnected staples to match a circumference of the selected graft vessel; and

connecting the graft vessel to a target vessel with the staples.

35. A stapling system for use in performing anastomosis between a graft vessel and a target vessel, the stapling system comprising:

a plurality of staples having ends configured to be inserted through tissue and bent over to secure the tissue;

a staple strip holding the plurality of staples in a spaced arrangement for insertion into the tissue as a row of staples; and

a frangible portion provided between each of the plurality of staples and the staple strip allowing the staples to be separated from the staple strip after insertion.