Anastomosis system and method for controlling a tissue site

• US 6,478,804 B2
• Filed: 04/27/2001
• Issued: 11/12/2002
• Est. Priority Date: 07/28/1999
• Status: Expired due to Term

• 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
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/842,792
• Publication Number:
  US 20010021857A1
• Time in Patent Office: 564 Days
• Field of Search: 606/153, 606/219, 606/215, 227/19, 227/175.1, 227/176.1
• 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. An anastomosis system for connecting a graft vessel to a target vessel, the graft vessel and the target vessel each having a lumen, the anastomosis system comprising:

an elongated anvil having staple bending features defined thereon and an incising element connected thereto;

a plurality of staples, each staple configured to engage at least one of the staple bending features; and

a staple holder in which the staples are held, said staple holder moveable relative to the anvil.

2. The anastomosis system of claim 1, wherein a plurality of said staple-bending features are aligned substantially linearly.

3. The anastomosis system of claim 1, wherein the at least one staple comprises a plurality of U-shaped staples.

4. The anastomosis system of claim 3, wherein the plurality of U-shaped staples are mounted on two staple holding strips which are received in the staple holder.

5. The anastomosis system of claim 4, 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.

6. The anastomosis system according to claim 4, 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.

7. The anastomosis device of claim 1, wherein the staple bending features are formed on a top side of the anvil.

8. The anastomosis system of claim 1, 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.

9. The anastomosis device of claim 8, wherein the staple body is formed from a plurality of struts.

10. The anastomosis system of claim 1, further comprising a clamp which is movable with respect to the anvil arm to trap tissue between the anvil and the clamp.

11. The anastomosis system of claim 10, 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.

12. The anastomosis system of claim 1, wherein the substantially parallel staple bending features each include a plurality of recesses.

13. The anastomosis system of claim 1, wherein the substantially parallel staple bending features are grooves extending along the elongated anvil.

14. The anastomosis system of claim 1, wherein said incising element is movable relative to said anvil.

15. The anastomosis system of claim 1, wherein said incising element is located at the distal end of said anvil.

16. 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 vessel wall;

positioning an end of 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 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.

17. The method of claim 16, wherein the opening is made in the target vessel after the graft vessel has been secured to the target vessel.

18. The method of claim 16, 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.

19. The method of claim 16, further comprising creating at least two flaps at an end of the graft blood vessel, wherein said positioning comprises placing said flaps adjacent an exterior of the target blood vessel wall.

20. 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, said backbone comprising a plurality of elements interconnected by at least one expanding member, wherein spacing between the plurality of staples may be changed.

21. The stapling system of claim 20, wherein the staples are connected to the backbone by frangible portions.

22. The stapling system of claim 20, wherein the expandable backbone is formed as a single piece.

23. 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 after said expanding.

24. A method of performing anastomosis between a graft vessel and a target vessel, comprising:

splitting an end of the graft vessel;

inserting at least one elongated anvil through the wall of the target vessel;

positioning the split end of the graft vessel against the exterior of the target vessel;

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

bending the at least one staple 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.

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

an anvil having staple-bending features defined thereon; and

a staple holder moveable relative to said anvil, said staple holder comprising at least two arms, wherein at least a portion of each said arm is spaced apart from at least a portion of at least one other said arm.

26. The anastomosis system of claim 25, further comprising a plurality of staples, each said staple configured to engage at least one of said staple bending features;

and wherein said staples are detachably connected to said arms.

27. The anastomosis system of claim 26, wherein at least one of said staples comprises a staple body and a plurality of tissue-puncturing staple ends extending from said staple body.

28. The anastomosis system of claim 26, wherein at least one of said staples is substantially U-shaped.

29. The anastomosis system of claim 25, wherein said staple-bending features are located on opposite sides of said anvil arm.

30. The anastomosis system of claim 25, wherein a plurality of said staple-bending features are aligned substantially linearly.

31. The anastomosis system of claim 25, further comprising a clamp movable relative to said anvil.

32. The anastomosis system of claim 25, wherein at least one said staple-bending feature is a recess.

33. The anastomosis system of claim 25, wherein at least one said staple-bending feature is a groove.

34. A method of performing anastomosis between a graft vessel and a target vessel, comprising:

placing the end of a graft vessel against the side of a target vessel at a first location;

inserting an elongated anvil through the wall of the target vessel at a second location, said second location upstream from said first location; and

deploying a plurality of connectors to secure the graft vessel to the target vessel.