Tissue bonding system and method for controlling a tissue site during anastomosis

• US 6,398,797 B2
• Filed: 11/29/2000
• Issued: 06/04/2002
• 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: Bender, Theodore, Yencho, Stephen A., Hausen, Bernard A., Hendricksen, Michael, Chang, Tenny, Donohoe, Brendan, Vargas, Jaime, Bombard, David, Nielsen, Jamey
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/725,232
• Publication Number:
  US 20010007069A1
• Time in Patent Office: 552 Days
• Field of Search: 606/153, 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

A method and system for performing anastomosis uses an anvil to control and support a tissue site during an anastomosis procedure involving tissue bonding techniques such as tissue welding and adhesive tissue bonding. The anvil is particularly useful for supporting a wall of a coronary artery during attachment of a graft vessel in a coronary artery bypass graft procedure. 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 an exterior of the target vessel. When tissue welding is used, a graft vessel fixture is positioned over the tissue surfaces to be welded in order to clamp the graft and target vessel tissue together. The tissue contacting surfaces of the anvil and/or graft vessel fixture are provided with one or more energy applying surfaces. Energy in the form of RF power, laser energy or ultrasonic energy is then applied to the compressed graft and target vessel tissue to weld the vessels together. When adhesive bonding is used, the adhesive may be applied to mating surfaces of the graft and/or target vessels either before or after the vessels are brought into contact. After tissue bonding 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. The incision may be made with an electro-cautery cutting device.

Claims

1. A method of performing anastomosis comprising steps of:

providing an anastomosis system comprising an elongated anvil and a graft vessel fixture movable with respect to said anvil, said graft vessel fixture comprising clamping members each having one or more clamping surfaces adapted to compress the tissue on opposite sides of the graft vessel against tissue contacting surfaces of the anvil;

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

moving the fixture toward the anvil to compress the graft and target vessel tissue between the anvil and the clamping surfaces of the fixture; and

applying energy to the tissue compressed between the anvil and the clamping surfaces of the fixture to secure the graft and target vessels together.

2. The method of claim 1, further comprising steps of:

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

removing the anvil.

3. The method according to claim 1, wherein the anvil and the clamping surfaces of the graft vessel fixture comprise one or more electrodes and wherein the tissue welds are formed by applying RF energy via the electrodes to the compressed tissue.

4. The method according to claim 1, wherein the anvil comprises a plurality of optical fibers having ends which are exposed at a tissue contacting surface thereof and wherein the tissue welds are formed by applying laser energy via the optical fibers to the compressed tissue.

5. The method according to claim 1, wherein the clamping surfaces of the graft vessel fixture comprise optical fibers having ends which are exposed at tissue contacting surfaces thereof and wherein the tissue welds are formed by applying laser energy via the optical fibers to the compressed tissue.

6. The method according to claim 1, wherein the clamping members of the graft vessel fixture comprise wires having ends which are exposed at the clamping surfaces thereof and wherein the tissue welds are formed by applying ultrasonic energy via the wires to the compressed tissue.

7. The method according to claim 3, wherein the electrodes on the graft vessel fixture comprise a plurality of projections each of which forms a separate clamping surface with the anvil.

8. The method according to claim 3, wherein the anvil comprises a plurality of projections each of which forms a separate clamping surface with the graft vessel fixture.

9. The method according to claim 7, wherein one or more of the projections are electrically isolated from the rest of the projections and wherein current is supplied sequentially to each electrically isolated projection.

10. The method according to claim 8, wherein one or more of the projections are electrically isolated from the rest of the projections and wherein current is supplied sequentially to each electrically isolated projection.

11. The method according to claim 1, wherein the anvil is an elongated member having a substantially uniform cross-section and a sharpened end, and wherein the anvil is inserted in the target vessel by puncturing the wall of the target vessel with the sharpened end of the anvil.

12. The method according to claim 1, wherein the incision in the target vessel is made with a cutting device which is electrically connected to a power source, said method further comprising the step of causing electric current to flow through the tissue between the electrode surfaces on the anvil and the cutting device while the incision is being made to cauterize the incision.

13. The method according to claim 1, wherein the anastomosis is performed on a pressurized target vessel.

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

an elongated anvil having tissue contacting surfaces thereon; and

a graft vessel fixture comprising clamping members each having one or more clamping surfaces adapted to compress the graft and target vessel tissue on opposite sides of the graft vessel against the tissue contacting surfaces of the anvil said fixture being movable relative to the anvil so as to allow the graft and target vessel tissue to be clamped between the anvil and the fixture at the anastomosis site;

wherein the tissue contacting surfaces of the anvil or the clamping surfaces of the fixture are provided with one or more energy applying surfaces.

15. The anastomosis system according to claim 14, wherein the energy applying surfaces are electrodes provided on both the tissue contacting surfaces of the anvil and the clamping surfaces of the graft vessel fixture.

16. The anastomosis system according to claim 15, wherein the clamping surfaces of the fixture comprise a plurality of projections each of which forms a separate clamping surface with the anvil.

17. The anastomosis system according to claim 15, wherein the tissue contacting surfaces of the anvil comprise a plurality of projections each of which forms a separate clamping surface with the graft vessel fixture.

18. The anastomosis system according to claim 16, wherein one or more of the projections are electrically isolated from the other projections.

19. The anastomosis system according to claims 17, wherein one or more of the projections are electrically isolated from the other projections.

20. The anastomosis system according to claim 14, further comprising a cutting device which is electrically connected to a power source to form an electrode.

21. The anastomosis system according to claim 14, wherein the anvil comprises a plurality of optical fibers having ends which are exposed at the tissue contacting surfaces thereof.

22. The anastomosis system according to claim 14, wherein the clamping surfaces of the graft vessel fixture comprise optical fibers having ends which are exposed at tissue contacting surfaces thereof.

23. The anastomosis system according to claim 14, wherein tissue clamping surfaces of the graft vessel fixture comprise wires having ends which are exposed at tissue contacting surfaces thereof.

24. The anastomosis system according to claim 14, wherein said fixture further comprises two arms movably mounted with respect to the clamping members, said clamping members and movable arms adapted for receiving and holding portions of the graft vessel therebetween.

25. An anvil for use in performing anastomosis between a graft vessel and a target vessel by the application of energy, the anvil comprising:

a handle; and

an elongated anvil arm extending from the handle, the anvil arm having at least one energy applying surface on a tissue contacting surface thereof.

26. The anvil according to claim 25, wherein the energy applying surface comprises one or more electrode patches on an upper tissue contacting surface thereof.

27. The anvil according to claim 25, wherein the anvil further comprises a temperature or impedance sensor.

28. The anvil according to claim 25, wherein the energy applying surface comprises a plurality of optical fibers having ends which are exposed at the tissue contacting surface thereof.

29. The anvil according to claim 25, wherein the anvil further comprises at least one energy applying assembly movably mounted in a track such that the assembly can be moved along the length of the anvil.

30. The anvil according to claim 29, wherein the energy applying assembly comprises optical fibers for application of laser energy.

31. The anvil according to claim 29, wherein the energy applying assembly comprises wires for application of ultrasonic energy.

32. The anvil according to claim 29, wherein the energy applying assembly comprises electrodes for application of RF energy.

33. A method of performing an anastomosis between a target vessel and the end of a graft vessel comprising steps of:

applying a tissue adhesive to mating surfaces of the graft vessel or target vessel;

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

positioning the end of the graft vessel adjacent an exterior of the target vessel wall; and

curing the adhesive.

34. The method of claim 33, further comprising steps of:

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

removing the anvil.

35. The method of claim 33, wherein the adhesive is activated by heat or light energy, the method further comprising applying heat or light energy to the adhesive.

36. The method of claim 33, wherein the tissue adhesive is applied to the mating surfaces before the graft vessel is positioned adjacent the target vessel wall.

37. The method of claim 33, wherein the tissue adhesive is applied to the mating surfaces after the graft vessel is positioned adjacent the target vessel wall.

38. The method of claim 37, wherein the tissue adhesive is applied to the mating surfaces with one or more hollow tubes or needles.

39. The method of claim 38, wherein the tissue adhesive is applied to the mating surfaces by injecting the adhesive through an opening in the graft vessel tissue.

40. An anastomosis system for connecting a graft vessel to a target vessel using a tissue adhesive, the anastomosis system comprising:

an elongated anvil having tissue contacting surfaces thereon; and

a graft vessel fixture comprising clamping members each having one or more clamping surfaces adapted to compress the graft and target vessel tissue on opposite sides of the graft vessel against the tissue contacting surfaces of the anvil, said fixture being movable relative to the anvil so as to allow the graft and target vessel tissue to be clamped between the anvil and the fixture at the anastomosis site;

wherein the anvil or the graft vessel fixture is provided with one or more tissue adhesive applicators adapted to supply a tissue adhesive to mating surfaces of the graft or target vessel.

41. The anastomosis system of claim 40, wherein the anvil is provided with a tissue adhesive applicator.

42. The anastomosis system of claim 40, wherein the graft vessel fixture further comprises a pin assembly adapted to trap the graft vessel against the clamping members, wherein the pin assembly is provided with one or more tissue adhesive applicators.

43. The anastomosis system of claim 40, wherein the tissue adhesive applicator is a hollow tube or needle.