Intraluminally directed anvil apparatus and related methods and systems

• US 6,726,694 B2
• Filed: 12/14/2000
• Issued: 04/27/2004
• Est. Priority Date: 04/16/1999
• Status: Expired due to Fees

• Current Assignee: DF Vital Holdings, LLC
• Original Assignee: Integrated Vascular Interventional Technologies LC (Integrated Vascular Interventional Technologies)
• Inventors: Burnett, Bruce M., Barrus, Michael C., Blatter, Duane D., Goodrich, Kenneth C.
• Primary Examiner(s): Lindsey, Rodney M.
• Application Number:
  US09/736,839
• Publication Number:
  US 20030078597A1
• Time in Patent Office: 1,230 Days
• Field of Search: 606/1, 606/108, 606/152, 606/153, 606/155, 606/170, 606/180, 606/139, 606/184, 606/185, 606/179, 128/899, 600/566, 600/567
• US Class Current: 606/139
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• 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 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• 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

Abstract

Anastomosis procedures are achieved through the use of an intraluminally directed anvil apparatus. The apparatus is inserted at a catheter site and is then positioned through the lumen of the blood vessel to a remote anastomosis site. The intraluminally directed anvil apparatus has an anvil pull extending from an anvil. At the anastomosis site, the anvil is extended through the wall of the vessel at an initial piercing. The anvil is too large to pass through the initial piercing so the anvil pull can be used to pull the anvil against the wall of the vessel and distend the vessel wall in preparation for being cut to form an opening. The apparatus is used with a cutter to form openings in a wall of a blood vessel. After the opening is formed then the vessel is joined with another vessel.

Claims

1. A method for anastomosis of a wall of a first vessel to a second vessel comprising:

inserting an intraluminally directed anvil apparatus within the lumen of a first vessel at a remote location relative to an anastomosis site, wherein the intraluminally directed anvil apparatus has an anvil and an anvil pull extending from an engaging end of the anvil;

advancing the intraluminally directed anvil apparatus within the lumen of the first vessel to the anastomosis site;

positioning the intraluminally directed anvil apparatus at the anastomosis site such that the anvil pull extends out of the first vessel through an initial piercing in the wall of the first vessel and can be maneuvered to hold the engaging end of the anvil against the interior of the wall of the first vessel;

forming a first vessel opening in the wall of the first vessel by pulling the anvil pull such that the engaging end of the anvil pushes against the interior of the wall of the first vessel while the engaging end of the anvil is engaged by a cutting device;

attaching a portion of the first vessel that defines the first vessel opening to a portion of a second vessel that defines a second vessel opening such that the first vessel and the second vessel are anastomosed together; and

removing the intraluminally directed anvil apparatus from the first vessel.

2. A method as recited in claim 1, wherein attaching a wall of a first vessel to a second vessel is accomplished by means for joining the portion of the first vessel that defines the first vessel opening to the portion of the second vessel that defines the second vessel opening.

3. A method as recited in claim 1, wherein attaching a wall of a first vessel to a second vessel is accomplished through the use of a compression plate apparatus.

4. A method as recited in claim 1, wherein attaching a wall of a first vessel to a second vessel is accomplished by means for joining the portion of the first vessel that defines the first vessel opening to the portion of the second vessel that defines the second vessel opening, wherein the joining means is selected from the group consisting of means for mechanically joining the portion of the first vessel that defines the first vessel opening to the portion of the second vessel that defines the second vessel opening, means for chemically joining the portion of the first vessel that defines the first vessel opening to the portion of the second vessel that defines the second vessel opening, radiation-based means for joining the portion of the first vessel that defines the first vessel opening to the portion of the second vessel that defines the second vessel opening, and combinations thereof.

5. A method as recited in claim 1, wherein attaching a wall of a first vessel to a second vessel is accomplished by means for mechanically joining the first vessel to the second vessel selected from the group consisting of suture thread, staples, and clips, and combinations thereof.

6. A method as recited in claim 1, wherein attaching a wall of a first vessel to a second vessel is accomplished by means for chemically joining the first vessel to the second vessel selected from the group consisting of biocompatible adhesives or glue;

solder;

biological procoagulant solution;

a combination of a chromophore and solder, and combinations thereof.

7. A method as recited in claim 1, wherein attaching a wall of a first vessel to a second vessel is accomplished by a radiation based means for joining the first vessel to the second vessel selected from the group consisting of a tissue welding radiation;

the combination of substances and radiation for laser sealing, and combinations thereof.

8. A method as recited in claim 1, wherein attaching a wall of a first vessel to a second vessel is accomplished by a device selected from the group consisting of a laser;

a radiofrequency radiation generator, and combinations thereof.

9. A method as recited in claim 1, wherein attaching a wall of a first vessel to a second vessel is accomplished by a device selected from the group consisting of a suturing device;

a staple device;

a clipping device;

a device for radiation welding;

a device for laser sealing;

a device for soldering;

a device for gluing; and

combinations thereof.

10. A method as recited in claim 1, further comprising:

piercing the wall of the first vessel from within the lumen of the first vessel to form the initial piercing in the wall of the first vessel.

11. A method as recited in claim 1, further comprising:

viewing the first vessel through remote viewing instrumentation to determine the location for the anastomosis site based on the observed condition of the anastomosis site, and then piercing the wall of the first vessel from within the lumen of the first vessel to form the initial piercing in the wall of the first vessel at the anastomosis site.

12. A method as recited in claim 10, wherein the initial piercing is formed by a piercing end of a penetration wire extending from a penetration catheter that was inserted into the lumen of the first vessel from a positioning catheter before the intraluminally directed anvil apparatus is positioned at the anastomosis site.

13. A method as recited in claim 12, wherein the intraluminally directed anvil apparatus is advanced within the lumen of the first vessel to the anastomosis site by removing the penetration wire from the penetration catheter and inserting the anvil pull into one end of the penetration catheter until it extends out of the other end of the penetration catheter at the anastomosis site.

14. A method as recited in claim 1, wherein the intraluminally directed anvil apparatus is advanced within the lumen of the first vessel by pushing a positioning stem that extends from the anvil opposite from the anvil pull.

15. A method as recited in claim 10, wherein the initial piercing is formed by a distal piercing end of the anvil pull.

16. A method as recited in claim 1, wherein the portion of the first vessel that defines the first vessel opening and the portion of the second vessel that defines a second vessel opening are attached such that at least the first vessel opening is at least partially everted and is not penetrated as the first vessel and the second vessel are anastomosed together.

17. A method as recited in claim 1, wherein the portion of the second vessel that defines a second vessel opening is at an end of the second vessel such that the anastomosis is an end-to-side anastomosis.

18. A method as recited in claim 1, wherein the portion of the second vessel that defines a second vessel opening is at a side of the second vessel such that the anastomosis is a side-to-side anastomosis.

19. An intraluminally directed anvil apparatus for anastomosing a first vessel to a second vessel in conjunction with an anastomosis device, comprising:

anvil means for engaging the interior surface of the wall of a first vessel at an anastomosis site, the anvil means being sized to pass within the lumen of the first vessel from an insertion site to a remotely located anastomosis site, the anvil means having an engaging end; and

anvil pull means for holding the engaging end of the anvil means against the interior of the wall of the first vessel, the anvil pull means having a proximal end and a distal end, the proximal end extending from the engaging end of the anvil means, the anvil pull means being adapted for movement within the lumen of the first vessel and for insertion within the lumen of the first vessel at the insertion site so that the anvil pull means can be intraluminally positioned at the anastomosis site and extend out of the first vessel through an initial piercing in the wall of the first vessel, the anvil pull means being sufficiently smaller in cross-sectional diameter relative to that of the engaging end of the anvil means such that once the anvil pull means extends out of the first vessel through the initial piercing in the wall of the first vessel then the anvil pull means can be pulled until the engaging end of the anvil means is pulled against the interior of the wall of the first vessel without also passing through the initial piercing in the wall of the first vessel;

wherein the engaging end of the anvil means is adapted to engage a cutting means for forming a first vessel opening in the wall of the first vessel that is directed at the engaging end of the anvil means from outside of the first vessel once the anvil means has been intraluminally positioned in contact with the interior surface of the wall of the first vessel at the anastomosis site and the anvil pull means is held outside of the first vessel.

20. The intraluminally directed anvil apparatus recited in claim 19, wherein the engaging end of the anvil means is spherical.

21. The intraluminally directed anvil apparatus recited in claim 19, wherein the engaging end of the anvil means is spherical and wherein the anvil means has cylindrical sidewalls that extend integrally from the spherical engaging end.

22. The intraluminally directed anvil apparatus recited in claim 19, wherein the anvil means is rigid.

23. The intraluminally directed anvil apparatus recited in claim 19, wherein the anvil means is solid and has a borehole through which the distal end of the anvil pull means extends.

24. The intraluminally directed anvil apparatus recited in claim 19, wherein the anvil means is selected from the group consisting of an expandable anvil adapted to receive a polymerizable material, an expandable anvil that is mechanically deployed, and a balloon anvil.

25. The intraluminally directed anvil apparatus recited in claim 19, wherein the anvil means is fixedly attached to the anvil pull means.

26. The intraluminally directed anvil apparatus recited in claim 19, wherein the anvil pull means is a wire.

27. The intraluminally directed anvil apparatus recited in claim 19, wherein the anvil pull means is a hollow shaft.

28. The intraluminally directed anvil apparatus recited in claim 19, further comprising a catheter apparatus that can be positioned in the receiving blood vessel and is configured such that the anvil means can be pulled with the catheter apparatus by the anvil pull means.

29. The intraluminally directed anvil apparatus recited in claim 19, wherein the distal end of the anvil pull means is a nonpiercing distal end.

30. The intraluminally directed anvil apparatus recited in claim 19, wherein the distal end of the anvil pull means is a piercing distal end that is adapted for piercing through the wall of the first vessel to form the initial piercing in the wall of the first vessel.

31. An intraluminally directed anvil apparatus for anastomosing a first vessel to a second vessel in conjunction with an anastomosis device, comprising:

an anvil adapted to engage the interior surface of the wall of a first vessel at an anastomosis site, the anvil being sized to pass within the lumen of the first vessel from an insertion site to a remotely located anastomosis site, the anvil having an engaging end; and

an anvil pull having a proximal end and a distal end, the proximal end extending from the engaging end of the anvil, the anvil pull being sufficiently flexible for movement within the lumen of the first vessel, the anvil pull being adapted for movement within the lumen of the first vessel and for insertion within the lumen of the first vessel at the insertion site so that the anvil pull can be intraluminally positioned at the anastomosis site and extend out of the first vessel through an initial piercing in the wall of the first vessel, the anvil pull being sufficiently smaller in cross-sectional diameter relative to that of the engaging end of the anvil such that once the anvil pull extends out of the first vessel through the initial piercing in the wall of the first vessel then the anvil pull can be pulled until the engaging end of the anvil is pulled against the interior of the wall of the first vessel without also passing through the initial piercing in the wall of the first vessel;

wherein the engaging end of the anvil is adapted to engage a cutting device adapted to form an opening in the wall of the first vessel that is directed at the engaging end of the anvil from outside of the first vessel once the anvil has been intraluminally positioned in contact with the interior surface of the wall of the first vessel at the anastomosis site and the anvil pull is held outside of the first vessel.

32. The intraluminally directed anvil apparatus recited in claim 31, wherein the engaging end of the anvil is spherical.

33. The intraluminally directed anvil apparatus recited in claim 31, wherein the engaging end of the anvil is spherical and wherein the anvil has cylindrical sidewalls that extend integrally from the spherical engaging end.

34. The intraluminally directed anvil apparatus recited in claim 31, wherein the anvil is rigid.

35. The intraluminally directed anvil apparatus recited in claim 31, wherein the anvil is solid and has a borehole through which the distal end of the anvil pull extends.

36. The intraluminally directed anvil apparatus recited in claim 31, wherein the anvil is selected from the group consisting of an expandable anvil adapted to receive a polymerizable material, an expandable anvil that is mechanically deployed and a balloon anvil.

37. The intraluminally directed anvil apparatus recited in claim 31, wherein the anvil is fixedly attached to the anvil pull.

38. The intraluminally directed anvil apparatus recited in claim 31, wherein the anvil pull is a wire.

39. The intraluminally directed anvil apparatus recited in claim 31, wherein the anvil pull is a hollow shaft.

40. The intraluminally directed anvil apparatus recited in claim 31, further comprising a catheter apparatus that can be positioned in the receiving blood vessel and is configured such that the anvil can be pulled with the catheter apparatus by the anvil pull.

41. The intraluminally directed anvil apparatus recited in claim 31, wherein the distal end of the anvil pull is a nonpiercing distal end.

42. The intraluminally directed anvil apparatus recited in claim 31, wherein the distal end of the anvil pull is a piercing distal end that is adapted for piercing through the wall of the first vessel to form the initial piercing in the wall of the first vessel.

43. An intraluminally directed anvil apparatus for anastomosing a first vessel to a second vessel in conjunction with an anastomosis device, comprising:

anvil means for engaging the interior surface of the wall of a first vessel at an anastomosis site, the anvil means being sized to pass within the lumen of the first vessel from an insertion site to a remotely located anastomosis site, the anvil means having a spherical engaging end and cylindrical sidewalls extending integrally from the spherical engaging end; and

anvil pull means for holding the engaging end of the anvil means against the interior of the wall of the first vessel, the anvil pull means having a proximal end and a distal end, the proximal end extending from the engaging end of the anvil means, the anvil pull means being adapted for movement within the lumen of the first vessel and for insertion within the lumen of the first vessel at the insertion site so that the anvil pull means can be intraluminally positioned at the anastomosis site and extend out of the first vessel through an initial piercing in the wall of the first vessel, the anvil pull means being sufficiently smaller in cross-sectional diameter relative to that of the engaging end of the anvil means such that once the anvil pull means extends out of the first vessel through the initial piercing in the wall of the first vessel then the anvil pull means can be pulled until the engaging end of the anvil means is pulled against the interior of the wall of the first vessel without also passing through the initial piercing in the wall of the first vessel;

wherein the anvil means is adapted to have a cutter urged against the spherical engaging end of the anvil means from outside of the first vessel once the anvil has been intraluminally positioned in contact with the interior surface of the wall of the first vessel at the anastomosis site and the anvil pull means is held outside of the first vessel.

44. An intraluminally directed anvil apparatus for anastomosing a first vessel to a second vessel in conjunction with an anastomosis device, comprising:

an anvil adapted to engage the interior surface of the wall of a first vessel at an anastomosis site, the anvil being sized to pass within the lumen of the first vessel from an insertion site to a remotely located anastomosis site, the anvil having a spherical engaging end and cylindrical sidewalls extending integrally from the spherical engaging end; and

an anvil pull having a proximal end and a distal end, the proximal end extending from the engaging end of the anvil, the anvil pull being adapted for movement within the lumen of the first vessel and for insertion within the lumen of the first vessel at the insertion site so that the anvil pull can be intraluminally positioned at the anastomosis site and extend out of the first vessel through an initial piercing in the wall of the first vessel, the anvil pull being sufficiently smaller in cross-sectional diameter relative to that of the engaging end of the anvil such that once the anvil pull extends out of the first vessel through the initial piercing in the wall of the first vessel then the anvil pull can be pulled until the engaging end of the anvil is pulled against the interior of the wall of the first vessel without also passing through the initial piercing in the wall of the first vessel;

wherein the anvil is adapted to have a cutter pushed against the spherical engaging end of the anvil from outside of the first vessel once the anvil has been intraluminally positioned in contact with the interior surface of the wall of the first vessel at the anastomosis site and the anvil pull is held outside of the first vessel.

45. A system for anastomosis of a wall of a first vessel to a second vessel, the system comprising:

an intraluminally directed anvil apparatus including

anvil means for engaging the interior surface of the wall of a first vessel at an anastomosis site, the anvil means being sized to pass within the lumen of the first vessel from an insertion site to a remotely located anastomosis site, the anvil means having an engaging end; and

anvil pull means for holding the engaging end of the anvil against the interior of the wall of the first vessel, the anvil pull means extending from the engaging end of the anvil means, the anvil pull means being adapted for insertion within the lumen of the first vessel at the insertion site to the remotely located anastomosis site so that the anvil pull means can reach the anastomosis site and extend out of the first vessel through an initial piercing in the wall of the first vessel,

wherein the intraluminally directed anvil apparatus is adapted such that the anvil is prevented from passing through the initial piercing in the wall of the first vessel as the anvil pull means extends out of the first vessel through the initial piercing in the wall of the first vessel and is used to pull the engaging end of the anvil means against the interior of the wall of the first vessel; and

cutting means for forming a first vessel opening in the wall of the first blood vessel as the cutting means is urged against the engaging end of the anvil means from outside of the first vessel once the anvil means has been intraluminally positioned in contact with the interior surface of the wall of the first vessel at the anastomosis site and the anvil pull means is held outside of the first vessel.

46. A system as recited in claim 45, further comprising

means for joining a portion of the first vessel that defines the first vessel opening to a portion of a second vessel that defines a second vessel opening such that the first vessel and the second vessel are anastomosed together and are in fluid communication.

47. A system as recited in claim 45, further comprising

attachment actuation means for actuating means for joining a portion of the first vessel that defines the first vessel opening to a portion of a second vessel that defines a second vessel opening such that the first vessel and the second vessel are anastomosed together and are in fluid communication.

48. A system for anastomosis of a wall of a first vessel to a second vessel, the system comprising:

an intraluminally directed anvil apparatus including

an anvil adapted to engage the interior surface of the wall of a first vessel at an anastomosis site, the anvil being sized to pass within the lumen of the first vessel from an insertion site to a remotely located anastomosis site, the anvil having an engaging end; and

an anvil pull having a proximal end and a distal end, the proximal end extending from the engaging end of the anvil, the anvil pull being adapted for movement within the lumen of the first vessel and for insertion within the lumen of the first vessel at the insertion site so that the anvil pull can be intraluminally positioned at the anastomosis site and extend out of the first vessel through an initial piercing in the wall of the first vessel, the anvil pull being sufficiently smaller in cross-sectional diameter relative to that of the engaging end of the anvil such that once the anvil pull extends out of the first vessel through the initial piercing in the wall of the first vessel then the anvil pull can be pulled until the engaging end of the anvil is pulled against the interior of the wall of the first vessel without also passing through the initial piercing in the wall of the first vessel;

wherein the engaging end of the anvil is adapted to engage a cutting device adapted to form an opening in the wall of the first vessel that is directed at the engaging end of the anvil from outside of the first vessel once the anvil has been intraluminally positioned in contact with the interior surface of the wall of the first vessel at the anastomosis site and the anvil pull is held outside of the first vessel; and

a cutting device that is adapted to engage the anvil of the intraluminally directed anvil apparatus to form a first vessel opening in the wall of the first vessel at the anastomosis site as the cutting device is urged against the engaging end of the anvil from outside of the first vessel once the anvil has been intraluminally positioned in contact with the interior surface of the wall of the first vessel at the anastomosis site and the anvil pull is held outside of the first vessel.

49. A system as recited in claim 48, further comprising

means for joining a portion of the first vessel that defines the first vessel opening to a portion of a second vessel that defines a second vessel opening such that the first vessel and the second vessel are anastomosed together and are in fluid communication.

50. A system as recited in claim 48, further comprising

an attachment actuation device adapted to actuate means for joining a portion of the first vessel that defines the first vessel opening to a portion of a second vessel that defines a second vessel opening such that the first vessel and the second vessel are anastomosed together and are in fluid communication.