Methods of Self-Aligning Stent Grafts

• US 20110218607A1
• Filed: 07/20/2010
• Published: 09/08/2011
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Berra, Humberto A., Ouellette, Gerry, Arbefeuille, Samuel
• Granted Patent: US 9,561,124 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A method for automatic endovascular alignment of a prosthesis includes loading the prosthesis in a distal delivery assembly, positioning a guidewire into a curved implantation site, and threading a guidewire lumen over the guidewire with the delivery assembly and into an implantation site to at least approximately align the curved distal portion to a curve of a curved implantation site and, thereby aligning the prosthesis.

Claims

1. A method for automatic endovascular alignment of a prosthesis in a curved implantation site of a vessel, which comprises:

providing a prosthesis delivery system with a longitudinally movable distal delivery assembly and a longitudinally movable guidewire lumen having a curved distal portion;

loading the prosthesis in the distal delivery assembly;

positioning a guidewire at least into the curved implantation site of the vessel;

threading the guidewire lumen over the guidewire along with the loaded distal delivery assembly to advance the guidewire lumen and the loaded distal delivery assembly along the guidewire towards the curved implantation site; and

further advancing the guidewire lumen with the curved distal portion and the loaded distal delivery assembly along the guidewire and into the curved implantation site to at least approximately align the curved distal portion to a curve of the curved implantation site and, thereby, orient the prosthesis.

2. The method according to claim 1, wherein the curved distal portion defines a distal portion plane and the curved implantation site of the vessel is a curved portion of an aorta, and which further comprises carrying out the loading step by substantially aligning a given longitudinal line of the prosthesis in the distal portion plane.

3. The method according to claim 2, which further comprises:

positioning the guidewire into the curved portion of the aorta; and

carrying out the further advancing step by orienting the prosthesis to at least approximately align the given longitudinal line with a superior longitudinal surface line of the curved portion of the aorta.

4. The method according to claim 2, which further comprises:

positioning the guidewire into the curved portion of the aorta; and

carrying out the further advancing step by orienting the prosthesis to substantially align the given longitudinal line with a superior longitudinal surface line of the curved portion of the aorta.

5. The method according to claim 2, which further comprises:

providing the prosthesis with a curved longitudinal support member disposed at least in part on the given longitudinal line; and

carrying out the further advancing step by orienting the prosthesis to at least approximately align the part of the support member with a superior longitudinal surface line of the curved portion of the aorta.

6. The method according to claim 5, which further comprises carrying out the loading step by aligning at least a part of the curved longitudinal support member in the distal portion plane.

7. The method according to claim 2, which further comprises:

providing the prosthesis with a curved longitudinal support member disposed at least in part on the given longitudinal line; and

carrying out the further advancing step by orienting the prosthesis to substantially align the part of the support member with a superior longitudinal surface line of the curved portion of the aorta.

8. The method according to claim 7, which further comprises carrying out the loading step by aligning at least a substantial part of the curved longitudinal support member in the distal portion plane.

9. The method according to claim 1, which further comprises carrying out the further advancing step by substantially aligning the curved distal portion with the curve of the curved implantation site.

10. The method according to claim 1, which further comprises carrying out the further advancing step by at least approximately aligning the curved distal portion with the curve of the curved implantation site by rotating the distal delivery assembly and the prosthesis loaded therein.

11. The method according to claim 1, which further comprises carrying out the further advancing step by orienting the prosthesis in a optimal superior surface position.

12. The method according to claim 1, which further comprises carrying out the further advancing step by automatically aligning the prosthesis in a optimal superior surface position while traversing a curve of the vessel in which the prosthesis is to be implanted.

13. The method according to claim 5, which further comprises automatically aligning the prosthesis to place at least a portion of the longitudinal support member at least approximately at the superior longitudinal surface line of the curved aorta while traversing the curved portion of the aorta.

14. The method according to claim 1, which further comprises pre-curving the prosthesis in a shape at least approximately corresponding to the curved shape of the curved implantation site.

15. The method according to claim 5, which further comprises pre-forming the longitudinal support member in a curved shape and attaching the curved longitudinal support member to the prosthesis.

16. The method according to claim 5, which further comprises pre-forming the longitudinal support member in a curved shape substantially corresponding to the curved portion of the aorta.

17. The method according to claim 5, which further comprises pre-forming the longitudinal support member in a curved shape substantially corresponding to the curved portion of the aorta in which the prosthesis is to be implanted.

18. The method according to claim 1, which further comprises:

viewing the curve of the vessel in which the prosthesis is to be implanted; and

subsequently forming the curved shape of the curved distal portion to correspond to the curve of the vessel viewed.

19. The method according to claim 18, which further comprises providing a curving device and forming the curved shape of the curved distal portion with the curving device to correspond to the curve of the vessel viewed.

20. The method according to claim 18, which further comprises providing a set of curving devices having differently curved shapes and forming the curved shape of the curved distal portion with at least one of the curing devices to at least approximately correspond to the curve of the vessel viewed.

21. The method according to claim 1, which further comprises connecting the guidewire lumen to the prosthesis delivery system to minimize a restoring force when the guidewire lumen is rotated along its longitudinal axis.

23. The method according to claim 1, which further comprises rotationally fixedly connecting the guidewire lumen to the distal delivery assembly as the guidewire lumen and the distal delivery assembly advance to the implementation site.

24. The method according to claim 1, which further comprises forming the guidewire lumen from a material permitting ends thereof to be twisted with respect to one another into an at least one-hundred eighty degree axially rotated orientation without deforming the guidewire lumen.

25. The method according to claim 1, which further comprises forming the guidewire lumen from a material permitting ends thereof to be twisted with respect to one another into an at least one-hundred eighty degree axially rotated orientation without producing a restoring force sufficient to harm a vessel wall.

26. The method according to claim 1, which further comprises forming the guidewire lumen from a metal.

27. The method according to claim 1, which further comprises forming the guidewire lumen from stainless steel.

28. The method according to claim 1, wherein the curved distal portion defines a distal portion plane and which further comprises carrying out the further advancing step by further advancing the guidewire lumen with the curved distal portion and the loaded distal delivery assembly into the curved implantation site to at least approximately align the curved distal plane to a superior longitudinal surface line of the curved portion of the vessel.

29. The method according to claim 1, wherein the curved distal portion defines a distal portion plane and which further comprises carrying out the further advancing step by further advancing the guidewire lumen with the curved distal portion and the loaded distal delivery assembly into the curved implantation site to orient the curved distal portion such that the curved distal plane intersects within seventy circumferential degrees of a plane passing through a superior longitudinal surface line of the curved portion of the vessel.

30. The method according to claim 1, which further comprises carrying out the further advancing step by further advancing the guidewire lumen with the curved distal portion and the loaded distal delivery assembly into the curved implantation site to at least approximately orient the prosthesis in an optimal implantation position.

31. The method according to claim 5, wherein the curved distal portion defines a distal portion plane and which further comprises carrying out the loading step by substantially aligning a plane passing through a proximal end of the curved longitudinal support member between thirty-five and fifty-five degrees around the circumference of the prosthesis to the distal portion plane.

32. The method according to claim 5, wherein the curved distal portion defines a distal portion plane and which further comprises carrying out the loading step by substantially aligning a plane passing through a proximal end of the curved longitudinal support member at approximately forty-five degrees around the circumference of the prosthesis to the distal portion plane.

33. The method according to claim 5, wherein a superior longitudinal surface line of the curved portion of the vessel in which the prosthesis is to be implanted defines a superior plane and which further comprises carrying out the further advancing step by further advancing the guidewire lumen with the curved distal portion and the loaded distal delivery assembly into the curved implantation site to at least approximately intersect the superior plane with a proximal half of the curved longitudinal support member.

77. The method according to claim 1, which further comprises connecting the guidewire lumen to the prosthesis delivery system at a proximal-most area of the guidewire lumen to minimize a restoring force when the guidewire lumen is rotated along its longitudinal axis.

22. The method according to claim 1, which further comprises freely rotatably connecting the guidewire lumen to the prosthesis delivery system to minimize a restoring force when the guidewire lumen is rotated along its longitudinal axis.

22-1. (canceled)

34. A method for automatic endovascular alignment of a prosthesis in a curved implantation site of a vessel, which comprises:

advancing a guidewire lumen having a curved distal portion along a guidewire and into the curved implantation site to at least approximately align the curved distal portion to a curve of the curved implantation site.

35-75. -75. (canceled)

76. A method for automatic endovascular alignment of a prosthesis, loaded in a delivery assembly, in a curved implantation site of a vessel having positioned therein a guidewire extending at least into the implantation site, which comprises:

providing a prosthesis delivery system with a longitudinally movable guidewire lumen having a curved distal portion;

threading the guidewire lumen over the guidewire along with the loaded distal delivery assembly to advance the guidewire lumen and the loaded distal delivery assembly towards the implementation site; and

advancing the curved distal portion and the loaded distal delivery assembly into the curved implantation site to at least approximately align the curved distal portion to a curve of the curved implantation site and, thereby, orient the prosthesis.