ADVANCED ENDOVASCULAR GRAFT

• US 20090264984A1
• Filed: 06/25/2009
• Published: 10/22/2009
• Est. Priority Date: 12/20/2001
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Trivascular Incorporated
• Inventors: Chobotov, Michael V.
• Granted Patent: US 8,709,065 B2
• Time in Patent Office: Days
• US Class Current: 623/1.170
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• 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 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• 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 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61M 2025/0177 : having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes

Abstract

This invention is a system for the treatment of body passageways; in particular, vessels with vascular disease. The system includes an endovascular graft with a low-profile delivery configuration and a deployed configuration in which it conforms to the morphology of the vessel or body passageway to be treated as well as various connector members and stents. The graft is made from an inflatable graft body section and may be bifurcated. One or more inflatable cuffs may be disposed at either end of the graft body section. At least one inflatable channel is disposed between and in fluid communication with the inflatable cuffs.

Claims

1. An endovascular graft, comprising:

a tubular graft body section;

a radially expandable stent extending from and affixed to the graft body section, said stent having a proximal end, a distal end and a serpentine ring configuration having a plurality of struts and apices; and

at least one barb integrally formed as an extension of each strut extending distally from a position on the strut that is distal of an adjacent proximal apex.

2. The graft of claim 1 wherein the at least one integrally formed barb is configured to extend distally in a deployed state generally parallel to an axis of a lumen in which they are deployed, partially penetrate a body passageway in which the graft is deployed and prevent axial migration of the graft due to distally oriented blood flow.

3. The graft of claim 2 wherein the at least one barb has an elevation angle with respect to a longitudinal axis of a strut from which the barb extends of about 10 degrees to about 45 degrees.

4. The graft of claim 2 wherein the at least one barb has a kick angle with respect to a longitudinal axis of a strut from which the barb extends of about 5 degrees to about 70 degrees.

5. The graft of claim 1 wherein the at least one barb has a length of about 1 mm to about 5 mm.

6. The graft of claim 1 wherein the radially expandable stent comprises a self-expanding stent.

7. The graft of claim 6 wherein the self-expanding stent comprises a superelastic alloy.

8. The graft of claim 7 wherein the superelastic alloy comprises NiTi.

9. The graft of claim 1 further comprising a connector member affixed to the graft body section, having a serpentine ring structure and being connected to the proximal stent.

10. The graft of claim 1 wherein the tubular graft body section further comprises at least one inflatable channel.

11. The graft of claim 1 wherein the tubular graft body section further comprises at least one inflatable cuff.

12. The graft of claim 1 wherein the graft body section comprises ePTFE.

13. The graft of claim 1 wherein the at least one distally oriented barb has a sharp point for tissue penetration.

14. The graft of claim 1 wherein proximal apices comprise a curved outer surface and a curved inner surface with both inner and outer surfaces of the apices comprising a circular radius of curvature with the radius of curvature of the outer surface being greater than the radius of curvature of the inner surface.

15. The graft of claim 14 wherein the circular radii of curvature comprise a common center point.

16. The graft of claim 14 wherein the circular radii of curvature comprise center points that are offset from each other by a distance up to about 0.03 inches.

17. The graft of claim 1 wherein the graft body section comprises a bifurcated graft body section.

18. The graft of claim 1 wherein the entire stent is formed from a single piece of material.

19. The graft of claim 18 wherein the entire stent is formed from a monolithic piece of NiTi material.

20. An endovascular graft, comprising

a graft body section;

a radially expandable stent extending from the graft body section, said stent having a proximal end, a distal end and a serpentine ring configuration having a plurality of struts and apices; and

at least one barb integrally formed as an extension of a strut extending distally from a position on the strut that is distal of an adjacent proximal apex.

21. The graft of claim 20 wherein the at least one barb has an elevation angle with respect to a longitudinal axis of a strut from which the barb extends of about 10 degrees to about 45 degrees.

22. The graft of claim 20 wherein the at least one barb has a kick angle with respect to a longitudinal axis of a strut from which the barb extends of about 5 degrees to about 70 degrees.

23. A radially expandable stent, comprising a proximal end, a distal end, a serpentine ring configuration having a plurality of struts and apices and a barb integrally formed as an extension of each strut extending distally from a position on the strut that is distal of an adjacent proximal apex.

24. An endovascular graft, comprising

a graft body section;

and

a radially expandable stent extending from the graft body section, said stent having a proximal end, a distal end, a plurality of proximal apices, a plurality of distal apices wherein the proximal apices comprise a curved outer surface and a curved inner surface with both inner and outer surfaces of the apices comprising a circular radius of curvature.

25. The graft of claim 24 wherein the circular radii of curvature comprise a common center point.

26. The graft of claim 24 wherein the circular radii of curvature comprise center points that are offset from each other.

27. The graft of claim 24 wherein the graft body section comprises a bifurcated graft body section.

28. The graft of claim 24 wherein the stent further comprises at least one distally oriented barb which is integrally formed with a strut and which extends distally from a position on the strut that is distal of an adjacent proximal apex.

29. A method of treating a patient'"'"'s vasculature, comprising

providing an endovascular graft that includes:

a graft body section,

a radially expandable stent extending from the graft body section, said stent having a proximal end, a distal end and a serpentine ring configuration having a plurality of struts and apices; and

at least one barb integrally formed as an extension of a strut extending distally from a position on the strut that is distal of an adjacent proximal apex;

delivering the graft to a treatment site within a patient'"'"'s body; and

deploying the graft at the treatment site such that the integrally formed barbs extend distally generally parallel to an axis of a lumen in which they are deployed, partially penetrate a body passageway in which the graft is deployed and prevent axial migration of the graft due to distally oriented blood flow.