Implantable vascular device comprising a bioabsorbable frame

• US 20060111770A1
• Filed: 07/19/2005
• Published: 05/25/2006
• Est. Priority Date: 06/02/1999
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Pavcnik, Dusan, Osborne, Thomas A., Keller, Frederick S., Rosch, Josef
• Granted Patent: US 7,918,882 B2
• Time in Patent Office: Days
• US Class Current: 623/1.130
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0058 X-shaped
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

A multiple-sided valve for implantation within a body vessel comprising a frame comprising a bioabsorbable material is provided. The devices can be pushed from a delivery catheter into the lumen of a duct or vessel and may include one or more barbs for anchoring purposes. A full or partial covering of fabric or other flexible material, or a bioabsorbable material, including a collagen-based material such as small intestinal submucosa (SIS), may be attached to the frame to form an occlusion device, a graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.

Claims

1. A stent graft comprising:

a tubular graft having an external surface and an interior surface, and having a first opening at a first end and a second opening at a second end, the interior surface defining a fluid conduit extending from the first opening to the second opening; and

a frame attached to the tubular graft, the frame having a closed circumference with an aperture therethrough, said closed circumference having a plurality of sides, adjacent sides of said plurality of sides being interconnected by at least one bend, said frame adapted to assume a planar configuration and a serpentine configuration comprising two or more legs.

2. The stent graft of claim 1, where the frame is attached to the external surface of the tubular graft when the frame is in the serpentine configuration.

3. The stent graft of claim 1, where the frame is attached to the internal surface of the tubular graft, when the frame is in the serpentine configuration.

4. The stent graft of claim 1, wherein the frame further comprises a covering attached to at least two of the plurality of sides and attached to the exterior surface of the tubular graft.

5. The stent graft of claim 4, wherein the covering is attached to at least four sides of the frame and defines a covering opening, and where the tubular graft is positioned within the covering opening.

6. The stent graft of claim 4, wherein the covering comprises an extracellular matrix material.

7. The stent graft of claim 1, wherein the tubular graft comprises an extracellular matrix material.

8. The stent graft of claim 7, wherein the tubular graft comprises a material selected from the group consisting of:

small intestine submucosa, pericardium, stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa and dura mater.

9. The stent graft of claim 1, wherein the frame is a first frame attached to the stent tubular graft at the first end of the tubular graft, and where the stent graft further comprises a second frame attached to the stent tubular graft at the second end of the tubular graft, where the second frame is attached to the tubular graft;

where the second frame has a closed circumference with an aperture therethrough, said closed circumference having a plurality of sides, adjacent sides of said plurality of sides being interconnected by at least one bend, said frame adapted to assume a planar configuration and a serpentine configuration comprising two or more legs.

10. The stent graft of claim 1, wherein the at least one frame is a first frame attached to the outer sleeve at the first end of the outer sleeve, and where the stent graft further comprises a second frame attached to the outer sleeve at the second end of the outer sleeve, where the second frame is attached to the internal surface of the outer sleeve;

where the second frame comprises a single frame having a closed circumference with an aperture therethrough, said closed circumference having a plurality of sides, adjacent sides of said plurality of sides being interconnected by at least one bend, said frame adapted to assume a planar configuration and a serpentine configuration comprising two or more legs; and

where the frame is in the serpentine configuration and at least a portion of the frame is positioned within the fluid conduit of the outer sleeve.

11. The stent graft of claim 1, wherein the tubular graft is a first tubular graft;

and where the stent graft further comprises a second tubular graft having a external surface and an interior surface, and having a first opening at a first end and a second opening at a second end, the interior surface defining a fluid conduit extending from the first opening to the second opening; and

where the frame attached to the external surface of the first tubular graft and to the external surface of the second tubular graft;

where the frame has a closed circumference with an aperture therethrough, said closed circumference having a plurality of sides, adjacent sides of said plurality of sides being interconnected by at least one bend, said frame adapted to assume a planar configuration and a serpentine configuration comprising two or more legs; and

where the tubular graft is positioned within the aperture of the closed circumference when the frame is in the serpentine configuration.

12. The stent graft of claim 11, wherein the second tubular graft comprises an extracellular matrix material.

13. The stent graft of claim 11, wherein the frame further comprises a covering attached to at least two of the plurality of sides and attached to the exterior surface of the first tubular graft and the exterior surface of the second tubular graft;

and wherein the covering is attached to at least four sides of the frame and defines a covering opening, and where the first tubular graft and the second tubular graft are positioned within the covering opening.

14. The stent graft of claim 1, wherein the frame comprises a material selected from the group consisting of:

stainless steel and a nickel-titanium alloy.

15. A stent graft comprising:

an outer sleeve having a external surface and an interior surface, and having a first opening at a first end and a second opening at a second end, the interior surface defining a fluid conduit extending from the first opening to the second opening; and

at least one frame contacting the interior surface of the tubular graft;

where the at least one frame has a closed circumference with an aperture therethrough, said closed circumference having a plurality of sides, adjacent sides of said plurality of sides being interconnected by at least one bend, said at least one frame adapted to assume a planar configuration and a serpentine configuration comprising two or more legs; and

where the at least one frame is in the serpentine configuration and at least a portion of the at least one frame is positioned within the fluid conduit of the outer sleeve.

16. The stent graft of claim 15, wherein the outer sleeve comprises an extracellular matrix material.

17. The stent graft of claim 15, wherein the outer sleeve comprises a material selected from the group consisting of:

small intestine submucosa, pericardium, stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa and dura mater.

18. The stent graft of claim 15, where the at least one frame is self-expanding and exerts an outward force against the interior surface of the outer sleeve when the at least one frame is in the serpentine configuration.

19. The stent graft of claim 15, where the at least one frame is a first frame contacting the interior surface of the tubular graft at the first end;

and where the stent graft further comprises a second frame contacting the interior surface of the tubular graft at the second end, where the first frame and the second frame independently have a closed circumference with an aperture therethrough, each closed circumference having a plurality of sides, adjacent sides of said plurality of sides being interconnected by at least one bend, the first frame and the second frame independently adapted to assume a planar configuration and a serpentine configuration comprising two or more legs; and

where the first frame and the second frame independently are in the serpentine configuration and at least a portion of the at least one frame is positioned within the fluid conduit of the outer sleeve; and

wherein the outer sleeve comprises a material selected from the group consisting of;

small intestine submucosa, pericardium, stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa and dura mater;

where the first frame and the second frame are independently self-expanding and exert an outward force against the interior surface of the outer sleeve when the first frame and the second frame are in the serpentine configuration.

20. A method of treating an aneurysm in a body vessel, comprising the step of implanting a stent graft, the stent graft comprising:

a tubular graft having a external surface and an interior surface, and having a first opening at a first end and a second opening at a second end, the interior surface defining a fluid conduit extending from the first opening to the second opening; and

a frame attached to the tubular graft;

where the frame comprises at least one frame having a closed circumference with an aperture therethrough, said closed circumference having a plurality of sides, adjacent sides of said plurality of sides being interconnected by at least one bend, said frame adapted to assume a planar configuration and a serpentine configuration comprising two or more legs; and

where the tubular graft is positioned within the aperture of the closed circumference when the frame is in the serpentine configuration; and

wherein the stent graft is implanted within the abdominal aorta having a vessel defect site such that at least a portion of the external surface of the tubular graft traverses the vessel defect site.