Endoluminal grafts having continuously curvilinear wireforms

• US 6,071,307 A
• Filed: 09/30/1998
• Issued: 06/06/2000
• Est. Priority Date: 09/30/1998
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Oh, Seik, McIntyre, John, Rhee, Richard
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Nguyen, Tram A.
• Application Number:
  US09/163,831
• Time in Patent Office: 615 Days
• Field of Search: 623/11, 623/12, 623/1.13, 623/1.18, 623/1.2, 606/108, 606/191, 606/194, 606/195, 606/198
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

An endoluminal grafts is provided which is constructed to be radially collapsed and/or radially compressed to a small diameter. The graft has wireforms which generally comprise a wire deformed into generally annular configuration and consisting of a plurality of curvilinear wave forms. The wave forms have a plurality of first apices in linear alignment with each other, a plurality of second apices in linear alignment with each other, and a plurality of curvilinear segments traversing back and forth between said first and second apices. The graft is i) initially disposable in a radially compact configuration of a first diameter and ii) subsequently expandable to a radially expanded configuration of a second diameter, said second diameter being larger than said first diameter. When in its radially compact configuration, the adjacent curvilinear segments of the wireforms will nest or seat in abutting contact with one another, thereby minimizing the diameter of the graft while in its radially compact configuration.

Claims

1. An intraluminal graft, comprising:

a biocompatible pliable tube, and

a support scaffold connected to the tube including at least one annular wireform, each wireform defining a central axis and including;

a wire shaped with a plurality of curvilinear waveforms, the waveforms having a plurality of first co-planar apices and a plurality of second co-planar apices, the first and second apices alternating and extending in opposite directions, and a plurality of curvilinear segments extending between and connecting the alternating first and second apices, the curvilinear segments each having a direction of curvature in the same rotational orientation about the central axis as an adjacent curvilinear segment.

2. The graft of claim 1, wherein the wireform is formed at least partially of resilient material and biased to said radially expanded configuration such that said wireform will self-expand to said radially expanded configuration when at body temperature and unconstrained.

3. The graft of claim 1, wherein said wireform is at least partially formed of malleable material which is initially formed to said radially compact configuration, and is plastically deformable to said radially expanded configuration.

4. The graft of claim 1, wherein the first and second apices are curvilinear and have radii of curvature and a corresponding center of radius.

5. The graft of claim 4, wherein each curvilinear segment connects to the adjacent first and second apices at points of tangency along the respective radii of curvature of the first and second apices.

6. The graft of claim 5, wherein each of a plurality of longitudinal apical axes extends in parallel to the central axis and through the center of radius of the first and second apices, and wherein a tangent line drawn between the points of tangency at the opposite ends of any one curvilinear segment defines an internal angle with respect to the adjacent longitudinal apical axes of about 37.5°

.

7. The graft of claim 6, wherein the points of tangency at the opposite ends of any one curvilinear segment are located along the respective curvilinear first and second apices at an external angle of about 70°

with respect to the corresponding longitudinal apical axes.

8. The graft of claim 1, wherein the support scaffold includes a plurality of the wireforms each spaced apart.

9. The graft of claim 8, wherein the graft is straight and the central axes of the plurality of wireforms are co-linear.

10. The graft of claim 8, wherein the first apices of the plurality of wireforms are aligned.

11. The graft of claim 1, wherein the wireform of the support scaffold is located substantially within the pliable tube.

12. The graft of claim 11, wherein the wireform is threaded through apertures provided in the pliable tube.

13. A wireform for medical stents or grafts, comprising:

a ring-shaped wireform defining a central axis and including a wire shaped with a plurality of curvilinear waveforms, the waveforms having a plurality of first co-planar apices and a plurality of second co-planar apices, the first and second apices alternating and extending in opposite directions, and a plurality of curvilinear segments extending between and connecting the alternating first and second apices, the curvilinear segments each having a direction of curvature in the same rotational orientation about the central axis as an adjacent curvilinear segment.

14. The wireform of claim 13, wherein the first and second apices are curvilinear and have radii of curvature and a corresponding center of radius.

15. The wireform of claim 14, wherein each curvilinear segment connects to the adjacent first and second apices at points of tangency along the respective radii of curvature of the first and second apices.

16. The wireform of claim 15, wherein each of a plurality of longitudinal apical axes extends in parallel to the central axis and through the center of radius of the first and second apices, and wherein a tangent line drawn between the points of tangency at the opposite ends of any one curvilinear segment defines an internal angle with respect to the adjacent longitudinal apical axes of about 37.5°

.

17. The wireform of claim 16, wherein the points of tangency at the opposite ends of any one curvilinear segment are located along the respective curvilinear first and second apices at an external angle of about 70°

with respect to the corresponding longitudinal apical axes.

18. An intraluminal graft that is highly compactable, comprising:

a biocompatible pliable tube, and

a plurality of annular wireforms, each wireform defining a central axis and including in a radially expanded state;

a wire having a zig-zag shape with a plurality of first apices extending in one axial direction and a plurality of second apices extending in the opposite axial direction, and a plurality of curvilinear segments extending between and connecting the alternating first and second apices, the curvilinear segments each having a direction of curvature in the same rotational orientation about the central axis as an adjacent curvilinear segment so that in a reduced-diameter state the curvilinear segments nest together.

19. The graft of claim 18, wherein the wireform is formed at least partially of resilient material and biased to said radially expanded state such that said wireform will self-expand to said radially expanded state when at body temperature and unconstrained.

20. The graft of claim 18, wherein said wireform is at least partially formed of malleable material which is initially formed to said reduced-diameter state, and is plastically deformable to said radially expanded state.

21. The graft of claim 18, wherein the first apices are co-planar, and the second apices are co-planar.

22. The graft of claim 18, wherein the first and second apices are curvilinear and have radii of curvature and a corresponding center of radius.

23. The graft of claim 22, wherein each curvilinear segment connects to the adjacent first and second apices at points of tangency along the respective radii of curvature of the first and second apices.

24. The graft of claim 18, wherein the plurality of wireforms are axially spaced apart and affixed to the pliable tube.

25. The graft of claim 18, wherein the wireforms are located substantially within the pliable tube.

26. The graft of claim 18, wherein the wireforms are threaded through apertures provided in the pliable tube.