Multi-stage expandable stent-graft

• US 6,336,937 B1
• Filed: 12/09/1998
• Issued: 01/08/2002
• Est. Priority Date: 12/09/1998
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated
• Inventors: Bruun, Steven R., Martin, Gerald R., Salzmann, Dennis L., Cully, Edward H., Vonesh, Michael J.
• Primary Examiner(s): Reip, David O.
• Assistant Examiner(s): Bui, Vy Q.
• Application Number:
  US09/207,944
• Publication Number:
  US 20010053929A1
• Time in Patent Office: 1,126 Days
• Field of Search: 606/108, 606/198, 606/195, 606/191, 604/7, 604/8, 604/96, 623/14, 623/1.37, 623/1.44, 623/1.17, 623/1.12, 623/1.39, 623/1-2-, 623/1.1, 623/1.11, 623/1.13, 623/1.14, 623/1.15, 623/1.16, 623/1.18, 623/1.19, 623/1.2, 623/1.21
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

An improved device for use in a conduit, such as a blood vessel, is provided. The device uniquely combines desirable properties from two distinct previous devices. The device of the present invention assumes and is constrained to a first diametrical dimension for insertion into the conduit. Once inserted and properly positioned in the conduit the device expands to a second diametrical dimension within the conduit when the constraint is removed. The device can then be dilated to one or more enlarged third diametrical dimensions by using a balloon catheter or similar device. The result is a device that provides desirable properties of both self-expanding stents and balloon-expandable endoprostheses. The device can be employed in a variety of applications.

Claims

1. An endoluminal prosthesis comprising

a self-expanding stent element;

a graft element comprising polytetrafluoroethylene attached to the stent element to form the endoluminal prosthesis;

wherein the endoluminal prosthesis is constrained by a constraint to a first diametrical dimension for insertion into a lumen;

wherein the endoluminal prosthesis self-expands to a second enlarged diametrical dimension when said constraint is removed, the endoluminal prosthesis being restricted from further diametrical enlargement by the graft element; and

wherein the graft element yields under applied distensive force to enlarge at least a portion of the endoluminal prosthesis to a third diametrical dimension at least 10% larger than the second diametrical dimension, the endoluminal prosthesis maintaining the third diametrical dimension when the distensive force is removed; and

wherein the stent element undergoes longitudinal shortening of less than 15% when enlarged from the first diametrical dimension to the third diametrical dimension.

2. The endoluminal prosthesis of claim 1 wherein the stent element provides the expansive force to achieve the second dimension.

3. The endoluminal prosthesis of claim 2 wherein the graft element is distensible to a third dimension upon application of a distensive force in excess of that exerted by the stent element.

4. The endoluminal prosthesis of claim 1 wherein the stent element provides at least a portion of the distensive force to achieve the third dimension.

5. The endoluminal prosthesis of claim 1 wherein the graft element comprises an expanded polytetrafluoroethylene.

6. The endoluminal prosthesis of claim 1 wherein the graft element undergoes deformation between the second and third dimensions.

7. The endoluminal prosthesis of claim 1 wherein the graft element undergoes deformation between the first and second dimensions.

8. The endoluminal prosthesis of claim 1 wherein the prosthesis is adapted to be expanded beyond its second dimension with a distensive force of an expandable balloon.

9. The endoluminal prosthesis of claim 1 wherein the prosthesis is capable of further expansion beyond the third dimension upon application of further distensive force thereto.

10. The endoluminal prosthesis of claim 1 wherein the prosthesis is capable of selective diametrical distention beyond the second dimension.

11. The endoluminal prosthesis of claim 1 wherein

the device has a fluid-flow lumen therethrough; and

the diameter of the lumen is adjustable beyond the second dimension to regulate flow through the lumen.

12. The endoluminal prosthesis of claim 1 wherein the prosthesis is adapted to be inserted into a body lumen and selectively diametrically expanded to prevent leakage of fluid around the device.

13. The endoluminal prosthesis of claim 1 wherein the prosthesis is adapted to be inserted into a body structure and selectively diametrically expanded to establish at least one intraluminal anastomosis.

14. The endoluminal prosthesis of claim 1 wherein the prosthesis is adapted to be inserted into a body structure and diametrically expanded to compensate for changes in the surrounding vasculature over time.

15. The endoluminal prosthesis of claim 1 wherein the prosthesis has smooth continuous internal surface therethrough, regardless of diameter, beyond the second dimension.

16. The endoluminal prosthesis of claim 1 wherein the prosthesis has smooth continuous internal surface therethrough, regardless of diameter beyond the first dimension.

17. The endoluminal prosthesis of claim 1 wherein

the prosthesis has a longitudinal length;

and

the prosthesis distends from the second diametrical dimension to the third diametrical dimension with substantially no shortening along the length of the prosthesis.

18. The endoluminal prosthesis of claim 1 wherein

the prosthesis includes at least a first and a second region;

and

the prosthesis includes different expansive properties between the first and the second regions.

19. The endoluminal prosthesis device of claim 1 wherein the prosthesis is resistant to expansion at initial installation between the second and the third dimensions until a minimum threshold distensive force is applied thereto.

20. The endoluminal prosthesis of claim 1 wherein the device is adapted to be inserted into a body structure and expanded in place to achieve and maintain a taper along its length.

21. The endoluminal prosthesis of claim 1 wherein once distended to a third diametrical dimension the prosthesis is resistant to recoil or further distention until a threshold pressure is reached.

22. The endoluminal prosthesis of claim 1 wherein the second dimension is at least 50% larger than the first dimension.

23. The endoluminal prosthesis of claim 1 wherein the second dimension is at least 75% larger than the first dimension.

24. The endoluminal prosthesis of claim 1 wherein the second dimension is at least 100% larger than the first dimension.

25. The endoluminal prosthesis of claim 1 wherein the third dimension is at least 30% larger than the second dimension.

26. The endoluminal prosthesis of claim 1 wherein the third dimension is at least 50% larger than the second dimension.

27. The endoluminal prosthesis of claim 1 wherein the third dimension is at least 75% larger than the second dimension.

28. The endoluminal prosthesis of claim 1 wherein the third dimension is at least 100% larger than the second dimension.

29. The endoluminal prosthesis of claim 1 wherein the prosthesis longitudinally shortens no more than 10%.

30. The endoluminal prosthesis of claim 1 wherein the prosthesis longitudinally shortens no more than 7%.

31. The endoluminal prosthesis of claim 1 wherein the prosthesis longitudinally shortens no more than 5%.

32. The endoluminal prosthesis of claim 1 wherein graft element has a relatively smooth continuous internal surface over a range of operative diameters.

33. The endoluminal prosthesis of claim 1

wherein the stent element exerts a continuous outward radial force after initial installation so as to allow the prosthesis to enlarge further over time.

34. The endoluminai prosthesis of claim 1

wherein the by a constraint is resistant to the stent element;

and

wherein after experiencing a threshold pressure, the constraint allows the stent element to self-expand.

35. The endoluminal prosthesis of claim 1 in which the stent element is constrained through the constraint external to the device.

36. The endoluminal prosthesis of claim 35 in wherein enlargement beyond the first diametrical dimension occurs when the constraint is removed.

37. The endoluminal prosthesis of claim 1 in which the stent element is constrained through the constraint integral to the device.

38. The endoluminal prosthesis of claim 37 in which deformation of the constraint allows diametrical enlargement beyond the first diameter.

39. The endoluminal prosthesis of claim 38 wherein deformation of the constraint is achieved via distensive force.

40. The endoluminal prosthesis of claim 38 in which disruption of the constraint allows enlargement beyond the first diameter.

41. The endoluminal prosthesis of claim 40 wherein disruption of the constraint is achieved via distensive force.