MULTI-STAGE EXPANDABLE STENT-GRAFT

• US 20010053929A1
• Filed: 12/09/1998
• Published: 12/20/2001
• Est. Priority Date: 12/09/1998
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated
• Inventors: CULLY, EDWARD H., VONESH, MICHAEL J., BRUUN, STEVEN R., MARTIN, GERALD R., SALZMANN, DENNIS L.
• Granted Patent: US 6,336,937 B1
• Time in Patent Office: Days
• US Class Current: 623/1.12
• 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 expandable tubular device that comprises

an essentially tubular component, the tubular component being constrained into a compacted first diametrical dimension;

wherein when not constrained in the first diametrical dimension the tubular component expands radially into an enlarged second diametrical dimension, the tubular component being resistant to permanent deformation from external compression when in the second dimension;

wherein the tubular component can be adjusted to a further enlarged third diametrical dimension when distensive force is applied thereto, the tubular component maintaining the third dimension when the distensive force is removed and being resistant to permanent deformation from external compression when in the third dimension; and

wherein the device undergoes minimal longitudinal shortening when enlarged between the first dimension and the third dimension.

2. The tubular device of

claim 1

wherein the tubular component comprises a self-expanding support structure and a polymer sleeve.

3. The tubular device of

claim 2

wherein the support structure provides the expansive force to achieve the second dimension.

4. The tubular device of

claim 2

wherein the support structure provides at least a portion of the distensive force to achieve the third dimension.

5. The tubular device of

claim 3

wherein the polymer sleeve is distensible to a third dimension upon application of a distensive force in excess of that exerted by the support structure.

6. The tubular device of

claim 2

wherein the polymer sleeve comprises an expanded polytetrafluoroethylene.

7. The tubular device of

claim 2

wherein the polymer sleeve undergoes deformation between the second and third dimensions.

8. The tubular device of

claim 2

wherein the polymer sleeve undergoes deformation between the first and second dimensions.

9. The tubular device of

claim 1

wherein the device is adapted to be expanded beyond its second dimension with a distensive force of an expandable balloon.

10. The tubular device of

claim 1

wherein the device is capable of further expansion beyond the third dimension upon application of further distensive force thereto.

11. The tubular device of

claim 1

wherein the device is capable of selective diametrical distention beyond the second dimension.

12. The tubular device 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.

13. The tubular device 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 fluid pressure along the lumen.

14. The tubular device of

claim 1

wherein the device is adapted to be inserted into a body lumen and selectively diametrically expanded to prevent leakage of fluid around the device.

15. The tubular device of

claim 1

wherein the device is adapted to be inserted into a body structure and selectively diametrically expanded to establish at least one intraluminal anastomosis.

16. The tubular device of

claim 1

wherein the device is adapted to be inserted into a body structure and diametrically expanded to compensate for time-dependent changes in the surrounding vasculature.

17. The tubular device of

claim 1

wherein the device has smooth continuous internal surface therethrough, regardless of diameter, beyond the second dimension.

18. The tubular device of

claim 1

wherein the device has smooth continuous internal surface therethrough, regardless of diameter beyond the first dimension.

19. The tubular device of

claim 10

wherein the internal surface comprises a polymer.

20. The tubular device of

claim 13

wherein the internal surface comprises an expanded polytetrafluoroethylene.

21. The tubular device of

claim 1

wherein

the device has a longitudinal length;

and

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

22. The tubular device of

claim 1

wherein

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

and

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

23. The tubular device of

claim 1

wherein the device is resistant to expansion at initial installation between the second and the third dimensions until a minimum threshold distensive force is applied thereto.

24. The tubular device 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.

25. The tubular device of

claim 1

wherein once distended to a third diametrical dimension the device is resistant to recoil or further distention until a threshold pressure is reached.

26. The tubular device of

claim 1

wherein the second dimension is at least 50% larger than the first dimension.

27. The tubular device of

claim 1

wherein the second dimension is at least 75% larger than the first dimension.

28. The tubular device of

claim 1

wherein the second dimension is at least 100% larger than the first dimension.

29. The tubular device of

claim 1

wherein the third dimension is at least 5% larger than the second dimension.

30. The tubular device of

claim 1

wherein the third dimension is at least 10% larger than the second dimension.

31. The tubular device of

claim 1

wherein the third dimension is at least 30% larger than the second dimension.

32. The tubular device of

claim 1

wherein the third dimension is at least 50% larger than the second dimension.

33. The tubular device of

claim 1

wherein the third dimension is at least 75% larger than the second dimension.

34. The tubular device of

claim 1

wherein the third dimension is at least 100% larger than the second dimension.

35. The tubular device of

claim 1

wherein the device longitudinally shortens no more than 15%.

36. The tubular device of

claim 1

wherein the device longitudinally shortens no more than 10%.

37. The tubular device of

claim 1

wherein the device longitudinally shortens no more than 7%.

38. The tubular device of

claim 1

wherein the device longitudinally shortens no more than 5%.

39. The tubular device of

claim 2

wherein polymer sleeve is adapted to have a relatively smooth continuous internal surface over a range of operative diameters.

40. The tubular device of

claim 2

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

41. The tubular device of

claim 2

wherein the prosthesis includes a constraining element that is resistant to support structure expansion;

and

wherein after experiencing a threshold yield pressure, the constraining element allows the support structure to self-expand.

42. The device of

claim 1

in which the tubular component is constrained through a constraint external to the device.

43. The device of

claim 42

in wherein enlargement beyond the first diametrical dimension occurs when the constraint is removed.

44. The device of

claim 1

in which the tubular component is constrained through a constraint integral to the device.

45. The device of

claim 44

in which deformation of the constraint allows diametrical enlargement beyond the first diametrical diameter.

46. The device of

claim 45

wherein deformation of the constraint is achieved via distensive force.

47. The device of

claim 45

in which disruption of constraint allows enlargement beyond the first diameter.

48. The device of

claim 47

wherein disruption of the constraint is achieved via distensive force.

49. An endoluminal prosthesis comprising:

a support structure that is self-expanding over a range of operative diameters;

a graft element attached to the support structure, the graft element being adapted to have an essentially smooth continuous internal surface over the range of operative diameters;

wherein the support structure exerts a continuous outward radial force after initial installation.

50. The endoluminal prosthesis of

claim 49

wherein the prosthesis includes a constraining element that is resistant to dilation via forces exerted by the support structure;

and

wherein after experiencing a threshold pressure, the constraining element allows the device to achieve a second diameter.

51. The endoluminal prosthesis of

claim 49

wherein the graft element provides resistance to support structure growth to a fully expanded state within the range of operative diameters upon initial installation.

52. The endoluminal prosthesis of

claim 49

wherein the prosthesis undergoes further enlargement upon application of an applied distensive force.

53. The endoluminal prosthesis of

claim 52

wherein the applied distensive force comprises a balloon.

54. The endoluminal prosthesis of

claim 52

wherein the applied distensive force comprises force exerted by the stent.

55. An endoluminal prosthesis comprising:

a stent element that is self-expanding;

a graft element attached to the stent element;

wherein the prosthesis includes a constraining element that is resistant to stent expansion; and

wherein after experiencing a threshold pressure, the constraining element allows the device to achieve a second diameter.

56. The tubular device of

claim 55

wherein the device has smooth continuous internal surface therethrough, regardless of diameter beyond the first dimension.

57. The tubular device of

claim 55

wherein

the device has a longitudinal length;

and

the device distends from the first diametrical dimension to the third diametrical dimension with substantially no shortening along the length of the device.

58. The tubular device of

claim 55

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

59. The endoluminal prosthesis of

claim 55

wherein the graft element includes the constraining element.

60. The tubular device of

claim 55

wherein the device has a smooth continuous internal surface therethrough, regardless of diameter.

62. The endoluminal prosthesis of

claim 60

wherein the prosthesis undergoes further expansion to a second diameter within the range of operative diameters when a further distensive force is applied.

63. The endoluminal prosthesis of

claim 60

wherein the polymer sleeve is expanded polytetrafluoroethylene.

61. An endoluminal prosthesis comprising

a self-expanding support structure

a polymer sleeve attached to the support structure;

wherein the polymer sleeve is adapted to have a relatively smooth continuous internal surface over a range of operative diameters; and

wherein the polymer sleeve deforms upon application of a distensive force to cause the prosthesis to expand to one diameter within the range of operative diameters;

wherein the prosthesis does not significantly recoil from the one diameter when the distensive force is removed.