Expandable stent and method for delivery of same

• US 6,858,037 B2
• Filed: 02/13/2002
• Issued: 02/22/2005
• Est. Priority Date: 03/05/1996
• Status: Expired due to Fees

• Current Assignee: Evysio Medical Devices ULC (Evysio Medical Devices)
• Original Assignee: Evysio Medical Devices ULC (Evysio Medical Devices)
• Inventors: Ricci, Donald R., Penn, Ian M.
• Primary Examiner(s): BUI, VY Q
• Application Number:
  US10/073,277
• Publication Number:
  US 20020165605A1
• Time in Patent Office: 1,105 Days
• Field of Search: 606/108, 606/191, 606/192, 606/194, 606/195, 606/198, 602 11- 12, 602 2364- 237, 600 1- 3
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0036 differing in thickness

Abstract

An expandable stent comprising a proximal end and a distal end in communication with one another and a tubular wall disposed between the proximal end and the distal end. The tubular wall has a longitudinal axis and a porous surface defined by a plurality of intersecting members comprising a series of longitudinal struts disposed substantially parallel to the longitudinal axis of the stent. Each longitudinal strut in the series comprises flexure means for substantially complementary extension and compression of a diametrically opposed pair of the longitudinal struts upon flexure of the stent. The stent is expandable from a first, contracted position to a second, expanded position upon the application of a radially outward force on the stent. The provision of such flexure means in the series of longitudinal struts leads to a very desirable balance of lateral flexibility of the unexpanded stent and radial rigidity of the expanded stent.

Claims

1. An unexpanded stent comprising:

a tubular wall having a series of undulating circumferential portions, each circumferential portion comprising alternating peaks and valleys;

the tubular wall also having a plurality of longitudinal portions connecting said series of undulating circumferential portions to form a porous, cylindrical surface;

a longitudinal portion connecting a peak in a first circumferential portion with a valley in a second circumferential portion adjacent to the first circumferential portion; and

each longitudinal portion having a flexure member, said flexure member, in two dimensions, being non-sinusoidal and arcuate, each flexure member being connected to an adjacent circumferential portion with a straight strut portion which is disposed parallel to a longitudinal axis of the stent.

2. The stent of claim 1, wherein one or more of said plurality of longitudinal portions includes multiple flexure members within the same longitudinal portion.

3. The stent of claim 2, wherein said multiple flexure members within the same longitudinal portion have a same shape.

4. The stent of claim 2, wherein said multiple flexure members within the same longitudinal portion have a different shape.

5. The stent of claim 2, wherein said multiple flexure members within the same longitudinal portion have a first lateral section and a second lateral section, and wherein the first lateral section and the second lateral section are present on the same side of the longitudinal portion.

6. The stent of claim 2, wherein said multiple flexure members within the same longitudinal portion have a first lateral section and a second lateral section, and wherein the first lateral section and the second lateral section are present on different sides of the longitudinal portion.

7. The stent defined in claim 1, wherein a relative flexibility of the stent is variable in accordance with a thickness of at least one of the plurality of radially-expandable circumferential struts varying in the range of from about 0.0015 to about 0.0045 inches when measured on the outer surface of the tubular wall.

8. The stent defined in claim 1, further comprising a medicinal coating disposed thereon.

9. A stent system comprising a balloon catheter having an expandable portion, the expandable portion having disposed thereon the stent defined in claim 8.

10. The stent defined in claim 2, wherein said multiple flexure members within the same longitudinal portion have substantially the same shape and differing size.

11. The stent defined in claim 2, wherein said multiple flexure members within the same longitudinal portion have differing shape and size.

12. The stent defined in claim 1, wherein the porous, cylindrical surface comprises a repeating pattern comprised of a polygon having a pair of side walls substantially parallel to a stent longitudinal axis, and wherein the flexure member is disposed in each of the side walls.

13. The stent defined in claim 1, wherein the longitudinal portions are aligned in a spaced relationship parallel to a stent longitudinal axis.

14. The stent defined in claim 1, wherein the longitudinal portions are aligned in an interconnected relationship parallel to a stent longitudinal axis.

15. The stent defined in claim 1, wherein the stent is constructed of stainless steel.

16. The stent defined in claim 1, wherein said flexure member, in two dimensions, has a width less than a width of said undulating circumferential portions when measured on the outer surface of the tubular wall.

17. The stent defined in claim 1, wherein said flexure member, in two dimensions, is U-shaped.

18. The stent defined in claim 1, wherein the stent is constructed of a self-expanding material which expands at a temperature of greater than about 30°

C.

19. The stent defined in claim 18, wherein the self-expanding material expands at a temperature of in the range of from about 30°

to about 40°

C.

20. The stent defined in claim 1, wherein adjacent undulating circumferential portions have substantially the same profile.

21. The stent defined in claim 1, wherein adjacent undulating circumferential portions have substantially different profiles.

55. The stent defined in claim 1, wherein the stent is constructed of a balloon expandable metal.

58. The stent defined in claim 12, wherein the polygon further comprises a first wall having a concave shape and a second wall having a convex shape.

59. The stent defined in claim 58, wherein at least one of the first wall and the second wall has a flat apex.

60. The stent defined in claim 59, wherein the flat apex comprises a pair of rounded shoulders.

61. The stent defined in claim 58, wherein at least one of the first wall and the second wall has a rounded apex.

62. The stent defined in claim 58, wherein at least one of the first wall and the second wall has a flat apex and the other of the first wall and the second wall has a rounded apex.

63. The stent defined in claim 62, wherein the flat apex comprises a pair of rounded shoulders.

22. An unexpanded stent comprising:

a tubular wall having a series of undulating circumferential portions, each circumferential portion comprising alternating peaks and valleys;

the tubular wall also having a plurality of longitudinal portions connecting said series of undulating circumferential portions to form a porous, cylindrical surface;

a longitudinal portion connecting a peak in a first circumferential portion with a valley in a second circumferential portion adjacent to the first circumferential portion; and

each of said plurality of longitudinal portions having a flexure member that provides lateral flexibility to said stent and is disposed within each of said plurality of longitudinal portions, each said flexure member, in two dimensions, being (i) non-sinusoidal, (ii) interposed between a pair of straight strut portions which are disposed parallel to a longitudinal axis of the stent, and (iii) arcuate.

23. The stent of claim 22, wherein one or more of said plurality of longitudinal portions includes multiple flexure members within the same longitudinal portion.

24. The stent of claim 23, wherein said multiple flexure members within the same longitudinal portion have a same shape.

25. The stent of claim 23, wherein said multiple flexure members within the same longitudinal portion have a different shape.

26. The stent of claim 23, wherein said multiple flexure members within the same longitudinal portion have a first lateral section and a second lateral section, and wherein the first lateral section and the second lateral section are present on the same side of the longitudinal portion.

27. The stent of claim 23, wherein said multiple flexure members within the same longitudinal portion have a first lateral section and a second lateral section, and wherein the first lateral section and the second lateral section are present on different sides of the longitudinal portion.

28. The stent defined in claim 22, wherein a relative flexibility of the stent is variable in accordance with a thickness of at least one of the plurality of radially-expandable circumferential struts varying in the range of from about 0.0015 to about 0.0045 inches when measured on the outer surface of the tubular wall.

29. The stent defined in claim 22, further comprising a medicinal coating disposed thereon.

30. A stent system comprising a balloon catheter having an expandable portion, the expandable portion having disposed thereon the stent defined in claim 29.

31. The stent defined in claim 23, wherein said multiple flexure members within the same longitudinal portion have substantially the same shape and differing size.

32. The stent defined in claim 23, wherein said multiple flexure members within the same longitudinal portion have differing shape and size.

33. The stent defined in claim 22, wherein the porous, cylindrical surface comprises a repeating pattern comprised of a polygon having a pair of side walls substantially parallel to a stent longitudinal axis, and wherein the flexure structures are disposed in each of the side walls.

34. The stent defined in claim 22, wherein the longitudinal portions are aligned in a spaced relationship parallel to a stent longitudinal axis.

35. The stent defined in claim 22, wherein the longitudinal portions are aligned in an interconnected relationship parallel to a stent longitudinal axis.

36. The stent defined in claim 22, wherein the stent is constructed of stainless steel.

37. The stent defined in claim 22, wherein the stent is constructed of a self-expanding material.

38. The stent defined in claim 37, wherein the self-expanding material comprises nitinol.

39. The stent defined in claim 37, wherein the self-expanding material expands at a temperature of greater than about 30°

C.

40. The stent defined in claim 22, wherein said flexure member, in two dimensions, has a width less than a width of said undulating circumferential portions when measured on an outer surface of the tubular wall.

41. The stent defined in claim 22, wherein adjacent undulating circumferential portions have substantially the same profile.

42. The stent defined in claim 22, wherein adjacent undulating circumferential portions have substantially different profiles.

56. The stent defined in claim 22, wherein the stent is constructed of a balloon expandable metal.

64. The stent defined in claim 33, wherein the polygon further comprises a first wall having a concave shape and a second wall having a convex shape.

65. The stent defined in claim 64, wherein at least one of the first wall and the second wall has a flat apex.

66. The stent defined in claim 65, wherein the flat apex comprises a pair of rounded shoulders.

67. The stent defined in claim 64, wherein at least one of the first wall and the second wall has a rounded apex.

68. The stent defined in claim 64, wherein at least one of the first wall and the second wall has a flat apex and the other of the first wall and the second wall has a rounded apex.

69. The stent defined in claim 68, wherein the flat apex comprises a pair of rounded shoulders.

43. An unexpanded stent comprising:

a tubular wall having a series of undulating circumferential portions, each circumferential portion comprising alternating peaks and valleys;

the tubular wall also having a plurality of longitudinal portions connecting said series of undulating circumferential portions to form a porous, cylindrical surface;

a longitudinal portion connecting a peak in a first circumferential portion with a valley in a second circumferential portion adjacent to the first circumferential portion; and

each of said plurality of longitudinal portions having a flexure member that provides lateral flexibility to said stent and is disposed within each of said plurality of longitudinal portions, each said flexure member, in two dimensions, being (i) non-sinusoidal, (ii) arcuate, and (iii) comprising a pair of substantially straight strut portions disposed substantially orthogonal to a longitudinal axis of the stent, the pair of substantially straight strut portions being interconnected by a curved portion.

45. The stent defined in claim 43, further comprising a medicinal coating disposed thereon.

46. A stent system comprising a balloon catheter having an expandable portion, the expandable portion having disposed thereon the stent defined in claim 43.

47. The stent defined in claim 43, wherein the porous, cylindrical surface comprises a repeating pattern comprised of a polygon having a pair of side walls substantially parallel to a stent longitudinal axis, and wherein the flexure members are disposed in each of the side walls.

48. The stent defined in claim 43, wherein the longitudinal portions are aligned in a spaced relationship parallel to a stent longitudinal axis.

49. The stent defined in claim 43, wherein the longitudinal portions are aligned in an interconnected relationship parallel to a stent longitudinal axis.

50. The stent defined in claim 43, wherein the stent is constructed of stainless steel.

51. The stent defined in claim 43, wherein the stent is constructed of a self-expanding material.

52. The stent defined in claim 43, wherein said flexure member, in two dimensions, has a width less than a width of the circumferential portions when measured on an outer surface of the tubular wall.

53. The stent defined in claim 43, wherein adjacent circumferential portions have substantially the same profile.

54. The stent defined in claim 43, wherein adjacent circumferential portions have substantially different profiles.

57. The stent defined in claim 43, wherein the stent is constructed of a balloon expandable metal.

70. The stent defined in claim 47, wherein the polygon further comprises a first wall having a concave shape and a second wall having a convex shape.

71. The stent defined in claim 70, wherein at least one of the first wall and the second wall has a flat apex.

72. The stent defined in claim 71, wherein the flat apex comprises a pair of rounded shoulders.

73. The stent defined in claim 70, wherein at least one of the first wall and the second wall has a rounded apex.

74. The stent defined in claim 70, wherein at least one of the first wall and the second wall has a flat apex and the other of the first wall and the second wall has a rounded apex.

75. The stent defined in claim 74, wherein the flat apex comprises a pair of rounded shoulders.

44. The stent defined in wherein a relative flexibility of the stent is variable in accordance with a thickness of at least one of the circumferential portions varying in the range of from about 0.0015 to about 0.0045 inches when measured on the outer surface of the tubular wall.