Expandable stent and method for delivery of same

• US 6,881,223 B2
• Filed: 07/09/2002
• Issued: 04/19/2005
• 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:
  US10/190,818
• Publication Number:
  US 20020169501A1
• Time in Patent Office: 1,015 Days
• Field of Search: 606/108, 606/191, 606/192, 606/194, 606/195, 606/198, 623 11- 12, 623 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 struts leads to a very desirable balance of lateral flexibility of the unexpanded stent and radial rigidity of the expanded stent.

Claims

1. An expandable stent comprising:

a proximal end and a distal end in communication with one another,

a tubular wall disposed between the proximal end and the distal end, the tubular wall having a longitudinal axis and a porous surface defined by a plurality of intersecting members comprising (i) a series of longitudinal struts disposed substantially parallel to the longitudinal axis of the stent, and (ii) a series of circumferential struts undulating in a circumferential direction,

each of the longitudinal struts comprising arcuate flexure means for substantially complementary extension and compression of a diametrically opposed pair of the longitudinal struts upon flexure of the stent, the stent being expandable from a first, contracted position to a second, expanded position upon the application of a radially outward force on the stent, said flexure means being thinner than at least one adjacent circumferential strut when measured on the other surface of the tubular wall, said flexure means comprising a sinusoidal cycle disposed between a start point and an end point which are in substantial alignment with the longitudinal axis, the distance between the start point and the end point being less than a minimum distance between an adjacent pair of circumferential struts.

2. The stent defined in claim 1, wherein said circumferential struts are arranged to define alternating peaks and valleys.

3. The stent defined in claim 2, wherein the peaks in adjacent circumferential struts are in substantial alignment along the longitudinal axis.

4. The stent defined in claim 1, wherein the flexure means comprises at least a first lateral section and second lateral section disposed in each longitudinal strut in the stent.

5. The stent defined in claim 4, wherein the first lateral section and the second lateral section are symmetric.

6. The stent defined in claim 4, wherein the first lateral section and the second lateral section are asymmetric.

7. The stent defined in claim 6, wherein the first lateral section and the second lateral section have substantially the same shape and differing size.

8. The stent defined in claim 6, wherein the first lateral section and the second lateral section have differing size.

9. The stent defined in claim 4, wherein the first lateral section and the second lateral section have substantially the same shape and differing size.

14. The stent defined in claim 1, wherein the series of longitudinal struts comprising the flexure means includes all longitudinal struts in the porous surface.

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

16. The stent defined in claim 1, wherein the stent is constructed of a self-expanding material.

17. The stent defined in claim 16, wherein the self-expanding material comprises nitinol.

18. The stent defined in claim 16, wherein the self-expanding material expands at a temperature of greater than about 30°

C.

19. The stent defined in claim 16, 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 the stent has a medicinal coating thereon.

21. A balloon catheter comprising an expandable portion and the stent defined in claim 1 disposed in the expandable portion.

57. The expandable stent defined in claim 1, wherein the longitudinal struts interconnect adjacent pairs of circumferential struts at a first connection point on a first circumferential strut and a second connection point on a second circumferential strut adjacent to the first circumferential strut such that a line drawn through the first connection point and the second connection point is substantially non-parallel to the longitudinal axis.

60. The expandable stent defined in claim 1, wherein the plurality of intersecting members are arranged to define a repeating pattern comprised of rows of polygons arranged circumferentially around the longitudinal axis, a longitudinally adjacent pair of polygons:

(i) sharing a common circumferential strut, and (ii) being identically oriented.

10. An expandable stent comprising:

a proximal end and a distal end in communication with one another,

a tubular wall disposed between the proximal end and the distal end, the tubular wall having a longitudinal axis and a porous surface defined by a plurality of intersecting members comprising (i) a series of longitudinal struts disposed substantially parallel to the longitudinal axis of the stent, and (ii) a series of circumferential struts undulating in a circumferential direction,

each of the longitudinal struts comprising a curved flexure member for substantially complementary extension and compression of a diametrically opposed pair of the longitudinal struts upon flexure of the stent, the stent being expandable from a first, contracted position to a second, expanded position upon the application of a radially outward force on the stent, said flexure member being thinner than adjacent circumferential struts when measured on the outer surface of the tubular wall, said flexure member comprising a sinusoidal cycle disposed between a start point and an end point which are in substantial alignment with the longitudinal axis, the distance between the start point and the end point being less than a minimum distance between an adjacent pair of circumferential struts, wherein the plurality of intersecting members are arranged to define a first repeating pattern comprised of a polygon having a pair of side walls substantially parallel to the longitudinal axis and the flexure member is disposed in each of the side walls.

11. The stent defined in claim 10, wherein the flexure member comprises a pair of joined curved sections, wherein each curved section has an arc of substantially 180°

.

12. The stent defined in claim 11, wherein the curved sections are of substantially the same size.

13. The stent defined in claim 11, wherein the curved sections are of different sizes.

22. The stent defined in claim 10, wherein the stent has a medicinal coating thereon.

23. A balloon catheter comprising an expandable portion and the stent defined in claim 10 disposed on the expandable portion.

58. The expandable stent defined in claim 10, wherein the longitudinal struts interconnect adjacent pairs of circumferential struts at a first connection point on a first circumferential strut and a second connection point on a second circumferential strut adjacent to the first circumferential strut such that a line drawn through the first connection point and the second connection point is substantially non-parallel to the longitudinal axis.

61. The expandable stent defined in claim 10, wherein the repeating pattern is comprised of rows of the polygons arranged circumferentially around the longitudinal axis, a longitudinally adjacent pair of polygons:

(i) sharing a common circumferential strut, and (ii) being identically oriented.

24. An unexpanded stent comprising:

a tubular wall having a porous surface defined by a plurality of intersecting members comprising (i) a series of longitudinally extending struts disposed substantially parallel to the longitudinal axis of the stent, and (ii) a series of nonlinear circumferential struts undulating in a circumferential direction,

a flexure member disposed in at least two of the longitudinally extending struts, each said flexure member comprising a curved undulating portion having a start point and an end point in substantial alignment with the longitudinal axis, said curved undulating portion being thinner than at least one adjacent circumferential strut when measured on the outer surface of the tubular wall, said flexure member comprising a sinusoidal cycle disposed between the start point and the end point, the distance between the start point and the end point being less than a minimum distance between an adjacent pair of circumferential struts.

25. The stent defined in claim 24, wherein the circumferential struts are undulating.

26. The stent defined in claim 24, wherein the tubular wall has a medicinal coating thereon.

27. A balloon catheter comprising an expandable portion and the stent defined in claim 24 disposed on the expandable portion.

28. The stent defined in claim 24, wherein the flexure member is isolated from two circumferential struts.

29. The stent defined in claim 24, wherein the flexure member comprises at least a first lateral section and a second lateral section disposed in each longitudinally extending strut in the stent.

30. The stent defined in claim 29, wherein the first lateral section and the second lateral section are symmetric.

31. The stent defined in claim 29, wherein the first lateral section and the second lateral section are asymmetric.

32. The stent defined in claim 29, wherein the first lateral section and the second lateral section have substantially the same shape and differing size.

33. The stent defined in claim 29, wherein the first lateral section and the second lateral section have differing size.

34. The stent defined in claim 29, wherein the first lateral section and the second lateral section have substantially the same shape and differing size.

35. The stent defined in claim 24, wherein the stent is constructed of stainless steel.

36. The stent defined in claim 24, wherein the stent is constructed of a self-expanding material.

37. The stent defined in claim 36, wherein the self-expanding material comprises nitinol.

38. The stent defined in claim 36, wherein the self-expanding material expands at a temperature of greater than about 30°

C.

39. The stent defined in claim 36, wherein the self-expanding material expands at a temperature of in the range of from about 30°

to about 40°

C.

40. The stent defined in claim 24, wherein the series of nonlinear circumferential struts comprises a plurality of circumferential rows of struts, each row of struts arranged to define alternating peaks and valleys.

41. The stent defined in claim 40, wherein peaks in adjacent circumferential rows of struts are in substantial alignment along the longitudinal axis.

42. The stent defined in claim 40, wherein valleys in adjacent circumferential rows of struts are in substantial alignment along the longitudinal axis.

43. The stent defined in claim 40, wherein peaks in a circumferential row of struts and valleys in an adjacent circumferential row are in substantial alignment along the longitudinal axis.

44. The stent defined in claim 40, wherein each peak in adjacent pairs of circumferential rows of struts is connected to a longitudinally extending strut.

45. The stent defined in claim 40, wherein each valley in adjacent pairs of circumferential rows of struts is connected to a longitudinally extending strut.

46. The stent defined in claim 40, wherein a longitudinally extending strut interconnects a valley and a peak in adjacent pairs of circumferential rows of struts.

47. The stent defined in claim 40, wherein the longitudinally extending struts interconnect adjacent pairs of circumferential rows of struts at a first connection point on a circumferential row of struts and a second connection point or an adjacent circumferential row of struts.

48. The stent defined in claim 47, wherein a line drawn through the first connection point and the second connection point is substantially parallel to the longitudinal axis.

49. The stent defined in claim 47, wherein a line drawn through the first connection point and the second connection point is substantially non-parallel to the longitudinal axis.

59. The unexpanded stent defined in claim 24, wherein the longitudinally extending struts interconnect adjacent pairs of circumferential struts at a first connection point on a first circumferential strut and a second connection point on a second circumferential strut adjacent to the first circumferential strut such that a line drawn through the first connection point and the second connection point is substantially non-parallel to the longitudinal axis.

62. The unexpanded stent defined in claim 24, wherein the plurality of intersecting members are arranged to define a repeating pattern comprised of rows of polygons arranged circumferentially around the longitudinal axis, a longitudinally adjacent pair of polygons:

(i) sharing a common circumferential strut, and (ii) being identically oriented.

50. An unexpanded stent comprising:

a tubular wall having a porous surface defined by a plurality of intersecting members comprising (i) a series of longitudinally extending struts disposed substantially parallel to the longitudinal axis of the stent, and (ii) a plurality of circumferential rows of struts undulating in a circumferential direction, each row of struts arranged to define alternating peaks and valleys,

a flexure member disposed in at least two of the longitudinally extending struts, each said flexure member comprising a curved undulating portion having a start point and an end point in substantial alignment with the longitudinal axis, said curved undulating portion being thinner than at least one adjacent circumferential strut when measured on the outer surface of the tubular wall, said flexure member comprising a sinusoidal cycle disposed between the start point and the end point, the distance between the start point and the end point being less than a minimum distance between an adjacent pair of circumferential struts;

wherein the longitudinally extending struts interconnect adjacent pairs of circumferential rows of struts at a first connection point on a circumferential row of struts and a second connection point on an adjacent circumferential row of struts such that a line drawn through the first connection point and the second connection point is substantially non-parallel to the longitudinal axis.

51. The stent defined in claim 50, wherein the flexure member comprises at least one S-shaped portion disposed in each longitudinally extending strut in the stent.

52. The stent defined in claim 50, wherein the flexure member comprises a circumferentially extending first curved section and a circumferentially extending second curved section.

53. The stent defined in claim 52, wherein the first section and the second section each comprises a curved apex.

54. The stent defined in claim 53, wherein the curved apex of the first section and the curved apex of the second section are interconnected by a straight section oriented transverse to the longitudinal axis.

55. The stent defined in claim 50, wherein the tubular wall has a medicinal coating thereon.

56. A balloon catheter comprising an expandable portion and the stent defined in claim 55 disposed in the expandable portion.

63. The unexpanded stent defined in claim 50, wherein the plurality of intersecting members are arranged to define a repeating pattern comprised of rows of polygons arranged circumferentially around the longitudinal axis, a longitudinally adjacent pair of polygons:

(i) sharing a common circumferential strut, and (ii) being identically oriented.