Expandable stent and method for delivery of same

• US 6,375,677 B1
• Filed: 09/29/2000
• Issued: 04/23/2002
• Est. Priority Date: 03/05/1996
• Status: Expired due to Term

• Current Assignee: Divysio Solutions ULC
• Original Assignee: Ewysio Medical Devices Incorporated
• Inventors: Ricci, Donald R., Penn, Ian M.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US09/672,767
• Time in Patent Office: 571 Days
• Field of Search: 623/1.15, 623/1.16, 623/1.35, 606/198
• US Class Current: 623/1.16
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2250/0018 differing in elasticity, stiffness or compressibility
• 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 unexpanded stent comprising:

a plurality of radially-expandable circumferential struts, each circumferential strut having more than one sinusoidal cycle; and

a plurality of longitudinally-expandable longitudinal struts, each longitudinal strut having a sinusoidal cycle which is spaced apart from said circumferential struts, adjacent longitudinal struts being separated by less than one sinusoidal cycle of said circumferential strut.

2. The stent defined in claim 1, wherein the sinusoidal cycle of the longitudinal strut comprises a start point and an end point which are substantially aligned along a longitudinal axis of the stent.

3. 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.

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

5. A stent system comprising a balloon catheter having an expandable portion, the expandable portion having disposed thereon the stent defined in claim 4.

6. An unexpanded stent comprising:

a plurality of S-shaped circumferential struts; and

a plurality of S-shaped longitudinal struts, each longitudinal strut having a sinusoidal cycle which is spaced apart from any circumferential strut; and

each circumferential strut having one complete sinusoidal cycle which is coupled to two radially adjacent longitudinal struts.

7. The stent defined in claim 6, wherein the sinusoidal cycle in the longitudinal strut comprises a start point and an end point substantially aligned along a longitudinal axis of the stent.

8. The stent defined in claim 6, 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.

9. The stent defined in claim 6, further comprising a medicinal coating disposed thereon.

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

11. An unexpanded stent having a design which comprises a plurality of polygons, each polygon having:

two longitudinally-extending side members, each side member comprising at least one sinusoidal cycle; and

two non-linear end members, each non-linear end member comprising less than one sinusoidal cycle, wherein each longitudinally-extending side member has a sinusoidal cycle which is spaced apart from said end members.

12. The stent defined in claim 11, wherein the sinusoidal cycle in each longitudinally-extending side member comprises a start point and an end point substantially aligned along a longitudinal axis of the stent.

13. The stent defined in claim 11, wherein the two end members comprise a first concave-shaped end member and a second convex-shaped end member.

14. The stent defined in claim 13, wherein the first concave-shaped end member and the second convex-shaped end member are superimposable.

15. The stent defined in claim 13, wherein the first concave-shaped end member and the second convex-shaped end member are non-superimposable.

16. The stent defined in claim 13, wherein the first concave-shaped end member comprises a first apex and the second convex-shaped end member comprises a second apex.

17. The stent defined in claim 16, wherein the first apex is substantially flat and the second apex is substantially curved.

18. The stent defined in claim 16, wherein the first apex and the second apex are substantially aligned with respect to a longitudinal axis of the stent.

19. The stent defined in claim 11, wherein a relative flexibility of the stent is variable in accordance with a thickness of at least one of the polygon members varying in the range of from about 0.0015 to about 0.0045 inches.

20. The stent defined in claim 11, further comprising a medicinal coating disposed thereon.

21. A stent system comprising a balloon catheter having an expandable portion, the expandable portion having disposed thereon the stent defined in claim 20.

22. A stent comprising:

a plurality of radially-expandable circumferential struts, each circumferential strut having more than one sinusoidal cycle; and

a plurality of longitudinally-disposed struts, each longitudinally-disposed strut having a sinusoidal cycle which is spaced apart from said circumferential struts,

wherein the plurality of radially-expandable circumferential struts disposed between adjacent longitudinal struts comprises a first strut section and a second strut section each substantially oppositely angled with respect to a longitudinal axis of the stent to define an apex section.

23. The stent defined in claim 22, wherein the sinusoidal cycle of the longitudinally-disposed strut comprises a start point and an end point which are substantially aligned along the longitudinal axis of the stent.

24. The stent defined in claim 22, wherein a relative flexibility of the stent is variable in accordance with a thickness of the first strut section varying in the range of from about 0.0015 to about 0.0045 inches.

25. The stent defined in claim 22, wherein a relative flexibility of the stent is variable in accordance with a thickness of the second strut section varying in the range of from about 0.0015 to about 0.0045 inches.

26. The stent defined in claim 22, wherein a relative flexibility of the stent is variable in accordance with a thickness of each of the first strut section and the second strut section varying in the range of from about 0.0020 to about 0.0045 inches.

27. The stent defined in claim 22, wherein the first strut section and the second strut section are substantial mirror image of one another about the longitudinal axis.

28. The stent defined in claim 22, wherein the apex section is substantially flat.

29. The stent defined in claim 22, wherein the apex section is curved.

30. The stent defined in claim 22, wherein the longitudinal struts are connected to the apex section.

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

32. A stent system comprising a balloon catheter having an expandable portion, the expandable portion having disposed thereon the stent defined in claim 31.

33. A stent comprising:

a plurality of undulating circumferential struts; and

a plurality of longitudinal struts, each longitudinal strut having a sinusoidal cycle which is spaced apart from any circumferential strut, the sinusoidal cycle comprising a first curved section and a second curved section,

wherein the first curved section and the second curved section are of a different size.

34. The stent defined in claim 33, wherein the first curved section is U-shaped.

35. The stent defined in claim 33, wherein the second curved section is U-shaped.

36. The stent defined in claim 33, wherein the both the first curved section and the second curved section are U-shaped.

37. The stent defined in claim 33, wherein the first curved section and second curved section are interconnected.

38. The stent defined in claim 33, wherein the first curved section and second curved section are in a spaced relationship to one another.

39. The stent defined in claim 33, 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.

40. The stent defined in claim 33, further comprising a medicinal coating disposed thereon.

41. A stent system comprising a balloon catheter having an expandable portion, the expandable portion having disposed thereon the stent defined in claim 40.

42. A stent comprising:

a plurality of undulating circumferential struts; and

a plurality of longitudinal struts, each longitudinal strut having a curved flex member which is spaced apart from any circumferential strut, the curved flex member comprising a first U-shaped section and a second U-shaped section;

wherein the first curved section and the second curved section are of a different size.

43. The stent defined in claim 42, wherein the first U-shaped section and the second U-shaped section are on opposite sides a longitudinal axis of the stent.

44. The stent defined in claim 42, wherein the first U-shaped section and second U-shaped section are interconnected.

45. The stent defined in claim 42, wherein each of the first U-shaped section and second U-shaped section comprise a pair of straight sections which are:

(i) parallel to each other, and (ii) substantially orthogonal to a longitudinal axis of the stent.

46. The stent defined in claim 42 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.

47. The stent defined in claim 42, further comprising a medicinal coating disposed thereon.

48. A stent system comprising a balloon catheter having an expandable portion, the expandable portion having disposed thereon the stent defined in claim 47.

49. An unexpanded stent comprising:

a plurality of circumferentially-disposed, radially-expandable rows of struts, each row of circumferentially-disposed struts comprising a plurality of first sinusoidal sections; and

a plurality of longitudinally-disposed, longitudinally-expandable rows of struts, each longitudinally-disposed strut comprising a curved second sinusoidal section,

adjacent rows of circumferentially-disposed struts being interconnected by longitudinally-disposed struts,

a complete cycle of the curved second sinusoidal section having a length less than a length between adjacent rows of circumferentially-disposed struts,

adjacent longitudinally-disposed struts being spaced at a distance which is less than a length of a complete cycle of the first sinusoidal section;

wherein the second sinusoidal section comprises a start point and an end point which define a segment substantially parallel to a longitudinal axis of the stent.

50. The stent defined in claim 49, wherein the row of circumferentially-disposed struts comprises struts, and wherein each having a flexibility which varies in accordance with a thickness thereof varying in the range of from about 0.0015 to about 0.0045 inches.

51. The stent defined in claim 49, further comprising a medicinal coating disposed thereon.

52. A stent system comprising a balloon catheter having an expandable portion, the expandable portion having disposed thereon the stent defined in claim 51.