Helical hybrid stent

• US 9,155,639 B2
• Filed: 04/21/2010
• Issued: 10/13/2015
• Est. Priority Date: 04/22/2009
• Status: Active Grant

• Current Assignee: Medinol Limited (Medinol USA Incorporated)
• Original Assignee: Medinol Limited (Medinol USA Incorporated)
• Inventors: Richter, Jacob
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US12/764,418
• Publication Number:
  US 20100274350A1
• Time in Patent Office: 2,001 Days
• Field of Search: 623/1.22, 623/1.42
• US Class Current: 1/1
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

An expandable helical stent is provided, wherein the stent may be formed of a main stent component and a securement. The main stent component is formed from a flat strip having one or more undulating side bands that may be connected to form geometrically shaped cells and are helically wound to form a stent. The helical coils of the main stent component may be spaced apart or nestled to each other. The nestling of the undulation of adjacent helical windings contributes to maintaining the tubular shape and uniformity of the helically coiled stent. Alternatively, the flat strip may comprise a single undulating pattern. At the ends of the main stent component are end bands, which when wound, form a cylindrical ring. In one embodiment, one or more struts of the main stent component may have a width sufficient to include one or more fenestrations. The fenestrated struts may be connected by loops or turns wherein the material is narrower than that of the fenestrated struts to provide enhanced flexibility. The helical tubular is maintained with a securement.

Claims

1. A stent having a tubular structure comprising:

a helically coiled main stent component having a first side band and a second side band, the first and second side bands being helically wound a plurality of times to form a plurality of windings, a first end band connected to said first side band and extending at an oblique angle from said first side band, and a second end band connected to said second side band and extending at an oblique angle from said second side band, wherein each of the bands has an undulating pattern, wherein the first and second side bands are each helically oriented and intermittently connected, and the first and second end bands each form a right cylinder at the longitudinal ends of the stent; and

a securement interconnecting the windings of the main stent component.

2. The main stent component of claim 1 wherein one or more said side bands contain struts having one or more fenestrations.

3. The main stent component of claim 2 wherein said fenestration is filled with a therapeutic agent.

4. The stent according of claim 1 wherein said first side band is nestled next to a helically neighboring second side band.

5. The main stent component of claim 1 wherein the first and second side bands are connected by at least one cross strut.

6. The main stent component according to claim 5, wherein at least one said cross strut has a loop.

7. The securement of claim 1 wherein said securement comprises a structure selected from a group consisting of a sheet, a thread, a wire and a ribbon.

8. The securement of claim 7, wherein said securement is wound around the stent in a helical path different from the helical path of the main stent component.

9. The securement of claim 7, wherein the securement overlaps at a point of connection with the main stent component periodically over the length of the stent.

10. The securement of claim 1 comprising a fiber mesh.

11. The securement of claim 1 comprising a porous material.

12. The securement of claims 1 comprising a durable material.

13. The securement of claim 12 wherein the durable material is polyurethane.

14. The securement of claim 1, wherein said securement is embedded across the entire length of the helical main stent component.

15. The securement of claim 1, wherein the securement is affixed to the helical main stent component at an end.

16. A cylindrical main stent component comprising a strip comprising:

a first side band having undulations;

a second side band having undulations and connected to the first side band, wherein said first side band and second side band are helically oriented and are helically wound a plurality of times to form a plurality of windings; and

a first end band having undulations, a first edge, and a second edge, said first end band connected to said first side band and extending at an oblique angle to said first side band.

17. The strip main stent component of claim 16 further comprising:

a second end band having undulations, a first edge and a second edge, said second end band connected to said second side band and extending at an oblique angle to said second side band.

18. The strip main stent component of claim 16, wherein said side band and end band having an undulating pattern of struts joined by loops, wherein one or more said struts contain a fenestration and said loops having a width narrower than the width of said struts containing said fenestration.

19. The strip main stent component of claim 18 wherein said fenestration is filled with a therapeutic agent.

20. The main stent component of claim 18, wherein some adjacent struts of the undulating pattern have the same lengths.

21. The main stent component of claim 16 wherein the first and second side bands are connected by at least one cross strut.

22. The main stent component according to claim 21, wherein at least one said cross strut has a loop.

23. The main stent component of claim 16 comprising a metal.

24. The main stent component of claim 16 cut from a flat sheet of metal.

25. The main stent component of claim 16 comprising an amorphous metal alloy.

26. The main stent component of claim 25, wherein said amorphous metal alloy comprises an element selected from the group consisting of silicon, boron, and phosphorous.

27. The main stent component according to claim 25, wherein said amorphous metal alloy is an iron-based alloy containing Fe, Cr, B, and P.

28. The main stent component according to claim 25 wherein the amorphous metal alloy contains silicon.

29. The main stent component according to claim 25 wherein the amorphous metal alloy comprises a Fe—

Cr—

B—

P alloy.

40. A method of making a stent from the flat strip of claim 16, comprising the steps of:

a) helically winding the main stent component along a longitudinal axis; and

b) bringing the first edge of the first end band with the second edge of the first end band in close proximity to form a right cylinder to the longitudinal axis of the stent.

41. The method of claim 40, further comprising the step of applying a securement.

65. The method of claim 40, further comprising the step of applying a polymer to the main stent component by electrospinning.

30. A cylindrical main stent component comprising:

a helically oriented side band having undulations, said side band being helically wound a plurality of times to form a plurality of windings;

a first end band having undulations, a first edge and a second edge, said first end band connected to said side band and extending at an oblique angle to said side band; and

a second end band having undulations, a first edge and a second edge, said second end band connected to said side band and extending at an oblique angle to said side band, wherein said side band and end band having an undulating pattern of struts joined by loops, wherein one or more said struts contain a fenestration and said loops having a width narrower than the width of said struts containing said fenestration.

31. The main stent component according to claim 30 wherein said fenestration is filled with a therapeutic agent.

32. The main stent component of claim 30, wherein some adjacent struts of the undulating pattern have the same lengths.

33. The main stent component of claim 30 comprising a metal.

34. The main stent component of claim 30 cut from a flat sheet of metal.

35. The main stent component of claim 30 comprising an amorphous metal alloy.

36. The main stent component of claim 35, wherein said amorphous metal alloy comprises an element selected from the group consisting of silicon, boron, and phosphorous.

37. The main stent component according to claim 35, wherein said amorphous metal 20 alloy is an iron-based alloy containing Fe, Cr, B, and P.

38. The main stent component according to claim 35 wherein the amorphous metal alloy contains silicon.

39. The main stent component according to claim 35 wherein the amorphous metal alloy comprises a Fe—

Cr—

B—

P alloy.

42. A method of making a stent from the main stent component of claim 30, comprising the steps of:

a) helically winding the main stent component along a longitudinal axis to form a helically coiled structure;

b) bringing the first edge of the first end band with the second edge and the first end band into close proximity to form a right cylinder to the longitudinal axis; and

c) bringing the first edge of the second end band with the second edge of the second end band into close proximity to form a right cylinder to the longitudinal axis.

43. The method of any of claim 42, further comprising the step of applying a securement.

44. The main stent component according to claim 30 wherein the side band is a first side band, said main stent component further comprising a second side band having an undulating pattern.

45. The main stent component according to claim 44, wherein the first and second side bands are intermittently connected.

46. The main stent component of claim 45 wherein the first and second side bands are connected by at least one cross strut.

47. The main stent component according to claim 46, wherein at least one said cross strut has a loop.

48. The main stent component according to claim 44 wherein the second side contains struts having one or more fenestrations.

49. The main stent component of claim 48 wherein said fenestration is filled with a therapeutic agent.

50. The main stent component according of claim 44 configured such that said first side band is nestled next to a helically neighboring second side band upon arrangement in a tubular structure.

51. The main stent component according to claim 44 wherein the main stent component is arranged in a tubular structure.

52. The main stent component according to claim 51 having a securement maintaining the tubular structure of the main stent component.

53. The main stent component of claim 52 wherein said securement comprises a structure selected from a group consisting of a sheet, a thread, a wire and a ribbon.

54. The main stent component of claim 53, wherein said securement is wound around the stent in a helical path different from the helical path of the main stent component.

55. The main stent component of claim 53, wherein the securement overlaps at a point of connection with the main stent component periodically over the length of the stent.

56. The main stent component of claim 52, wherein said securement comprises a fiber mesh.

57. The main stent component of claim 52, wherein said securement comprises a porous material.

58. The main stent component of claims 52, wherein said securement comprises a durable material.

59. The main stent component of claim 58 wherein the durable material is polyurethane.

60. The main stent component of claim 52, wherein said securement is embedded across the entire length of the helical main stent component.

61. The main stent component of claim 52, wherein the securement is affixed to the helical main stent component at an end.

62. The main stent component of claim 52, wherein the securement provides longitudinal flexibility for the stent.

63. The main stent component of claim 52, wherein the securement provides structural support for the stent.

64. The main stent component of claim 52, wherein the main stent component forms a plurality of windings along the longitudinal axis of the stent, and the securement interconnects adjacent windings of the main stent component in the longitudinal direction.

66. The method of claim 42, further comprising the step of applying a polymer to the main stent component by electrospinning.