Intraluminal stent

• US 6,730,117 B1
• Filed: 11/15/2000
• Issued: 05/04/2004
• Est. Priority Date: 03/05/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Parsons, Bruce, Golds, Ellen, Tseng, David
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US09/623,347
• Time in Patent Office: 1,266 Days
• Field of Search: 623/1.15, 623/1.16, 623/1.22, 623/1.17, 623/1.18, 623/1.19, 623/1.2
• US Class Current: 623/1.16
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/30322 differing in surface structures
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2250/0026 differing in surface structures
• CPC Class Codes: A61F 2250/006 modular

Abstract

This invention is an intraluminal stent (10) made of a zigzag or sinusoidal member defining a successive series of struts (14) connected by apex sections (15), and formed into a series of axially displaced hoop members (12a-12n) wherein at least one of the hoop members has at least one strut (14) connected to a strut (14) of an adjacent hoop. The connected struts (14) may be connected by spot welding, continuous welding, or suturing, for example, or by a bridging member (26) connected to each strut (14), and may be spaced along the length of the stent in a pattern to form a connective spine (16). The number of zigs of the zigzag member in each hoop member (12a-12n) may be varied, as can the zig length (L1). A plurality of connective spines (16) may also be included.

Claims

1. A tubular stent having a tubular axis, said stent comprising a single continuous filament wound into a non-helical configuration to form a plurality of circumferential hoops linearly disposed in succession along said axis, each of said hoops comprising elements defined by a successive series of struts, each angled with respect to the stent tubular axis when the stent is in an expanded configuration, connected by apex sections alternately pointing in opposite axial directions, at least one pair of adjacent hoops being connected to one another by a connecting member, said connecting member connecting a first strut connected to a first apex section, which is part of one of said connected adjacent hoops, to a second strut connected to a second apex section facing said first apex section, which is part of the other of said adjacent hoops, wherein said first apex section is circumferentially offset from said second apex section, and said first and second struts are aligned with one another.

2. The stent according to claim 1 wherein each connecting member comprises a connector selected from the group consisting of:

a spot weld, a continuous weld, an absorbable suture, a non-absorbable suture, a staple, absorbable glue, non-absorbable glue, and a polymer-containing connection.

3. The stent according to claim 1 wherein axially opposed apex sections of adjacent hoops are axially spaced from one another and said connecting member comprises a bridging member aligned with and connected to said first and second struts.

4. The stent according to claim 3 wherein each bridging member is connected to each of said first and second struts by a connector selected from the group consisting of:

a spot weld, a continuous weld, an absorbable suture, a non-absorbable suture, a staple, absorbable glue, non-absorbable glue, and a polymer-containing connection.

5. The stent according to claim 3 wherein said bridging member and said struts connected thereto are comprised of the same material of construction and are of the same cross sectional dimensions.

6. The stent according to claim 3 wherein said bridging member comprises a portion of said single continuous filament.

7. The stent according to claim 1 wherein the single continuous filament comprises a material selected from the group consisting of:

nitinol wire, stainless steel wire, and thermoplastic polymer.

8. The stent according to claim 1 comprising four to six similarly-oriented apex sections in each hoop.

9. The stent according to claim 1 in which all of said hoops have a similar number of similarly-oriented apex sections.

10. The stent of claim 1 wherein each apex section pointing in a first direction and two struts attached thereto comprise an element, the element length and element width of each adjacent element being uniform in each hoop.

11. The stent according to claim 1 having an diameter of 3-40 millimeters.

12. The stent according to claim 1 further comprising a graft layer enclosing at least a portion of the interior space defined by said stent.

13. The stent according to claim 1 wherein the apex sections have a geometry selected from the group consisting of:

rounded or straight-edged.

14. The stent according to claim 1 further comprising at least one selected surface area, said selected surface area having a different radiopacity than the surface area surrounding said selected surface area.

15. The stent according to claim 1 wherein the elements have a zig-zag or sinusoidal configuration.

17. The stent according to claim 1 wherein the connecting members of adjacent pairs of hoops are arranged in a pattern to form a connective spine along the length of the stent.

18. The stent according to claim 17 wherein the connected struts forming said connective spine are aligned with one another helically along the length of said stent.

19. The stent according to claim 17 wherein the connected struts forming said connective spine are not aligned with one another along the length of said stent.

16. A tubular stent having a tubular axis, said stent comprising a single continuous filament wound into a non-helical configuration to form a plurality of circumferential hoops linearly disposed in succession along said axis and axially spaced from one another, each of said hoops comprising elements defined by a successive series of struts connected by apex sections alternately pointing in opposite axial directions, at least one pair of adjacent hoops being connected to one another by a connecting member, said connecting member connecting a first strut connected to a first apex section, which is part of one of said connected adjacent hoops, to a second strut connected to a second apex section facing said first apex section, which is part of the other of said adjacent hoops, wherein said first apex section is circumferentially offset from said second apex section, said first and second struts are aligned with one another, and one or both of said first and second struts are elongated, relative to remaining struts in said adjacent hoops, to lie adjacent one another for at least some axial distance to permit connection therebetween.

20. A tubular stent having a tubular axis, said stent comprising a single continuous filament wound into a non-helical configuration to form a plurality of circumferential hoops linearly disposed in succession along said axis, each of said hoops comprising elements defined by a successive series of struts connected by apex sections alternately pointing in opposite axial directions, at least one pair of adjacent hoops being connected to one another by a connecting member, said connecting member connecting a first strut connected to a first apex section, which is part of one of said connected adjacent hoops, to a second strut connected to a second apex section facing said first apex section, which is part of the other of said adjacent hoops, wherein said first apex section is circumferentially offset from said second apex section, said first and second struts are aligned with one another, and each pair of adjacent hoops includes a plurality of paired struts in axially opposed apex sections, each of said strut pairs being connected to one another to form a plurality of connective spines along the length of said stent.

21. A tubular stent having a tubular axis, said stent comprising a single continuous filament wound into a non-helical configuration to form a plurality of circumferential hoops linearly disposed in succession along said axis, each of said hoops comprising elements defined by a successive series of struts connected by apex sections alternately pointing in opposite axial directions, at least one pair of adjacent hoops being connected to one another by a connecting member, said connecting member connecting a first strut connected to a first apex section, which is part of one of said connected adjacent hoops, to a second strut connected to a second apex section facing said first apex section, which is part of the other of said adjacent hoops, wherein said first apex section is circumferentially offset from said second apex section, said first and second struts are aligned with one another, and the stent comprises at least two longitudinal segments, the hoops in at least one of said segments differing from those in another of said segments with respect one or more of:

apex section included angles, element length, and number of apex sections per hoop.

22. A tubular stent having a tubular axis, said stent comprising a single continuous filament wound into a non-helical configuration to form a plurality of circumferential hoops linearly disposed in succession along said axis, each of said hoops comprising elements defined by a successive series of struts connected by apex sections alternately pointing in opposite axial directions, at least one pair of adjacent hoops being connected to one another by a connecting member, said connecting member connecting a first strut connected to a first apex section, which is part of one of said connected adjacent hoops, to a second strut connected to a second apex section facing said first apex section, which is part of the other of said adjacent hoops, wherein said first apex section is circumferentially offset from said second apex section, said first and second struts are aligned with one another, and the stent comprises at least two longitudinal segments, each hoop in a first of said segments having a first element length and each hoop in a second of said segments having a second element length that is different from said first element length.

23. The stent according to claim 22 further comprising a transition segment between said first and second segments, each hoop in said transition segment having a third element length intermediate said first and second element lengths.

24. The stent according to claim 22 further comprising a transition segment between said first and said second segments, said transition segment having a plurality of element lengths that provide a gradual transition between said first and second element lengths.

25. A tubular stent having a tubular axis, said stent comprising a single continuous filament wound into a non-helical configuration to form a plurality of circumferential hoops linearly disposed in succession along said axis, each of said hoops comprising elements defined by a successive series of struts connected by apex sections alternately pointing in opposite axial directions, at least one pair of adjacent hoops being connected to one another by a connecting member, said connecting member connecting a first strut connected to a first apex section, which is part of one of said connected adjacent hoops, to a second strut connected to a second apex section facing said first apex section, which is part of the other of said adjacent hoops, wherein said first apex section is circumferentially offset from said second apex section and said first and second struts are aligned with one another, each apex section pointing in a first direction and two struts attached thereto comprising an element, each element having a different element length, a different element width, or a combination thereof, with respect to each circumferentially adjacent element.

26. The stent of claim 25 wherein one or more selected elements of each hoop are connected to an element of an adjacent hoop with a bridging member.

27. The stent of claim 26 wherein the bridging members between selected elements of a first and second hoop are angled with respect to the stent tubular axis in a first direction and bridging members between selected elements of said second and a third hoop are angled with respect to the stent tubular axis in a second direction opposite said first direction.

28. A tubular stent having a tubular axis, said stent comprising a plurality of elements arranged in a helix, said elements defined by a successive series of struts connected by apex sections alternately pointing in first and second axial directions, the apex sections that point in the first direction axially overlapping the apex sections that point in the second direction on axially adjacent traversals of said helix, wherein at least a portion of a first of said struts of a first set of said apex sections that points in the first direction on a first traversal of said helix is aligned parallel to at least a portion of a second of said struts of a second set of said apex sections that points in the second direction on a second traversal, adjacent said first traversal, wherein said first strut and second strut portions are welded together to comprise a connecting member and less than all apex sections of said first set of apex sections are so aligned with apex sections of said second set of apex sections.

29. The stent of claim 28 further comprising a plurality of connecting members uniformly distributed along the stent according to a predetermined helical spacing.

30. The stent of claim 29 wherein the predetermined helical spacing is once approximately every 450 degrees.

31. The stent according to claim 28 wherein each apex section in said helix comprises two struts attached thereto, one strut being longer than the other.

32. The stent according to claim 28 wherein each apex section comprises an included angle, the apex sections being arranged in a pattern wherein the included angles are generally uniform except for selected apex sections in which the included angles are non-uniform to effect said alignment of said first and second struts.

33. The stent according to claim 28 wherein each apex section comprises an axial length, the axial lengths being generally uniform except for selected apex sections comprising one or both end hoops of said stent.

34. The stent according to claim 33 wherein said end apex sections define a plane perpendicular to said tubular axis at the end of said stent.

35. The stent according to claim 28 further comprising an end hoop disposed at each end of said stent in which apex sections that point outwardly from said stent lie in a common plane perpendicular to the axis of the stent.

36. The stent according to claim 35 wherein the elements of said end hoop have a progressively shorter axial length or amplitude leading to an end strut.

37. The stent according to claim 35 wherein the struts between apex sections of said end hoop progressively further overlap struts of an adjacent hoop leading to an end strut.

38. The stent according to claim 37 wherein the end hoops each comprise an end strut that is aligned adjacent to and connected to another strut of said end hoop.

39. The stent according to claim 38 wherein said end strut is connected to said another strut with a weld having a first weld length and said connecting members in said hoops that are not end hoops comprise a weld having a second weld length that is less than said first weld length.

40. The stent according to claim 39 wherein the end strut terminates short of said common plane perpendicular to the axis of the stent on which lie said end hoop apex sections that point outwardly from said stent.

41. A method of making a stent comprising,

a) winding a first wire in a predetermined pattern about pins disposed on the surface of a mandrel conforming generally to the intended stent outer shape:

i) transversely about the pins into a series of elements defined by a successive series of substantially straight sections connected by apex sections alternately pointing in opposite axial directions,

ii) circumferentially about the mandrel to form at least two adjacent circumferential hoops of elements disposed axially in succession along the length of said stent,

b) winding a second wire having end portions between a pair of weld segment pins disposed between proximate sections of said adjacent circumferential hoops, respectively,

c) welding the end portions of the second wire to proximate sections of said adjacent circumferential hoops to define a weld segment connecting said adjacent circumferential hoops.

42. The method of claim 41 wherein step c) includes directing a laser through a hole formed in the mandrel to weld the end portions of the second wire to the first wire, to shorten the end portions of the second wire, or a combination thereof.

43. A method of making a stent comprising,

first, winding a filament in a predetermined pattern around pins on a mandrel, said predetermined pattern including segments wherein a first portion of said filament lies adjacent a second portion of said filament at an area on said mandrel surface which includes an access hole to the interior of said mandrel, and,

second, using said access hole to connect said first and second portions of said filament.

44. The method of claim 43 wherein said filamentary material is a wire and said access hole is used to connect said first and second filamentary portions by a weldment thereof.

45. A method of making a stent segment comprising (1) winding N filaments, where N is a whole number of at least 2, around N respective sets of pegs on a tubular mandrel, each of said N sets including at least three axially offset pegs at a preselected axial location on said mandrel, each of said sets including at least one common peg adjacent a circumferentially adjoining set, each of said filaments following a common path for a full distance between the common pegs of said circumferentially adjoining sets, and (2) forming a connection between said filaments along said common paths, and thus forming a circumferential stent segment comprising a succession of elements defined by a successive series of substantially straight sections connected by apex sections alternately pointing in opposite axial directions.

46. A method of making a stent comprising making an axial succession of circumferential stent segments, as recited in claim 45.

47. A method of making a stent segment comprising (1) winding N filaments, where N is a whole number of at least 1, around N respective sets of pegs on a tubular mandrel, each of said N sets including at least three axially offset pegs at a preselected axial location on said mandrel, circumferentially successive pairs of pegs being axially offset in a preselected direction from the pair which precedes it so as to form a helical pattern along the length of the stent segment, wherein in at least one circumferential location in each traversal of a preselected angular portion of the mandrel by said pegs there is a common peg approximately 360°

offset from an adjacent peg of the same or a circumferentially adjoining set, adjacent which each filament contacts a portion of the same filament or an adjacent filament, and (2) forming a connection between said contacting adjacent filament portions, and thus forming a circumferential stent segment comprised of a helical succession of elements defined by a successive series of substantially straight sections connected by apex sections alternately pointing in opposite axial directions.

48. A tubular stent having a tubular axis, said stent comprising a plurality of circumferential hoops linearly disposed in succession along said axis, each of said hoops comprising elements defined by a successive series of struts connected by apex sections alternately pointing in opposite axial directions to form a continuous series of similarly-oriented apex sections that point in a first direction, said similarly-oriented apex sections arranged in a helix in which each hoop comprises one 360-degree wrap of said helix, at least one pair of adjacent hoops being connected to one another by a connecting member, said connecting member connecting a first strut, which is part of one of said connected adjacent hoops, to a second strut, which is part of the other of said adjacent hoops, wherein axially opposed apex sections of adjacent hoops are axially spaced from one another and said connecting member is a bridging member aligned with and connected to said first and second struts.

49. A tubular stent having a tubular axis, said stent comprising a plurality of circumferential hoops linearly disposed in succession along said axis, each of said hoops comprising elements defined by a successive series of struts connected by apex sections alternately pointing in opposite axial directions, at least one pair of adjacent hoops being connected to one another by a connecting member, said connecting member connecting a first strut, which is part of one of said connected adjacent hoops, to a second strut, which is part of the other of said adjacent hoops, said facing apex sections being circumferentially offset from one another such that said first and second struts are aligned, wherein axially opposed apex sections of adjacent hoops are axially spaced from one another and one or both of said first and second struts are elongated, relative to remaining struts in said adjacent hoops, such that said axially-opposed apex sections containing said first and second struts lie circumferentially adjacent one another for at least some axial distance to permit connection therebetween.

50. A tubular stent having a tubular axis, said stent comprising a plurality of circumferential hoops linearly disposed in succession along said axis, each of said hoops comprising elements defined by a successive series of struts connected by apex sections alternately pointing in opposite axial directions, at least one pair of adjacent hoops being connected to one another by a connecting member, said connecting member connecting a first strut, which is part of one of said connected adjacent hoops, to a second strut, which is part of the other of said adjacent hoops, said connected facing apex sections having a first circumferential offset from one another such that said first and second struts are aligned with one another, the stent having at least two longitudinal segments, the hoops in at least one of said segments differing from those in another of said segments with respect to one or more of:

apex section included angle, element length, and number of apex sections per hoop.

51. A tubular stent having a tubular axis, said stent comprising a plurality of circumferential hoops linearly disposed in succession along said axis, each of said hoops comprising elements defined by a successive series of struts connected by apex sections alternately pointing in opposite axial directions, at least one pair of adjacent hoops being connected to one another by a connecting member, said connecting member connecting a first strut, which is part of one of said connected adjacent hoops, to a second strut, which is part of the other of said adjacent hoops, said stent comprising at least two longitudinal segments, at least one of said segments having a different number of continuous filaments and connective spines than a second of said segments.

52. A tubular stent having a tubular axis, said stent comprising a plurality of circumferential hoops linearly disposed in succession along said axis, each of said hoops comprising elements defined by a successive series of struts connected by apex sections alternately pointing in opposite axial directions, at least one pair of adjacent hoops being connected to one another by a connecting member, said connecting member connecting a first strut, which is part of one of said connected adjacent hoops, to a second strut, which is part of the other of said adjacent hoops, the stent comprising at least three longitudinal segments:

a first segment in which each hoop has a first element length, a second segment in which each hoop has a second element length that is different from said first element length, and a transition segment between said first and second segments.

53. A tubular stent having a tubular axis, said stent comprising a plurality of circumferential hoops linearly disposed in succession along said axis, each of said hoops comprising elements defined by a successive series of struts connected by apex sections alternately pointing in opposite axial directions, at least one pair of adjacent hoops being connected to one another by a connecting member, said connecting member connecting a first strut, which is part of one of said connected adjacent hoops, to a second strut, which is part of the other of said adjacent hoops, each apex section pointing in a first direction and two struts attached thereto comprising an element, each element having a different element length, a different element width, or a combination thereof, with respect to each circumferentially adjacent element.

54. A tubular stent having a tubular axis, said stent comprising a plurality of circumferential hoops linearly disposed in succession along said axis, each of said hoops comprising elements defined by a successive series of struts connected by apex sections alternately pointing in opposite axial directions, at least one pair of adjacent hoops being connected to one another by a connecting member, said connecting member connecting a first strut connected to a first apex section, which is part of one of said connected adjacent hoops, to a second strut connected to a second apex section facing said first apex section, which is part of the other of said adjacent hoops, wherein said first apex section is circumferentially offset from said second apex section, said first and second struts are aligned with one another, said stent comprises a single continuous filament wound into a non-helical configuration to form said plurality of hoops, and said connecting member does not comprise a portion of said single continuous filament.

55. The stent of claim 54 wherein each strut is angled with respect to the stent tubular axis.