AXIALLY-RADIALLY NESTED EXPANDABLE DEVICE

• US 20090143853A1
• Filed: 12/04/2007
• Published: 06/04/2009
• Est. Priority Date: 11/30/2007
• Status: Active Grant

• Current Assignee: REVA Medical Inc.
• Original Assignee: REVA Medical Inc.
• Inventors: Morris, Andrew, Sheriff, Jeffrey T., Schmid, Eric, Esser, Keith
• Granted Patent: US 7,988,721 B2
• Time in Patent Office: Days
• US Class Current: 623/1.160
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/93 circumferentially expandable by using ratcheting locks
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/0058 X-shaped
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

Expandable medical implants for maintaining support of a body lumen are disclosed. These implants comprise an axially-radially nested, diametrically expandable, moveable vascular device for enlarging an occluded portion of a vessel. The device can be configured to allow for motion such as translating and/or slide and lock. One advantage of the axially-radially nested stent is that it maintains the expanded size, without significant recoil.

Claims

1. An axially-radially nested stent being expandable from an axially-radially nested unexpanded state to an expanded state, the stent comprising a tubular member having longitudinal and circumferential axes, the tubular member comprising a plurality of linkage assemblies, each linkage assembly comprising:

a linkage section having a central body and at least one interconnection member extending from the central body in a circumferential direction, the central body including at least one engagement aperture being disposed through the central body in a circumferential direction, the engagement aperture being sized and configured to receive a given interconnection member from an adjacent linkage assembly to provide one-way movement of the linkage assembly relative to the adjacent linkage assembly from the axially-radially nested unexpanded state to the expanded state; and

a connector having at least one connection point whereat an interlocking end of the interconnection member can be coupled to the connector, the connector further having at least one engagement aperture being disposed through the connector in a circumferential direction, the engagement aperture being sized and configured to receive another given interconnection member of another adjacent linkage assembly to provide one-way movement of the linkage assembly relative to the other adjacent linkage assembly during expansion of the stent.

2. The axially-radially nested stent of claim 1, wherein the tubular member is formed with the plurality of linkage assemblies being oriented substantially co-circumferentially about the tubular member.

3. The axially-radially nested stent of claim 2, wherein the plurality of linkage assemblies move about the circumference of the tubular member relative to each other during expansion from the axially-radially nested unexpanded state.

4. The axially-radially nested stent of claim 3, wherein the plurality of linkage assemblies do not overlap beyond the circumference of the tubular member.

5. The axially-radially nested stent of claim 1, wherein the plurality of linkage assemblies do not include radially-protruding elements.

6. The axially-radially nested stent of claim 1, wherein the plurality of linkage assemblies slide relative to each other during expansion of the stent.

7. The axially-radially nested stent of claim 1, wherein the interconnection member includes a connecting means disposed thereon for engaging an engaging aperture of the other adjacent linkage and an engaging aperture of a connector of the adjacent linkage.

8. The axially-radially nested stent of claim 7, wherein the connecting means is a plurality of teeth disposed along a side of the interconnection member

9. The axially-radially nested stent of claim 1, further comprising a plurality of scales extending from an exterior surface of at least one of the linkage assemblies of the tubular member to at least engage a sidewall of a body lumen

10. The axially-radially nested stent of claim 1, further comprising a therapeutic agent.

11. The axially-radially nested stent of claim 10, wherein the therapeutic agent is selected from the group consisting of an antiproliferative agent, an anti-inflammatory agent, an anti-matrix metalloproteinase agent, a lipid lowering agent, a cholesterol modifying agent, an anti-thrombotic agent and an antiplatelet agent.

12. The axially-radially nested stent of claim 11, wherein the therapeutic agent is an antiproliferative agent selected from the group consisting of Paclitaxel, Rapamycin, ABT-578, Biolimus A9, Everolimus, tacrolimus, and derivatives and analogs thereof.

106. The stent of claim 1, further comprising a sheath.

107. The stent of claim 106, wherein the sheath comprises at least one structural pattern.

13. An axially-radially nested stent being expandable from an axially-radially nested unexpanded state to an expanded state, the stent comprising a tubular member having longitudinal and circumferential axes, the tubular member comprising a plurality of linkage sections, each linkage section comprising:

a central body including at least one engagement aperture being disposed through the central body in a circumferential direction; and

at least one interconnection member extending from the central body in a circumferential direction;

wherein the engagement aperture is sized and configured to receive a given interconnection member from an adjacent linkage section to provide one-way movement of the linkage section relative to the adjacent linkage section from the axially-radially nested unexpanded state to the expanded state, and wherein the interconnection member is axially offset from the given interconnection member of the adjacent linkage section.

14. An offset rail stent being expandable from an axially-radially nested unexpanded state to an expanded state, the stent comprising a tubular member having longitudinal and circumferential axes, the tubular member comprising a plurality of linkage assemblies, each linkage assembly comprising:

a linkage section being disposed along the circumferential axis of the tubular member, the linkage section defining a radial thickness and comprising;

a central section having first and second ends;

at least first and second ratcheting elements coupled to the respective ones of the first and second ends of the central section and extending in a generally circumferential direction, the first and second ratcheting elements having respective first and second distal interlocking ends; and

first and second bridge sections being disposed adjacent the respective ones of the first and second ends of the central section, the first and second bridge sections having a reduced thickness relative to other portions of the linkage section for allowing first and second ratcheting elements of an adjacent linkage section to pass therealong for reducing the axial profile of the tubular member;

a first connector comprising a first connection point whereto the first distal interlocking end of the first ratcheting element can be coupled, the first connector further comprising at least one first engagement aperture wherethrough a ratcheting element of a third adjacent linkage assembly or module can be received and engaged by the first engagement aperture for facilitating one-way circumferential movement of the first connector and linkage assembly relative to the third adjacent linkage assembly or module with the third adjacent linkage assembly or module moving in a direction opposite to the direction of one-way movement of the first adjacent linkage assembly or module; and

a second connector comprising a second connection point whereto the second distal interlocking end of the second ratcheting element can be coupled, the second connector further comprising at least one second engagement aperture wherethrough a ratcheting element of a fourth adjacent linkage assembly or module can be received and engaged by the second engagement aperture for facilitating one-way circumferential movement of the second connector and linkage assembly relative to the fourth adjacent linkage assembly or module with the fourth adjacent linkage assembly or module moving in a direction opposite to the direction of one-way movement of the second adjacent linkage assembly or module.

15. The offset rail stent of claim 14, wherein the linkage assembly includes first and second pairs of ratcheting elements coupled to the respective ones of the first and second ends of the central section and extending in a generally circumferential direction, the first and second pairs of ratcheting elements being configured to interconnect with the respective ones of first and second pairs of connection points of the first and second connectors.

16. The offset rail stent of claim 15, wherein the first and second connectors include respective first and second pairs of engagement apertures being configured to receive and engage pairs of ratcheting elements from the respective ones of the third and fourth adjacent linkage assemblies or modules.

17. The offset rail stent of claim 15, wherein the first pair of ratcheting elements is configured to be received and engaged by a pair of engagement apertures of a connector of the first adjacent linkage assembly or module, and the second pair of ratcheting elements is configured to be received and engaged by a pair of engagement apertures of a connector of the second adjacent linkage assembly or module.

18. The offset rail stent of claim 14, wherein the central section includes first and second connection ends each extending toward and interconnecting with the respective ones of the first and second connector elements, the central sections of the plurality of linkage assemblies facilitating bending of the tubular member along the longitudinal axis thereof.

19. The offset rail stent of claim 14, wherein the ratcheting elements of the stent are generally parallel to each other.

20. The offset rail stent of claim 14, wherein the ratcheting elements include a plurality of teeth disposed along at least one side of the ratcheting element.

21. The offset rail stent of claim 14, wherein the first and second connectors each include respective ones of at least first and second locking tabs extending from the respective connector adjacent the respective ones of the first and second engagement apertures, the first and second locking tabs being configured to engage the ratcheting elements of the respective ones of the third and fourth adjacent linkage assemblies or modules.

22. The offset rail stent of claim 14, further comprising a plurality of scales extending from an exterior surface of at least one of the linkage assemblies of the tubular member to at least engage a sidewall of a body lumen

23. The offset rail stent of claim 14, further comprising a therapeutic agent.

24. The offset rail stent of claim 23, wherein the therapeutic agent is selected from the group consisting of an antiproliferative agent, an anti-inflammatory agent, an anti-matrix metalloproteinase agent, a lipid lowering agent, a cholesterol modifying agent, an anti-thrombotic agent and an antiplatelet agent.

25. The offset rail stent of claim 24, wherein the therapeutic agent is an antiproliferative agent selected from the group consisting of Paclitaxel, Rapamycin, ABT-578, Biolimus A9, Everolimus, tacrolimus, and derivatives and analogs thereof.

26. An offset rail stent being expandable from an axially-radially nested unexpanded state to an expanded state, the stent comprising a tubular member having longitudinal and circumferential axes, the tubular member comprising:

a plurality of linkage strands extending in generally parallel directions along the longitudinal axis, each linkage strand having a plurality of central bodies being interconnected in an end-to-end fashion via flexible portions, each central body comprising at least one interconnection member having an interlocking end and extending from the central body in a circumferential direction, each central body including at least one bridge section being disposed on the central body, the bridge section having a reduced thickness relative to other portions of the linkage strand for allowing passage of an interconnection member of an adjacent linkage strand therealong for reducing an axial profile of the stent; and

at least one connector having at least one connection point whereat the interlocking end of the interconnection member can be coupled to the connector, the connector further having at least one engagement aperture being disposed through the connector in a circumferential direction, the engagement aperture being sized and configured to receive another given interconnection member of another adjacent linkage strand to provide one-way movement of the linkage strand relative to the other adjacent linkage strand during expansion of the stent from an axially-radially nested unexpanded state to an expanded state.

27. The offset rail stent of claim 26, wherein each central body has two interconnection members extending therefrom.

28. The offset rail stent of claim 27, wherein the connector includes two connection points whereat the interlocking ends of the two interconnection members can be coupled.

29. The offset rail stent of claim 28, wherein the connector further comprises two engagement apertures for receiving a pair of other given interconnection members of another adjacent linkage strand.

30. The offset rail stent of claim 26, wherein the linkage strand is configured with adjacent central bodies being circumferentially offset relative to each other.

31. The offset rail stent of claim 30, wherein the adjacent central bodies of the strand are disposed in one of a top or bottom position.

32. The offset rail stent of claim 26, wherein the interconnection member includes a connecting means disposed thereon being configured to engage an engagement aperture of a connector of the adjacent linkage strand.

33. The offset rail stent of claim 32, wherein the connecting means is a plurality of teeth disposed along a side of the interconnection member.

34. The offset rail stent of claim 26, wherein the linkage strands define a strand radial thickness and the connector defines a connector radial thickness, the strand radial thickness being less than the connector radial thickness.

35. The offset rail stent of claim 34, wherein the stent does not include radially protruding ends.

36. The offset rail stent of claim 26, further comprising a plurality of scales extending from an exterior surface of at least one of the linkage strands of the tubular member to at least engage a sidewall of a body lumen.

37. The offset rail stent of claim 26, further comprising a therapeutic agent.

38. The offset rail stent of claim 37, wherein the therapeutic agent is selected from the group consisting of an antiproliferative agent, an anti-inflammatory agent, an anti-matrix metalloproteinase agent, a lipid lowering agent, a cholesterol modifying agent, an anti-thrombotic agent and an antiplatelet agent.

39. The offset rail stent of claim 38, wherein the therapeutic agent is an antiproliferative agent selected from the group consisting of Paclitaxel, Rapamycin, ABT-578, Biolimus A9, Everolimus, tacrolimus, and derivatives and analogs thereof.

40. A telescoping slide-and-lock stent being expandable from an axially-radially nested unexpanded state to an expanded state, the stent comprising a tubular member having longitudinal and circumferential axes, the tubular member comprising:

at least one linkage component being disposed along the longitudinal axis of the tubular member, each linkage component comprising at least one section, the section including a pair of flexible portions, the section further including generally elongate rail portions attached to the flexible portions, the rail portions each having distal ends and proximal ends whereat the rail portions are attached to the flexible portions, the rail portions being oriented generally parallel with respect to each other;

a slide-and-lock element having a head portion and an elongate neck portion, the head portion having a pair of apertures being sized and configured to receive the rail portions of the section of the linkage component to facilitate one-way movement of the linkage component relative to the slide-and-lock element, the neck portion being longitudinally interposed between the rail portions; and

an interconnector block being disposed intermediate the flexible portions of the section of the linkage component, the interconnector block comprising a pair of central connection points being sized and configured to receive the respective ones of the distal ends of the rail portions, the interconnector block further comprising at least one engagement aperture wherethrough the neck portion of the slide-and-lock element can be received for facilitating one-way circumferential movement of the slide-and-lock element relative to the linkage component.

41. The telescoping slide-and-lock stent of claim 40, wherein the linkage component further includes a central joint interconnecting the flexible portions of the first and second sections such that the rail portions are oriented generally parallel with respect to each other

42. The telescoping slide-and-lock stent of claim 40, wherein the neck portion of the slide-and-lock element includes a distal end being configured to attach to an additional interconnector block interconnecting another pair of linkage components, the interconnector blocks being oriented substantially parallel relative to each other.

43. The telescoping slide-and-lock stent of claim 40, wherein the interconnector blocks are oriented generally parallel relative to the longitudinal axis of the tubular member.

44. The telescoping slide-and-lock stent of claim 40, wherein the head portion of the slide-and-lock element is configured to provide one-way movement relative to the rail portions of the first sections of the pair of linkage components.

45. The telescoping slide-and-lock stent of claim 40, wherein the neck portion of the slide-and-lock element includes a pair of elongate rails.

46. The telescoping slide-and-lock stent of claim 40, wherein each linkage component defines a component radial thickness and the interconnector block defines a block radial thickness, the component radial thickness being less than the block radial thickness.

47. The telescoping slide-and-lock stent of claim 40, wherein the pair of linkage components are symmetric.

48. The telescoping slide-and-lock stent of claim 40, further comprising a plurality of scales extending from an exterior surface of at least one of the linkage component of the tubular member to at least engage a sidewall of a body lumen.

49. The telescoping slide-and-lock stent of claim 40, further comprising a therapeutic agent.

50. The telescoping slide-and-lock stent of claim 49, wherein the therapeutic agent is selected from the group consisting of an antiproliferative agent, an anti-inflammatory agent, an anti-matrix metalloproteinase agent, a lipid lowering agent, a cholesterol modifying agent, an anti-thrombotic agent and an antiplatelet agent.

51. The telescoping slide-and-lock stent of claim 50, wherein the therapeutic agent is an antiproliferative agent selected from the group consisting of Paclitaxel, Rapamycin, ABT-578, Biolimus A9, Everolimus, tacrolimus, and derivatives and analogs thereof.

52. A modular dual expansion stent being expandable from an axially-radially nested unexpanded state to an expanded state, the stent comprising a tubular member having longitudinal and circumferential axes, the tubular member comprising:

a plurality of strands of interconnected expandable modules being disposed along the longitudinal axis of the tubular member, each module comprising first and second portions, the first and second portions being interconnected via opposing flexible portions, the first portion having a belt component extending therefrom in the circumferential direction, the second portion having a guide rail component and a buckle component, the guide rail component extending in the circumferential direction adjacent and generally parallel to the belt component, the guide rail component having at least one lateral protrusion, the guide rail component and the belt component being configured to facilitate an individual mode of expansion for the module wherein the belt component moves relative to the guide rail component, the buckle component being sized and configured for receiving therethrough a belt component and a guide rail component from another module of another circumferentially adjacent strand for interconnecting the strands about the circumferential axis of the tubular member and providing a group mode of expansion, the buckle component being operative to slide along the guide rail component and engage the at least one lateral protrusion for facilitating one-way circumferential movement of the buckle component of the module relative to the guide rail component of the other module for facilitating one-way circumferential expansion of the stent; and

at least one stabilizer block being attachable to the guide rail component, the stabilizer block being sized and configured to engage the belt component such that relative movement between the guide rail component and the belt component produces one-way circumferential expansion of the module to provide a second means of circumferential expansion of the stent.

53. The modular dual expansion stent of claim 52, wherein the first portion is disposed at a bottom end of the module and the second portion is disposed at an upper end of the module.

54. The modular dual expansion stent of claim 52, wherein the module is generally ovular in shape.

55. The modular dual expansion stent of claim 52, wherein adjacent modules of the strand are interconnected at a joint in an end-to-end fashion.

56. The modular dual expansion stent of claim 55, wherein the flexible portions of the module extend intermediate the respective first and second portions and the adjacent joints.

57. The modular dual expansion stent of claim 52, wherein the guide rail component comprises a pair of circumferentially extending side rails defining a cavity therebetween, the cavity being sized and configured to receive the belt component therein.

58. The modular dual expansion stent of claim 57, wherein the stabilizer block is interposed between the side rails of the guide rail component, the stabilizer block including a central aperture wherethrough the belt component is receivable to engage the belt component for providing one-way movement of the belt component relative to the guide rail component.

59. The modular dual expansion stent of claim 52, further comprising a plurality of scales extending from an exterior surface of at least one of the strands of the tubular member to at least engage a sidewall of a body lumen.

60. The modular dual expansion stent of claim 52, further comprising a therapeutic agent.

61. The modular dual expansion stent of claim 60, wherein the therapeutic agent is selected from the group consisting of an antiproliferative agent, an anti-inflammatory agent, an anti-matrix metalloproteinase agent, a lipid lowering agent, a cholesterol modifying agent, an anti-thrombotic agent and an antiplatelet agent.

62. The modular dual expansion stent of claim 61, wherein the therapeutic agent is an antiproliferative agent selected from the group consisting of Paclitaxel, Rapamycin, ABT-578, Biolimus A9, Everolimus, tacrolimus, and derivatives and analogs thereof.

63. A process of making a therapeutic agent-eluting device comprising:

applying at least one therapeutic agent to a polymer film;

separating at least one frame from the polymer film; and

forming the device using the at least one frame.

64. The process of claim 63, wherein the step of separating the at least one frame from a polymer film is performed after the step of applying at least one therapeutic agent onto a polymer film.

65. The process of claim 63, further comprising a step of creating a pattern on the polymer film to define the at least one frame such that the at least one frame is detachable from the film.

66. The process of claim 65, wherein the creating a pattern step is performed before the applying at least one therapeutic agent step is performed.

67. The process of claim 65, wherein the creating a pattern step comprises using a laser to lase the pattern onto the polymer film.

68. The process of claim 63, wherein the applying step further comprises mounting the polymer film in a spraying apparatus.

69. The process of claim 63, wherein the applying step further comprises spraying at least one time the therapeutic agent onto the polymer film.

70. The process of claim 63, wherein the applying step further comprises applying a plurality of therapeutic agents to at least a portion of the polymer film.

71. The process of claim 63, wherein the applying step further comprises applying at least one therapeutic agent onto one side of the polymer film.

72. The process of claim 63, wherein the applying step further comprises applying at least one therapeutic agent onto both sides of the polymer film.

73. The process of claim 63, wherein the applying step further comprises dipping the polymer film into at least one therapeutic agent.

74. The process of claim 63, wherein the applying step further comprises impregnating the polymer film with at least one therapeutic agent.

75. The process of claim 63, wherein the device is a stent.

76. The process of claim 63, further comprising the step of cleaning the polymer film with a cleaning solution.

77. The process of claim 63, further comprising the step of drying the polymer film after applying the at least one therapeutic agent thereto.

78. A process of making a therapeutic agent-eluting device comprising:

applying at least one therapeutic agent to at least one frame of the device; and

forming the device using the at least one frame.

79. The process of claim 78, further comprising a step of creating a pattern on a polymer film to define the at least one frame such that the at least one frame is detachable from the film.

80. The process of claim 79, wherein the creating a pattern step is performed before the applying at least one therapeutic agent step is performed.

81. The process of claim 79, wherein the creating a pattern step comprises using a laser to lase the pattern onto the polymer film.

82. The process of claim 78, wherein the applying step further comprises mounting the at least one frame in a spraying apparatus.

83. The process of claim 78, wherein the applying step further comprises spraying at least one time the therapeutic agent onto the at least one frame.

84. The process of claim 78, wherein the applying step further comprises applying a plurality of therapeutic agents to at least a portion of the at least one frame.

85. The process of claim 78, wherein the applying step further comprises applying at least one therapeutic agent onto one side of the at least one frame.

86. The process of claim 78, wherein the applying step further comprises applying at least one therapeutic agent onto both sides of the at least one frame.

87. The process of claim 78, wherein the applying step further comprises dipping the at least one frame into at least one therapeutic agent.

88. The process of claim 78, wherein the applying step further comprises impregnating the at least one frame with at least one therapeutic agent.

89. The process of claim 78, wherein the device is a stent.

90. The process of claim 78, further comprising a step of cleaning the at least one frame with a cleaning solution.

91. The process of claim 78, further comprising a step of drying the at least one frame after applying the at least one therapeutic agent thereto.

92. The process of claim 78, further comprising a step of separating the at least one frame from a polymer film.

93. An offset rail stent being expandable from an axially-radially nested unexpanded state to an expanded state, the stent comprising a tubular member having longitudinal and circumferential axes, the tubular member comprising:

a plurality of linkage strands extending in generally parallel directions along the longitudinal axis, each linkage strand having a plurality of frame elements being interconnected in an end-to-end fashion via at least one interconnection element, each frame element comprising at least one rail member extending from the frame element in a circumferential direction, each frame element further comprising at least one engagement aperture configured to receive an adjacent rail member of an adjacent linkage strand; and

a plurality of coupling elements each being attachable to a respective rail member after insertion of the rail member through the engagement aperture, engagement of the coupling element and the engagement aperture providing one-way movement of a given linkage strand relative to an adjacent linkage strand during expansion of the stent from an axially-radially nested unexpanded state to an expanded state

94. The offset rail stent of claim 93, wherein each frame element has two rail members extending therefrom.

95. The offset rail stent of claim 94, wherein the coupling elements are formed in pairs.

96. The offset rail stent of claim 95, wherein the coupling elements are formed in a U-shape.

97. The offset rail stent of claim 93, wherein a given coupling element is bonded to a given rail member.

98. The offset rail stent of claim 93, wherein each linkage strand is configured with adjacent frame elements being circumferentially offset relative to each other.

99. The offset rail stent of claim 93, wherein the coupling element includes a connecting means disposed thereon being configured to engage an engagement aperture of a frame element of an adjacent linkage strand.

100. The offset rail stent of claim 99, wherein the connecting means is a plurality of teeth disposed along a side of the coupling element.

101. The offset rail stent of claim 99, wherein the connecting means is a plurality of teeth disposed along a top portion of the coupling element.

102. The offset rail stent of claim 93, further comprising a plurality of scales extending from an exterior surface of at least one of the linkage strands of the tubular member to at least engage a sidewall of a body lumen.

103. The offset rail stent of claim 93, further comprising a therapeutic agent.

104. The offset rail stent of claim 103, wherein the therapeutic agent is selected from the group consisting of an antiproliferative agent, an anti-inflammatory agent, an anti-matrix metalloproteinase agent, a lipid lowering agent, a cholesterol modifying agent, an anti-thrombotic agent and an antiplatelet agent.

105. The offset rail stent of claim 104, wherein the therapeutic agent is an antiproliferative agent selected from the group consisting of Paclitaxel, Rapamycin, ABT-578, Biolimus A9, Everolimus, tacrolimus, and derivatives and analogs thereof.