Balloon expandable crush-recoverable stent device

• US 7,763,065 B2
• Filed: 07/21/2004
• Issued: 07/27/2010
• Est. Priority Date: 07/21/2004
• Status: Active Grant

• Current Assignee: REVA Medical Inc.
• Original Assignee: REVA Medical Inc.
• Inventors: Eisele, Robert F, Padilla, Orlando M, Howard, Steven C, Schmid, Eric V., Nguyen, John, Morris, Andrew, Simpson, Philip J
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Severson; Ryan J
• Application Number:
  US10/897,235
• Publication Number:
  US 20060020324A1
• Time in Patent Office: 2,197 Days
• Field of Search: 623/1.15
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching

Abstract

An intraluminal, balloon expandable stent for implantation in a body lumen is disclosed. The present invention provides a lumen support stent with an unobstructed through-lumen for use in a blood vessel. A constraining mechanism is provided for securely maintaining the stent in the collapsed condition during delivery. The stent is preferably formed with a series of interconnected slide and lock mechanisms for permitting movement from a collapsed condition to an expanded condition and inhibiting radial recoil from the expanded condition. The stent may be formed from a shape memory alloy for providing crush-recovery after deployment.

Claims

1. A balloon expandable crush-recoverable stent, comprising:

at least two radial elements arranged to form a tubular member, the radial elements being slidably interconnected for allowing the tubular member to expand from a collapsed diameter to an expanded diameter, at least one radial element comprising;

a locking mechanism for maintaining the tubular member in the expanded diameter after deployment, the locking mechanism comprising a plurality of teeth disposed on a first deflectable member that extends from a first end of the at least one radial element to a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the at least one radial element; and

a constraining mechanism integrated into the at least one radial element for maintaining the tubular member in the collapsed diameter until released by radial expansion, the constraining mechanism comprising at least one recess disposed on a first containment member that extends from the first end of the at least one radial element to the second end thereof, the constraining mechanism further comprising a hold-down tab disposed at the second end of the at least one radial element;

wherein the radial elements are fabricated from a shape-memory material for providing crush-recoverability.

2. The balloon expandable crush-recoverable stent of claim 1, wherein the locking mechanism comprises a plurality of teeth disposed on a second deflectable member that extends from the first end of the at least one radial element to the second end thereof, the second deflectable member being disposed adjacent to the first deflectable member to form a gap therebetween, the gap being configured to receive the locking tab therein for allowing slidable movement in only one direction.

3. The balloon expandable crush-recoverable stent of claim 2, wherein the locking tab comprises a neck portion and a head portion that is wider than the neck portion, the neck portion of the at least one radial element extending through a gap formed between first and second deflectable members of a radial element.

4. The balloon expandable crush-recoverable stent of claim 1, wherein the teeth are deflectable for allowing the locking tab to pass over the teeth during expansion of the tubular member.

5. The balloon expandable crush-recoverable stent of claim 1, wherein the plurality of teeth allows the tubular member to be maintained at a selectable expanded diameter.

6. The balloon expandable crush-recoverable stent of claim 1, wherein the constraining mechanism further comprises at least one recess disposed on a second containment member that extends from the first end of the at least one radial element to the second end thereof, a hold-down tab of a first radial element configured to be releasably held within the recesses of the first and second containment members of the at least one radial element.

7. The balloon expandable crush-recoverable stent of claim 6, wherein the first containment member of the constraining mechanism is disposed adjacent to the first deflectable member of the locking mechanism to form a first gap therebetween, and wherein the second containment member of the constraining mechanism is disposed adjacent to the second deflectable member of the locking mechanism to form a second gap therebetween, the hold-down tab of the first radial element being positioned over the first and second deflectable members of the second radial element and disposed through the first and second gaps to be releasably held within the recesses of the first and second containment members of the second radial element.

8. The balloon expandable crush-recoverable stent of claim 1, wherein the tubular member is configured for delivering a therapeutic agent to a vessel wall at a treatment site.

9. The balloon expandable crush-recoverable stent of claim 8, wherein the therapeutic agent is an antiproliferative agent.

10. The balloon expandable crush-recoverable stent of claim 1, further comprising a retractable sheath sized for enclosing the tubular member during delivery to a treatment site.

11. The balloon expandable crush-recoverable stent of claim 1, wherein each radial element of the stent comprises a locking mechanism and a constraining mechanism.

12. The balloon expandable crush-recoverable stent of claim 1, wherein all of the radial elements of the stent have a substantially identical structure.

13. A balloon expandable stent, comprising:

a substantially flat sheet fabricated from a shape-memory material, the flat sheet comprising at least one radial element being configured to be rolled into a cylindrical configuration for providing a tubular member, the tubular member being configured for expansion from a collapsed diameter to an expanded diameter, the at least one radial element comprising;

a locking mechanism provided along the at least one radial element for maintaining the tubular member in the expanded diameter, the locking mechanism comprising first and second deflectable members extending from a first end of the at least one radial element to a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the at least one radial element, the first and second deflectable members forming a gap therebetween, the gap being configured to receive the locking tab therein; and

a constraining mechanism integrated into the at least one radial element for maintaining the tubular member in the collapsed diameter until released by radial expansion, the constraining mechanism comprising first and second containment members extending from the first end of the at least one radial element to the second end thereof, the first containment member being disposed adjacent to the first deflectable member of the locking mechanism to form a first gap therebetween, the second containment member being disposed adjacent to the second deflectable member of the locking mechanism to form a second gap therebetween, the constraining mechanism further comprising a hold-down tab disposed at the second end of the at least one radial element, the hold-down tab being positionable over first and second deflectable members and positionable through first and second gaps to maintain the at least one radial element in a slidable relationship.

14. A stent delivery system, comprising:

the balloon expandable stent of claim 13; and

a catheter with an inflatable balloon disposed along a distal end portion, wherein the stent is provided along an outer surface of the inflatable balloon.

15. A method for treating a vessel at a treatment site, comprising:

positioning the stent delivery system of claim 14 at the treatment site; and

inflating the inflatable balloon for causing the stent to expand from the collapsed diameter to the expanded diameter.

16. The balloon expandable stent of claim 13, wherein the locking mechanism comprises a plurality of teeth along the first and second deflectable members that are configured for slidable engagement with the locking tab.

17. The balloon expandable stent of claim 13, wherein the constraining mechanism comprises at least one recess formed along the first and second containment members, wherein the recesses of the first and second containment members are configured for capturing the hold-down tab.

18. The balloon expandable stent of claim 13, wherein the stent comprises first and second radial elements, the hold-down tab of a first radial element being disposed over the first and second deflectable members of a second radial element and disposed through the first and second gaps thereof to maintain the first and second radial elements in a slidable relationship.

19. The balloon expandable stent of claim 13, wherein the constraining mechanism comprises at least one hook disposed at the second end of the at least one radial element and at least one loop formed along a containment member at the second end of the at least one radial element.

20. The balloon expandable stent of claim 19, wherein a hook of a first radial element engages a loop of a second radial element, the hook being released from the loop upon radial expansion of an inflatable balloon for permitting expansion of the tubular member.

21. The balloon expandable stent of claim 20, wherein the loop is unbroken upon release of the hook therefrom.

22. The balloon expandable stent of claim 19, wherein the hook extends from the hold-down tab at the second end of the at least one radial element.

23. The balloon expandable stent of claim 13, wherein the constraining mechanism comprises at least one deflectable wing.

24. The balloon expandable stent of claim 23, wherein a deflectable wing of a first radial element is received within a gap formed between first and second deflectable members of a second radial element, the deflectable wing defining a passing profile that is larger than the gap, the deflectable wing being configured such that the wing can be disposed through the gap in an unexpanded state and provide initial resistance to radial expansion until flexing upon radial expansion of an inflatable balloon such that the deflectable wing is released from the gap for permitting expansion of the tubular member.

25. The balloon expandable stent of claim 13, wherein the locking tab of the locking mechanism comprises a neck portion and a head portion that is wider than the neck portion, a neck portion of a first element extending through a gap formed between first and second deflectable members of a second element.

26. The balloon expandable stent of claim 13, wherein the constraining mechanism comprises at least one deflectable arm disposed at the second end of the at least one radial element and at least one lock formed along a containment member of the at least one radial element, the arm extending from the at least one radial element such that the arm of the at least one radial element contacts a flexible lock of another radial element to provide initial resistance to radial expansion, the arm being deflectable relative to the lock to disengage with the lock upon forcible radial expansion.

27. The balloon expandable stent of claim 26, wherein the lock comprises a raised protrusion.

28. The balloon expandable stent of claim 13, wherein the constraining mechanism comprises an adhesive.

29. The balloon expandable stent of claim 13, wherein the first and second deflectable members are disposed between the first and second containment members.

30. A balloon expandable crush-recoverable stent, comprising:

a tubular member comprising a series of pivotally connected links fabricated from a shape-memory material, each link comprising a first end and a second end, each link comprising one or more ridges along the surface thereof, the ridges of a given link being configured to contact ridges of an adjacent pivotally connected link to limit the pivoting of the given link and the adjacent link relative to each other in a collapsed direction, the pivotally connected links being configured for allowing the tubular member to be adjusted from a collapsed diameter to an expanded diameter, at least one link comprising;

a locking mechanism formed between the first and second ends of the at least one link, the locking mechanism configured for maintaining the tubular member in the expanded diameter; and

a constraining mechanism integrated into the tubular member and formed between the first and second ends of the at least one link, the constraining mechanism configured for maintaining the tubular member in the collapsed diameter until released by radial expansion of the balloon; and

a flexible mechanism for connecting multiple links together to form a stent having a desired axial length.

31. The balloon expandable crush-recoverable stent of claim 30, wherein the tubular member is configured for delivering a therapeutic agent to a vessel wall at a treatment site.

32. The balloon expandable crush-recoverable stent of claim 30, wherein each link of the tubular member comprises a locking mechanism and a constraining mechanism.

33. The balloon expandable crush-recoverable stent of claim 30, wherein all of the links of the tubular member have a substantially identical structure.

34. An expandable stent, comprising:

a tubular member comprising a series of slidably interconnected elements fabricated from a biocompatible material, the tubular member being configured for expansion from a collapsed diameter to an expanded diameter, at least one element comprising;

a locking mechanism for maintaining the tubular member in the expanded diameter, the locking mechanism comprising a plurality of teeth disposed on a deflectable member that extends from a first end of the at least one element to a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the at least one element; and

a constraining mechanism for maintaining the tubular member in the collapsed diameter until released by radial expansion, the constraining mechanism comprising at least one lock formed along a containment member that extends from the first end of the at least one element to the second end thereof, the constraining mechanism further comprising at least one arm disposed at the second end of the at least one element, the arm extending from the at least one element such that the arm of the at least one element contacts a lock of an element to provide initial resistance to radial expansion, the arm being deflectable relative to the lock to disengage with the lock upon forcible radial expansion.

35. The expandable stent of claim 34, wherein the biocompatible material includes a therapeutic agent for delivery to a vessel wall.

36. The expandable stent of claim 34, wherein each element of the tubular member comprises a locking mechanism and a constraining mechanism.

37. The expandable stent of claim 34, wherein all of the elements of the tubular member have a substantially identical structure.

38. An expandable stent, comprising:

first and second expandable modules, each expandable module comprising at least one radial element, each expandable module forming a substantially tubular member and being adjustable from a collapsed condition to an expanded condition, at least one radial element comprising;

a locking mechanism for maintaining the tubular member in the expanded diameter after deployment, the locking mechanism comprising a plurality of teeth disposed on a first deflectable member that extends from a first end of the at least one radial element to a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the at least one radial element; and

a constraining mechanism for maintaining the stent in the collapsed condition during delivery to a treatment site, the constraining mechanism comprising at least one recess disposed on a first containment member that extends from the first end of the at least one radial element to the second end thereof, the constraining mechanism further comprising a hold-down tab disposed at the second end of the at least one radial element; and

a flexible coupling portion for coupling the first and second expandable modules together;

wherein each of the expandable modules is substantially independently expandable.

39. The expandable stent of claim 38, wherein at least one of the expandable modules is fabricated from a shape memory material.

40. The expandable stent of claim 38, wherein at least one of the expandable modules comprises a plurality of radial elements slidably interconnected for allowing the stent to expand from the collapsed condition to the expanded condition.

41. The expandable stent of claim 40, wherein the locking mechanism of the at least one radial element further comprises a second deflectable member, the first and second deflectable members defining a gap therebetween for slidably interconnecting with a locking tab of the at least one radial element.

42. The expandable stent of claim 41, wherein each of the first and second deflectable members comprises a plurality of angled teeth, and wherein the locking tab of the at least one radial element is held within the teeth of the at least one radial element for providing the locking mechanism.

43. The expandable stent of claim 40, wherein the constraining mechanism further comprises a second containment member, the first containment member of the constraining mechanism being disposed adjacent to the first deflectable member of the locking mechanism to form a first gap therebetween, the second containment member of the constraining mechanism being disposed adjacent to the second deflectable member of the locking mechanism to form a second gap therebetween, a hold-down tab of a radial element being positioned over the first and second deflectable members of the at least one radial element and disposed through the first and second gaps of the at least one radial element for providing the constraining mechanism.

44. The expandable stent of claim 43, wherein the first and second containment members comprise at least one recess configured to releasably receive the hold-down tab, the hold-down tab being deformable such that the hold-down tab is releasable from within the recesses of the first and second containment members of the at least one radial element under a sufficient radial force during deployment.

45. The expandable stent of claim 43, wherein the first and second containment members are deformable such that the hold-down tab is releasable under a sufficient radial force during deployment.

46. The expandable stent of claim 38, wherein each radial element of the first and second expandable modules comprises a locking mechanism and a constraining mechanism.

47. The expandable stent of claim 38, wherein all of the radial elements of the first and second expandable modules have a substantially identical structure.

48. An expandable stent for supporting a blood vessel, comprising:

a tubular member fabricated from a biocompatible material, the tubular member comprising at least one radial element and having a first end portion and a second end portion, the tubular member being configured for expansion from a collapsed diameter to an expanded diameter, the tubular member having a central region disposed between the first end portion and the second end portion, the at least one radial element comprising;

a locking mechanism for maintaining the tubular member in the expanded diameter after deployment, the locking mechanism comprising a plurality of teeth disposed on a first deflectable member that extends from a first end of the at least one radial element to a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the at least one radial element; and

a constraining mechanism for maintaining the tubular member in the collapsed diameter until released by radial expansion, the constraining mechanism comprising at least one recess disposed on a first containment member that extends from the first end of the at least one radial element to the second end thereof, the constraining mechanism further comprising a hold-down tab disposed at the second end of the at least one radial element; and

wherein at least a portion of the central region of the tubular member is formed with a substantially impermeable wall.

49. The expandable stent of claim 48, wherein the impermeable wall extends at least 2 mm along the length of the stent.

50. The expandable stent of claim 48, further comprising an opening formed through the impermeable wall for allowing blood to pass into a branch vessel.

51. A balloon expandable crush-recoverable stent, comprising:

a first row of radial elements extending along the longitudinal axis of the stent;

a second row of radial elements extending along the longitudinal axis of the stent;

wherein a radial element of the first row and a corresponding radial element of second row each comprises;

a locking mechanism comprising a plurality of teeth disposed on a first deflectable member that extends from a first end of the radial element to a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the radial element; and

a constraining mechanism comprising at least one loop formed along a first containment member that extends from the first end of the radial element to a second end thereof, the constraining mechanism further comprising at least one hook disposed at the second end of the radial element;

wherein the locking tab of the radial element of the second row is operative to engage the teeth of the radial element of the first row; and

wherein the radial elements in the first row slidably interconnect with the radial elements in the second row for providing a series of expandable modules, the constraining mechanism maintaining at least one expandable module in a collapsed diameter until released by radial expansion of an inflatable balloon, wherein each of the modules is expandable to a different diameter.

52. The balloon expandable crush-recoverable stent of claim 51, wherein the constraining mechanism comprises a hook and a loop, wherein a hook of the radial element of the first row can be releasably held within a loop of the radial element of the second row for maintaining the collapsed diameter.

53. The balloon expandable crush-recoverable stent of claim 51, wherein at least some of the radial elements in each of the first and second rows are coupled by flexible coupling members.

54. The balloon expandable crush-recoverable stent of claim 51, wherein the radial elements in each of the first and second rows are coupled together in a staggered arrangement.

55. The balloon expandable crush-recoverable stent of claim 51, wherein each radial element of the stent comprises a locking mechanism and a constraining mechanism.

56. The balloon expandable crush-recoverable stent of claim 51, wherein all of the radial elements of the stent have a substantially identical structure.

57. A balloon expandable crush-recoverable stent, comprising:

a first row of radial elements extending along the longitudinal axis of the stent;

a second row of radial elements extending along the longitudinal axis of the stent;

wherein at least one radial element comprises;

a locking mechanism comprising a plurality of teeth disposed on a first deflectable member that extends from a first end of the at least one radial element a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the at least one radial element, the locking tab of the at least one radial element being operative to engage the teeth of another radial element; and

a constraining element comprising a gap formed by at least one deflectable member at a second end of the at least one radial element, the constraining mechanism further comprising a flexible wing disposed at the second end of the at least one radial element, the flexible wing defining a passing profile that is larger than the gap, the wing being configured such that the wing can be disposed through a gap of another radial element with the stent being in an unexpanded state and provide initial resistance to radial expansion of the stent until deflecting and exiting the gap;

wherein the first and second rows of radial elements form at least a portion of a tubular member, the first and second rows of radial elements being slidably interconnected along a plurality of points for allowing the tubular member to expand from a collapsed condition to an expanded condition, the constraining mechanism maintaining the tubular member in the collapsed condition until released by radial expansion of an inflatable balloon.

58. The balloon expandable crush-recoverable stent of claim 57, wherein each radial element of the stent comprises a locking mechanism and a constraining element.

59. The balloon expandable crush-recoverable stent of claim 57, wherein all of the radial elements of the stent have a substantially identical structure.

60. A balloon expandable crush-recoverable stent, comprising:

first and second expandable modules, each module comprising a series of slidably interconnected elements fabricated from a shape-memory material, each element comprising a pair of containment members extending generally parallel to at least one deflectable member that is spaced between the containment members, the containment members and the deflectable member extending from a first end of the element to a second end thereof, the containment members being spaced from the at least one deflectable member to define first and second gaps therebetween, the interconnected elements being configured for allowing the module to be adjusted from a collapsed diameter to an expanded diameter, each element further comprising;

a locking mechanism being configured such that the interconnected elements are slidable in only one direction for maintaining the expandable module in the expanded diameter; and

a constraining mechanism comprising a hold-down tab extending from the second end of each radial element, a hold-down tab of a first radial element being disposed over at least one deflectable member and disposed through first and second gaps of a second radial element to maintain the first and second radial elements in a slidable relationship, the constraining mechanism being configured to maintain the expandable module in the collapsed diameter until released by radial expansion of an inflatable balloon during deployment at a treatment site.

61. The balloon expandable crush-recoverable stent of claim 60, wherein each element comprises a pair deflectable members extending between the pair of containment members.

62. The balloon expandable stent of claim 60, wherein all of the elements of the modules have a substantially identical structure.

63. A balloon expandable stent, comprising:

at least two substantially flat elements configured to be rolled into a cylindrical configuration to provide a tubular member, each of the flat elements forming a portion of a circumference of the tubular member, the elements being slidably interconnected for allowing the tubular member to expand from a collapsed diameter to an expanded diameter without any substantial plastic deformation of the elements, at least one element comprising;

a locking mechanism comprising a plurality of teeth disposed on a first deflectable member that extends from a first end of the at least one element to a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the at least one element; and

a constraining mechanism for maintaining the tubular member in the collapsed diameter until released by radial expansion, the constraining mechanism comprising at least one loop formed along a first containment member that extends from the first end of the at least one element to the second end thereof, the constraining mechanism further comprising at least one hook disposed at the second end of the at least one element; and

an expandable sheath disposed over the tubular member, the expandable sheath being configured to expand during deployment of the stent at the treatment site.

64. The balloon expandable stent of claim 63, wherein the elements are fabricated from a shape-memory material for providing the tubular member with crush-recoverability.

65. The balloon expandable stent of claim 64, wherein the expandable sheath is configured for use as a vessel graft at a treatment site.

66. The balloon expandable stent of claim 63, wherein each element of the tubular member comprises a locking mechanism and a constraining mechanism.

67. The balloon expandable stent of claim 63, wherein all of the elements of the tubular member have a substantially identical structure.