Vascular bifurcation prosthesis with multiple linked thin fronds

• US 8,641,751 B2
• Filed: 01/29/2009
• Issued: 02/04/2014
• Est. Priority Date: 04/14/2003
• Status: Active Grant

• Current Assignee: Poseidon Medical Inc.
• Original Assignee: Tryton Medical, Inc.
• Inventors: Davis, H. Richard, Kaplan, Aaron
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US12/362,300
• Publication Number:
  US 20090163999A1
• Time in Patent Office: 1,832 Days
• Field of Search: 623 111- 154
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/006 modular

Abstract

A prosthesis is disclosed for placement at an Os opening from a main body lumen to a branch body lumen. The prosthesis comprises a radially expansible support at one end, a circumferentially extending link at the other end and at least one frond extending axially therebetween. The support is configured to be deployed in the branch body lumen, with the circumferentially extending link in the main lumen and the frond extendable across the Os.

Claims

1. A prosthesis for placement at an opening from a main body lumen to a branch body lumen, the prosthesis comprising:

a radially expansible support having a cylindrical body extending between a distal end and a proximal end of the support and along a longitudinal axis of the prosthesis, the support configured to be deployed in at least a portion of the branch body lumen;

a plurality of fronds extending axially from either the proximal or distal end of the support and disposed around the longitudinal axis, the fronds having sufficient length to reach a portion of the main body lumen opposing the ostium; and

at least one circumferential link connecting at least a first and a second frond, the circumferential link spaced axially apart from the support.

2. The prosthesis as in claim 1, wherein the circumferential link connects each of the plurality of fronds.

3. The prosthesis as in claim 2, wherein the circumferential link is expandable from a first, reduced diameter to a second, enlarged diameter.

4. The prosthesis as in claim 1, wherein the plurality of fronds includes at least three fronds.

5. The prosthesis as in claim 1, wherein at least one of the fronds comprises a closed loop shape.

6. The prosthesis as in claim 1, wherein the fronds comprise a resilient metal.

7. The prosthesis as in claim 1, wherein at least one of the fronds is configured to be expandably deployed proximate a vessel wall by an expandable portion of a catheter.

8. The prosthesis as in claim 1, further comprising a first strut configured to increase at least one of a longitudinal or a torsional stiffness of at least one of the fronds.

9. The prosthesis as in claim 8, wherein the strut has a substantially triangular shape in the expanded state.

10. The prosthesis as in claim 8, further comprising a second expandable strut, the second strut having a curved shape in the expanded state.

11. The prosthesis as in claim 1, wherein at least a portion of the prosthesis comprises a lubricous coating.

12. The prosthesis as in claim 1, wherein at least a portion of the radially expansible support comprises a drug coating, and at least a portion of the fronds and the circumferential link are without a drug coating.

13. The prosthesis as in claim 12, wherein the drug coating is a drug eluting coating.

14. The prosthesis as in claim 12, wherein the drug coating is configured to produce at least one of a controlled drug release rate, a constant drug release rate, bi-modal drug release rate or a controlled concentration of drug proximate a target vessel wall.

15. The prosthesis as in claim 12, wherein the drug coating comprises one of an anti-cell proliferative, anti-cell migration, anti-neo-plastic, or an anti-inflammatory drug.

16. The prosthesis as in claim 12, wherein the drug coating is configured to reduce an incidence or amount of restenosis.

17. The prosthesis as in claim 12, wherein the drug coating includes a first drug and a second drug.

18. The prosthesis as in claim 12, wherein the drug coating includes a first coating and a second coating.

19. The prosthesis as in claim 18, wherein the first coating is configured to produce a first drug release rate and the second coating is configured to produce a second drug release rate.

20. The prosthesis as in claim 1, wherein the fronds have an axial length which is at least about 1.5 times the width of the support prior to radial expansion.

21. The prosthesis as in claim 1, wherein the plurality of fronds comprises two fronds spaced 180 degrees from each other.

22. The prosthesis as in claim 1, wherein the plurality of fronds comprises three fronds equally spaced apart from the center of the longitudinal axis.

23. The prosthesis as in claim 1, wherein the plurality of fronds is disposed around the longitudinal axis of the prosthesis at least in an unexpanded state.

24. The prosthesis as in claim 1, wherein when deployed at the opening, a flow path is maintained in the main body lumen through the at least one circumferential link.

25. The prosthesis as in claim 1, wherein the circumferential link comprises at least two filaments extending transversely to a longitudinal axis of at least the first and second fronds.

26. The prosthesis as in claim 25, wherein the two filaments are provided between the first and second fronds.

27. The prosthesis as in claim 25, wherein the circumferential link comprises a plurality of filaments provided between adjacent fronds.

28. The prosthesis as in claim 1, wherein at least a portion of the prosthesis is impermanent over time.

29. The prosthesis as in claim 28, wherein a proximal or distal portion of the prosthesis including the circumferential link is impermanent over time.

30. The prosthesis as in claim 28, wherein the circumferential link is bioabsorbable.

31. The prosthesis as in claim 28, wherein the circumferential link is bioerodeable.

32. The prosthesis as in claim 28, wherein the circumferential link is biodegradable.

33. The prosthesis as in claim 28, wherein a polymer matrix on a surface of the prosthesis is impermanent over time.

34. A prosthesis for placement at an ostium opening from a main body lumen to a branch body lumen, the prosthesis comprising:

a radially expansible branch vessel support having a first wall pattern, the support configured to be deployed in at least a portion of the branch body lumen;

a plurality of fronds extending axially from either a proximal or distal end of the support, the fronds having a second wall pattern different from the first wall pattern; and

a radially expansible connector, spaced axially apart from the branch vessel support by the fronds and connecting each of the fronds.

35. The prosthesis as in claim 34, wherein the support is balloon expandable.

36. The prosthesis as in claim 34, wherein the support is self expandable.

37. The prosthesis as in claim 34, wherein the expansible connector is balloon expandable.

38. The prosthesis as in claim 34, wherein the expansible connector is self expandable.

39. The prosthesis as in claim 34, wherein the fronds comprise a zone disposed between an elongate portion and the support, the zone comprising a third wall pattern different from the first wall pattern of the support and the second wall pattern of the elongate portion.

40. The prosthesis as in claim 34, wherein the connector comprises two filaments extending transversely to a longitudinal axis of adjacent fronds.

41. The prosthesis as in claim 40, wherein the two filaments are provided between the adjacent fronds.

42. The prosthesis as in claim 34, wherein at least a portion of the prosthesis is impermanent over time.

43. The prosthesis as in claim 42, wherein a proximal or distal portion of the prosthesis including the connector is impermanent over time.

44. The prosthesis as in claim 42, wherein the connector is bioabsorbable.

45. The prosthesis as in claim 42, wherein the connector is bioerodeable.

46. The prosthesis as in claim 42, wherein the connector is biodegradable.

47. The prosthesis as in claim 42, wherein a polymer matrix on a surface of the prosthesis is impermanent over time.

48. A prosthesis for placement at an opening from a main body lumen to a branch body lumen, the prosthesis comprising:

a radially expansible support having a cylindrical body extending along a longitudinal axis between a distal end and a proximal end, at least the distal end entirely surrounding the longitudinal axis, the support configured to be deployed in at least a portion of the branch body lumen;

at least one frond extending from either the proximal or distal end of the support and configured to be positioned across the ostium and into the main body lumen; and

at least one circumferential member connected to the frond, the circumferential member spaced axially apart from the support.

49. The prosthesis as in claim 48, wherein the circumferential member is expandable from a first, reduced diameter to a second, enlarged diameter.

50. The prosthesis as in claim 48, wherein the at least one frond includes at least three fronds.

51. The prosthesis as in claim 48, wherein the at least one frond comprises a helical configuration.

52. The prosthesis as in claim 51, wherein the at least one frond comprises a plurality of helical fronds.

53. The prosthesis as in claim 48, wherein at least a portion of the frond comprises a lubricous coating.

54. The prosthesis as in claim 48, wherein the support is on a first end of the frond, and the circumferential member is on a second end of the frond.

55. The prosthesis as in claim 48 wherein the circumferential member is radiopaque.

56. The prosthesis as in claim 55, wherein the circumferential member has a greater radiopacity than the frond.

57. The prosthesis as in claim 48, comprising an endothelial cell ingrowth surface.

58. The prosthesis as in claim 48, comprising a non thrombogenic surface.

59. The prosthesis as in claim 48, wherein the radially expansible support has a first radial strength when expanded and the circumferential member has a second radial strength when expanded that is less than the first radial strength.

60. The prosthesis as in claim 48, wherein when deployed at the opening, a flow path is maintained in the main body lumen through the at least one circumferential member.

61. The prosthesis as in claim 60, wherein the at least one frond is configured to extend into and at least partially expandably circumscribe the main body lumen and reach a portion of the main body lumen opposing the opening.

62. The prosthesis as in claim 48, wherein the circumferential member comprises a plurality of filaments.

63. The prosthesis as in claim 62, wherein the circumferential member comprises a plurality of filaments provided between adjacent fronds.

64. The prosthesis as in claim 48, wherein at least a portion of the prosthesis is impermanent over time.

65. The prosthesis as in claim 64, wherein a proximal or distal portion of the prosthesis including the circumferential member is impermanent over time.

66. The prosthesis as in claim 64, wherein the circumferential member is bioabsorbable.

67. The prosthesis as in claim 64, wherein the circumferential member is bioerodeable.

68. The prosthesis as in claim 64, wherein the circumferential member is biodegradable.

69. The prosthesis as in claim 64, wherein a polymer matrix on a surface of the prosthesis is impermanent over time.