Ostium support for treating vascular bifurcations

• US 8,529,618 B2
• Filed: 09/03/2009
• Issued: 09/10/2013
• Est. Priority Date: 04/14/2003
• Status: Expired due to Fees

• Current Assignee: Poseidon Medical Inc.
• Original Assignee: Tryton Medical, Inc.
• Inventors: Davis, H. Richard, Kaplan, Aaron V.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US12/553,933
• Publication Number:
  US 20090326641A1
• Time in Patent Office: 1,468 Days
• Field of Search: 623 111- 154
• US Class Current: 623/1.16
• 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 2002/91508 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 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A prosthesis is disclosed for placement across an ostium 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 spiral frond extending axially therebetween.

Claims

1. A prosthesis for placement at an ostium 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;

an elongate, flexible spiral frond attached to and extending axially 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 spaced axially apart from the support by the spiral frond.

2. The prosthesis as in claim 1, wherein the circumferential member comprises a sinusoidal wall pattern.

3. The prosthesis as in claim 1, wherein the circumferential member is expandable from a first, reduced diameter to a second, enlarged diameter.

4. The prosthesis as in claim 1, wherein the frond comprises a resilient metal.

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

6. 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 frond and the circumferential member are without a drug coating.

7. The prosthesis as in claim 6, wherein the drug coating is a drug eluting coating.

8. The prosthesis as in claim 6, 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.

9. The prosthesis as in claim 6, wherein the drug coating comprises one of an anti-cell proliferative, anti-cell migration, anti-neo-plastic, or anti-inflammatory drug.

10. The prosthesis as in claim 6, wherein the drug coating is configured to reduce an incidence or amount of restenosis.

11. The prosthesis as in claim 6, wherein the drug coating includes a first drug and a second drug.

12. The prosthesis as in claim 6, wherein the drug coating includes a first coating and a second coating.

13. The prosthesis as in claim 12, 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.

14. The prosthesis as in claim 1, wherein the frond extends for at least about two full revolutions around the longitudinal axis.

15. The prosthesis as in claim 1, wherein the frond extends in a spiral about a longitudinal axis of the support.

16. The prosthesis as in claim 1, wherein the frond provides sufficient radial force as a stent when deployed.

17. The prosthesis as in claim 1, wherein the circumferential member comprises a plurality of filaments.

18. The prosthesis as in claim 1, wherein at least a portion of the prosthesis decreases in mass over time.

19. The prosthesis as in claim 18, wherein the circumferential member is bioabsorbable.

20. The prosthesis as in claim 18, wherein the circumferential member is bioerodable.

21. The prosthesis as in claim 18, wherein the circumferential member is biodegradable.

22. The prosthesis as in claim 18, wherein a polymer matrix on a surface of the prosthesis decreases in mass over time.

23. The prosthesis as in claim 18, wherein any one or combination of the frond and support decreases in mass over time.

24. The prosthesis as in claim 18, wherein a proximal or distal portion of the prosthesis including the circumferential member decreases in mass over time.

25. 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 tubular body with a longitudinal axis, the support configured to be deployed in at least a portion of the branch body lumen; and

a spiral frond attached to and extending axially from either a proximal or distal end of the support;

the frond extending through at least four complete revolutions around the longitudinal axis in at least an unexpanded state and adapted to extend across the ostium.

26. The prosthesis as in claim 25, wherein the support is balloon expandable.

27. The prosthesis as in claim 25, wherein the support is self expandable.

28. The prosthesis as in claim 25, wherein the frond provides sufficient radial force as a stent when deployed.

29. The prosthesis as in claim 25, wherein the frond decreases in mass over time.

30. 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;

an ostium section which comprises at least one frond attached to and extending in a spiral from either the proximal or distal end of the support and disposed around the longitudinal axis, the frond 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.

31. The prosthesis as in claim 30, wherein the circumferential member is expandable from a first, reduced diameter to a second, enlarged diameter.

32. The prosthesis as in claim 30, wherein the at least one frond includes at least three fronds.

33. The prosthesis as in claim 30, wherein at least a portion of the frond comprises a lubricous coating.

34. The prosthesis as in claim 30 wherein the circumferential member is radiopaque.

35. The prosthesis as in claim 34, wherein the circumferential member has a greater radiopacity than the frond.

36. The prosthesis as in claim 30, comprising an endothelial cell ingrowth surface.

37. The prosthesis as in claim 30, comprising a non thrombogenic surface.

38. The prosthesis as in claim 30, wherein the frond provides sufficient radial force as a stent when deployed.

39. The prosthesis as in claim 30, wherein the at least one frond extends about the longitudinal axis of the prosthesis at least in an unexpanded state.

40. The prosthesis as in claim 30, wherein the circumferential member comprises a plurality of filaments.

41. The prosthesis as in claim 30, wherein at least a portion of the prosthesis decreases in mass over time.

42. The prosthesis as in claim 41, wherein the circumferential member is bioabsorbable.

43. The prosthesis as in claim 41, wherein the circumferential member is bioerodable.

44. The prosthesis as in claim 41, wherein the circumferential member is biodegradable.

45. The prosthesis as in claim 41, wherein a polymer matrix on a surface of the prosthesis decreases in mass over time.

46. The prosthesis as in claim 41, wherein any one or combination of the frond and support decreases in mass over time.

47. The prosthesis as in claim 41, wherein a proximal or distal portion of the prosthesis including the circumferential member decreases in mass over time.

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

a radially expansible support, the support configured to be deployed in at least a portion of the branch body lumen;

an elongate, flexible spiral frond attached to and extending axially from either a 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 spaced axially apart from the support by the spiral frond, wherein the frond is attached to either the proximal or distal end of the support by a transition zone that provides wall coverage and radial strength at the ostium when deployed.

49. The prosthesis as in claim 48, wherein the transition zone comprises a plurality of connectors having axial length enlarging at progressive circumferential positions about the support to accommodate an inclined angle of a distal most loop of the frond.

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

51. The prosthesis as in claim 48, wherein at least a portion of the prosthesis decreases in mass over time.

52. The prosthesis as in claim 51, wherein the circumferential member is bioabsorbable.

53. The prosthesis as in claim 51, wherein the circumferential member is bioerodable.

54. The prosthesis as in claim 51, wherein the circumferential member is biodegradable.

55. The prosthesis as in claim 51, wherein a polymer matrix on a surface of the prosthesis decreases in mass over time.

56. The prosthesis as in claim 51, wherein any one or combination of the frond and support decreases in mass over time.

57. The prosthesis as in claim 51, wherein a proximal or distal portion of the prosthesis including the circumferential member decreases in mass over time.