Vascular bifurcation prosthesis with multiple linked thin fronds

• US 20060025849A1
• Filed: 07/27/2005
• Published: 02/02/2006
• Est. Priority Date: 04/14/2003
• Status: Active Grant

• Current Assignee: Poseidon Medical Inc.
• Original Assignee: Anvil Medical Corporation
• Inventors: Kaplan, Aaron, Davis, H. Richard
• Granted Patent: US 8,083,791 B2
• Time in Patent Office: Days
• US Class Current: 623/1.150
• 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, the support configured to be deployed in at least a portion of the branch body lumen;

a plurality of fronds extending axially from an end of the support and configured to be positioned across the Os and into the main body lumen; 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 is one of an anti-cell prolifertive, anti cell migration, anti-neo plastic, anti inflammatory drug.

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

17. The prosthesis as in claim 12, wherein the drug includes a first drug and second a 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. A 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. A prosthesis for placement at an Os opening from a main body lumen to a branch body lumen, the prosthesis comprising:

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

a plurality of fronds extending axially from an end of the support;

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

22. A prosthesis as in claim 21, wherein the support is balloon expandable.

23. A prosthesis as in claim 21, wherein the support is self expandable.

24. A prosthesis as in claim 21, wherein the expansible connector is balloon expandable.

25. A prosthesis as in claim 21, wherein the expansible connector is self expandable.

26. A method for treating a bifurcation between a main lumen and a branch lumen, comprising the steps of:

providing a radially expandable scaffold, having a proximal end, a distal end, a support structure on the distal end, a circumferential link on the proximal end and at least two fronds extending axially between the support structure and the circumferential link;

transluminally navigating the scaffold to a treatment site; and

deploying the scaffold at the site such that the support is in the branch lumen and the circumferential link is in the main lumen.

27. A method as in claim 26, further comprising the step of positioning an inflatable balloon in the main lumen, and deforming the circumferential link such that it conforms to at least a portion of the wall of the main lumen.

28. A method as in claim 27, further comprising the step of deploying a stent in the main lumen.

29. A prosthesis for placement at an opening 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;

at least one frond extending from an end of the support and configured to be positioned across the Os and into the main body lumen; and

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

30. The prosthesis as in claim 29, wherein the circumferential link is expandable from a first, reduced diameter to a second, enlarged diameter.

31. The prosthesis as in claim 29, wherein the at least one frond includes at least three fronds.

32. The prosthesis as in claim 29, wherein the at least one frond comprises a helical configuration.

33. The prosthesis as in claim 32, comprising a plurality of helical fronds.

34. The prosthesis as in claim 29, wherein at least a portion of the frond comprises a lubricous coating.

35. The prosthesis as in claim 29, wherein the support is on a first end of the frond, and the circumferential link is on a second end of the frond.

36. The prosthesis as in claim 29 wherein the circumferential link is radiopaque.

37. The prosthesis as in claim 36, wherein the circumferential link has a greater radiopacity than the frond.

38. The prosthesis as in claim 29, comprising an endothelial cell ingrowth surface.

39. The prosthesis as in claim 29, comprising a non thrombogenic surface.

40. A method of supporting a vessel wall in the vicinity of an os between a main vessel and a branch vessel, comprising the steps of:

positioning at least one frond across the os, the frond having a first end on a first, branch vessel side of the os and a second end on a second, main vessel side of the os;

supporting the first end of the frond against the vessel wall on the first side of the os; and

supporting the second end of the frond against the vessel wall on the second side of the os.

41. A method of supporting a vessel wall as in claim 40, wherein the supporting the first end step comprises expanding a first expandable support structure against the vessel wall.

42. A method of supporting a vessel wall as in claim 41, wherein the first expandable support structure is attached to the first end of the frond.

43. A method of supporting a vessel wall as in claim 41, wherein the expanding step comprises permitting the first expandable support structure to self expand.

44. A method of supporting a vessel wall as in claim 41, wherein the expanding step comprises forcibly expanding the first expandable support structure.

45. A method of supporting a vessel wall as in claim 40, wherein the supporting the second end step comprises expanding a second expandable support structure against the vessel wall.

46. A method of supporting a vessel wall as in claim 45, wherein the second expandable support structure is attached to the second end of the frond.

47. A method of supporting a vessel wall as in claim 45, wherein the expanding step comprises expanding the second support structure such that the second end of the frond is entrapped between the second support structure and the vessel wall.

48. A method of supporting a vessel wall as in claim 40, wherein the frond extends helically about a longitudinal axis.

49. A method of supporting a vessel wall as in claim 40, comprising the step of positioning at least two fronds across the os.

50. A method of supporting a vessel wall as in claim 40, comprising the step of positioning at least four fronds across the os.