Prosthesis for treating vascular bifurcations

• US 8,672,994 B2
• Filed: 10/13/2005
• Issued: 03/18/2014
• Est. Priority Date: 04/14/2003
• Status: Active Grant

• Current Assignee: Poseidon Medical Inc.
• Original Assignee: Tryton Medical, Inc.
• Inventors: Kaplan, Aaron, Davis, H. Richard
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US10/584,968
• Publication Number:
  US 20080039919A1
• Time in Patent Office: 3,078 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.15, 623/1.16, 623/1.35, 623/1.36, 623 142- 146
• US Class Current: 623/1.15
• 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 2/97 the outer sleeve being splittable
• 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 2002/9155 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 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• 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 stepped balloon catheter prosthesis deployment system is disclosed for placement of a prosthesis across 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 prosthesis is configured to be deployed from a stepped diameter balloon with the support 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 comprising a first wall pattern, the support configured to be deployed in at least a portion of the branch body lumen, the support adapted to provide a first radial force to support a body lumen;

at least two elongate, flexible fronds extending from an end of the support, each frond having a first end, a second end, and comprising first and second spaced apart filaments each having first and second ends, the first end of the first filament being directly connected to a first proximal apex of the radially expansible support, the first end of the second filament being directly connected to a second proximal apex of the radially expansible support, the first proximal apex being spaced apart from the second proximal apex, the second end of the second filament being coupled with the first filament at a location proximal of a transition portion of the frond, the transition portion comprising a second wall pattern different from the first wall pattern, the transition portion of the frond extending from an end of the support and configured to be positioned across the opening and into the main body lumen, the fronds comprising an elongate portion disposed proximal of the transition portion, the elongate portion having a third wall pattern different from the second wall pattern;

at least one circumferential link connected to the second ends of the fronds, the second end of each frond connected to a corresponding single location of the circumferential link, the circumferential link spaced axially apart from the support by the fronds and adapted to provide a second radial force that is less than the first radial force; and

a plurality of elongate side wall openings located at least partially proximal of the transition portion in between adjacent fronds sized and configured to receive a stent deployment device therethrough;

the elongate flexible fronds, the support and the circumferential link defining a unitary body as deployed, the elongate side wall openings in between adjacent fronds for facilitating crossing of a main vessel stent therethrough when the support is positioned in the branch body lumen and the circumferential link is positioned in the main body lumen.

2. The prosthesis as in claim 1, wherein the circumferential link comprises an undulating pattern having at least three apexes.

3. The prosthesis as in claim 1, comprising three fronds.

4. The prosthesis as in claim 1, wherein at least one frond comprises a helical configuration.

5. The prosthesis as in claim 4, comprising a plurality of helical fronds.

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

7. The prosthesis as in claim 1, wherein the fronds have an axial length of at least about 8 mm.

8. The prosthesis as in claim 1, wherein the circumferential link is radiopaque.

9. The prosthesis as in claim 8, wherein the circumferential link has a greater radiopacity than the fronds.

10. The prosthesis as in claim 1, comprising an endothelial cell ingrowth surface.

11. The prosthesis as in claim 1, comprising a non-thrombogenic surface.

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 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.

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

15. The prosthesis as in claim 12, wherein the drug coating is configured to reduce restenosis.

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

17. The prosthesis as in claim 16, 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.

18. The prosthesis as in claim 1, wherein the circumferential link comprises a single transverse filament.

19. The prosthesis as in claim 1, wherein the prosthesis includes a drug incorporated into a polymer matrix.

20. The prosthesis as in claim 19, wherein the polymer matrix includes a base layer and a top layer, the drug being incorporated into at least one of the top layer and the base layer.

21. The prosthesis as in claim 1, wherein the prosthesis includes one or more reservoirs configured to be loaded with a drug.

22. The prosthesis as in claim 21, wherein the prosthesis includes one or more drugs in the one or more reservoirs.

23. The prosthesis as in claim 1, wherein the second end of the second filament is coupled with a side portion of the first filament.

24. 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 two elongate, flexible fronds extending from an end of the support, each frond having a transition zone adapted to traverse from a branch vessel side of an ostium into a main vessel side of the ostium, the transition zone having a distal end directly connected to a plurality of spaced apart apices of the branch vessel support and a proximal end opposite the distal end, the fronds further having an elongate portion extending proximally from the proximal end of the transition zone between first and second ends of the fronds; and

a circumferential link connected to the second ends of the fronds, the circumferential link spaced axially apart from the support by the fronds;

wherein the second end of each of the fronds is directly connected to the circumferential link at a corresponding single apex of the circumferential link; and

wherein the transition zone provides a greater degree of scaffolding than the portion of the fronds extending proximally therefrom.

25. The prosthesis as in claim 24, wherein the first end of the fronds is connected to three spaced apart apices of the radially expansible support.

26. The prosthesis as in claim 24, wherein the radially expansible support is adapted to provide a first radial force to support the branch body lumen and the circumferential link is adapted to provide a second radial force that is less than the first radial force when applied to the main body lumen.

27. The prosthesis as in claim 24, wherein the fronds further comprises first and second spaced apart filaments having distal and proximal ends, the distal ends of each of the first and second filaments being directly coupled with spaced apart proximal apices of the radially expansible support.

28. The prosthesis as in claim 27, wherein the proximal end of the second filament is coupled with a side portion of the first filament between the distal and proximal ends of the first filament.

29. The prosthesis as in claim 24, further comprising a plurality of elongate side wall openings in between adjacent fronds sized and configured to receive a stent deployment balloon catheter therethrough.