Prosthesis for treating vascular bifurcations

• US 8,641,755 B2
• Filed: 05/04/2007
• 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): Dornbusch, Dianne
• Application Number:
  US11/744,812
• Publication Number:
  US 20070203571A1
• Time in Patent Office: 2,468 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, 623/1.3, 623/1.31
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/067 modular
• 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 2002/91583 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 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: A61F 2250/006 : modular
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• 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 ostium opening from a main body lumen to a branch body lumen, the prosthesis comprising:

a generally tubular distal portion comprising a radially expansible support having a plurality of proximal apices, the support configured to be deployed in at least a portion of the branch body lumen;

a plurality of fronds extending proximally from an end of the support between a distal end attached to proximal apices of the support and a proximal end, each frond having a first section with four side-by-side filaments and a second section proximal of the first section having two side-by-side filaments, the four side-by-side filaments being attached to three adjacent proximal apices of the support, the fronds configured to be deformably deployed in at least a portion of the main body lumen and to apply less radial force to adjacent tissue than the expanded support applies in the branch body lumen; and

a circumferential link comprising an undulating configuration comprising a plurality of apices, the circumferential link connecting the proximal ends of the fronds, wherein the proximal end of each frond is connected to a single apex of the circumferential link.

2. The prosthesis of claim 1, wherein the plurality of fronds includes at least three fronds.

3. The prosthesis of claim 1, wherein at least one frond comprises a helical configuration.

4. The prosthesis of claim 3, comprising a plurality of helical fronds.

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

6. The prosthesis of claim 1, comprising an endothelial cell ingrowth surface.

7. The prosthesis of claim 1, comprising a non thrombogenic surface.

8. The prosthesis of 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.

9. The prosthesis of claim 8, 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.

10. The prosthesis of claim 8, wherein the drug coating comprises one of an anti-cell proliferative, anti-cell migration, anti-neo-plastic, or anti-inflammatory drug.

11. The prosthesis of claim 8, wherein the drug coating is configured to reduce restenosis.

12. The prosthesis of claim 8, wherein the drug coating includes a first coating and a second coating.

13. The prosthesis of 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 of claim 1, wherein the support is on a first end of at least one of the fronds, and the circumferential link is on a second end of at least one of the fronds defining the frond length therebetween, and the frond length is at least about 35% of the overall length of the prosthesis.

15. The prosthesis of claim 1, wherein the circumferential link is radiopaque.

16. The prosthesis of claim 1, wherein the circumferential link has a greater radiopacity than the fronds.

17. The prosthesis of claim 1 wherein the frond length is at least about 5 times the width of the prosthesis prior to expansion.

18. The prosthesis of claim 1 wherein the fronds comprise an undulating structure.

19. The prosthesis of claim 1, wherein the second section extends proximally from the first section to the circumferential link.

20. The prosthesis of claim 1, wherein the prosthesis has substantially less radial rigidity in the region of the plurality of fronds than in the region of the radially expansible support and substantially more open area in the region of the fronds than in the region of the radially expansible support.

21. The prosthesis of claim 1, wherein each frond has a length between the first and second ends along which it is not connected to any adjacent frond, said length being at least about 1.5 times the width of the prosthesis prior to expansion.

22. The prosthesis of claim 1, wherein each frond has a length between the first and second ends along which it is not connected to any adjacent frond, said length being substantially equal to the length of the radially expansible support.

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

a generally tubular distal portion comprising a radially expansible support having a plurality of proximal apices, the support configured to be deployed in at least a portion of the branch body lumen;

a plurality of fronds extending proximally from an end of the support between a distal end attached to proximal apices on the support and a proximal end, each frond having a distal section having four side-by-side filaments and a proximal section having two side-by-side filaments, each of the four side-by-side filaments being directly coupled with a proximal apex of the support, the fronds configured to be deformably deployed in at least a portion of the main body lumen and to apply less radial force to adjacent tissue than the expanded support applies in the branch body lumen; and

a circumferential link connecting the proximal ends of the fronds, each frond coupled with the circumferential link at a single location.

24. The prosthesis of claim 23, wherein the two side-by-side filaments in the proximal section extend proximally to the circumferential link.

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

a generally tubular distal portion comprising a radially expansible support having a plurality of proximal apices, the support configured to be deployed in at least a portion of the branch body lumen, the radially expansible support having a branch support wall pattern configured to provide scaffolding for the branch body lumen;

a plurality of fronds extending proximally from an end of the support and having a first section, a second section located proximally of the first section, the first section having a first frond wall pattern different from the branch support wall pattern, the first frond wall pattern configured to traverse the ostium opening between the branch body lumen and the main body lumen and to scaffold the ostium opening, the second section having a second frond wall pattern different from the branch support wall pattern and different from the first frond wall pattern, the second frond wall pattern configured to provide for passage of another stent therethrough, at least one of the fronds having a first elongate filament extending within the second section distally to the first section, the first section of the at least one frond having a second elongate filament and a third elongate filament, the second and third elongate filaments being coupled at first ends with a distal end of the first elongate filament and being coupled at second ends thereof with proximal peaks of the support, providing a greater density of filaments in the distal section than in the proximal section of the at least one frond; and

a circumferential link connecting the proximal ends of the fronds.

26. The prosthesis of claim 25, wherein the first filament is coupled at a proximal end with the circumferential link.

27. The prosthesis of claim 25, wherein the second ends of the second and third filaments are coupled with immediately adjacent proximal peaks of the support.

28. The prosthesis of claim 25, wherein the second section of at least one of the fronds comprises a fourth filament and the first section comprises fifth and sixth elongate filaments, the fifth and sixth elongate filaments being coupled at first ends to a distal end of the fourth elongate filament and being coupled at second ends thereof with proximal apices of the support.

29. The prosthesis of claim 25, wherein the second ends of the second and third elongate filaments are coupled with immediately adjacent apices of the support.