Prothesis and deployment catheter for treating vascular bifurcations

• US 8,187,314 B2
• Filed: 01/29/2009
• Issued: 05/29/2012
• 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:
  US12/362,342
• Publication Number:
  US 20090163988A1
• Time in Patent Office: 1,216 Days
• Field of Search: 623 111- 154
• US Class Current: 623/1.12
• 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 and deployment catheter system for treating 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 either a proximal or distal end of the support, the fronds being configured to be positioned across the ostium and into the main body lumen; and

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

wherein the prosthesis is mounted on a balloon catheter such that the radially expansible support is carried by a first portion of a balloon that is inflatable to a first diameter and the circumferential link is carried by a second portion of a balloon that is inflatable to a second diameter that is larger than the first diameter.

2. The system of claim 1, wherein the circumferential link connects each of the plurality of fronds.

3. The system of claim 1, wherein the plurality of fronds includes at least three fronds.

4. The system of claim 1, wherein the fronds comprise a resilient metal.

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

6. The system of claim 1, wherein the balloon catheter comprises a single, stepped balloon having a proximal section with a larger inflated diameter than an inflated diameter of a distal section.

7. The system as in claim 6, 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.

8. The system as in claim 7, wherein the drug coating is a drug eluting coating.

9. The system of claim 7, 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 system of claim 7, wherein the drug is one of an anti-cell proliferative, anti-cell migration, anti-neo-plastic, or an anti-inflammatory drug.

11. The system of claim 7, wherein the drug is configured to reduce an incidence or amount of restenosis.

12. The system of claim 7, wherein the drug includes a first drug and a second drug.

13. The system of claim 7, wherein the drug coating includes a first coating and a second coating.

14. The system of claim 13, 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.

15. The system of claim 1, wherein the circumferential link comprises two filaments provided between at least the first and second fronds.

16. The system of claim 1, wherein the circumferential link comprises a plurality of filaments provided between adjacent fronds.

17. The system of claim 1, wherein the fronds have sufficient length to reach a portion of the main body lumen opposing the ostium.

18. The system of claim 1, wherein at least a portion of the prosthesis is impermanent over time.

19. The system of claim 18, wherein a proximal or distal portion of the prosthesis including the circumferential link is impermanent over time.

20. The system of claim 18, wherein the circumferential link is bioabsorbable.

21. The system of claim 18, wherein the circumferential link is bioerodeable.

22. The system of claim 18, wherein the circumferential link is biodegradable.

23. The system of claim 18, wherein a polymer matrix on a surface of the prosthesis is impermanent over time.

24. A prosthesis and deployment system assembly, comprising:

an elongate, flexible catheter body;

a balloon on the body, the balloon having an inflated profile with a first section having a first diameter, a second section having a second diameter, and a balloon transition in between the first and second sections; and

a prosthesis having an inner surface, the entire inner surface carried on the balloon, the prosthesis comprising a first frond, a second frond, and a circumferential link comprising at least one filament coupling the first frond to the second frond;

wherein the prosthesis has a wall having a first wall pattern adjacent the first section of the balloon, and a second wall pattern adjacent the balloon transition.

25. A prosthesis and deployment system assembly as in claim 24, wherein the prosthesis has a third wall pattern adjacent the second section of the balloon.

26. The assembly of claim 24, wherein the second wall pattern is different than the first wall pattern.

27. The assembly of claim 24, wherein the first and second fronds of the prosthesis comprise a zone disposed between an elongate portion and a support of the prosthesis, 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.

28. The assembly of claim 24, wherein the circumferential link of the prosthesis comprises two filaments extending transversely to a longitudinal axis of at least the first and second fronds.

29. The assembly of claim 28, wherein the circumferential link of the prosthesis comprises a plurality of filaments provided between the first and second fronds.

30. The assembly of claim 24, wherein the first section extends longitudinally along a longitudinal axis of the balloon, and the second section extends longitudinally along the longitudinal axis of the balloon.

31. The assembly of claim 24, wherein a radially expansible support of the prosthesis is carried by the first section of the balloon and the circumferential link of the prosthesis is carried by the second section of the balloon.

32. The assembly of claim 24, wherein the circumferential link is bioabsorbable.

33. The assembly of claim 24, wherein the circumferential link is bioerodeable.

34. The assembly of claim 24, wherein the circumferential link is biodegradable.

35. A prosthesis and deployment catheter system for treating 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, the support further having a first radial strength when deployed;

a plurality of fronds extending axially from an end of the support and configured to be positioned across the ostium 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 and having a second radial strength when deployed, the second radial strength being less than the first radial strength;

wherein the prosthesis is mounted on a balloon catheter such that the radially expansible support is carried by a first portion of a balloon that is inflatable to a first diameter and the circumferential link is carried by a second portion of a balloon that is inflatable to a second diameter that is larger than the first diameter.

36. The system of claim 35, wherein the circumferential link comprises two filaments provided between at least the first and second fronds.

37. The system of claim 35, wherein the circumferential link comprises a plurality of filaments provided between adjacent fronds.

38. The system of claim 35, wherein at least a portion of the prosthesis is impermanent over time.

39. The system of claim 38, wherein a proximal or distal portion of the prosthesis including the circumferential link is impermanent over time.

40. The system of claim 38, wherein the circumferential link is bioabsorbable.

41. The system of claim 38, wherein the circumferential link is bioerodeable.

42. The system of claim 38, wherein the circumferential link is biodegradable.

43. The system of claim 38, wherein a polymer matrix on a surface of the prosthesis is impermanent over time.