Bifurcated stent assemblies

• US 8,961,586 B2
• Filed: 05/01/2007
• Issued: 02/24/2015
• Est. Priority Date: 05/24/2005
• Status: Active Grant

• Current Assignee: Inspired Industry, LLC, InspireMD, Ltd.
• Original Assignee: InspireMD, Ltd.
• Inventors: Holzer, Asher, Bar, Eli, Paz, Ofir
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US11/797,168
• Publication Number:
  US 20070276468A1
• Time in Patent Office: 2,856 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.13, 623/1.16, 623/1.35
• US Class Current: 623/1.35
• 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 2/90 characterised by a net-like or mesh-like structure
• 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 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2250/006 modular

Abstract

Disclosed is a stent assembly for expanding in vivo vessels, the assembly comprising first and second radially expandable mesh stents, wherein the first stent is separated by a predetermined distance from the second stent and a stent jacket spans the predetermined distance such that a first end of the jacket is operatively associated with the first stent and a second end of the jacket is operatively associated with the second stent.

Claims

1. A stent system adapted to expand in vivo in a patient'"'"'s vessel, the stent system comprising:

a) first and second radially expandable mesh stents adapted to expand from a contracted state to a radially expanded state, wherein said first stem is separated by a predetermined distance from said second stent; and

b) a stent jacket comprising a mesh structure formed of a plurality of fibers defining apertures having a center dimension of at least 180 micrometers that are limited by the fibers having a diameter of about 7 micrometers to 18 micrometers, the stent jacket spanning said predetermined distance such that a first end of said jacket is disposed over said first stem and a second end of said jacket is disposed over said second stent; and

c) a third stent axially disposed and movably set on a guide wire,

wherein said stent racket is configured to encircle the axially disposed third stent in a contracted state, while said stent system is being delivered to an in situ location in the patient'"'"'s vessel with the first and second stents in the contracted state,

wherein said stem jacket comprises at least one aperture in the mesh structure sized and dimensioned to allow passage of the guide wire and third stent, and the guide wire is configured to be manipulated through the aperture while said third stent is contracted, and wherein the third stent is configured to move along the guide wire through the at least one aperture at an angle to an axis running between said first and second stent.

2. The stent system according to claim 1, wherein upon radial expansion of said first and second stems, said first jacket end expands radially and encircles at least a portion of said first stent and said second end of said jacket expands radially and encircles at least a portion of said second stent.

3. The stent system according to claim 1, wherein said stent jacket spanning said distance is configured to encircle the axially disposed third stent in the contracted state following delivery of said first and second stents to an in situ location.

4. The stent system according to claim 1, wherein said at least one aperture is additionally configured to encircle an outer surface of said third stent while said third stent is contracted.

5. The stent system according to claim 4, wherein the angle is at least about 15 degrees and no more than about 165 degrees.

6. The stent system according to claim 4, wherein the mean diameter of said at least one aperture is configured to expand when said contracted third stent is expanded while encircled by said aperture.

7. The stent system according to claim 6, wherein upon expansion of said third stent, at least a portion of said stent jacket spanning said distance is configured to encircle at least a portion of an outer surface of said third stent.

8. The stent system according to claim 7, wherein during expansion, said first stent and said second stent are of a sufficient diameter to press at least a portion of the inner walls of a parent vessel with a pressure of at least one atmosphere and no more than about 50 atmospheres.

9. The stent system according to claim 7, wherein during expansion, said first stent and said second stem are of a sufficient diameter to press at least a portion of the inner walls of a parent vessel with a pressure of about 15 atmospheres.

10. The stent system according to claim 7, wherein during expansion, said third stent is of a sufficient diameter to press at least a portion of the inner walls of a branch vessel with a pressure of at least one atmosphere and no more than about 50 atmospheres.

11. The stent system according to claim 10, wherein during expansion, said third stent is of a sufficient diameter to press at least a portion of the inner walls of a branch vessel with a pressure of about 15 atmospheres.

12. The stent system according to claim 7, wherein during expansion, said first stent and said third stent are of a sufficient diameter to press at least a portion of the inner walls of a parent vessel with a pressure of at least one atmosphere and no more than about 50 atmospheres.

13. The stent system according to claim 12, wherein during expansion, said first stent and said third stent are of a sufficient diameter to press at least a portion of the inner walls of a parent vessel with a pressure of about 15 atmospheres.

14. The stent system according to claim 7, wherein during expansion, said second stent is of a sufficient diameter to press at least a portion of the inner walls of a branch vessel with a pressure of at least one atmosphere and no more than about 50 atmospheres.

15. The stent system according to claim 14, wherein during expansion, said second stent is of a sufficient diameter to press at least a portion of the inner walls of a branch vessel with a pressure of about 15 atmospheres.

16. The stent system according to claim 1, wherein said third stent, following expansion of said first stent and said second stent, is configured to have an end pressed into a portion of said stent jacket.

17. The stent system according to claim 16, wherein said pressed portion of said stent jacket is configured to stretch when said third stent is expanded during said pressing.

18. The stent system according to claim 17, wherein said stretched portion of said stent jacket is configured to be punctured by a puncturing tool, wherein the resulting puncture is of a sufficient diameter to allow said third stent to pass through said puncture.

19. The stent system according to claim 18, wherein said third stent is configured to pass through said puncture at an angle to an axis running between said first and second stent, said angle being at least about 15 degrees and no more than about 165 degrees.

20. The stent system according to claim 19, wherein a portion of said stent jacket spanning said distance remains substantially intact following said puncturing.

21. The stent system according to claim 18, wherein said puncturing tool comprises an expandable balloon.

22. The stent system according to claim 21, wherein said stent jacket spanning said distance comprises at least one aperture configured to encircle said expandable balloon in a contracted state.

23. The stent system according to claim 22, wherein said at least one aperture is configured to rip as said expandable balloon is inflated.

24. The stent system according to claim 18, wherein upon passage of said third stent through said puncture, at least a portion of said jacket is configured to encircle at least a portion of an outer surface of said third stent.

25. The stent system according to claim 24, wherein during expansion, said first stent and said second stent are of a sufficient diameter to press at least a portion of the inner walls of a parent vessel with a pressure of at least one atmosphere and no more than about 50 atmospheres.

26. The stent system according to claim 25, wherein during expansion, said first stent and said second stent are of a sufficient diameter to press at least a portion of the inner walls of a parent vessel with a pressure of about 15 atmospheres.

27. The stent system according to claim 24, wherein during expansion, said third stent is of a sufficient diameter to press at least a portion of the inner walls of a branch vessel with a pressure of at least one atmosphere and no more than about 50 atmospheres.

28. The stent system according to claim 27, wherein during expansion, said third stent is of a sufficient diameter to press at least a portion of the inner walls of a branch vessel with a pressure of about 15 atmospheres.

29. The stent system according to claim 27, wherein during expansion said stents are configured to expand in a manner that dilates the adjacent vessels.

30. The stent system according to claim 27, wherein following expansion the vessels are supported with one layer of stent metal.

31. The stent system according to claim 24, wherein during expansion, said first stem and said third stent are of a sufficient diameter to press at least a portion of the inner walls of a parent vessel with a pressure of at least one atmosphere and no inure than about 50 atmospheres.

32. The stent system according to claim 31, wherein during expansion, said first stent and said third stent are of a sufficient diameter to press at least a portion of the inner walls of a parent vessel with a pressure of about 15 atmospheres.

33. The stent system according to claim 24, wherein during expansion, said second is of a sufficient diameter to press at least a portion of the inner walls of a branch vessel with a pressure of at least one atmosphere and no more than about 50 atmospheres.

34. The stent system according to claim 33, wherein during expansion, said second stent is of a sufficient diameter to press at least a portion of the inner wails of a branch vessel with a pressure of about 15 atmospheres.

35. The stent system according to claim 1, wherein said stents comprise a metallic base from the group consisting of stainless steel, nitinol, tantalum, MP35N alloy, a cobalt-based alloy, a cobalt-chromium alloy, platinum, titanium, and other biocompatible metal alloy.

36. The stent system according to claim 1, wherein said stents are selected from the group consisting of a cardiovascular stent, a peripheral stent, a coronary stent, an abdominal aortic aneurysm stent, a cerebral stent, a carotid stem, an endovascular stent, an aortic valve stent, and a pulmonary valve stent.

37. The stent system according to claim 1, wherein said stent jacket comprises a material manufactured by a process from the group consisting of interlacing knitting, interlocked knitting, braiding, interlacing, and dipping a porous mold into one or more reagents.

38. The stent system of claim 1, wherein one or more of the first, second, and third stents and the stent jacket is coated or imbued with one or more active pharmaceutical agents.

39. The stent system of claim 38, wherein the one or more active pharmaceutical agents comprises a chemotherapeutic, an analgesic, an antihistamine, a corticosteroid, a hormone, a non-steroidal anti-inflammatory agent, or a vasodilator.