Multi-component expandable supportive bifurcated endoluminal grafts and methods for using same

• US 8,317,856 B2
• Filed: 03/05/2008
• Issued: 11/27/2012
• Est. Priority Date: 03/05/2007
• Status: Active Grant

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon, Benary, Rafi
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US12/529,936
• Publication Number:
  US 20100063575A1
• Time in Patent Office: 1,728 Days
• Field of Search: 623/1.13, 623/1.15, 623/1.35
• US Class Current: 623/1.35
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve

Abstract

A multiple-component expandable endoluminal system for treating a lesion at a bifurcation including a self expandable tubular root member having a side-looking engagement aperture, a self expandable tubular trunk member comprising a substantially blood impervious polymeric liner secured therealong; both having a radially compressed state adapted for percutaneous intraluminal delivery and a radially expanded state adapted for endoluminal support.

Claims

1. A stent graft system comprising:

a first component, which comprises a tubular structure, which comprises a first support element and a first covering element attached to said first support element, two sides of said first component being positionable, respectively, in first and second branches that branch from a main trunk of a subject, wherein said first covering element is shaped so as to define an opening arranged to face said main trunk; and

a second component, which comprises a second support element and a second covering element attached to said second support element, said second component partially disposed within said first component, extending out of said first component through said opening,

wherein said second component comprises a proximal segment and a distal segment, said proximal segment being anchorably disposed within exactly one of said two sides of said first component, such that said proximal segment engages said exactly one side, and wherein said distal segment of said second component extends out of said first component through said opening, and

wherein said second covering element only partially covers said second support element so as to allow blood flow to both of said two sides of said first component.

2. The stent graft system according to claim 1, wherein said first component is adapted for transluminal delivery for transport to a site within a body lumen by being radially compressed from a larger cross-section to a smaller cross-section.

3. The stent graft system according to claim 1, wherein said second component is adapted for transluminal delivery for transport to a site within a body lumen by being radially compressed from a larger cross-section to a smaller cross-section.

4. The stent graft system according to claim 1, wherein said first covering element only partially covers said first support element.

5. The stent graft system according to claim 1, wherein said first and second components are radially compressible from respective larger cross-sections to respective smaller cross-sections, wherein said first and second components are adapted for transluminal delivery for transport to a site within a body lumen, and wherein said second component is adapted for transluminal delivery through said first component when said first component assumes its larger cross-section.

6. The stent graft system according to claim 5, wherein said first component, when it assumes its larger cross-section, is dimensioned to intraluminally fit iliac arteries of said subject, and wherein said second component, when it assumes its larger cross-section, is dimensioned to intraluminally fit an abdominal aorta of said subject.

7. The stent graft system according to claim 1, wherein said second covering element substantially covers said distal segment but does not generally cover said proximal segment.

8. The stent graft system according to claim 1, wherein said second covering element substantially covers said distal segment, covers a proximal portion of said proximal segment, and does not cover a distal portion of said proximal segment.

9. The stent graft system according to claim 1, wherein said second component includes sections having varying diameters, such that a portion of said second component is disposable within a section of said first component.

10. The stent graft system according to claim 1, wherein a diameter of a distal section of said distal segment not disposed within said first component is greater than a diameter of said opening, and wherein said diameter of said distal section increases as said distal section exits from said opening.

11. The stent graft system according to claim 1, wherein a section of said second covering element extends through said opening and within a portion of said first component when said proximal segment is anchorably disposed within said exactly one of said two sides of said first component.

12. The stent graft system according to claim 1, wherein said proximal segment of said second component is concentrically located within at least a portion of said first component when said proximal segment is anchorably disposed within said exactly one of said two sides of said first component.

13. The stent graft system according to claim 1, wherein said first component widens in a vicinity of said opening.

14. The stent graft system according to claim 1, wherein said first component is configured such that a perimeter of said opening is less than a perimeter of supports of said first component surrounding said opening, such that a portion of said first covering element surrounding said opening extends from said supports towards said opening.

15. The stent graft system according to claim 1, wherein said second component has a generally cylindrical form.

16. A method comprising:

implanting, respectively in first and second iliac arteries that branch from an abdominal aorta of a subject, two sides of a first component of a stent graft system, which first component includes a first support element and a first covering element attached to said first support element, such that an opening defined by said first covering is aligned to face said abdominal aorta; and

thereafter, implanting a second component of said system, which second component includes a second support element and a second covering attached to said second support element, by;

transluminally advancing a catheter tube through one open end of exactly one of said two sides of said first component and out through the opening into the abdominal aorta, while said second component is radially compressed within said catheter tube, and

withdrawing said catheter tube so that (a) at least a distal segment of said second component is freed from said catheter tube and radially expands within said abdominal aorta, and (b) thereafter, at least a proximal segment of said second component is freed from said catheter tube and radially expands within said exactly one of said two sides of said first component, thereby anchoring said at least a proximal segment of said second component to said first component,

wherein said second covering element only partially covers said second support element so as to allow blood flow to both of said two sides of said first component.

17. The method according to claim 16, wherein said second covering element substantially covers said distal segment but does not generally cover said proximal segment.

18. The method according to claim 16, wherein said second covering element substantially covers said distal segment, covers a proximal portion of said proximal segment, and does not cover a distal portion of said proximal segment.

19. The method according to claim 16, wherein said second component includes sections having varying diameters, such that a portion of said second component is disposable within a section of said first component.

20. The method according to claim 16, wherein anchoring said at least a proximal portion of said second component comprises disposing said second component such that a section of said second covering element extends through said opening and within a portion of said first component.

21. The method according to claim 16, wherein anchoring said at least a proximal segment of said second component comprises concentrically locating said at least a proximal segment of said second component within at least a portion of said exactly one of said two sides of said first component.

22. The method according to claim 16,

wherein said catheter tube is a second catheter tube, and

wherein implanting said first component comprises transluminally delivering said first component by:

advancing a first catheter tube into said first and second iliac arteries, while said first component is radially compressed within said first catheter tube, and

thereafter freeing said first component from said first catheter tube such that said first component radially expands in said first and second iliac arteries.

23. The method according to claim 16, wherein said second component is generally cylindrical.

24. The method according to claim 16, wherein withdrawing said catheter tube comprises withdrawing said catheter tube such that said distal segment that radially expands within said abdominal aorta has a diameter that (a) is greater than a diameter of said opening, and (b) increases as said distal segment exits from said opening.