Intraluminal vascular graft and method

• US 5,871,536 A
• Filed: 12/07/1995
• Issued: 02/16/1999
• Est. Priority Date: 11/08/1993
• Status: Expired due to Fees

• Current Assignee: Harrison M Lazarus
• Original Assignee: Harrison M Lazarus
• Inventors: Lazarus, Harrison M.
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/568,559
• Time in Patent Office: 1,167 Days
• Field of Search: 600/36, 606/157, 606/158, 606/153, 606/198, 606/194, 606/195, 623/1, 623/11, 623/12
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• 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
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0007 for adjusting length
• 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

Abstract

An intraluminal vascular graft structure is disclosed which is structured to be deployable within a vessel without use of hooks or barbs. The intraluminal vascular graft structure comprises a tubular body formed of a biocompatible material and a frame structure, having both circumferential support and longitudinal support structures, which support the graft at a distal end thereof and upwardly from the distal end. The vascular graft may also include attachment means which initiate an inflammatory response with the inner wall of the vessel to promote attachment of the device to the vessel wall. The intraluminal vascular graft may include one or more leg portions suitable for repairing bifurcated vessels which, in conjunction with the circumferential and longitudinal support structures, assure positioning and support of the vascular graft within the vessel and against the crotch of the bifurcation. Also disclosed is a method of deployment of the vascular graft within the vessel.

Claims

1. An intraluminal vascular graft structure for maintaining and repairing diseased or damaged vessels in animals comprising:

a flexible tubular body formed from a biocompatible material, said tubular body having an open proximal end for orientation upstream in a vessel, an open distal end for orientation downstream in said vessel and a longitudinal axis oriented between said open ends, said tubular body being inwardly compressible along the entirety of its length in a direction transverse said longitudinal axis and in a longitudinally non-lengthening manner to provide compression of said tubular body to a first reduced cross section and subsequent radially-outward expansion of said tubular body to a second expanded cross section;

frame structure positioned to contact said tubular body with a portion of said frame structure oriented substantially in alignment with said longitudinal axis and with a portion positioned to extend around the circumferential dimension of said tubular body, said frame structure being formed and shaped to support said flexible tubular body circumferentially at said distal end and to rigidly support said flexible tubular body longitudinally from said distal end to said proximal end.

2. The intraluminal vascular graft structure of claim 1 wherein said frame structure comprises at least one circumferential support structure substantially oriented about the circumference of said distal end and longitudinal support structures oriented substantially in alignment with said longitudinal axis, said longitudinal support structures being interconnected with said circumferential support structure at said distal end.

3. The intraluminal vascular graft structure of claim 2 wherein said flexible tubular body further includes two leg portions extending from said distal end, said leg portions forming a crotch area therebetween to provide support of said frame structure at said crotch area.

4. Intraluminal vascular graft structure comprising:

a tubular body constructed of a biocompatible material and having a proximal end and a distal end sized and formed to be positioned on the cusp of a bifurcated vessel and to be supported on said cusp, said tubular body being structured to be inwardly compressible in a direction transverse a longitudinal axis and in a longitudinally non-lengthening manner for deployment and subsequent radially-outward expansion;

at least one leg portion attached to said tubular body and extending from said distal end;

frame structure attached to said tubular body and configured to support said tubular body in a circumferentially expanded mode at said distal end of said tubular body and to rigidly support said tubular body longitudinally from said distal end to said proximal end; and

non-perforating attachment structure positioned proximate said tubular body in proximity to said proximal end to provide attachment of said tubular body to the inner wall of a vessel.

5. The intraluminal vascular graft of claim 4 wherein said frame structure further comprises circumferential support structures which are compressible to provide a reduced cross sectional dimension and which are expandable again to provide a selected maximum cross sectional dimension, said circumferential support structures being positioned at said proximal end and said distal end of said tubular body.

6. The intraluminal vascular graft of claim 5 wherein said frame structure further includes a plurality of longitudinal support structures interconnected with said circumferential support structures and extending along a length of said tubular body between said proximal end and said distal end to provide rigid longitudinal support to said tubular body.

7. The intraluminal vascular graft of claim 6 further including movement inhibiting structures positioned in logitudinal alignment along said frame for engaging said inner wall of said vessel.

8. The intraluminal vascular graft of claim 6, wherein said plurality of longitudinal support structures includes at least two longitudinal support structures which extend beyond said proximal end of said tubular body.

9. The intraluminal vascular graft of claim 4 wherein said tubular body further includes an opening formed in said distal end of said tubular body proximate said leg portion.

10. The intraluminal vascular graft of claim 4, wherein said at least one said leg portion has associated therewith a support structure.

11. The intraluminal vascular graft of claim 4 wherein said frame structure is at least partially constructed from material which induces an inflammatory response in vascular tissue to promote attachment of said vascular tissue to said frame structure.

12. The intraluminal vascular graft of claim 4 wherein said frame structure is treated with a substance which facilitates ingrowth of tissue into said frame for incorporation of said frame into said vessel.

13. The intraluminal vascular graft of claim 4 wherein said tubular body is treated with a substance which facilitates ingrowth of tissue into said frame for incorporation of said frame into said vessel.

14. The intraluminal vascular graft of claim 4 further including transportation structure sized to receive and retain said tubular body, frame and attachment means therein for transport to a vessel for deployment.

15. The intraluminal vascular graft of claim 14 wherein said transportation structure includes a capsule sized to receive said tubular body and deployment structure for maintaining said tubular in position within said vessel while said capsule is removed from said vessel.

16. The intraluminal vascular graft of claim 15 further including guide wire structure to facilitate placement of said tubular body.

17. An intraluminal vascular graft structure for maintaining and repairing diseased or damaged vessels in animals comprising:

a flexible tubular body formed from a biocompatible material, said tubular body having an open proximal end, an open distal end, a selected length between said open ends and a longitudinal axis between said open ends, said tubular body being inwardly compressible in a non-longitudinally lengthening manner along the entirety of its length in a direction transverse said longitudinal axis from an expanded cross sectional dimension to a radially inwardly reduced cross sectional dimension;

frame structure positioned adjacent said flexible tubular body, said frame structure including a circumferential support structure attached to said flexible tubular body at said distal end thereof sized and configured to be supported on the cusp of a bifurcated vessel and longitudinal support structures in substantial alignment with said longitudinal axis of said flexible tubular body, said longitudinal support structures being positioned relative to said circumferential support structure to extend coextensively with said length of said flexible tubular body to support said flexible tubular body from said distal end to said proximal end;

non-perforating attachment structure positioned proximate said tubular body at said proximal end thereof to attach said flexible tubular body to the tissue of the inner wall of the vessel in which said flexible tubular body is positioned.

18. The intraluminal vascular graft structure of claim 17 wherein said circumferential support structure is constructed to be compressible to a reduced circumferential dimension and expandable to a selected maximum circumferential dimension.

19. The intraluminal vascular graft structure of claim 18 wherein said frame structure is positioned within said tubular body.

20. The intraluminal vascular graft structure of claim 18 wherein said frame structure is positioned outside said tubular body.

21. The intraluminal vascular graft structure of claim 20 wherein said non-perforating attachment structures are portions of material positioned on said longitudinal support structures, said portions of material producing an inflammatory response on the interior wall of a vessel to provide a non-puncturing attachment of said vascular graft structure to said wall of a vessel.

22. The intraluminal vascular graft structure of claim 21 further including movement inhibiting structures formed proximate said longitudinal support structures and oriented toward said vessel wall for engaging said vessel wall.

23. The intraluminal vascular graft structure of claim 21 wherein said tubular body further includes a first leg portion extending from said distal end thereof.

24. An intraluminal vascular graft structure for maintaining and repairing diseased or damaged vessels in animals comprising:

a flexible tubular body formed from a biocompatible material, said tubular body having an open proximal end for orientation upstream in a vessel, an open distal end for orientation downstream in said vessel and sized and shaped for positioning at the cusp of a bifurcation of a vessel and a longitudinal axis oriented between said open ends, said tubular body being inwardly compressible in a direction transverse said longitudinal axis for providing expansion from a first reduced cross section about said longitudinal axis to a second radially expanded cross section from said longitudinal axis;

frame structure positioned to contact said tubular body with a portion oriented substantially in alignment with said longitudinal axis and with a portion positioned to extend around the circumferential dimension of said tubular body, said frame structure being formed and shaped to support said flexible tubular body circumferentially at said distal end and to rigidly support said flexible tubular body longitudinally from said distal end to said proximal end.

25. An intraluminal vascular graft structure for maintaining and repairing diseased or damaged vessels in animals comprising:

a flexible tubular body formed from a biocompatible material, said tubular body having an open proximal end for orientation upstream in a vessel, an open distal end for orientation downstream in said vessel and a longitudinal axis oriented between said open ends, said tubular body being inwardly compressible in a direction transverse said longitudinal axis for providing expansion from a reduced cross section to a radially expanded cross section;

frame structure positioned in contact with said tubular body and having a portion oriented substantially in alignment with said longitudinal axis and also having a portion positioned to extend around the circumference of said tubular body, said frame structure being formed and shaped to support said flexible tubular body circumferentially at said distal end and to rigidly support said flexible tubular body longitudinally from said distal end to said proximal end; and

attachment structures positioned in proximity to said frame structure to promote attachment to the tissue of a vessel wall, said attachment structures being formed of a material configured to create an inflammatory response with said vessel wall by frictional and non-perforating contact with said vessel wall to facilitate integration of said attachment structures into said vessel wall.

26. The intraluminal vascular graft structure of claim 25 wherein said attachment structures are formed of a non-perforating material.

27. The intraluminal vascular graft structure of claim 26 wherein said attachment structures comprise a flat band of material that has a first end and a second end, wherein said band is movable between a first expanded position wherein said first end overlaps said second end to provide a first circumference selected to urge said vascular graft outward against the vessel wall and a second position wherein said first end is moved about said flat band to have a second circumference less than the circumference of said vessel.

28. The intraluminal vascular graft structure of claim 27 wherein said first end is formed and shaped to snuggly contact said flat band and to slide over the wall of said vessel.

29. An intraluminal vascular graft structure for maintaining and repairing diseased or damaged vessels in animals comprising:

a flexible tubular body formed from a biocompatible material, said flexible tubular body having an open proximal end, a cylindrical portion extending therefrom and a Y-shaped portion extending from said cylindrical portion, said Y-shaped portion having a first leg and a second leg defining a crotch configured for support by the cusp of a bifurcation in a vessel;

frame structure comprising a circumferential support structure attached to said cylindrical portion proximate said crotch, said circumferential support being sized and shaped to extend substantially about the circumference of said cylindrical support and to be supported by the vessel at said cusp, and longitudinal support structures attached to said circumferential support structure in substantial alignment with the longitudinal axis of said flexible tubular body and being coextensive with said flexible tubular body to support said flexible tubular body from said circumferential support structure outwardly.

30. Intraluminal vascular graft structure comprising:

a tubular body constructed of a biocompatible material and having a proximal end and a distal end sized and formed to be positioned on the cusp of a bifurcated vessel and to be supported on said cusp;

two leg portions attached to said tubular body and extending from said distal end;

frame structure attached to said tubular body and configured to support said tubular body in a circumferentially expanded mode at said distal end of said tubular body and to rigidly support said tubular body longitudinally from said distal end to said proximal end; and

non-perforating attachment structure positioned proximate said tubular body in proximity to said proximal end to provide attachment of said tubular body to the inner wall of a vessel.

31. The intraluminal vascular graft of claim 30 wherein one of said two leg portions is open to allow fluid flow therethrough and one of said two leg portions is closed to prevent fluid flow therethrough.

32. The intraluminal vascular graft of claim 30 wherein one of said leg portions is shorter in length dimension than the other.

33. An intraluminal vascular graft structure for maintaining and repairing diseased or damaged vessels in animals comprising:

a flexible tubular body formed from a biocompatible material, said tubular body having an open proximal end, an open distal end, a selected length between said open ends and a longitudinal axis between said open ends and having a first leg portion and a second leg portion, said tubular body being inwardly compressible along the entirety of its length in a plane transverse said longitudinal axis from an expanded cross sectional dimension to a radially inwardly reduced cross sectional dimension;

frame structure positioned adjacent to and on the outside of said flexible tubular body, said frame structure including a circumferential support structure attached to said flexible tubular body at said distal end thereof sized and configured to be supported on the cusp of a bifurcated vessel and said circumferential support being constructed to be compressible to a reduced circumferential dimension and expandable to a selected maximum circumferential dimension longitudinal support structures in substantial alignment with said longitudinal axis of said flexible tubular body, said longitudinal support structures being positioned relative to said circumferential support structure to extend coextensively with said length of said flexible tubular body to support said flexible tubular body from said distal end to said proximal end;

non-perforating attachment structure formed as portions of material positioned on said longitudinal support structures, said portions of material producing an inflammatory response on the interior wall of a vessel to provide a non-puncturing attachment of said vascular graft structure to said wall of a vessel.