Bifurcated endoluminal prosthesis

• US 7,780,720 B2
• Filed: 10/24/2003
• Issued: 08/24/2010
• Est. Priority Date: 02/09/1994
• Status: Expired due to Fees

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Hudson, John, Goicoechea, George, Cragg, Andrew H., Dake, Michael D., Mialhe, Claude
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US10/692,886
• Publication Number:
  US 20040098086A1
• Time in Patent Office: 2,496 Days
• Field of Search: 623/1.35, 623 111- 115, 623/1.16, 623/1.31, 623/1.44, 606/108, 606/153
• US Class Current: 623/1.16
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• 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 2002/061 provided with means for allowing access to secondary lumens
• 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 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0066 stapled
• 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 2230/0067 conical
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: Y10S 623/903 : Blood vessel
• CPC Class Codes: Y10T 29/49826 : Assembling or joining

Abstract

An introducer for delivering into the vasculature a straight or bifurcated stent or prosthesis; a method for delivering into the vasculature a straight or bifurcated stent or prosthesis; a method of treating and angiological disease using a bifurcated stent; an endoluminal stent having perpendicular hoop members, each hoop member formed of wire in a sinuous configuration, at least some of juxtaposed apices in neighboring hoops being secured to one another, such stents also forming axially aligned segments in straight stents, and segments of bifurcated stents in particular embodiments. Certain embodiments of such stents also include barbs, fabric covering and radiopaque markers.

Claims

1. A graft for treatment of aneurysms or occlusive diseases comprising:

a primary graft body, said primary graft body having a primary graft flow lumen therethrough, said primary graft body comprising a proximal end and a distal end; and

a supplemental graft body, said supplemental graft body having a secondary graft flow lumen therethrough, said supplemental graft body comprising a first end and a second end, said first end of said supplemental graft body being dockable to said distal end of said primary graft body while inside of a vessel to define a single flow lumen which transfers substantially all flow between said primary graft flow lumen and said secondary graft flow lumen;

wherein said primary graft body is carried by a plurality of separated wire hoops each having a sinuous configuration with a plurality of apices, said plurality of separated wire hoops each having a circumference that lies in a plane substantially perpendicular to a common axis and each being axially displaced in a tubular configuration along the common axis;

wherein said plurality of separated wire hoops of said primary graft body includes hoops associated with said proximal end and said distal end that have a unit width between said apices and intermediate hoops between the loops associated with said proximal end and said distal end that have a width between said apices greater than the unit width; and

wherein each of said plurality of separated wire hoops comprises two opposing ends, said ends on adjacent wire loops being joined together on the outside surface of said primary graft body at a number of juxtaposed apices.

2. The graft as defined in claim 1, wherein at least one of the wire hoops is attached to said primary graft body via sutures.

3. The graft as defined in claim 1, wherein at least one of the wire hoops is attached to said primary graft body.

4. The graft as defined in claim 1, wherein said supplemental graft body is carried by a plurality of wire hoops.

5. The graft as defined in claim 4, wherein at least one of the wire hoops is attached to said supplemental graft body via sutures.

6. The graft as defined in claim 4, wherein at least one of the wire hoops is attached to said supplemental graft body.

7. The graft as defined in claim 4, wherein at least one of the wire hoops has a different amplitude than the next adjacent wire hoop.

8. The graft as defined in claim 1, wherein at least one of the wire hoops has a different amplitude than the next adjacent wire hoop.

9. The graft as defined in claim 1, wherein one of the wire hoops is located at one end of the primary graft body and has alternate apices extending beyond said one end of the primary graft body.

10. The graft as defined in claim 1, wherein said primary graft body and said supplemental graft body are formed of a thin biocompatible material.

11. A graft for treatment of aneurysms or occlusive diseases comprising:

a primary graft body, said primary graft body having a primary graft flow lumen therethrough, said primary graft body comprising a proximal end and a distal end; and

a supplemental graft body, said supplemental graft body having a secondary graft flow lumen therethrough, said supplemental graft body comprising a first end and a second end, said first end of said supplemental graft body being dockable to said distal end of said primary graft body while inside of a vessel to define a single flow lumen which transfers substantially all flow between said primary graft flow lumen and said secondary graft flow lumen;

wherein said primary graft body is carried by a plurality of separated wire hoops each having a sinuous configuration with a plurality of apices, said plurality of separated wire hoops each having a circumference that lies in a plane substantially perpendicular to a common axis and each being axially displaced in a tubular configuration along the common axis;

wherein said plurality of separated wire hoops of said primary graft body includes hoops associated with said proximal end and said distal end that have a unit width between said apices and intermediate hoops between the loops associated with said proximal end and said distal end that have a width between said apices greater than the unit width; and

wherein each of said plurality of separated wire hoops comprises two opposing ends, said ends on adjacent wire loops being joined together on the outside surface of said primary graft body at a number of juxtaposed apices.

12. A graft comprising:

a first graft body, said first graft body having a first graft body proximal end and a first graft body distal end to define a flow passage therethrough; and

a second graft body, said second graft body having a second graft body proximal portion and a second graft body distal portion to define a flow passage therethrough;

said second graft body proximal portion being attachable in an overlapping relationship with said first graft body distal end while inside of a vessel to define a continuous flow passage through said first graft body proximal end, said first graft body distal portion, said second graft body proximal portion and said second graft body distal portion;

wherein the first graft body is carried by a wire structure comprising a plurality of separated wire hoops each having a sinuous configuration with a plurality of apices, said plurality of separated wire hoops each having a circumference that lies in a plane substantially perpendicular to a common axis and each being axially displaced in a tubular configuration along the common axis;

wherein at least one of the first graft body and the second graft body is a multi-layered graft body and the wire structure is sandwiched between layers of said multi-layered graft body;

wherein said plurality of separated wire hoops of said first graft body includes hoops associated with said proximal end and said distal end that have a unit width between said apices and intermediate hoops between the loops associated with said proximal end and said distal end that have a width between said apices greater than the unit width; and

wherein each of said plurality of separated wire hoops comprises two opposing ends, said ends on adjacent wire loops being joined together on the outside surface of said primary graft body at a number of juxtaposed apices.

13. The graft of claim 12 wherein the wire structure is formed of a metal.

14. The graft of claim 12 wherein the wire structure is sutured to the respective graft body.

15. The graft of claim 12 wherein at least a portion of one of the first graft body and the second graft body is made of PTFE.

16. The graft of claim 12 wherein the wire structure is disposed at least in part on an outside surface of the respective graft body.

17. The graft of claim 12 wherein the wire structure is disposed substantially on an inside surface of the respective graft body.

18. The graft of claim 12 wherein the wire structure is interwoven with the surface of the respective graft body.

19. The graft of claim 12 wherein the wire structure is X-ray detectable.

20. The graft of claim 12 wherein the second graft body is substantially cylindrical.

21. The graft of claim 12 wherein one of the first graft body and the second graft body comprises a frustoconical portion.

22. The graft of claim 21 wherein said frustoconical portion is about 18 mm in length.

23. A graft comprising:

a first graft body, said first graft body having a first graft body proximal end and a first graft body distal end to define a flow passage therethrough; and

a second graft body, said second graft body having a second graft body proximal portion and a second graft body distal portion to define a flow passage therethrough;

said second graft body proximal portion being attachable in an overlapping relationship with said first graft body distal end while inside of a vessel to define a continuous flow passage through said first graft body proximal end, said first graft body distal end, said second graft body proximal portion and said second graft body distal portion;

wherein the second graft body is frusto-conical in shape;

wherein the first graft body is carried by a wire structure comprising a plurality of separated wire hoops each having a sinuous configuration with a plurality of apices, said plurality of separated wire hoops each having a circumference that lies in a plane substantially perpendicular to a common axis and each being axially displaced in a tubular configuration along the common axis;

wherein said plurality of separated wire hoops of said first graft body includes hoops associated with said proximal end and said distal end that have a unit width between said apices and intermediate hoops between the loops associated with said proximal end and said distal end that have a width between said apices greater than the unit width; and

wherein each of said plurality of separated wire hoops comprises two opposing ends, said ends on adjacent wire loops being joined together on the outside surface of said primary graft body at a number of juxtaposed apices.

24. A graft for treatment of aneurysms or occlusive diseases comprising:

a first graft body, said first graft body having a proximal end and a distal end to define a flow passage therethrough; and

a second graft body, said second graft body having a proximal portion and a distal portion to define a flow passage therethrough;

said proximal portion of said second graft body being attachable in an overlapping relationship with said distal end of said first graft body while inside of a vessel to define a continuous flow passage between said proximal end and said distal portion of said first graft body and said proximal portion and said distal portion of said second graft body;

wherein at least one of the first graft body and the second graft body is carried by a metal wire structure comprising a plurality of separated wire hoops each having a sinuous configuration with a plurality of apices, said plurality of separated wire hoops each having a circumference that lies in a plane substantially perpendicular to a common axis and each being axially displaced in a tubular configuration along the common axis;

wherein said plurality of separated wire hoops of said first graft body includes hoops associated with said proximal end and said distal end that have a unit width between said apices and intermediate hoops between the loops associated with said proximal end and said distal end that have a width between said apices greater than the unit width;

wherein each of said plurality of separated wire hoops comprises two opposing ends, said ends on adjacent wire loops being joined together on the outside surface of said primary graft body at a number of juxtaposed apices; and

said graft comprising a male engaging portion on a selected one of said first graft body and said second graft body, and a female portion on another one of said first graft body and said second graft body, said male engaging portion being configured to be positioned at least partially within said female portion for inter-engagement between the outer surface of said male engaging portion and the inner surface of said female portion to resist longitudinal movement to prevent separation of said first graft body and said second graft body in service, each of said male engaging portion and said female portion comprising a stent and at least one of said first graft body and said second graft body comprising a graft layer attached to said stent, said graft layer being configured to be interposed between said male engaging portion and said female portion to faun a substantially fluid-tight seal upon assembly.

25. The graft of claim 24 wherein the metal wire structure comprises at least one wireform.

26. The graft of claim 24 wherein the metal wire structure comprises a plurality of wireforms.

27. The graft of claim 25 wherein said at least one wireform has a sinuous configuration.

28. The graft for treatment of aneurysms or occlusive diseases as claimed in claim 24, wherein a portion of at least one of said first graft body and said second graft body and said metal wire structure has a radiopaque marker, said radiopaque marker facilitating proper alignment of said first graft body and said second graft body with respect to one another during said engagement.

29. The graft for treatment of aneurysms or occlusive diseases as claimed in claim 24 further comprising:

a radiopaque marker on at least one of said first graft body and said second graft body and said metal wire structure, wherein the profile of said radiopaque marker varies with the rotation of said at least one of said first graft body and said second graft body and said metal wire structure in a body lumen;

wherein the rotation of said at least one of said first graft body and said second graft body and said metal wire structure in the body lumen is indicated by said profile for optional adjustment of the rotation.

30. The graft for treatment of aneurysms or occlusive diseases as claimed in claim 24, further including a system for introducing the graft into a vessel to define a continuous lumen, said system comprising:

a first introducer for introducing said first graft body of said graft for treatment of aneurysms or occlusive diseases into the vessel, said first graft body having a portion adapted for connection to said second graft body; and

a second introducer for (a) introducing said second graft body of said graft for treatment of aneurysms or occlusive diseases in a radially compressed state into the vessel and into said portion of said first graft body, and (b) deploying said second graft body to connect to said portion of said first graft body and to define said continuous lumen through said first graft body and said second graft body.

31. The graft for treatment of aneurysms or occlusive diseases as claimed in claim 24, one of said first graft body and said second graft body being configured for placement at an angiological bifurcation of a vessel into two branched vessels, one of said first graft body and said second graft body being at least partially supported by a bifurcated stent member, defining two lumens, at least one of which is configured to be disposed entirely within said vessel and is adapted to mate with the other of said first graft body and said second graft body configured to extend into one of the two branched vessels.