Bifurcated endoluminal prothesis

• US 20070265697A1
• Filed: 07/18/2007
• Published: 11/15/2007
• Est. Priority Date: 02/09/1994
• Status: Active Grant

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: Andrew Cragg, Claude Mialhe, George Goicoechea, John Hudson, Michael Dake
• Inventors: Dake, Michael, Hudson, John, Goicoechea, George, Mialhe, Claude, Cragg, Andrew
• Granted Patent: US 7,901,449 B2
• Time in Patent Office: Days
• US Class Current: 623/1.150
• 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

The invention comprises: 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 angeological 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. An endoluminal prosthesis system comprising:

an expandable tubular Y-connector module having a common lumen, a first branch lumen, and a second branch lumen, the first and second branch lumens being in communication with the common lumen; and

a plurality of radially expandable prosthetic modules, each module having a tubular body portion and an end which fittingly engages at least one of the common lumen, the first branch lumen, and the second branch lumen;

wherein the plurality of body portions provide different selectable assembled endoluminal prosthetic characteristics.

2. A prosthesis system as claimed in claim 1, wherein at least two of the plurality of body portions differ in cross-section.

3. A prosthesis system as claimed in claim 1, wherein engagement of the end of each prosthetic module with the Y-connector module affixes the prosthetic module and the Y-connector module with an axial overlap.

9. The endoluminal prosthesis system as claimed in claim 1, wherein a portion of at least one of said modules has a different radiopacity, said portion of different radiopacity facilitating proper alignment of said modules with respect to one another during said engagement.

10. The endoluminal prosthesis system as claimed in claim 1 further comprising:

radiographic indicia defined on at least one of said modules and having different radiopacity from said module, wherein the composite radiographic image of said radiographic indicia varies with the rotational orientation of said module in a body lumen;

wherein the rotational orientation of said module in the body lumen is indicated by said radiographic image for optional adjustment of the rotational orientation.

11. A system for introducing the endoluminal prosthesis system of claim 1 into a vessel to define a continuous lumen, said system comprising:

a first introducer for introducing a first module of said endoluminal prosthesis system into the vessel, said first module having a portion adapted for connection to another module; and

a second introducer for (a) introducing a second module of said endoluminal prosthesis system in a radially compressed state into the vessel and into said portion of said first module, and (b) deploying said second module to connect to said portion of said first module and to define said continuous lumen through said first module and said second module.

12. The endoluminal prosthesis system as claimed in claim 1, said endoluminal prosthesis system being configured for placement at an angeological bifurcation of a vessel into two branched vessels, said expandable tubular Y-connector module 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 one of said radially expandable prosthetic modules configured to extend into one of the two branched vessels.

13. The endoluminal prosthesis system as claimed in claim 1, said endoluminal prosthesis system comprising a male engaging portion on a selected one of said modules, and a female portion on another one of said modules, 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 modules in service, each of said male engaging portion and said female portion comprising a stent and at least one of said modules 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 form a substantially fluid-tight seal upon assembly.

4. A position-indicating stent-graft comprising:

a radially expandable tubular frame;

a flexible liner supported by the frame;

an attachment mechanism which holds the liner on the frame; and

markers disposed on at least one of the frame, the liner, and the attachment mechanism, the markers visible under imaging to indicate at least one of axial and rotational position of the stent-graft.

5. A position-indicating stent-graft as claimed in claim 4, wherein the markers indicate position under imaging while in a compressed mode and while in an expanded mode.

6. A position-indicating stent-graft as claimed in claim 4, wherein the markers comprise a rotational indicator.

7. A modular endoluminal prosthesis placement method comprising:

inserting a Y-connector prosthetic module within a body lumen system;

positioning a main body of the Y-connector prosthetic module at a target location of a body lumen, the target location adjacent to first and second branch lumens of the body lumen system;

radially expanding the first prosthetic module at the target location;

selecting a preferred first branch prosthetic module from a plurality of alternative branch prosthetic modules having differing prosthetic characteristics; and

positioning an end of the preferred first branch prosthetic module within the first branch of the body lumen system and radially expanding the preferred first branch prosthetic module, the expanded preferred first branch prosthetic module engaging the Y-connector prosthetic module.

8. A method for assembling endoluminal prosthetic modules within a body lumen, the method comprising:

deploying a first tubular prosthetic module within the body lumen;

inserting a second tubular prosthetic module into the body lumen in a radially compressed configuration;

aligning an image of markings disposed on at least one of the first prosthetic module and the second prosthetic module with an image of the other of the first prosthetic module and the second prosthetic module; and

expanding an end of the aligned second prosthetic module to engage an end of the first prosthetic module.

14. A prosthesis comprising:

(i) a bifurcated base structure which defines a common flow lumen and a pair of connector legs which define divergent flow lumens from the common flow lumen; and

(ii) a graft which is adapted to be anchored within one of the flow lumens of said bifurcated base structure to form a continuous extension of that lumen.

15. The prosthesis as defined in claim 14, wherein said bifurcated base structure and said graft are formed of a thin biocompatible material.

16. A prosthesis comprising:

a bifurcated base graft structure which defines a common flow lumen and a pair of connector legs which define divergent flow lumens from the common flow lumen; and

a second graft structure which is adapted to overlap and be attached to one of the flow lumens of said bifurcated base graft structure to form a continuous extension of that lumen;

wherein at least one of the bifurcated base graft structure and the second graft structure comprises a first end and a second end, and wherein at least one of the first and the second ends is reinforced with a wire structure which has a plurality of apices extending beyond at least a portion of the corresponding end.

17. The prosthesis of claim 16 wherein the first and the second ends are each reinforced with a wire structure which has a plurality of apices extending beyond the first and the second ends.

18. A prosthesis comprising:

a bifurcated base graft structure which defines a common flow lumen and a pair of connector legs which define divergent flow lumens from the common flow lumen; and

a second graft structure which is adapted to overlap and be attached to one of the flow lumens of said bifurcated base graft structure to form a continuous extension of that lumen;

wherein the second graft structure is adapted to overlap and be attached to one of the divergent flow lumens.

19. The prosthesis of claim 18 wherein one of the bifurcated base graft structure and the second graft structure is reinforced by a metal wire structure.

20. The prosthesis of claim 19 wherein at least a portion of said metal wire structure is X-ray detectable.

21. The prosthesis of claim 19 wherein the metal wire structure comprises a plurality of wireforms.

22. The prosthesis of claim 21 wherein each wireform of the plurality of wireforms has a closed sinusoidal shape.

23. The prosthesis of claim 18 wherein each of the bifurcated base graft structure and the second graft structure comprises an inlet end and at least one outlet end;

wherein the prosthesis is adapted to be placed in a lumen of a first vessel that intersects with a second vessel such that at least one of the inlet end of the bifurcated base graft structure and the outlet end of the second graft structure is placed adjacent said intersection between the first vessel and the second vessel; and

wherein the at least one of the inlet end of the bifurcated based graft structure and the outlet end of the second graft structure is provided with a wire structure which has a plurality of apices extending beyond at least a portion of the corresponding inlet end of the bifurcated base graft structure and outlet end of the second graft structure.

24. A prosthesis comprising:

a bifurcated base graft structure which defines a common flow lumen and a pair of connector legs which define divergent flow lumens from the common flow lumen; and

a second graft structure which is adapted to overlap and be attached to one of the flow lumens of said bifurcated base structure to form a continuous extension of that lumen;

wherein at least one of the bifurcated base graft structure and the second graft structure comprises a first end and a second end, and wherein at least one of the first and second ends is provided with a wire structure which has a plurality of apices extending beyond at least a portion of the corresponding end.

25. A position-indicating stent-graft comprising:

a radially expandable tubular frame;

a flexible liner supported by the frame;

an attachment mechanism which holds the liner on the frame; and

at least one marker disposed on the frame, the at least one marker visible under imaging to indicate at least one of axial and rotational position of the stent-graft.

26. An intraluminal graft comprising a tubular graft body which is circumferentially reinforced along its length by a plurality of separate, spaced-apart, maleable wires, each of which has a generally closed sinusoidal or zig-zag shape, one of the wires being located adjacent to one end of the graft body such that alternate crests or apices of the wire projects beyond at least part of that end.

27. An intraluminal graft as claimed in claim 26 in which each end of the graft body is provided with a wire which has alternate crests or apices extending beyond the adjacent end of the graft body.

28. An intraluminal graft as claimed in claim 26 in which the wavelength of the wires is substantially constant along a length of the graft body.

29. An intraluminal graft as claimed in claim 26 in which wires are interwoven with the graft body.

30. An intraluminal graft as claimed in claim 26 in which the alternate crests or apices extend completely beyond the end of the graft body.

31. A method for positioning an intraluminal graft, comprising introducing a catheter into a vein, artery or other vessel in the body, causing an intraluminal graft as claimed in any one of claims 26 to 30 to be carried through the catheter until the graft extends into the vessel from the proximal end of the catheter, inflating the balloon to cause the alternate crests or apices of the one wire to be urged into contact with the wall of the vessel, deflating the balloon and withdrawing the balloon and the catheter from the vessel.