Percutaneous endoprosthesis using suprarenal fixation and barbed anchors

Abstract

An endoprosthetic device for treating abdominal aortic aneurysms using suprarenal fixation. A stent ring is anchored in an area above the renal arties using self-flaring barbs that project during the nitinol expansion process. Sutures extend from the stent ring to an area below the renal arties to a bifurcated trunk portion comprising a nitinol fabric on a non-kinking frame. The bifurcated trunk is sealed proximal the iliac arteries and includes iliac leg holders having self-flaring retention struts for non-traumatic holding of iliac leg prosthetics. Suprarenal fixation and collapsible cells having retention projections and barbs that only flare during the nitinol expansion process assist in lowering the devices profile and sheathability for percutaneous delivery and may provide for recapturing the anchored device.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is described with reference to the accompanying drawings. In the drawings, like reference numerals indicate identical or functionally similar elements.

FIG. 1 illustrates an embodiment of a percutaneous endoprosthesis device with suprarenal fixation assembled in-situ to treat an abdominal aortic aneurysm according to the invention.

FIG. 2 is an isolation view of an embodiment of a bifurcated trunk portion of an unassembled endoprosthesis device according to the invention.

FIG. 3 is an isolation view of an embodiment of an iliac leg member of an unassembled endoprosthesis device according to the invention.

FIG. 4 illustrates the principle of foreshortening using a collapsed diamond shaped cell.

FIG. 5 illustrates a collapsed and expanded diamond shaped cell having a center strut that is displace out of plane due to foreshortening.

FIG. 6A-B are side views of retention mechanisms for endoleg retention according to the invention.

FIG. 7 includes an unexpanded, expanded front view and expanded side view of an embodiment of a cell having a “Y” shaped center strut.

FIG. 8 includes an unexpanded, expanded front view and expanded side view of the cell of FIG. 7 including a self-flaring barb member according to the invention.

FIG. 9 includes an unexpanded, expanded front view and expanded side view of an alternative embodiment of an anchoring mechanism including a self-flaring barb member according to the invention.

FIG. 10 includes an unexpanded, expanded front view and expanded side view of another alternative embodiment of an anchoring mechanism including a self-flaring barb member according to the invention.

FIG. 11 includes an unexpanded, expanded front view and expanded side view of yet another alternative embodiment of an anchoring mechanism including a self-flaring barb member according to the invention.

Claims

1. A percutaneous endoprosthesis device for treating an abdominal aortic aneurysm comprising: a bifurcated trunk and a pair of endolegs mateable with said trunk to serve as a conduit for blood flow to a patient's iliac arteries;said bifurcated trunk comprising a proximal stent connected to a bifurcated body portion via a matrix of sutures;said proximal stent being collapsible into a low profile configuration for percutaneous delivery and expandable into a deployed configuration wherein said stent frictionally anchors to an interior of a vessel being treated;said bifurcated body portion having an aortic neck on a first end and a bifurcated leg section on a second end, said aortic neck having an outer wall configured to seal with an interior wall of said vessel and said bifurcated leg section having an inner wall defining a pair of endoleg receiving apertures;a pair of endolegs configured for insertion into a respective endoleg aperture of said bifurcated leg section of said bifurcated body portion of said bifurcated trunk;wherein said inner wall defining said endoleg receiving apertures includes at least one interiorly disposed endoleg retention projection, said retention projection being formed by a cell configured to be collapsible to a narrow first shape for percutaneous delivery and expandable to a wider second shape including said retention projection.

2. The device of claim 1, wherein said bifurcated body portion comprises a nitinol fabric on a thin frame.

3. The device of claim 2, wherein said fabric has dimensions of 20 microns or less.

4. The device of claim 3, wherein said frame is a thin nitinol stent that resists kinking.

5. The device of claim 4, wherein said frame self-expands to seal said bifurcated trunk with a wall of the proximal neck of an abdominal aortic aneurysm being treated.

6. The device of claim 5, wherein said device is deployed in the aorta of a patient said sutures are disposed in the area of the renal arteries and provide unobstructed flow to into the arteries.

7. The device of claim 6, wherein said frame includes at least one expandable cell member configured to be collapsible to a narrow first shape for percutaneous delivery and expandable to a wider second shape defining a barb anchor extending outside the diameter of the frame for engaging the inner wall of the aorta.

8. The device of claim 7, wherein said proximal stent includes at least one expandable cell member configured to be collapsible to a narrow first shape for percutaneous delivery and expandable to a wider second shape defining a barb anchor extending outside the diameter of the stent for engaging the inner wall of the aorta.

9. The device of claim 1, wherein said endolegs include at least one window for engaging said at least one retention projection.

10. The device of claim 1, wherein said endolegs respectively comprise a Dacron graft onto which nitinol stent rings are attached, and wherein at least one stent ring being employed for engaging with said at least one retention projection.

11. A percutaneous endoprosthesis device for treating an abdominal aortic aneurysm comprising: a bifurcated trunk and a pair of endolegs mateable with said trunk to serve as a conduit for blood flow to a patient's iliac arteries;said bifurcated trunk comprising a proximal stent connected to a bifurcated body portion via a matrix of sutures;said proximal stent being collapsible into a low profile configuration for percutaneous delivery and expandable into a deployed configuration wherein said stent frictionally anchors to an interior of a vessel being treated, said stent including at least one expandable cell member configured to be collapsible to a narrow first shape for percutaneous delivery and expandable to a wider second shape defining a barb anchor extending outside the diameter of the stent for engaging the interior of said vesselsaid bifurcated body portion having an aortic neck on a first end and a bifurcated leg section on a second end, said aortic neck having an outer wall configured to seal with an interior wall of said vessel and said bifurcated leg section having an inner wall defining a pair of endoleg receiving apertures; anda pair of endolegs configured for insertion into a respective endoleg aperture of said bifurcated leg section of said bifurcated body portion of said bifurcated trunk.

12. The device of claim 11, wherein said aortic neck includes a self-flaring barb.

13. The device of claim 11, wherein said bifurcated trunk comprises a nitinol fabric on a thin frame.

14. A cell for a percutaneous intra-luminal device comprising: a frame of material having a pair of arms and a top area and a bottom area, said frame having a collapsed state and an expanded state, wherein in said collapsed state said arms are generally straight and disposed generally parallel to each and wherein in said expanded state said arms are bent and extend generally laterally away from one another due to diamond foreshortening; anda centrally disposed strut extending between said top area and said bottom area of said frame, wherein when said frame is in said collapsed state said strut runs generally parallel to said arms and when said frame is in said expanded state at least a part of said strut protrudes out of plane from said arms.

15. The cell of claim 14, wherein said strut includes a weak area, said weak area operating to cause said strut to bend at said weak area and defining the apex of a protrusion defined by said strut.

16. The cell of claim 15, wherein said strut includes at least one additional weak area, whereby said strut takes on a “W” shape in said expanded state.

17. The cell of claim 14, further comprising a barb member associated with said strut, wherein said barb extends in a direction opposite to a protrusion defined by said strut.

18. The cell of claim 14, wherein said cell comprises nitinol.

19. The cell of claim 14, wherein said cell is part of an percutaneous radially expandable intra-luminal device and wherein a portion of said strut protrudes into the interior of said device upon expansion.

20. The cell of claim 19, wherein said strut includes an associated barb projection that extends beyond the outer diameter of said device upon expansion.