Vascular prostheses for treating aneurysms

• US 8,870,938 B2
• Filed: 06/23/2010
• Issued: 10/28/2014
• Est. Priority Date: 06/23/2009
• Status: Active Grant

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon, Benary, Rafi
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): David, Shaun L
• Application Number:
  US13/380,278
• Publication Number:
  US 20120150274A1
• Time in Patent Office: 1,588 Days
• Field of Search: 623 111- 115, 623/1.37, 623/1.35
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 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 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• 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 2002/8483 Barbs
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0062 : Kits of prosthetic parts to be assembled in various combinations for forming different prostheses

Abstract

An endovascular sealing stent-graft is configured to initially be positioned in a delivery catheter in a radially-compressed state, and to assume a radially-expanded state upon being deployed from the delivery catheter. The stent-graft includes a structural member, which includes a plurality of structural stent elements, and which, when the stent-graft assumes the radially-expanded state, has a generally tubular shape, and is shaped so as to define at least two elongated indentations, each of which extends rostrally to a rostral end of the structural member, and is tapered in a caudal direction until the indentation converges with the generally tubular shape of the structural member, and each of which has an axial length of at least 2 cm. The stent-graft further includes a fluid flow guide, which is coupled to at least a portion of the structural member, and covers at least a portion of each of the elongated indentations.

Claims

1. Apparatus for use with a delivery catheter, the apparatus comprising an endovascular sealing stent-graft, which is configured to initially be positioned in the delivery catheter in a radially-compressed state, and to assume a radially-expanded state upon being deployed from the delivery catheter, and which comprises:

a structural member, which comprises a plurality of structural stent elements, and which, when the stent-graft assumes the radially-expanded state, has a generally tubular shape, and is shaped so as to define at least two elongated indentations, each of which (a) extends rostrally to a rostral end of the structural member, (b) is tapered in a caudal direction until the indentation converges with the generally tubular shape of the structural member, (c) has an axial length of at least 2 cm, and (d) defines a concave surface that is open to an exterior of the stent-graft along the entire axial length of the indention; and

a fluid flow guide, which comprises at least one biologically-compatible substantially fluid-impervious flexible sheet, and which is coupled to at least a portion of the structural member, and covers at least a portion of each of the elongated indentations.

2. The apparatus according to claim 1, further comprising the delivery catheter.

3. The apparatus according to claim 1, wherein a rostral end of the fluid flow guide is disposed within 4 cm of the rostral end of the structural member.

4. The apparatus according to claim 1, wherein a caudal end of the fluid flow guide is disposed within 2 cm of a caudal end of the structural member.

5. The apparatus according to claim 1, wherein the stent-graft further comprises a plurality of anchoring elements, which are generally radially oriented when the stent-graft assumes the radially-expanded state.

6. The apparatus according to claim 1, wherein a rostral end of each of the elongated indentations spans an arc of between 10 and 40 degrees, when the stent-graft assumes the radially-expanded state.

7. The apparatus according to claim 1, wherein, when the stent-graft assumes the radially-expanded state, centers of two of the elongated indentations are offset by an angle of between 70 and 220 degrees, as measured with respect to a central longitudinal axis of the structural member.

8. The apparatus according to claim 7, wherein the angle is between 150 and 170 degrees.

9. The apparatus according to claim 1, wherein a diameter of the structural member is between 2.5 and 3 cm, when the stent-graft assumes the radially-expanded state.

10. The apparatus according to claim 1, wherein an axial length of the structural member is between 4 and 7 cm, when the stent-graft assumes the radially-expanded state.

11. The apparatus according to claim 1, wherein the axial length of each of the elongated indentations is no more than 4 cm, when the stent-graft assumes the radially-expanded state.

12. The apparatus according to claim 1, wherein a rostral end of each of the elongated indentations is indented between 0.5 and 1 cm from the generally tubular shape of the structural member, when the stent-graft assumes the radially-expanded state.

13. The apparatus according to claim 1, wherein the structural member comprises a self-expanding material.

14. The apparatus according to claim 1, wherein the structural member comprises a super-elastic alloy.

15. The apparatus according to claim 14, wherein the super-elastic alloy comprises Nitinol.

16. A method comprising:

providing an endovascular sealing stent-graft, which is configured to assume a radially-compressed state and a radially-expanded state, and which includes (a) a structural member, which includes a plurality of structural stent elements, and which, when the stent-graft assumes the radially-expanded state, has a generally tubular shape, and is shaped so as to define at least two elongated indentations, each of which (i) extends rostrally to a rostral end of the structural member, (ii) is tapered in a caudal direction until the indentation converges with the generally tubular shape of the structural member, (iii) has an axial length of at least 2 cm, and (iv) defines a concave surface that is open to an exterior of the stent-graft along the entire axial length of the indention, and (b) a fluid flow guide, which includes at least one biologically-compatible substantially fluid-impervious flexible sheet, and which is coupled to at least a portion of the structural member, and covers at least a portion of the elongated indentations;

transvascularly introducing the stent-graft into an aorta of a human subject, in a vicinity of renal arteries of the subject, while the stent-graft is positioned in a delivery catheter in the radially-compressed state; and

transitioning the stent-graft to the radially-expanded state by deploying the stent-graft from the delivery catheter in the aorta, such that two of the elongated indentations are radially aligned with the renal arteries, with rostral ends of the elongated indentations rostral to the renal arteries, respectively, and caudal ends of the elongated indentations caudal to the renal arteries, respectively.

17. The method according to claim 16, further comprising identifying the subject as suffering from an aortic aneurysm, wherein introducing comprises transvascularly introducing the stent-graft responsively to the step of identifying.

18. The method according to claim 16, wherein the stent-graft is one of a plurality of stent-grafts having different, respective angles of offset between two of the elongated indentations, and wherein providing the stent-graft comprises:

assessing an angle between the renal arteries; and

selecting one of the stent-grafts having an angle of offset closest to the assessed angle between the renal arteries.