Vascular prosthesis for treating aneurysms

• US 9,918,825 B2
• Filed: 10/20/2014
• Issued: 03/20/2018
• Est. Priority Date: 06/23/2009
• Status: Active Grant

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon, Benary, Raphael
• Primary Examiner(s): David, Shaun L
• Application Number:
  US14/518,542
• Publication Number:
  US 20150039074A1
• Time in Patent Office: 1,247 Days
• 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 stent-graft is provided that includes a structural member, which includes structural stent elements, at least a portion of which define a stent body when the stent-graft assumes a radially-expanded state; and a fluid flow guide. When the stent-graft assumes the radially-expanded state, (a) a first subset of the structural stent elements are configured to cause the stent body and the fluid flow guide to define a bulge that extends radially outward and has a greatest cross-sectional area that is equal to at least 120% of a cross-sectional area of a narrowest portion of the stent-graft rostral to the bulge, and (b) a second subset of the structural stent elements are not configured to cause the fluid flow guide to define the bulge. The structural stent elements of the first subset at least partially overlap the structural stent elements of the second subset lengthwise along the stent body.

Claims

1. Apparatus for use with a delivery catheter, the apparatus comprising an endovascular 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, at least a portion of which define a stent body when the stent-graft assumes the radially-expanded state; and

a fluid flow guide, which comprises at least one biologically-compatible substantially fluid-impervious flexible sheet, and which is coupled to the stent body,

wherein, when the stent-graft assumes the radially-expanded state;

a first subset of the structural stent elements of the stent body are configured to cause the stent body and the fluid flow guide to define a bulge that extends radially outward, which has a greatest cross-sectional area that is equal to at least 120% of a cross-sectional area of a narrowest portion of the stent-graft rostral to the bulge,

the fluid flow guide is shaped so as to define radially-diverging and radially-converging portions, which together define the bulge, wherein the radially-diverging portion is rostral to the radially-converging portion,

a second subset of the structural stent elements of the stent body are not configured to cause the fluid flow guide to define the bulge, and

the structural stent elements of the first subset overlap the structural stent elements of the second subset lengthwise along the entire radially-diverging portion.

2. The apparatus according to claim 1, wherein, when the stent-graft assumes the radially-expanded state, the fluid flow guide, including a bulging portion thereof that defines the bulge, defines a fluid flow path through the stent body.

3. The apparatus according to claim 1, wherein the structural stent elements comprise a metal, and wherein the structural stent elements of the first subset contact at least a portion of the structural stent elements of the second subset, when the stent-graft assumes the radially-compressed state.

4. The apparatus according to claim 1, wherein a spring coefficient of the first subset, measured during application of a radial force by a rigid circular disk at a region centered at a first point of the first subset that is furthest from a central longitudinal axis of the stent-graft, is at least 20% less than a spring coefficient of the second subset, measured during application of a radial force by the disk at a region centered at a second point of the second subset that is axially aligned with the first point, wherein the circular disk has a radius equal to 50% of a radius of the stent body at the first point.

5. The apparatus according to claim 1, wherein the structural stent elements of the second subset are shaped so as to define a substantially tubular structure, when the stent-graft assumes the radially-expanded state.

6. The apparatus according to claim 5, wherein the substantially tubular structure is a constant diameter cylinder, when the stent-graft assumes the radially-expanded state.

7. The apparatus according to claim 5, wherein the substantially tubular structure is a flared cylinder, when the stent-graft assumes the radially-expanded state.

8. The apparatus according to claim 1, wherein, when the stent-graft assumes the radially-expanded state, the structural stent elements of the first subset are shaped so as to define a plurality of arms that extend radially outward, and are configured to cause the fluid flow guide to define the bulge.

9. The apparatus according to claim 8, wherein the arms extend radially outward in a caudal direction, when the stent-graft assumes the radially-expanded state.

10. The apparatus according to claim 1, wherein the first and second subsets are mutually exclusive.

11. The apparatus according to claim 1, wherein the first and second subsets share at least one of the structural stent elements.

12. The apparatus according to claim 1, wherein the structural stent elements of the first subset are interconnected.

13. The apparatus according to claim 1, wherein the structural stent elements of the second subset are interconnected.

14. The apparatus according to claim 1, wherein a third subset of the structural stent elements of the stent body connect the structural stent elements of the first subset with the structural stent elements of the second subset.

15. The apparatus according to claim 14, wherein the structural stent elements of the third subset are substantially radially oriented, when the stent-graft assumes the radially-expanded state.

16. The apparatus according to claim 1, wherein the structural stent elements of the first subset are concentric with the structural stent elements of the second subset, when the stent-graft assumes the radially-expanded state.

17. The apparatus according to claim 1, wherein the structural stent elements of the first subset radially converge with the structural elements of the second subset at respective rostral ends of the first and second subsets.

18. The apparatus according to claim 1, wherein the structural stent elements of the first subset radially converge with the structural elements of the second subset at respective caudal ends of the first and second subsets.

19. The apparatus according to claim 1, wherein, when the stent-graft assumes the radially-expanded state, the structural stent elements of the first subset are grouped into a plurality of axially-disposed arrays of the structural stent elements, each of the arrays generally circumscribing at least a 360-degree arc, each of the arrays being substantially morphologically deformable independently of the axially adjacent arrays.

20. The apparatus according to claim 19, wherein at least a portion of the arrays are structurally connected to the axially adjacent arrays.

21. The apparatus according to claim 19, wherein at least a portion of the arrays are not structurally connected to the axially adjacent arrays.

22. The apparatus according to claim 1, wherein the bulge is adapted to apply an axial force vector in a rostral direction.

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

24. The apparatus according to claim 1, wherein a site on the bulge that has the greatest cross-section area is within 5 cm of a rostral end of the fluid flow guide, when the stent-graft assumes the radially-expanded state.

25. The apparatus according to claim 1,

wherein the at least a portion of the structural stent elements is a first portion of the structural stent elements, and wherein a rostral-most second portion of the structural stent elements define a plurality of anchoring elements that extend radially outwardly when the stent-graft assumes the radially-expanded state, and

wherein the structural member is configured such that the bulge applies a radially-outward force that is less than a radially-outward force applied by the anchoring elements, when the stent-graft assumes the radially-expanded state.

26. The apparatus according to claim 1, wherein, when the stent-graft assumes the radially-expanded state, the structural stent elements of the first subset overlap the structural stent elements of the second subset lengthwise along the entire radially-diverging portion and along the entire radially-converging portion.

27. Apparatus for use with a delivery catheter, the apparatus comprising an endovascular 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, at least a portion of which define a stent body when the stent-graft assumes the radially-expanded state; and

a fluid flow guide, which comprises at least one biologically-compatible substantially fluid-impervious flexible sheet, and which is coupled to the stent body,

wherein, when the stent-graft assumes the radially-expanded state;

a first subset of the structural stent elements of the stent body are configured to cause the stent body and the fluid flow guide to define a bulge that extends radially outward, which has a greatest cross-sectional area that is equal to at least 120% of a cross-sectional area of a narrowest portion of the stent-graft rostral to the bulge, and

a second subset of the structural stent elements of the stent body (a) are not configured to cause the fluid flow guide to define the bulge, and (b) are shaped so as to define a substantially tubular structure that overlaps the structural stent elements of the first subset lengthwise along the stent body.

28. The apparatus according to claim 27, wherein, when the stent-graft assumes the radially-expanded state, the fluid flow guide is shaped so as to define radially-diverging and radially-converging portions, which together define the bulge, wherein the radially-diverging portion is rostral to the radially-converging portion.

29. The apparatus according to claim 28, wherein, when the stent-graft assumes the radially-expanded state, the substantially tubular structure overlaps the structural stent elements of the first subset overlap the structural stent elements of the second subset lengthwise along the entire radially-diverging portion.

30. The apparatus according to claim 27, wherein, when the stent-graft assumes the radially-expanded state, the structural stent elements of the first subset are shaped so as to define a plurality of arms that extend radially outward, and are configured to cause the fluid flow guide to define the bulge.

31. A method comprising:

providing an endovascular 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, at least a portion of which define a stent body when the stent-graft assumes the radially-expanded state, and (b) a fluid flow guide, which includes at least one biologically-compatible substantially fluid-impervious flexible sheet, and which is coupled to the stent body, wherein, when the stent-graft assumes the radially-expanded state, (a) a first subset of the structural stent elements of the stent body are configured to cause the stent body and the fluid flow guide to define a bulge that extends radially outward, which has a greatest cross-sectional area that is equal to at least 120% of a cross-sectional area of a narrowest portion of the stent-graft rostral to the bulge, (b) the fluid flow guide is shaped so as to define radially-diverging and radially-converging portions, which together define the bulge, wherein the radially-diverging portion is rostral to the radially-converging portion, (c) a second subset of the structural stent elements of the stent body are not configured to cause the fluid flow guide to define the bulge, and (d) the structural stent elements of the first subset overlap the structural stent elements of the second subset lengthwise along the entire radially-diverging portion;

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

deploying the stent-graft from the delivery catheter at least partially in the aorta such that the bulge extends radially outward against and sealingly contacts a rostral portion of an abdominal aortic aneurysm in the aorta when the stent-graft assumes the radially-expanded state.

32. The method according to claim 31, wherein when the stent-graft assumes the radially-expanded state, the fluid flow guide, including a bulging portion thereof that defines the bulge, defines a fluid flow path through the stent body.

33. The method according to claim 31, wherein, when the stent-graft assumes the radially-expanded state, the structural stent elements of the first subset overlap the structural stent elements of the second subset lengthwise along the entire radially-diverging portion and along the entire radially-converging portion.

34. A method comprising:

providing an endovascular 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, at least a portion of which define a stent body when the stent-graft assumes the radially-expanded state, and (b) a fluid flow guide, which includes at least one biologically-compatible substantially fluid-impervious flexible sheet, and which is coupled to the stent body, wherein, when the stent-graft assumes the radially-expanded state, (a) a first subset of the structural stent elements of the stent body are configured to cause the stent body and the fluid flow guide to define a bulge that extends radially outward, which has a greatest cross-sectional area that is equal to at least 120% of a cross-sectional area of a narrowest portion of the stent-graft rostral to the bulge, and (b) a second subset of the structural stent elements of the stent body (i) are not configured to cause the fluid flow guide to define the bulge, and (ii) are shaped so as to define a substantially tubular structure that overlaps the structural stent elements of the first subset lengthwise along the stent body;

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

deploying the stent-graft from the delivery catheter at least partially in the aorta such that the bulge extends radially outward against and sealingly contacts a rostral portion of an abdominal aortic aneurysm in the aorta when the stent-graft assumes the radially-expanded state.

35. The method according to claim 34, wherein, when the stent-graft assumes the radially-expanded state, the fluid flow guide is shaped so as to define radially-diverging and radially-converging portions, which together define the bulge, wherein the radially-diverging portion is rostral to the radially-converging portion.

36. The method according to claim 35, wherein, when the stent-graft assumes the radially-expanded state, the substantially tubular structure overlaps the structural stent elements of the first subset overlap the structural stent elements of the second subset lengthwise along the entire radially-diverging portion.

37. The method according to claim 34, wherein, when the stent-graft assumes the radially-expanded state, the structural stent elements of the first subset are shaped so as to define a plurality of arms that extend radially outward, and are configured to cause the fluid flow guide to define the bulge.