Multi-component stent-graft system for aortic dissections

• US 9,668,892 B2
• Filed: 02/18/2014
• Issued: 06/06/2017
• Est. Priority Date: 03/11/2013
• Status: Active Grant

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon, Marmur, Yaniv
• Primary Examiner(s): Sevilla, Christian
• Assistant Examiner(s): WOLF, MEGAN YARNALL
• Application Number:
  US14/772,016
• Publication Number:
  US 20160030209A1
• Time in Patent Office: 1,204 Days
• Field of Search: None
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

A generally tubular stent-graft (24) has distal and proximal stent-graft ends (36, 38) and includes a generally tubular support element (30) and a covering element (32). When the stent-graft (24) is unconstrained in a radially-expanded state: (1) the covering and support elements (32, 30) are shaped so as to together define a lateral fenestration (34) having distal and proximal fenestration ends (35, 37), (2) a perimeter (P1) of the distal stent-graft end (36) equals at least 200% of a perimeter (P2) of the proximal stent-graft end (38), and (3) the stent-graft (24) includes a dissection-reinforcement axial portion (48), which (a) has a proximal dissection-reinforcement end (52) that is disposed no more than 20 mm proximal to the proximal fenestration end (37), (b) extends along the stent-graft for a distance equal to between 5% and 32% of a greatest perimeter of the stent-graft (24) distally to the distal fenestration end (35), and (c) has a radial strength that is at least 10% greater than an average radial strength of the entire stent-graft (24). Other embodiments are also described.

Claims

1. Apparatus comprising a generally tubular stent-graft, which has distal and proximal stent-graft ends and comprises:

a generally tubular support element, which comprises a plurality of structural stent elements; and

a covering element that is attached to and at least partially covers the support element,

wherein when the stent-graft is unconstrained in a radially-expanded state;

the covering element and the support element are shaped so as to together define a lateral fenestration having distal and proximal fenestration ends,

a first perimeter of the distal stent-graft end equals at least 200% of a second perimeter of the proximal stent-graft end, and

the stent-graft includes a dissection-reinforcement axial portion, which (a) includes a portion of the structural stent elements, (b) has (i) a distal dissection-reinforcement end and (ii) a proximal dissection-reinforcement end that is disposed along the stent-graft no more than 20 mm proximal to the proximal fenestration end, (c) extends along the stent-graft for a distance, and (d) has a radial strength that is at least 10% greater than an average radial strength of the entire stent-graft, wherein the distance is equal to between 5% and 32% of a greatest perimeter of the stent-graft distally to the distal fenestration end.

2. The apparatus according to claim 1,

wherein the portion of the structural stent elements included by the dissection-reinforcement axial portion is a first portion of the structural stent elements, and

wherein when the stent-graft is unconstrained in the radially-expanded state:

the stent-graft includes a distal-end axial portion, which includes a second portion of the structural stent elements, and

the distal-end axial portion axially extends along the stent-graft from the distal end of the stent-graft for a distance, wherein the distance is equal to between 5% and 32% of a greatest perimeter of the stent-graft distally to the distal fenestration end, and

the distal-end axial portion has a radial strength that is at least a 10% greater than the average radial strength of the entire stent-graft.

3. The apparatus according to claim 1, wherein an axial length of the dissection-reinforcement axial portion is between 1 and 3 cm when the stent-graft is unconstrained in the radially-expanded state.

4. The apparatus according to claim 1, wherein the proximal dissection-reinforcement end is disposed along the stent-graft no more proximal than the distal fenestration end when the stent-graft is unconstrained in the radially-expanded state.

5. The apparatus according to claim 1, wherein the proximal dissection-reinforcement end is disposed along the stent-graft between the distal fenestration end and the proximal fenestration end, inclusive, when the stent-graft is unconstrained in the radially-expanded state.

6. The apparatus according to claim 1, wherein a distance between the distal dissection-reinforcement end and the distal stent-graft end equals between 32% and 160% of a largest perimeter of the stent-graft when the stent-graft is unconstrained in the radially-expanded state.

7. The apparatus according to claim 1, wherein the dissection-reinforcement axial portion extends along the stent-graft for a distance when the stent-graft is unconstrained in the radially-expanded state, wherein the distance is equal to between 10% and 22% of a greatest perimeter of the stent-graft distally to the distal fenestration end.

8. The apparatus according to claim 1, wherein the first perimeter equals at least 250% of the second perimeter.

9. The apparatus according to claim 1, wherein the dissection-reinforcement axial portion is configured to be generally straight when the stent-graft is unconstrained in the radially-expanded state.

10. The apparatus according to claim 1, wherein the structural stent elements of the dissection-reinforcement axial portion are arranged as a plurality of circumferential stent springs, and wherein a height, measured axially along the stent-graft, of at least one of the stent springs varies by less than 10% around a circumference of the stent spring when the stent-graft is unconstrained in the radially-expanded state.

11. The apparatus according to claim 1, wherein the stent-graft is shaped so as to define exactly one lateral fenestration when the stent-graft is unconstrained in the radially-expanded state.

12. The apparatus according to claim 1,

wherein the lateral fenestration is an inferior first lateral fenestration, which faces in a first radial direction, and

wherein, when the stent-graft is unconstrained in the radially-expanded state, the covering element and the support element are shaped so as to together define a superior second lateral fenestration, which faces in a second radial direction generally opposite the first radial direction.

13. Apparatus comprising a generally tubular stent-graft, which has distal and proximal stent-graft ends and comprises:

a generally tubular support element, which comprises a plurality of structural stent elements arranged as a plurality of circumferential stent springs; and

a covering element that is attached to and at least partially covers the support element,

wherein when the stent-graft is unconstrained in a radially-expanded state;

the covering element and the support element are shaped so as to together define a lateral fenestration having distal and proximal fenestration ends,

a first perimeter of the distal stent-graft end equals at least 200% of a second perimeter of the proximal stent-graft end,

the stent-graft includes a dissection-reinforcement axial portion, which (a) includes a first plurality of the stent springs, (b) has (i) a distal dissection-reinforcement end and (ii) a proximal dissection-reinforcement end that is disposed along the stent-graft no more than 20 mm proximal to the proximal fenestration end, (c) extends along the stent-graft for a distance, and (d) is configured to be generally straight, wherein the distance is equal to between 5% and 32% of a greatest perimeter of the stent-graft distally to the distal fenestration end,

the stent-graft includes a distal axial portion, which (a) includes a second plurality of the stent springs, (b) is disposed along the stent-graft distal and axially adjacent to the distal dissection-reinforcement end, (c) extends along the stent-graft for a distance, wherein the distance is equal to between 5% and 32% of the greatest perimeter of the stent-graft distally to the distal fenestration end,

the stent springs have respective average heights, measured axially along the stent-graft, and

an average of the average heights of the first plurality of the stent springs is less than 75% of the average height of a proximal-most one of the second plurality of the stent springs.

14. The apparatus according to claim 13, wherein each of the average heights of the first plurality of the stent springs is less than 75% of the average heights of the proximal-most one of the second plurality of stent springs when the stent-graft is unconstrained in the radially-expanded state.

15. The apparatus according to claim 13, wherein the average of the average heights of the first plurality of the stent springs is less than 75% of the average height of a second one of the second plurality of stent springs, other than the proximal-most one of the second plurality of stent springs when the stent-graft is unconstrained in the radially-expanded state.

16. The apparatus according to claim 13, wherein the average of the average heights of the first plurality of the stent springs is less than 75% of each of the average heights of the second plurality of stent springs when the stent-graft is unconstrained in the radially-expanded state.

17. The apparatus according to claim 13, wherein the distal axial portion is configured to be generally straight when the stent-graft is unconstrained in the radially-expanded state.

18. The apparatus according to claim 13, wherein an axial length of the dissection-reinforcement axial portion is between 1 and 3 cm when the stent-graft is unconstrained in the radially-expanded state.

19. The apparatus according to claim 13, wherein the proximal dissection-reinforcement end is disposed along the stent-graft no more proximal than the distal fenestration end when the stent-graft is unconstrained in the radially-expanded state.

20. The apparatus according to claim 13, wherein the proximal dissection-reinforcement end is disposed along the stent-graft between the distal fenestration end and the proximal fenestration end, inclusive, when the stent-graft is unconstrained in the radially-expanded state.

21. The apparatus according to claim 13, wherein an axial spacing between two of the first plurality of the stent springs equals less than 10% of an average of the average heights of the two stent springs.

22. The apparatus according to claim 13, wherein the first perimeter equals at least 300% of the second perimeter.

23. The apparatus according to claim 13, wherein the dissection-reinforcement axial portion extends along the stent-graft for a distance when the stent-graft is unconstrained in the radially-expanded state, wherein the distance is equal to between 10% and 32% of the greatest perimeter of the stent-graft distally to the distal fenestration end.

24. The apparatus according to claim 13, wherein the distal axial portion extends to and reaches the distal stent-graft end.

25. The apparatus according to claim 13, wherein the average height of at least one of the first plurality of stent springs varies by less than 10% around a circumference of the stent spring when the stent-graft is unconstrained in the radially-expanded state.

26. The apparatus according to claim 13,

wherein, if the distal axial portion, when the stent-graft is in the radially-expanded state, is placed and constrained in a first curved tube having a circular cross-section and an inner diameter equal to an outer diameter of the distal axial portion, the distal axial portion experiences kinking only when at least an axial portion of the first curved tube has less than a first radius of curvature, and

wherein, if the dissection-reinforcement axial portion, when the stent-graft is in the radially-expanded state, is placed and constrained in a second curved tube having a circular cross-section and an inner diameter equal to an outer diameter of the dissection-reinforcement axial portion, the dissection-reinforcement axial portion experiences kinking only when at least an axial portion of the second curved tube has less than a second radius of curvature, which second radius of curvature is at least 30% less than the first radius of curvature.

27. The apparatus according to claim 13,

wherein the lateral fenestration is an inferior first lateral fenestration, which faces in a first radial direction, and

wherein, when the stent-graft is unconstrained in the radially-expanded state, the covering element and the support element are shaped so as to together define a superior second lateral fenestration, which faces in a second radial direction generally opposite the first radial direction.

28. A method for treating a patient comprising:

endovascularly introducing a generally tubular stent-graft, while in a radially-compressed state, and positioning the stent-graft such that (a) a proximal stent-graft end of the stent-graft is positioned in a branch of an aortic arch selected from the group consisting of;

a left subclavian artery, and a left common carotid artery, and (b) a distal stent-graft end of the stent-graft is positioned in a descending aorta, wherein the stent-graft includes (a) a generally tubular support element, which includes a plurality of structural stent elements, and (b) a covering element that is attached to and at least partially covers the support element; and

thereafter, transitioning the stent-graft to a radially-expanded state, in which (a) the covering element and the support element are shaped so as to together define a lateral fenestration that is disposed in the aortic arch, with the lateral fenestration facing upstream generally toward an ascending aorta, the lateral fenestration having distal and proximal fenestration ends, (b) a first perimeter of the distal stent-graft end of the stent-graft equals at least 200% of a second perimeter of the proximal stent-graft end, and (c) the stent-graft includes a dissection-reinforcement axial portion, which (i) includes a portion of the structural stent elements, (ii) has (x) a distal dissection-reinforcement end and (y) a proximal dissection-reinforcement end that is disposed along the stent-graft no more than 20 mm proximal to the proximal fenestration end, (iii) extends along the stent-graft for an axial distance, and (iv) has a radial strength that is at least 10% greater than an average radial strength of the entire stent-graft, wherein the axial distance is equal to between 5% and 32% of a greatest perimeter of the stent-graft distally to the distal fenestration end.

29. A method for treating a patient comprising:

endovascularly introducing a generally tubular stent-graft, while in a radially-compressed state, and positioning the stent-graft such that (a) a proximal stent-graft end of the stent-graft is positioned in a branch of an aortic arch selected from the group consisting of;

a left subclavian artery, and a left common carotid artery, and (b) a distal stent-graft end of the stent-graft is positioned in a descending aorta, wherein the stent-graft includes (a) a generally tubular support element, which includes a plurality of structural stent elements arranged as a plurality of circumferential stent springs, and (b) a covering element that is attached to and at least partially covers the support element; and

thereafter, transitioning the stent-graft to a radially-expanded state, in which (a) the covering element and the support element are shaped so as to together define a lateral fenestration that is disposed in the aortic arch, with the lateral fenestration facing upstream generally toward an ascending aorta, the lateral fenestration having distal and proximal fenestration ends, (b) a first perimeter of the distal stent-graft end of the stent-graft equals at least 200% of a second perimeter of the proximal stent-graft end, (c) the stent-graft includes a dissection-reinforcement axial portion, which (i) includes a first plurality of the stent springs, (ii) has (x) a distal dissection-reinforcement end and (y) a proximal dissection-reinforcement end that is disposed along the stent-graft no more than 20 mm proximal to the proximal fenestration end, (iii) extends along the stent-graft for a distance, and (iv) is configured to be generally straight when the stent-graft is unconstrained in the radially-constrained state, wherein the distance is equal to between 5% and 32% of a greatest perimeter of the stent-graft distally to the distal fenestration end, (d) the stent-graft includes a distal axial portion, which (i) includes a second plurality of the stent springs, (ii) is disposed along the stent-graft distal and axially adjacent to the distal dissection-reinforcement end, (iii) extends along the stent-graft for a distance, wherein the distance is equal to between 5% and 32% of the greatest perimeter of the stent-graft distally to the distal fenestration end, (e) the stent springs have respective average heights, measured axially along the stent-graft, and (f) an average of the average heights of the first plurality of the stent springs is less than 75% of the average height of a proximal-most one of the second plurality of the stent springs.