Multi-component stent-graft system for implantation in a blood vessel with multiple branches

• US 10,201,413 B2
• Filed: 12/16/2014
• Issued: 02/12/2019
• Est. Priority Date: 11/30/2009
• Status: Active Grant

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon, Raz, Sagi, Benary, Rafi
• Primary Examiner(s): Schall, Matthew
• Application Number:
  US14/572,156
• Publication Number:
  US 20150105851A1
• Time in Patent Office: 1,519 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0065 telescopic

Abstract

A multi-component stent-graft system includes a first stent-graft, and second, third, and fourth branching stent-grafts. The first stent-graft is shaped so as to define, when in a radially-expanded state, proximal and distal superior first lateral openings facing in a first radial direction, and a distal inferior first lateral opening facing a second radial direction generally opposite the first radial direction. The second, third, and fourth branching stent-grafts are configured assume radially-expanded states, wherein the first, the second, the third, and the fourth stent-grafts are configured such that the branching stent-grafts form respective blood-impervious seals with the first stent-graft around the distal inferior first lateral opening, the distal superior first lateral opening, and the proximal superior first lateral opening, respectively, when the branching stent-grafts are disposed therethrough, respectively, and the first, the second, the third, and the fourth stent-grafts are in their radially-expanded states.

Claims

1. Apparatus comprising a multi-component stent-graft system, which comprises:

a first stent-graft, which is shaped so as to define, when in a radially-expanded state, exactly three lateral openings consisting of (a) proximal and distal superior first lateral openings facing in a first radial direction, and (b) a distal inferior first lateral opening facing in a second radial direction substantially opposite the first radial direction, the proximal and distal superior first lateral openings and distal inferior first lateral opening having respective perimeters; and

second, third, and fourth branching stent-grafts, which are configured assume radially-expanded states, wherein the first, the second, the third, and the fourth stent-grafts are configured such that the branching stent-grafts form respective blood-impervious seals with the first stent-graft around the distal inferior first lateral opening, the distal superior first lateral opening, and the proximal superior first lateral opening, respectively, when the branching stent-grafts are disposed therethrough, respectively, and the first, the second, the third, and the fourth stent-grafts are in their radially-expanded states.

2. The apparatus according to claim 1,

wherein the first stent-graft comprises exactly one first substantially tubular support element and a first covering element attached to the first support element so as to at least partially cover the first support element, and the first covering element and the first support element are shaped so as to together define, when the first stent-graft is in its radially-expanded state, the proximal and the distal superior first lateral openings facing in the first radial direction, and the distal inferior first lateral opening facing in the second radial direction, and

wherein the second, the third, and the fourth branching stent-grafts comprise respective substantially tubular branching support elements and respective branching covering elements, attached to the branching support elements so as to at least partially cover the branching support elements, and the first, the second, the third, and the fourth stent-grafts are configured such that the branching covering elements form the respective blood-impervious seals with the first covering element around the distal inferior first lateral opening, the distal superior first lateral opening, and the proximal superior first lateral opening, respectively, when the branching stent-grafts are disposed therethrough, respectively, and the first, the second, the third, and the fourth stent-grafts are in their radially-expanded states.

3. The apparatus according to claim 1, wherein the distal inferior first lateral opening is not axially aligned with either of the proximal or distal superior first lateral openings.

4. The apparatus according to claim 3, wherein the distal inferior first lateral opening does not axially overlap with either of the proximal or distal superior first lateral openings.

5. The apparatus according to claim 2,

wherein, when the second stent-graft is disposed through the first lateral opening and the first and the second stent-grafts are in their radially-expanded states:

a proximal portion of the second support element is disposed within the first stent-graft, and

the second covering element does not fully cover the proximal portion of the second support element, thereby allowing blood flow through the first stent-graft.

6. The apparatus according to claim 5, wherein an axial portion of the proximal portion of the second support element having a length of at least 1 cm has a perimeter that is at least 10% greater than a perimeter of a portion of the first stent-graft in which the proximal portion of the second support element is disposed, when the first and second stent-grafts are in their radially-expanded states.

7. The apparatus according to claim 5, wherein the second covering element is configured to cover a distal sub-portion, and not a proximal sub-portion, of the proximal portion of the second support element.

19. The apparatus according to claim 1, wherein the first stent-graft is shaped so as to define, when in the radially-expanded state, a first distal end and a second proximal end having a first perimeter and a second perimeter, respectively, the first perimeter equal to at least 150% of the second perimeter.

20. The apparatus according to claim 19, wherein the distal inferior first lateral opening is closer to the second distal end of the first stent-graft than the distal superior first lateral opening is to the second distal end of the first stent-graft.

8. A method for treating a patient, comprising:

transvascularly introducing a first stent-graft in a radially-compressed state, wherein the first stent-graft is shaped so as to define exactly three lateral openings consisting of (a) a proximal superior first lateral opening, (b) a distal superior first lateral opening, and (c) a distal inferior first lateral opening, and wherein the proximal and distal superior first lateral openings and distal inferior first lateral opening have respective perimeters;

positioning the first stent-graft such that (a) a proximal portion of the first stent-graft, including a proximal end of the first-stent-graft, is in an upper part of a descending aorta, (b) a distal portion of the first stent-graft, including a distal end of the first stent-graft, is in a brachiocephalic artery, (c) the distal inferior first lateral opening faces upstream, substantially toward an ascending aorta, and (d) the proximal and the distal superior first lateral openings face and are aligned with a left subclavian artery and a left common carotid artery, respectively;

transitioning the first stent-graft to a radially-expanded state after positioning the first stent-graft, such that the proximal and the distal superior first lateral openings face in a first radial direction, and the distal inferior first lateral opening faces in a second radial direction substantially opposite the first radial direction;

transvascularly introducing and passing a second stent-graft, while in a radially-compressed state, through the proximal portion of the first stent-graft such that the second stent-graft is disposed through the distal inferior first lateral opening and is disposed partially in an aortic arch;

transitioning the second stent-graft from the radially-compressed state to a radially-expanded state such that the second stent-graft forms a blood-impervious seal with the first stent-graft around the distal inferior first lateral opening;

transvascularly introducing and positioning third and fourth stent-grafts, while in respective radially-compressed states, through the proximal portion of the first stent-graft such the third and fourth stent-grafts are disposed through the proximal superior first lateral opening and the distal superior first lateral openings, respectively, and are disposed partially in the left common carotid artery and the left subclavian artery, respectively; and

transitioning the third and the fourth stent-grafts from the respective radially-compressed states to respective radially-expanded states such that the third and the fourth stent-grafts form blood-impervious seals with the first stent-graft around the proximal superior first lateral opening and the distal superior first lateral opening, respectively.

9. The method according to claim 8,

wherein the first stent-graft comprises exactly one first substantially tubular support element and a first covering element attached to the first support element so as to at least partially cover the first support element, and the first covering element and the first support element are shaped so as to together define, when the first stent-graft is in its radially-expanded state, the proximal and the distal superior first lateral openings facing in the first radial direction, and the distal inferior first lateral opening facing in the second radial direction, and

wherein the second, the third, and the fourth branching stent-grafts comprise respective substantially tubular branching support elements and respective branching covering elements, attached to the branching support elements so as to at least partially cover the branching support elements, and the first, the second, the third, and the fourth stent-grafts are configured such that the branching covering elements form the respective blood-impervious seals with the first covering element around the distal inferior first lateral opening, the distal superior first lateral opening, and the proximal superior first lateral opening, respectively, when the branching stent-grafts are disposed therethrough, respectively, and the first, the second, the third, and the fourth stent-grafts are in their radially-expanded states.

10. The method according to claim 9,

wherein, when the second stent-graft is disposed through the first lateral opening and the first and the second stent-grafts are in their radially-expanded states:

a proximal portion of the second support element is disposed within the first stent-graft, and

the second covering element does not fully cover the proximal portion of the second support element, thereby allowing blood flow through the first stent-graft.

11. The method according to claim 10, wherein an axial portion of the proximal portion of the second support element having a length of at least 1 cm has a perimeter that is at least 10% greater than a perimeter of a portion of the first stent-graft in which the proximal portion of the second support element is disposed, when the first and second stent-grafts are in their radially-expanded states.

12. The method according to claim 10, wherein the second covering element is configured to cover a distal sub-portion, and not a proximal sub-portion, of the proximal portion of the second support element.

13. The method according to claim 8, wherein the distal inferior first lateral opening is not axially aligned with either of the proximal or distal superior first lateral openings.

14. The method according to claim 8, wherein the distal inferior first lateral opening does not axially overlap with either of the proximal or distal superior first lateral openings.

15. The method according to claim 8, further comprising identifying that the patient suffers from a thoracic aortic aneurysm of the aortic arch, and wherein transvascularly introducing the first stent-graft comprises transvascularly introducing the first stent-graft responsively to the identifying.

16. Apparatus comprising a multi-component stent-graft system, which comprises:

a first stent-graft, which is shaped so as to define, when in a radially-expanded state, proximal and distal superior first lateral openings facing in a first radial direction, and a distal inferior first lateral opening facing in a second radial direction substantially opposite the first radial direction, the proximal and distal superior first lateral openings and distal inferior first lateral opening having respective perimeters, wherein the perimeter of the distal inferior first lateral opening is at least 4.5 cm; and

second, third, and fourth branching stent-grafts, which are configured assume radially-expanded states, wherein the first, the second, the third, and the fourth stent-grafts are configured such that the branching stent-grafts form respective blood-impervious seals with the first stent-graft around the distal inferior first lateral opening, the distal superior first lateral opening, and the proximal superior first lateral opening, respectively, when the branching stent-grafts are disposed therethrough, respectively, and the first, the second, the third, and the fourth stent-grafts are in their radially-expanded states.

17. The apparatus according to claim 16, wherein the first stent-graft is shaped so as to define, when in the radially-expanded state, a first distal end and a second proximal end having a first perimeter and a second perimeter, respectively, the first perimeter equal to at least 150% of the second perimeter.

18. The apparatus according to claim 17, wherein the distal inferior first lateral opening is closer to the second distal end of the first stent-graft than the distal superior first lateral opening is to the second distal end of the first stent-graft.

21. A method for treating a patient, comprising:

transvascularly introducing a first stent-graft in a radially-compressed state, wherein the first stent-graft is shaped so as to define a proximal superior first lateral opening, a distal superior first lateral opening, and a distal inferior first lateral opening, and wherein the proximal and distal superior first lateral openings and distal inferior first lateral opening have respective perimeters, wherein the perimeter of the distal inferior first lateral opening is at least 4.5 cm;

positioning the first stent-graft such that (a) a proximal portion of the first stent-graft, including a proximal end of the first-stent-graft, is in an upper part of a descending aorta, (b) a distal portion of the first stent-graft, including a distal end of the first stent-graft, is in a brachiocephalic artery, (c) the distal inferior first lateral opening faces upstream, substantially toward an ascending aorta, and (d) the proximal and the distal superior first lateral openings face and are aligned with a left subclavian artery and a left common carotid artery, respectively;

transitioning the first stent-graft to a radially-expanded state after positioning the first stent-graft, such that the proximal and the distal superior first lateral openings face in a first radial direction, and the distal inferior first lateral opening faces in a second radial direction substantially opposite the first radial direction;

transvascularly introducing and passing a second stent-graft, while in a radially-compressed state, through the proximal portion of the first stent-graft such that the second stent-graft is disposed through the distal inferior first lateral opening and is disposed partially in an aortic arch;

transitioning the second stent-graft from the radially-compressed state to a radially-expanded state such that the second stent-graft forms a blood-impervious seal with the first stent-graft around the distal inferior first lateral opening;

transvascularly introducing and positioning third and fourth stent-grafts, while in respective radially-compressed states, through the proximal portion of the first stent- graft such the third and fourth stent-grafts are disposed through the proximal superior first lateral opening and the distal superior first lateral openings, respectively, and are disposed partially in the left common carotid artery and the left subclavian artery, respectively; and

transitioning the third and the fourth stent-grafts from the respective radially- compressed states to respective radially-expanded states such that the third and the fourth stent-grafts form blood-impervious seals with the first stent-graft around the proximal superior first lateral opening and the distal superior first lateral opening, respectively.