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

• US 8,945,203 B2
• Filed: 11/30/2010
• Issued: 02/03/2015
• 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): Sweet, Thomas J
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US13/512,778
• Publication Number:
  US 20130013050A1
• Time in Patent Office: 1,526 Days
• Field of Search: 623/1.13, 623/1.35
• US Class Current: 623/1.13
• 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 (10) comprises first, second, and third generally tubular stent-grafts (20, 22, 24), which are configured to assume radially-expanded states. The first (20) is shaped so as to define a first lateral opening (34) when radially-expanded. The second (22) is shaped so as to define a second lateral opening (44) when radially-expanded. The first and second (20, 22) are configured such that the second (22) forms a blood-impervious seal with the first (20) around the first lateral opening (34) when the second stent-graft (22) is disposed therethrough, and the first and the second (20, 22) are radially-expanded. The second and the third (22, 24) are configured such that the third (24) forms a blood-impervious seal with the second (22) around the second lateral opening (44) when the third (24) is disposed therethrough, and the second and third (22, 24) are radially-expanded. Other embodiments also described.

Claims

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

a first generally tubular stent-graft, which (i) when unconstrained in a radially-expanded state;

(a) defines a first lateral opening having a first lateral opening perimeter, and (b) has a first perimeter of a first end thereof that equals at least 200% of a second perimeter of a second end thereof, and (ii) is configured for positioning the first end thereof in a descending aorta, and the second end thereof in one of the branches of an aortic arch, with the first lateral opening disposed in the aortic arch facing upstream; and

a second generally tubular stent-graft, which is configured to assume a radially-expanded state, wherein the first and the second stent-grafts are configured such that the second stent-graft forms a blood-impervious seal with the first stent-graft around the first lateral opening when the second stent-graft is disposed therethrough, and the first and second stent-grafts are in their radially-expanded states.

2. The apparatus according to claim 1,

wherein the first stent-graft comprises exactly one first generally 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 the first lateral opening through the first stent-graft when the first stent-graft is in its radially-expanded state, and

wherein the second stent-graft comprises exactly one second generally tubular support element and a second covering element attached to the second support element so as to at least partially cover the second support element, and the first and the second stent-grafts are configured such that the second covering element forms the blood-impervious seal with the first covering element around the first lateral opening when the second stent-graft is disposed therethrough, and the first and the second stent-grafts are in their radially-expanded states.

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

4. The apparatus according to claim 3, wherein the first perimeter equals at least 300% of the second perimeter.

5. The apparatus according to claim 1, wherein the first perimeter is between 7.5 and 15 cm, and the second perimeter is between 2.5 and 5.7 cm.

6. The apparatus according to claim 1, wherein, when the first stent-graft is unconstrained in its radially-expanded state, the first lateral opening perimeter is at least 40% of the first perimeter.

7. The apparatus according to claim 1, wherein, when the first stent-graft is unconstrained in its radially-expanded state, the first lateral opening perimeter is at least 60% of the second perimeter.

8. The apparatus according to claim 1, wherein the second stent-graft is configured to transition, without inverting, from a radially-compressed state to its radially-expanded state.

9. The apparatus according to claim 1,

wherein the first lateral opening is a superior first lateral opening,

wherein the first stent-graft is shaped so as to define the superior first lateral opening facing in a first radial direction, and an inferior first lateral opening facing a second radial direction generally opposite the first radial direction, and

wherein the first and the second stent-grafts are configured such that the second stent-graft forms the blood-impervious seal with the first stent-graft around the superior first lateral opening when the second stent-graft is disposed therethrough, and the first and second stent-grafts are in their radially-expanded states.

10. 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.

11. The apparatus 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 apparatus 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.

22. The apparatus according to claim 1,

wherein the second generally tubular stent-graft is shaped so as to define a second lateral opening having a second lateral opening perimeter, when in the radially-expanded state, and

wherein the stent-graft system further comprises a third generally tubular stent-graft, which is configured to assume a radially-expanded state, wherein the second and the third stent-grafts are configured such that the third stent-graft forms a blood-impervious seal with the second stent-graft around the second lateral opening when the third stent-graft is disposed therethrough, and the second and third stent-grafts are in their radially-expanded states.

23. The apparatus according to claim 22,

wherein the first stent-graft comprises exactly one first generally 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 the first lateral opening through the first stent-graft when the first stent-graft is in its radially-expanded state,

wherein the second stent-graft comprises exactly one second generally tubular support element and a second covering element attached to the second support element so as to at least partially cover the second support element, and the second covering element and the second support element are shaped so as to together define the second lateral opening through the second stent-graft when the second stent-graft is in its radially-expanded state, and the first and the second stent-grafts are configured such that the second covering element forms the blood-impervious seal with the first covering element around the first lateral opening when the second stent-graft is disposed therethrough, and the first and the second stent-grafts are in their radially-expanded states, and

wherein the third stent-graft comprises exactly one third generally tubular support element and a third covering element attached to the third support element so as to at least partially cover the third support element, and the second and the third stent-grafts are configured such that the third covering element forms the blood-impervious seal with the second covering element around the second lateral opening when the third stent-graft is disposed therethrough, and the second and third stent-grafts are in their radially-expanded states.

24. The apparatus according to claim 23, wherein the first, the second, and the third covering elements are not fixed to one another when the first, the second, and the third stent-grafts are in their radially-compressed states.

25. The apparatus according to claim 23, wherein, when the third stent-graft is disposed through the second lateral opening and the second and the third stent-grafts are in their radially-expanded states:

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

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

26. The apparatus according to claim 9,

wherein the superior first lateral opening is a proximal superior first lateral opening,

wherein the wherein the first stent-graft is shaped so as to further define a distal superior first lateral opening facing in the first radial direction, and

wherein the first perimeter equals at least 250% of the second perimeter.

47. The apparatus according to claim 1, wherein, when the first stent-graft is unconstrained in its radially-expanded state, a first cross-sectional area of the first end equals at least 400% of a second cross-sectional area of the second end.

48. The apparatus according to claim 47, wherein, when the first stent-graft is unconstrained in its radially-expanded state, the first cross-sectional area equals at least 625% of the second cross-sectional area.

49. The apparatus according to claim 48, wherein, when the first stent-graft is unconstrained in its radially-expanded state, the first cross-sectional area equals at least 900% of the second cross-sectional area.

50. The apparatus according to claim 1, wherein the first stent-graft has exactly one first end opening defined by the first end, and exactly one second end opening defined by the second end.

51. The apparatus according to claim 1, wherein the first stent-graft has a generally curved longitudinal axis when unconstrained in its radially-expanded state.

52. The apparatus according to claim 1, wherein, when the first stent-graft is unconstrained in its radially-expanded state, the first lateral opening perimeter is at least 4.5 cm.

53. The apparatus according to claim 6, wherein, when the first stent-graft is unconstrained in its radially-expanded state, the first lateral opening perimeter is at least 75% of the first perimeter.

13. A method for treating a patient, comprising:

transvascularly introducing and positioning a first stent-graft, which is shaped so as to define one or more first lateral openings having respective first lateral opening perimeters, 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 branch of an aortic arch, and (c) one of the one or more first lateral openings is disposed within the aortic arch facing upstream, generally toward an ascending aorta; and

transvascularly introducing and passing a second stent-graft through the proximal portion of the first stent-graft such that the second stent-graft is disposed through the one of the one or more first lateral openings and is disposed partially in the aortic arch, and forms a blood-impervious seal with the first stent-graft around the one of the one or more first lateral openings.

14. The method according to claim 13, wherein the branch is a left subclavian artery, and wherein positioning the first stent-graft comprises positioning the first stent-graft such that the distal portion of the first stent-graft, including the distal end of the first stent-graft, is in the left subclavian artery.

15. The method according to claim 14, wherein passing comprises passing the second stent-graft through the proximal portion of the first stent-graft such that the second stent-graft is disposed through the one of the one or more first lateral openings and is disposed partially in the aortic arch, and a distal portion of the second stent-graft, including a distal end of the second stent-graft, is in a left common carotid artery.

16. The method according to claim 13,

wherein the branch is a brachiocephalic artery,

wherein the first lateral openings include proximal and distal superior first lateral openings, and a distal inferior first lateral opening,

wherein positioning the first stent-graft comprises positioning the first stent-graft such that (a) the distal portion of the first stent-graft, including the distal end of the first stent-graft, is in the brachiocephalic artery, (b) the distal inferior first lateral opening faces upstream, generally toward the ascending aorta, and (c) 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, and

wherein passing the second stent-graft comprises passing the second stent-graft 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 the distal portion of the main blood vessel.

17. The method according to claim 16, further comprising transvascularly introducing and positioning third and fourth stent-grafts through the proximal portion of the first stent-graft such the third and fourth stent-grafts are disposed through the proximal and the distal superior first lateral openings, respectively, and are disposed partially in the left subclavian artery and the left common carotid artery, respectively, and form blood-impervious seals with the first stent-graft around the proximal and the distal superior first lateral openings, respectively.

18. The method according to claim 13,

wherein the branch is a left common carotid artery,

wherein the first lateral openings include a superior first lateral opening and an inferior first lateral opening,

wherein positioning the first stent-graft comprises positioning the first stent-graft such that (a) the distal portion of the first stent-graft, including the distal end of the first stent-graft, is in the left common carotid artery, (b) the inferior first lateral opening faces upstream, generally toward the ascending aorta, and (c) the superior first lateral opening faces and is aligned with a left subclavian artery, and

further comprising transvascularly introducing a third stent-graft via a right subclavian artery, and positioning the third stent-graft such that a proximal portion of the third stent-graft, including a proximal end of the third stent-graft is disposed in a brachiocephalic artery, and a distal portion of the third stent-graft, including a proximal end of the third-stent graft, is disposed in a portion of at least one blood vessel selected from the group consisting of:

the aortic arch, and an upper part of an ascending aorta, and a third lateral opening defined by the third stent-graft faces upstream, generally toward the descending aorta,

wherein passing the second stent-graft comprises passing the second stent-graft through the proximal portion of the first stent-graft such that the second stent-graft is disposed through the inferior first lateral opening and the third lateral opening, and is disposed partially in the aortic arch.

19. The method according to claim 13, wherein transvascularly introducing the first and the second stent-grafts comprises separately transvascularly introducing the first and the second stent-grafts while they are not fixed to one another.

20. The method according to claim 13,

wherein transvascularly introducing the first stent-graft comprises transvascularly introducing the first stent-graft while in a radially-compressed state, and transitioning the first stent-graft to a radially-expanded state after positioning the first stent-graft,

wherein transvascularly introducing the second stent-graft comprises transvascularly introducing the second stent-graft while in a radially-compressed state,

wherein passing the second stent-graft comprising passing the second stent-graft, while in its radially-compressed state, through the proximal portion after the first stent-graft has been transitioned to its radially-expanded state, and

wherein the method further comprises, after passing the second stent-graft, transitioning, without inverting, the second stent-graft from a radially-compressed state to a radially-expanded state.

21. The method according to claim 20, wherein transitioning the first stent-graft comprises transitioning the first stent-graft to its radially-expanded state in which a first perimeter of the proximal end of the first stent-graft equals at least 200% of a second perimeter of the distal end of the first stent-graft.

54. The method according to claim 21, wherein transitioning the first stent-graft comprises transitioning the first stent-graft to its radially-expanded state in which the one of the one or more first lateral openings has a first lateral opening perimeter that equals at least 75% of the first perimeter of the proximal end.

55. The method according to claim 21, wherein transitioning the first stent-graft comprises transitioning the first stent-graft to its radially-expanded state in which a first cross-sectional area of the proximal end equals at least 400% of a second cross-sectional area of the distal end.

56. The method according to claim 55, wherein transitioning the first stent-graft comprises transitioning the first stent-graft to its radially-expanded state in which the first cross-sectional area equals at least 625% of the second cross-sectional area.

57. The method according to claim 56, wherein transitioning the first stent-graft comprises transitioning the first stent-graft to its radially-expanded state in which the first cross-sectional area equals at least 900% of the second cross-sectional area.

58. The method according to claim 21, wherein the first stent-graft has exactly one first end opening defined by the proximal end, and exactly one second end opening defined by the distal end.

59. The method according to claim 21, wherein the first stent-graft has a generally curved longitudinal axis when unconstrained in its radially-expanded state.

27. A method for assembling a multi-component stent-graft system, the method comprising:

providing (a) a first generally tubular stent-graft, which (i) when unconstrained in a radially-expanded state;

(i) defines a first lateral opening having a first lateral opening perimeter, and (ii) has a first perimeter of a first end thereof that equals at least 200% of a second perimeter of a second end thereof, and (b) a second generally tubular stent-graft, and (ii) is configured for positioning the first end thereof in a descending aorta, and the second end thereof in one of the branches of an aortic arch, with the first lateral opening disposed in the aortic arch facing upstream; and

while the first stent-graft is in its radially-expanded state and the second stent-graft is in a radially-compressed state, disposing the second stent-graft through the first lateral opening, and causing the second stent-graft to transition to a radially-expanded state, such that the second stent-graft forms a blood-impervious seal with the first stent-graft around the first lateral opening.

28. The method according to claim 27,

wherein the first stent-graft includes exactly one first generally 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 the first lateral opening through the first stent-graft when the first stent-graft is in its radially-expanded state, and

wherein the second stent-graft includes exactly one second generally tubular support element and a second covering element attached to the second support element so as to at least partially cover the second support element, and the first and the second stent-grafts are configured such that the second covering element forms the blood-impervious seal with the first covering element around the first lateral opening when the second stent-graft is disposed therethrough, and the first and the second stent-grafts are in their radially-expanded states.

29. The method according to claim 28,

wherein disposing the second stent-graft through the first lateral opening comprises disposing the second stent-graft through the first lateral opening, such that 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.

30. The method according to claim 29, 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.

31. The method according to claim 29, 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.

32. The method according to claim 27, wherein the first perimeter equals at least 250% of the second perimeter.

33. The method according to claim 32, wherein the first perimeter equals at least 300% of the second perimeter.

34. The method according to claim 27, wherein the first perimeter is between 7.5 and 15 cm, and the second perimeter is between 2.5 and 5.7 cm.

35. The method according to claim 27, wherein, when the first stent-graft is unconstrained in its radially-expanded state, the first lateral opening perimeter is at least 40% of the first perimeter.

36. The method according to claim 27, wherein, when the first stent-graft is unconstrained in its radially-expanded state, the first lateral opening perimeter is at least 60% of the second perimeter.

37. The method according to claim 27, wherein causing the second stent-graft to transition to its radially-expanded state comprises causing the second stent-graft to transition, without inverting, from a radially-compressed state to its radially-expanded state.

38. The method according to claim 27,

wherein the first lateral opening is a superior first lateral opening,

wherein the first stent-graft is shaped so as to define the superior first lateral opening facing in a first radial direction, and an inferior first lateral opening facing a second radial direction generally opposite the first radial direction, and

wherein disposing the second stent-graft through the first lateral opening comprises disposing the second stent-graft through the first lateral opening such that the second stent-graft forms the blood-impervious seal with the first stent-graft around the superior first lateral opening when the second stent-graft is disposed therethrough, and the first and second stent-grafts are in their radially-expanded states.

39. The method according to claim 38,

wherein the superior first lateral opening is a proximal superior first lateral opening,

wherein the wherein the first stent-graft is shaped so as to further define a distal superior first lateral opening facing in the first radial direction, and

wherein the first perimeter equals at least 250% of the second perimeter.

40. The method according to claim 27,

wherein the second generally tubular stent-graft is shaped so as to define a second lateral opening having a second lateral opening perimeter, when in the radially-expanded state, and wherein the method further comprises:

providing a third generally tubular stent-graft, which is configured to assume a radially-expanded state; and

disposing the third stent-graft through the second lateral opening, and causing the third stent-graft to transition to its radially-expanded state such that the third stent-graft forms a blood-impervious seal with the second stent-graft around the second lateral opening.

41. The method according to claim 40,

wherein the first stent-graft includes exactly one first generally 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 the first lateral opening through the first stent-graft when the first stent-graft is in its radially-expanded state,

wherein the second stent-graft includes exactly one second generally tubular support element and a second covering element attached to the second support element so as to at least partially cover the second support element, and the second covering element and the second support element are shaped so as to together define the second lateral opening through the second stent-graft when the second stent-graft is in its radially-expanded state, and the first and the second stent-grafts are configured such that the second covering element forms the blood-impervious seal with the first covering element around the first lateral opening when the second stent-graft is disposed therethrough, and the first and the second stent-grafts are in their radially-expanded states, and

wherein the third stent-graft includes exactly one third generally tubular support element and a third covering element attached to the third support element so as to at least partially cover the third support element, and the second and the third stent-grafts are configured such that the third covering element forms the blood-impervious seal with the second covering element around the second lateral opening when the third stent-graft is disposed therethrough, and the second and third stent-grafts are in their radially-expanded states.

42. The method according to claim 41, wherein the first, the second, and the third covering elements are not fixed to one another when the first, the second, and the third stent-grafts are in their radially-compressed states.

43. The method according to claim 41, wherein disposing the third stent-graft through the second lateral opening comprises disposing the third stent-graft through the second lateral opening, such that when the third stent-graft is disposed through the second lateral opening and the second and the third stent-grafts are in their radially-expanded states:

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

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

60. The method according to claim 27, wherein, when the first stent-graft is unconstrained in its radially-expanded state, the first lateral opening perimeter is at least 4.5 cm.

61. The method according to claim 35, wherein, when the first stent-graft is unconstrained in its radially-expanded state, the first lateral opening perimeter is at least 75% of the first perimeter.

62. The method according to claim 27, wherein, when the first stent-graft is unconstrained in its radially-expanded state, a first cross-sectional area of the first end equals at least 400% of a second cross-sectional area of the second end.

63. The method according to claim 62, wherein, when the first stent-graft is unconstrained in its radially-expanded state, the first cross-sectional area equals at least 625% of the second cross-sectional area.

64. The method according to claim 63, wherein, when the first stent-graft is unconstrained in its radially-expanded state, the first cross-sectional area equals at least 900% of the second cross-sectional area.

65. The method according to claim 27, wherein the first stent-graft has exactly one first end opening defined by the proximal end, and exactly one second end opening defined by the distal end.

66. The method according to claim 27, wherein the first stent-graft has a generally curved longitudinal axis when unconstrained in its radially-expanded state.

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

a first generally tubular stent-graft, which, when unconstrained in a radially-expanded state;

(a) has a first perimeter of a first end thereof that equals at least 200% of a second perimeter of a second end thereof, and (b) defines a first lateral opening having a first lateral opening perimeter that equals at least 75% of the first perimeter of the first end; and

a second generally tubular stent-graft, which is configured to assume a radially-expanded state, wherein the first and the second stent-grafts are configured such that the second stent-graft forms a blood-impervious seal with the first stent-graft around the first lateral opening when the second stent-graft is disposed therethrough, and the first and second stent-grafts are in their radially-expanded states.

45. The apparatus according to claim 44, wherein the first stent-graft is configured for disposing the first lateral opening in an aortic arch facing upstream, generally toward an ascending aorta.

46. The apparatus according to claim 44, wherein, when the first stent-graft is unconstrained in its radially-expanded state, the first lateral opening perimeter is at least 4.5 cm.