ASCENDING AORTA STENT-GRAFT SYSTEM

• US 20160193029A1
• Filed: 05/18/2014
• Published: 07/07/2016
• Est. Priority Date: 05/23/2013
• Status: Abandoned Application

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: SHALEV, Alon
• Application Number:
  US14/893,201
• Publication Number:
  US 20160193029A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• 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 2002/075 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 2230/005 Rosette-shaped, e.g. star-shaped

Abstract

A generally tubular stent-graft (20) includes a generally tubular support element (30) and a covering element (32) that is attached to and at least partially covers the support element (30). When the stent-graft (20) is unconstrained in a radially-expanded state, a proximal end portion (40) of the covering element (32) is shaped so as to define at least first and second proximally-extending pieces (42A, 42B). When the stent-graft (20) is unconstrained in the radially-expanded state and the proximally-extending pieces (42A, 42B) are fully proximally extended, the proximally-extending pieces (42A, 42B) (a) are shaped so as to define respective distal bases (46), which (i) have respective base lengths (L1) measured circumferentially around the stent-graft (20), and (ii) circumferentially circumscribe respective base arcs (a) of between 100 and 140 degrees, (b) are shaped so as to define respective proximal-most portions (48) more proximal than all other respective portions of the covering element (32) that circumscribe the respective base arcs (a), and (c) have respective axial lengths (L2) that equal between 50% and 150% of the respective base lengths (L1).

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, a proximal end portion of the covering element is shaped so as to define at least first and second proximally-extending pieces,

wherein when the stent-graft is unconstrained in the radially-expanded state and the proximally-extending pieces are fully proximally extended, the proximally-extending pieces;

are shaped so as to define respective distal bases, which (a) have respective base lengths measured circumferentially around the stent-graft, and (b) circumferentially circumscribe respective base arcs, each of which base arcs has an angle of between 100 and 140 degrees,

are shaped so as to define respective proximal-most portions, which are more proximal than all other respective portions of the covering element that circumscribe the respective base arcs, and

have respective axial lengths, measured axially between the respective distal bases and the respective proximal-most portions, which lengths equal between 50% and 150% of the respective base lengths, and

wherein when the stent-graft is unconstrained in the radially-expanded state and the proximally-extending pieces are fully proximally extended, the first and the second proximally-extending pieces are shaped so as to define respective blood-flow paths therethrough, by;

the first and the second proximally-extending pieces being shaped so as to define respective fenestrations through the covering element, each of which fenestrations has an area of at least 6 mm2, or

the first and the second proximally-extending pieces being shaped so as to define respective scallops, which have respective axial lengths measured from respective distal-most portions of the scallops to the respective proximal most-portions of the respective proximally-extending pieces, each of which axial lengths is at least 7 mm.

2. The apparatus according to claim 1, wherein when fully proximally extended, the first and the second proximally-extending pieces have respective surface areas equal to at least 15% of the square of the respective base lengths.

4. The apparatus according to claim 1, wherein one or more proximal-most points of the covering element coincide with the proximal stent-graft end.

6. The apparatus according to claim 1, wherein the respective axial lengths of the proximally-extending piece are between 15 mm and 30 mm, when the stent-graft is unconstrained in the radially-expanded state and the proximally-extending pieces are fully proximally extended.

7. The apparatus according to claim 1, wherein the proximally-extending pieces are outwardly convex when the stent-graft is unconstrained in the radially-expanded state.

8. The apparatus according to claim 1, wherein the proximally-extending pieces are outwardly conically flared at an angle of between 10 and 30 degrees with a central longitudinal axis of the stent-graft, when the stent-graft is unconstrained in the radially-expanded state and the proximally-extending pieces are fully proximally extended.

9. The apparatus according to claim 1, wherein the first and the second proximally-extending pieces are shaped so as to define the respective fenestrations through the covering element.

10. The apparatus according to claim 9, comprising a multi-component stent-graft system, which comprises:

the stent-graft; and

first and second branching covered stents, which have respective end portions that are sized and configured to form blood-impervious seals with the fenestrations of the first and the second proximally-extending pieces of the stent-graft, respectively.

11. The apparatus according to claim 9, wherein one or more of the structural stent elements are attached to each of the first and the second proximally-extending pieces, such that at least a portion of the one or more of the structural stent elements is proximal to the fenestrations when the stent-graft is unconstrained in the radially-expanded state and the proximally-extending pieces are fully proximally extended.

14. The apparatus according to claim 9, wherein the fenestrations are circumferentially centered on the respective proximally-extending pieces when the stent-graft is unconstrained in the radially-expanded state and the proximally-extending pieces are fully proximally extended.

17. The apparatus according to claim 1, wherein the first and the second proximally-extending pieces are shaped so as to define the respective scallops.

18. The apparatus according to claim 17, wherein one or more of the structural stent elements are attached to each of the first and the second proximally-extending pieces such that respective portions of at least one of the one or more of the structural stent elements traverse the scallops when the stent-graft is unconstrained in the radially-expanded state and the proximally-extending pieces are fully proximally extended.

19. The apparatus according to claim 1, wherein the first and the second proximally-extending pieces are shaped as first and second lobes, respectively, when the stent-graft is unconstrained in the radially-expanded state and the proximally-extending pieces are fully proximally extended.

20. The apparatus according to claim 19, wherein the first and the second lobes are semicircular, when the stent-graft is unconstrained in the radially-expanded state and the lobes are fully proximally extended.

24. The apparatus according to claim 1, wherein an arc between circumferentially nearest portions of the first and the second proximally-extending pieces has an angle of no more than 50 degrees, when the stent-graft is unconstrained in the radially-expanded state.

26. The apparatus according to claim 1,

wherein when the stent-graft is unconstrained in the radially-expanded state, the proximal end portion of the covering element is shaped so as to define a third proximally-extending piece, and

wherein when the stent-graft is unconstrained in the radially-expanded state and the third proximally-extending piece is fully proximally extended, the third proximally-extending piece:

is shaped so as to define a third distal base, which (a) has a third base length measured circumferentially around the stent-graft, and (b) circumferentially circumscribes a third base arc, which third base arc has an angle of between 100 and 140 degrees,

is shaped so as to define a third proximal-most portion, which is more proximal than all other portions of the covering element that circumscribe the third base arc, and

has a third axial length, measured axially between the third distal base and the third proximal-most portion, which length equals between 50% and 150% of the third base length.

27. The apparatus according to claim 26,

wherein the first and the second proximally-extending pieces are shaped so as to define the respective fenestrations through the covering element, and

wherein the third proximally-extending piece is not shaped so as to define any fenestrations through the covering element.

28. The apparatus according to claim 26,

wherein the first and the second proximally-extending pieces are shaped so as to define the respective scallops, and

wherein the third proximally-extending piece is not shaped so as to define any scallops.

29. The apparatus according to claim 1, further comprising a delivery tool, which (a) is configured to convey the stent-graft in the radially-compressed state to a target location in vasculature of a subject, and deploy the stent-graft at the target location, and (b) comprises:

at least one inner shaft, which is shaped so as to define a primary bore and first and second secondary bores therethrough; and

an external sheath,

wherein the stent-graft is removably positioned, while in the radially-compressed state, within the external sheath, such that the distal stent-graft end surrounds an axial portion of the at least one inner shaft, and

wherein the delivery tool is configured such that axial translation of the external sheath facilitates a transition of the stent-graft from the radially-compressed state to the radially-expanded state.

30. The apparatus according to claim 29,

wherein the at least one inner shaft comprises:

a primary inner shaft, which is shaped so as to define the primary bore therethrough; and

first and second secondary inner shafts, which are shaped so as to define the first and the second secondary bores therethrough, respectively, and

wherein the stent-graft is removably positioned, while in the radially-compressed state, within the external sheath, such that (a) the distal stent-graft end surrounds respective axial portions of the primary inner shaft and the first and the second secondary inner shafts, (b) the proximal stent-graft end surrounds an axial portion of the primary inner shaft, and (c) the first and the second secondary inner shafts extend proximally beyond the proximal stent-graft end.

31. The apparatus according to claim 30,

wherein the first and the second proximally-extending pieces are shaped so as to define the respective first and second fenestrations through the covering element, and

wherein the first and the second secondary inner shafts pass through the first and the second fenestrations, respectively, when the stent-graft is removably positioned such that the first and the second secondary inner shafts extend proximally beyond the proximal stent-graft end.

32. The apparatus according to claim 30,

wherein the first and the second proximally-extending pieces are shaped so as to define the respective first and second scallops, and

wherein the first and the second secondary inner shafts pass through the first and the second scallops, respectively, when the stent-graft is removably positioned such that the first and the second secondary inner shafts extend proximally beyond the proximal stent-graft end.

33. The apparatus according to claim 30,

wherein the delivery tool further comprises a proximal tip coupled to a proximal end portion of the primary inner shaft, and

wherein an external surface of the proximal tip is shaped so as to define first and second grooves, which (a) extend axially along at least an axial portion of the tip, and (b) are shaped and sized so as to reversibly receive respective proximal end portions of the first and the second secondary inner shafts.

34. The apparatus according to claim 30, wherein the delivery tool further comprises at least one stent-graft support member which is securely fixed to an external surface of the primary inner shaft, and which is configured to prevent distal axial translation of the stent-graft as the external sheath is distally axially translated to facilitate the transition of the stent-graft from the radially-compressed state to the radially-expanded state.

77. The apparatus according to claim 9, wherein each of the fenestrations has an area of no more than 35 mm2 when the stent-graft is unconstrained in the radially-expanded state and the proximally-extending pieces are fully proximally extended.

3. (canceled)

5. (canceled)

12-13. -13. (canceled)

15-16. -16. (canceled)

21-23. -23. (canceled)

25. (canceled)

35-63. -63. (canceled)

64. A method comprising:

providing a generally tubular stent-graft, which has distal and proximal stent-graft ends and includes;

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

(b) 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, a proximal end portion of the covering element is shaped so as to define at least first and second proximally-extending pieces, and wherein when the stent-graft is unconstrained in the radially-expanded state and the proximally-extending pieces are fully proximally extended, the proximally-extending pieces;

(i) are shaped so as to define respective distal bases, which (a) have respective base lengths measured circumferentially around the stent-graft, and (b) circumferentially circumscribe respective base arcs, each of which base arcs has an angle of between 100 and 140 degrees, (ii) are shaped so as to define respective proximal-most portions, which are more proximal than all other respective portions of the covering element that circumscribe the respective base arcs, and (iii) have respective axial lengths, measured axially between the respective distal bases and the respective proximal-most portions, which lengths equal between 50% and 150% of the respective base lengths; and

implanting the stent-graft in an ascending aorta of a subject, such that (a) the proximal stent-graft end is between an aortic valve of the subject and the distal stent-graft end, and (b) the proximal-most portions of the proximally-extending pieces are positioned in respective aortic sinuses of the subject.

65. The method according to claim 64,

wherein providing the stent-graft comprises providing the stent-graft in which the first and the second proximally-extending pieces are shaped so as to define respective fenestrations through the covering element, each of which fenestrations has an area of at least 6 mm2 when the stent-graft is unconstrained in the radially-expanded state and the proximally-extending pieces are fully proximally extended, and

wherein implanting the stent-graft comprises implanting the stent-graft such that the fenestrations are aligned with left and right coronary ostia of the subject, respectively.

66. The method according to claim 65, further comprising:

providing first and second branching covered stents; and

implanting the first and the second branching covered stents in left and right coronary arteries of the subject, respectively, and coupling respective end portions thereof to form blood-impervious seals with the fenestrations of the first and the second proximally-extending pieces of the stent-graft, respectively.

67. The method according to claim 64, wherein providing the stent-graft comprises providing the stent-graft in which the first and the second proximally-extending pieces are shaped so as to define respective scallops, which have respective axial lengths measured from respective distal-most portions of the scallops to the respective proximal most-portions of the respective proximally-extending pieces, each of which axial lengths is at least 7 mm when the stent-graft is unconstrained in the radially-expanded state and the proximally-extending pieces are fully proximally extended, and

wherein implanting the stent-graft comprises implanting the stent-graft such that the scallops are aligned with left and right coronary ostia of the subject, respectively.

68. The method according to claim 64,

wherein providing the stent-graft comprises providing the stent-graft in which, when the stent-graft is unconstrained in the radially-expanded state, the proximal end portion of the covering element is shaped so as to define a third proximally-extending piece, and wherein when the stent-graft is unconstrained in the radially-expanded state and the third proximally-extending piece is fully proximally extended, the third proximally-extending piece:

(i) is shaped so as to define a third distal base, which (a) has a third base length measured circumferentially around the stent-graft, and (b) circumferentially circumscribes a third base arc, which third base arc has an angle of between 100 and 140 degrees, (ii) is shaped so as to define a third proximal-most portion, which is more proximal than all other portions of the covering element that circumscribe the third base arc, and (iii) has a third axial length, measured axially between the third distal base and the third proximal-most portion, which length equals between 50% and 150% of the third base length, and

wherein implanting comprises implanting the stent-graft in the ascending aorta, such that the third proximal-most portion is positioned in an aortic sinus of the subject other than the aortic sinuses in which the first and the second proximally-extending pieces are positioned.

69. The method according to claim 64, wherein implanting the stent-graft comprises:

using a delivery tool, advancing the stent-graft to the ascending aorta while removably positioned in the radially-compressed state within an external sheath of the delivery tool, such that the distal stent-graft end surrounds an axial portion of at least one inner shaft of the delivery tool, which at least one inner shaft is shaped so as to define a primary bore and first and second secondary bores therethrough; and

deploying the stent-graft in the ascending aorta by axially translating the external sheath so as to transition the stent-graft from the radially-compressed state to the radially-expanded state.

70. The method according to claim 69,

wherein the at least one inner shaft includes a primary inner shaft, which is shaped so as to define the primary bore therethrough, and first and second secondary inner shafts, which are shaped so as to define the first and the second secondary bores therethrough, respectively, and

wherein advancing the stent-graft comprises advancing the stent-graft while removably positioned in the radially-compressed state within the external sheath, such that (a) the distal stent-graft end surrounds respective axial portions of the primary inner shaft and the first and the second secondary inner shafts, (b) the proximal stent-graft end surrounds an axial portion of the primary inner shaft, and (c) the first and the second secondary inner shafts extend proximally beyond the proximal stent-graft end.

71. The method according to claim 70,

wherein the first and the second proximally-extending pieces are shaped so as to define respective first and second fenestrations through the covering element, and

wherein advancing the stent-graft comprises advancing the stent-graft while removably positioned in the radially-compressed state within the external sheath, such that the first and the second secondary inner shafts pass through the first and the second fenestrations, respectively.

72. The method according to claim 70,

wherein the first and the second proximally-extending pieces are shaped so as to define respective first and second scallops, and

wherein advancing the stent-graft comprises advancing the stent-graft while removably positioned in the radially-compressed state within the external sheath, such that the first and the second secondary inner shafts pass through the first and the second scallops, respectively.

73. The method according to claim 70,

wherein the delivery tool further includes a proximal tip coupled to a proximal end portion of the primary inner shaft,

wherein an external surface of the proximal tip is shaped so as to define first and second grooves, which (a) extend axially along at least an axial portion of the tip, and (b) are shaped and sized so as to reversibly receive respective proximal end portions of the first and the second secondary inner shafts, and

wherein advancing the stent-graft comprises advancing the stent-graft while the proximal end portion of the first and the second secondary inner shafts are reversibly positioned at least partially within the first and the second grooves, respectively.

74. The method according to claim 70, wherein the delivery tool further includes at least one stent-graft support member which is securely fixed to an external surface of the primary inner shaft, and which is configured to prevent distal axial translation of the stent-graft as the external sheath is distally axially translated to facilitate the transition of the stent-graft from the radially-compressed state to the radially-expanded state.

75-76. -76. (canceled)