Reduced-strain extra-vascular ring for treating aortic aneurysm

• US 9,486,341 B2
• Filed: 03/01/2012
• Issued: 11/08/2016
• Est. Priority Date: 03/02/2011
• Status: Active Grant

• Current Assignee: Japan Lifeline Co., Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon
• Primary Examiner(s): McEvoy, Thomas
• Application Number:
  US14/001,641
• Publication Number:
  US 20140052236A1
• Time in Patent Office: 1,713 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 2/93 circumferentially expandable by using ratcheting locks
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• 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 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

Apparatus (10) is provided that includes an extra-vascular ring (12) and an endo vascular stent-graft (14). The ring (12) comprises a structural member (30), which is configured to assume an elongate hollow shape (32), which has first and second longitudinal ends (40, 42), and is suitable for placement at least partially around an aorta (20) so as to provide a generally cylindrical landing zone. The endovascular stent-graft (14) is suitable for endovascular placement inside the aorta (20) such that a portion of the stent-graft (14) is positioned against an internal wall of the aorta (20) at the landing zone provided by the structural member (30). If the structural member (30) is unrolled to a planar shape (82), one side (90) of the planar shape (82) is defined by the first longitudinal end (40), and at least the first longitudinal end (40) has a profile that defines a series of curved portions and has no singularities or discontinuities, which profile extends along at least 50% of the first longitudinal end (40).

Claims

1. Apparatus for attachment to an aorta of a patient, the apparatus comprising:

an extra-vascular ring, which comprises a structural member, which is configured to assume, when in a relaxed state, an elongate hollow shape, which (a) has first and second longitudinal ends that are curved at least partially around a longitudinal axis defined by the elongate hollow shape, and (b) is suitable for placement at least partially around the aorta so as to provide a generally cylindrical landing zone; and

an endovascular stent-graft, which is suitable for endovascular placement inside the aorta such that a portion of the endovascular stent-graft is positioned against an internal wall of the aorta at the landing zone provided by the structural member,

wherein, if the structural member is unrolled to a planar shape, one side of the planar shape is defined by the first longitudinal end of the structural member, and at least the first longitudinal end has a profile that defines a series of curved portions and has no singularities or discontinuities, which profile extends along at least 50% of the first longitudinal end, wherein the profile is a corrugated profile that defines a series of smooth undulations that are shaped so as to define alternating curved peaks and curved valleys, which curved peaks extend in a direction away from the second longitudinal end and have a radius of curvature equal to at least 3% of a length of the first longitudinal end,

wherein the length of the first longitudinal end is measured around the longitudinal axis when the structural member is in the relaxed state, and

wherein the structural member comprises a plurality of stent struts, and wherein, if the structural member is unrolled to the planar shape, at least one of the stent struts extends completely alongside at least two of the undulations, such that the strut substantially prevents longitudinal stretching of the at least two of the undulations.

2. The apparatus according to claim 1, wherein the corrugated profile has a substantially sinusoidal form.

3. The apparatus according to claim 1, wherein the at least one of the stent struts geometrically encompasses at least one straight line segment that is parallel to the one side and extends completely alongside the at least two of the undulations, when the structural member has the planar shape.

4. The apparatus according to claim 1, wherein the at least one of the stent struts is straight when the structural member has the planar shape.

5. The apparatus according to claim 1, wherein, when the structural member has the planar shape, the at least one stent strut has a length, measured in a direction parallel to the one side, equal to at least 90% of a length of the one side.

6. The apparatus according to claim 1, wherein the profile defines the series of curves interspersed with one or more straight portions.

7. The apparatus according to claim 1,

wherein, if the structural member is unrolled to the planar shape, the length of the first longitudinal end is equal to between 30 and 120 mm, and

wherein the elongate hollow shape has a longitudinal length, measured parallel to the longitudinal axis of the elongate hollow shape, that equals between 10 and 40 mm.

8. The apparatus according to claim 1,

wherein the structural member, when having the elongate hollow shape, is shaped so as to define a gap that extends longitudinally along an entire longitudinal length of the elongate hollow shape from the first longitudinal end to the second longitudinal end, and

wherein the structural member is shaped so as to define (a) a first extension, which first extension defines at least one slot, and (b) a second extension, which is shaped so as to define a tab adapted to fit into the at least one slot, such that inserting the tab into the slot closes the gap.

9. The apparatus according to claim 1,

wherein the structural member, when having the elongate hollow shape, is shaped so as to define a gap that extends longitudinally along an entire longitudinal length of the elongate hollow shape from the first longitudinal end to the second longitudinal end, and

wherein the extra-vascular ring further comprises one or more fastening elements for closing the gap.

10. The apparatus according to claim 1, further comprising a hollow, generally tubular delivery shaft, in which the extra-vascular ring is removably disposed with the structural member in a deformed state.

11. The apparatus according to claim 1, wherein the structural member comprises a shape memory material, which is heat-set to assume the elongate hollow shape.

12. A method comprising:

providing an extra-vascular ring, which includes a structural member, which is configured to assume, when in a relaxed state, an elongate hollow shape, which has first and second longitudinal ends that are curved at least partially around a longitudinal axis defined by the elongate hollow shape, wherein, if the structural member is unrolled to a planar shape, one side of the planar shape is defined by the first longitudinal end of the structural member, and at least the first longitudinal end has a profile that defines a series of curved portions and has no singularities or discontinuities, which profile extends along at least 50% of the first longitudinal end;

wherein the profile is a corrugated profile that defines a series of smooth undulations that are shaped so as to define alternating curved peaks and curved valleys, which curved peaks extend in a direction away from the second longitudinal end and have a radius of curvature equal to at least 3% of a length of the first longitudinal end;

wherein the length of the first longitudinal end is measured around the longitudinal axis when the structural member is in the relaxed state; and

wherein the structural member comprises a plurality of stent struts; and

wherein, if the structural member is unrolled to the planar shape, at least one of the stent struts extends completely alongside at least two of the undulations, such that the strut substantially prevents longitudinal stretching of the at least two of the undulations;

placing the extra-vascular ring at least partially around a neck of an aneurysmal aorta of a patient so as to provide a generally cylindrical landing zone, such that the profile homogenously distributes strain on aortic tissue at the first longitudinal end of the structural member; and

placing an endovascular stent-graft inside the aorta such that a portion of the endovascular stent-graft is positioned against an internal wall of the neck at the landing zone provided by the structural member.

13. The method according to claim 12,

wherein placing the extra-vascular ring comprises advancing, to an external surface of the aorta, a hollow, generally tubular delivery shaft, in which the extra-vascular ring is removably disposed with the structural member in a deformed state, and

wherein advancing the delivery shaft comprises advancing the delivery shaft through a laparoscopic working channel to an abdominal location adjacent to renal arteries of the aorta, and laparoscopically placing the extra-vascular stent around the neck of the abdominal aorta in a vicinity of the renal arteries.

14. The method according to claim 12, wherein providing the extra-vascular ring comprises providing the extra-vascular ring in which the corrugated profile has a substantially sinusoidal form.

15. The method according to claim 12, wherein providing the extra-vascular ring comprises providing the extra-vascular ring in which the at least one of the stent struts geometrically encompasses at least one straight line segment that is parallel to the one side and extends completely alongside the at least two of the undulations, when the structural member has the planar shape.

16. The method according to claim 12, wherein providing the extra-vascular ring comprises providing the extra-vascular ring in which the at least one of the stent struts is straight when the structural member has the planar shape.

17. The method according to claim 12, wherein providing the extra-vascular ring comprises providing the extra-vascular ring in which, when the structural member has the planar shape, the at least one stent strut has a length, measured in a direction parallel to the one side, equal to at least 90% of a length of the one side.

18. The method according to claim 12, wherein providing the extra-vascular ring comprises providing the extra-vascular ring in which the profile defines the series of curved portions interspersed with one or more straight portions.

19. The method according to claim 12, wherein placing the extra-vascular ring comprises advancing, to an external surface of the aorta, a hollow, generally tubular delivery shaft, in which the extra-vascular ring is removably disposed with the structural member in a deformed state.

20. The method according to claim 12, wherein placing the extra-vascular ring comprises identifying the patient as suffering from an aneurysm of an abdominal aorta, and treating the aortic aneurysm by placing the extra-vascular ring at least partially around the neck of the abdominal aorta.

21. The method according to claim 12, wherein providing the extra-vascular ring comprises providing the extra-vascular ring in which the structural member comprises a shape memory material, which is heat-set to assume the elongate hollow shape.