Branched stent-graft system

• US 9,597,204 B2
• Filed: 12/04/2012
• Issued: 03/21/2017
• Est. Priority Date: 12/04/2011
• Status: Active Grant

• Current Assignee: Japan Lifeline Co., Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Benary, Raphael, Shalev, Alon, Nae, Nir Shalom
• Primary Examiner(s): Sevilla, Christian
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US14/362,194
• Publication Number:
  US 20140350658A1
• Time in Patent Office: 1,568 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• 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 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

An endovascular stent-graft (10) includes a generally tubular hourglass-shaped body (22), which is configured to assume a radially-compressed delivery configuration and a radially-expanded deployment configuration. The hourglass-shaped body (22) includes a flexible stent member (26), which includes a plurality of structural stent elements (28); and a tubular fluid flow guide (24), which includes a fabric (29), and is attached to the structural stent elements (28). The hourglass-shaped body (22) is shaped so as to define a narrow waist portion (32) longitudinally surrounded by and adjacent to wider first and second longitudinal portions (30, 34). The fabric (29) along the waist portion (32) is shaped so as to define at least first and second lateral apertures (36, 38). Other embodiments are also described.

Claims

1. Apparatus comprising an endovascular stent-graft, which (a) is configured to assume a radially-compressed delivery configuration and a radially-expanded deployment configuration, and (b) comprises a generally tubular hourglass-shaped body, which comprises:

a flexible stent member, which comprises a plurality of structural stent elements; and

a tubular fluid flow guide, which comprises a fabric, and is attached to the structural stent elements,

wherein, when the stent-graft is in the radially-expanded deployment configuration, the hourglass-shaped body is shaped so as to define a narrow waist portion longitudinally surrounded by and adjacent to wider first and second longitudinal portions of the hourglass-shaped body,

wherein the fabric along the narrow waist portion is shaped so as to define at least first and second lateral apertures, and

wherein the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is configured to assume an intermediate deployment configuration, in which (a) the hourglass-shaped body is shaped so as to define the narrow waist portion surrounded by and adjacent to the wider first and second longitudinal portions, and (b) an average diameter of the narrow waist portion is at least 10% less than when the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the radially-expanded deployment configuration.

2. The apparatus according to claim 1, further comprising an endovascular angioplasty balloon comprising a proximal lobe and a distal lobe and a radiopaque marker positioned therebetween, wherein the proximal and distal lobes of the balloon are sized to be expandable to at least 10% greater than a greater of (a) a diameter of the first lateral aperture and (b) a diameter of the second lateral aperture.

3. The apparatus according to claim 1, wherein the apparatus further comprises a releasable latching mechanism, which is configured to assume a latched state in which the mechanism confines the structural stent elements of the narrow waist portion in the intermediate deployment configuration.

4. The apparatus according to claim 3, wherein the releasable latching mechanism is configured to effect a transition of the narrow waist portion from the intermediate deployment configuration to the radially-expanded deployment configuration upon a triggering event.

5. The apparatus according to claim 4, wherein the triggering event is an exertion of outward radial pressure inside the narrow waist portion.

6. The apparatus according to claim 4, wherein the releasable latching mechanism comprises a longitudinal latching shaft that passes along at least a portion of a central longitudinal axis of the hourglass-shaped body, and wherein the triggering event is a generally axial translation of the longitudinal latching shaft.

7. The apparatus according to claim 4, wherein the releasable latching mechanism comprises a longitudinal latching shaft that passes along at least a portion of a central longitudinal axis of the hourglass-shaped body, and wherein the triggering event is a generally rotational translation of the longitudinal latching shaft.

8. The apparatus according to claim 1, wherein the fabric along the first longitudinal portion is shaped so as to define at least one superior scallop, the superior scallop being characterized by a width and a height, when the stent-graft, including the hourglass-shaped body, is in the radially-expanded deployment configuration.

9. The apparatus according to claim 8, wherein the superior scallop is disposed so as to define a superior scallop arc angle around a central longitudinal axis of the hourglass-shaped body between (a) a center of the superior scallop and (b) a midpoint of an arc angle between respective centers of the first and the second lateral apertures, the superior scallop arc angle being less than 60 degrees when the stent-graft, including the hourglass-shaped body, is in the radially-expanded deployment configuration.

10. The apparatus according to claim 8, wherein the width of the superior scallop is between 5 and 12 mm.

11. The apparatus according to claim 8, wherein the height of the superior scallop is between 5 and 25 mm.

12. The apparatus according to claim 1,

wherein, when the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the radially-expanded deployment configuration, the narrow waist portion defines a first angle between (a) a line perpendicular to a plane defined by the first lateral aperture and (b) a central longitudinal axis of the hourglass-shaped body,

wherein, when the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the intermediate deployment configuration, the narrow waist portion defines a second angle between (a) a line perpendicular to a plane defined by the first lateral aperture and (b) the central longitudinal axis, and

wherein the second angle is less than the first angle.

13. The apparatus according to claim 1, wherein the first and the second lateral apertures are less sideways-facing when the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the intermediate deployment configuration than when the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the radially-expanded deployment configuration.

14. The apparatus according to claim 1, wherein greatest respective diameters of the first and the second longitudinal portions of the hourglass-shaped body remain constant (a) when the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the radially-expanded deployment configuration, and (b) when the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the intermediate deployment configuration.

15. A method comprising:

providing an endovascular stent-graft, which includes a generally tubular hourglass-shaped body, which includes (a) a flexible stent member, which includes a plurality of structural stent elements, and (b) a tubular fluid flow guide, which comprises a fabric, and is attached to the structural stent elements;

transvascularly introducing the stent-graft into a blood vessel of a human subject while the stent-graft, including the hourglass-shaped body, is in a radially-compressed delivery configuration;

thereafter, transitioning the stent-graft, including the hourglass-shaped body, to an intermediate deployment configuration, in which the hourglass-shaped body is shaped so as to define a narrow waist portion longitudinally surrounded by and adjacent to wider first and second longitudinal portions of the hourglass-shaped body, and the fabric along the second portion is shaped so as to define at least first and second lateral apertures; and

thereafter, transitioning the stent-graft, including the hourglass-shaped body, to a radially-expanded deployment configuration in the blood vessel, in which radially-expanded configuration the hourglass-shaped body is shaped so as to define the narrow waist portion longitudinally surrounded by and adjacent to the wider first and second longitudinal portions, and the fabric along the second portion is shaped so as to define at least the first and the second lateral apertures,

wherein, when the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the intermediate deployment configuration, an average diameter of the narrow waist portion is at least 10% less than when the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the radially-expanded deployment configuration.

16. The method according to claim 15,

wherein the method further comprises inserting first and second guidewires into the stent-graft and out of the first and the second lateral apertures, respectively, while the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the intermediate deployment configuration,

wherein transitioning the stent-graft, including the hourglass-shaped body, to the radially-expanded deployment configuration comprises transitioning the stent-graft, including the hourglass-shaped body, to the radially-expanded deployment configuration with the first and the second two guidewires still passing through the first and the second lateral apertures, and

wherein the method further comprises subsequently deploying first and second branching stent-grafts through the first and the second lateral apertures, respectively, using the first and the second guidewires, respectively.

17. The method according to claim 15,

wherein, when the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the radially-expanded deployment configuration, the narrow waist portion defines a first angle between (a) a line perpendicular to a plane defined by the first lateral aperture and (b) a central longitudinal axis of the hourglass-shaped body,

wherein, when the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the intermediate deployment configuration, the narrow waist portion defines a second angle between (a) a line perpendicular to a plane defined by the first lateral aperture and (b) the central longitudinal axis, and

wherein the second angle is less than the first angle.

18. The method according to claim 15, wherein the first and the second lateral apertures are less sideways-facing when the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the intermediate deployment configuration than when the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the radially-expanded deployment configuration.

19. The method according to claim 15, wherein greatest respective diameters of the first and the second longitudinal portions of the hourglass-shaped body remain constant (a) when the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the radially-expanded deployment configuration, and (b) when the stent-graft, including the hourglass-shaped body, including the narrow waist portion, is in the intermediate deployment configuration.

20. The method according to claim 15, wherein transitioning the stent-graft, including the hourglass-shaped body, to the intermediate deployment configuration comprises providing a releasable latching mechanism in a latched state in which the mechanism confines the structural stent elements of the narrow waist portion in the intermediate deployment configuration.

21. The method according to claim 20, wherein transitioning the stent-graft, including the hourglass-shaped body, to the radially-expanded deployment configuration comprises triggering the releasable latching mechanism to effect a transition of the narrow waist portion from the intermediate deployment configuration to the radially-expanded deployment configuration.

22. The method according to claim 21, wherein triggering the releasable latching mechanism comprises exerting outward radial pressure inside the narrow waist portion.

23. The method according to claim 21, wherein the releasable latching mechanism includes a longitudinal latching shaft that passes along at least a portion of a central longitudinal axis of the hourglass-shaped body, and wherein triggering the releasable latching mechanism comprises generally axially translating the longitudinal latching shaft.

24. The method according to claim 21, wherein the releasable latching mechanism includes a longitudinal latching shaft that passes along at least a portion of a central longitudinal axis of the hourglass-shaped body, and wherein triggering the releasable latching mechanism comprises generally rotationally translating the longitudinal latching shaft.

25. The method according to claim 15, further comprising, after transitioning the stent-graft, including the hourglass-shaped body, to the radially-expanded deployment configuration, inflating, inside the stent-graft, an endovascular angioplasty balloon that includes a proximal lobe and a distal lobe and a radiopaque marker positioned therebetween, wherein the proximal and distal lobes of the balloon are sized to be expandable to at least 10% greater than a greater of (a) a diameter of the first lateral aperture and (b) a diameter of the second lateral aperture.

26. The method according to claim 15, wherein the fabric along the first longitudinal portion is shaped so as to define at least one superior scallop, the superior scallop being characterized by a width and a height, when the stent-graft, including the hourglass-shaped body, is in the radially-expanded deployment configuration.

27. The method according to claim 26, wherein the superior scallop is disposed so as to define a superior scallop arc angle around a central longitudinal of the hourglass-shaped body axis between (a) a center of the superior scallop and (b) a midpoint of an arc angle between respective centers of the first and the second lateral apertures, the superior scallop arc angle being less than 60 degrees when the stent-graft, including the hourglass-shaped body, is in the radially-expanded deployment configuration.

28. The method according to claim 26, wherein the width of superior scallop is between 5 and 12 mm.

29. The method according to claim 26, wherein the height of superior scallop is between 5 and 25 mm.