Triple-collar stent-graft

• US 9,427,339 B2
• Filed: 10/29/2012
• Issued: 08/30/2016
• Est. Priority Date: 10/30/2011
• Status: Active Grant

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US14/355,438
• Publication Number:
  US 20140288635A1
• Time in Patent Office: 1,401 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 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2250/006 modular

Abstract

An endovascular stent-graft (20, 120, 180, 220, 320) includes a fluid flow guide (22), and a plurality of structural stent elements (24) attached to at least a portion of the fluid flow guide (22). The stent-graft is configured to define a generally tubular foldable section (30), which comprises first, second, and third subsections (32, 34, 36). The stent-graft is configured to assume a delivery configuration and a deployment configuration. In the delivery configuration, (a) the stent-graft, including the foldable section (30), is in a radially-compressed state, and (b) the foldable section (30) is in a longitudinally-expanded state, in which state the first and the third subsections (32, 36) longitudinally surround the second subsection (34). In the deployment configuration, (a) the stent-graft, including the foldable section (30), is in a radially-expanded state, and (b) the foldable section (30) is in a longitudinally-folded state, such that the second subsection (34) is radially sandwiched between the first and the third subsections (32, 36). Other embodiments are also described.

Claims

1. Apparatus comprising:

an endovascular stent-graft, which comprises;

(a) a fluid flow guide; and

(b) a plurality of structural stent elements attached to at least a portion of the fluid flow guide; and

an elongated delivery tool,

wherein the stent-graft is configured (a) to define a generally tubular foldable section, which comprises first, second, and third subsections, and (b) to assume;

a delivery configuration, when disposed in the elongated delivery tool, in which delivery configuration (a) the stent-graft, including the foldable section, is in a radially-compressed state, and (b) the foldable section is in a longitudinally-expanded state, in which state the first and the third subsections longitudinally surround the second subsection, and

a deployment configuration, in which (a) the stent-graft, including the foldable section, is in a radially-expanded state, and (b) the foldable section is in a longitudinally-folded state, such that the second subsection is radially sandwiched between the first and the third subsections.

2. The apparatus according to claim 1, wherein an average surface coverage ratio of the structural stent elements on the fluid flow guide along the second subsection is no more than 20% of the greater of (a) an average surface coverage ratio of the structural stent elements of the fluid flow guide along the first subsection and (b) an average surface coverage ratio of the structural stent elements on the fluid flow guide along the third subsection.

3. The apparatus according to claim 1,

wherein a first subgroup of the structural stent elements is attached to the first subsection, and a second subgroup of the structural stent elements is attached to the third subsection, and

wherein one of the first and the second subgroups of the structural stent elements is attached to an internal surface of the fluid flow guide, and the other of the first and the second subgroups is attached to an external surface of the fluid flow guide.

4. The apparatus according to claim 1, wherein, when the stent-graft is in the delivery configuration, the first and the second subsections are arranged longitudinally contiguously, and the second and the third subsections are arranged longitudinally contiguously.

5. The apparatus according to claim 1, wherein a first subgroup of the structural stent elements are attached to the fluid flow guide along the first subsection, and at least partially curves inwardly, when the foldable section is in the longitudinally-folded state.

6. The apparatus according to claim 1, wherein a second subgroup of the structural stent elements are attached to the fluid flow guide along the third subsection, and at least partially curves inwardly, when the foldable section is in the longitudinally-folded state.

7. The apparatus according to claim 1, wherein first and second subgroups of the structural stent elements are attached to the fluid flow guide along the first and the third subsections, respectively, and wherein the first and the second subgroups are shaped to interlock the first and the third subsections when the foldable section is in the longitudinally-folded state.

8. The apparatus according to claim 1,

wherein the stent-graft is a first stent-graft,

wherein the apparatus further comprises a second stent-graft, which is shaped so as to define a side-facing fenestration, and

wherein the foldable section of the first stent-graft is dimensioned to be fixed to the side-facing fenestration, when the second stent-graft is in a radially-expanded state and the foldable section is in the longitudinally-folded state.

9. The apparatus according to claim 1, wherein the stent-graft further comprises a plurality of circumferentially-disposed radiopaque markers.

10. The apparatus according to claim 9,

wherein the first subsection has first and second longitudinal edges,

wherein the second subsection has third and fourth longitudinal edges,

wherein the third subsection has fifth and sixth longitudinal edges,

wherein the second edge joins the third edge,

wherein the fourth edge joins the fifth edge, and

wherein a first subset of the radiopaque markers are disposed near the first edge of the first subsection, and a second subset of the radiopaque markers are disposed near the fifth edge of the third subsection.

11. The apparatus according to claim 1, wherein the elongated delivery tool comprises:

a tubular external shaft; and

an internal shaft, which is slidably disposed within the external shaft,

wherein the stent-graft is initially disposed, in the delivery configuration, between the external and the internal shafts of the delivery tool, in a vicinity of a distal end of the external shaft.

12. The apparatus according to claim 11, wherein the delivery tool further comprises a stopper member fixed to the internal shaft, which is initially disposed proximally adjacent the stent-graft, thereby preventing proximal movement of the stent-graft inside the delivery tool when the external shaft is withdrawn proximally relative to the internal shaft.

13. The apparatus according to claim 1, wherein the foldable section is configured, when in the longitudinally-folded state, to provide blood-flow sealing between the longitudinally-folded foldable section and a wall of a blood vessel, so as to reduce a risk of type I endoleak.

14. A method comprising:

providing an endovascular stent-graft, which includes a fluid flow guide, and a plurality of structural stent elements attached to at least a portion of the fluid flow guide, wherein the stent-graft is configured to define a generally tubular foldable section, which comprises first, second, and third subsections;

transvascularly introducing the stent-graft into a blood vessel of a human subject while the stent-graft is disposed in an elongated delivery tool in a delivery configuration, in which (a) the stent-graft, including the foldable section, is in a radially-compressed state, and (b) the foldable section is in a longitudinally-expanded state, in which state the first and the third subsections longitudinally surround the second subsection; and

thereafter, transitioning the stent-graft to a deployment configuration in the blood vessel, in which configuration (a) the stent-graft, including the foldable section, is in a radially-expanded state, and (b) the foldable section is in a longitudinally-folded state, such that the second subsection is radially sandwiched between the first and the third subsections.

15. The method according to claim 14, wherein providing the stent-graft comprises providing the stent-graft in which an average surface coverage ratio of the structural stent elements of the structural stent elements on the fluid flow guide along the second subsection is no more than 20% of the greater of (a) an average surface coverage ratio of the structural stent elements on the fluid flow guide along the first subsection and (b) an average surface coverage ratio of the structural stent elements on the fluid flow guide along the third subsection.

16. The method according to claim 14, wherein providing the stent-graft comprises providing the stent-graft in which:

a first subgroup of the structural stent elements is attached to the first subsection, a second subgroup of the structural stent elements is attached to the third subsection, one of the first and the second subgroups of the structural stent elements is attached to an internal surface of the fluid flow guide, and the other of the first and the second subgroups is attached to an external surface of the fluid flow guide.

17. The method according to claim 14, wherein transitioning comprises transitioning the stent-graft to the deployment configuration in which the first and the second subsections are arranged longitudinally contiguously, and the second and the third subsections are arranged longitudinally contiguously.

18. The method according to claim 14, wherein providing the stent-graft comprises providing the stent-graft in which a first subgroup of the structural stent elements are attached to the fluid flow guide along the first subsection, and at least partially curves inwardly, when the foldable section is in the longitudinally-folded state.

19. The method according to claim 14, wherein providing the stent-graft comprises providing the stent-graft in which a second subgroup of the structural stent elements are attached to the fluid flow guide along the third subsection, and at least partially curves inwardly, when the foldable section is in the longitudinally-folded state.

20. The method according to claim 14, wherein providing the stent-graft comprises providing the stent-graft in which first and second subgroups of the structural stent elements are attached to the fluid flow guide along the first and the third subsections, respectively, and wherein transitioning the stent-graft to the deployment configuration comprises interlocking the first and the third subsections.

21. The method according to claim 14, wherein the stent-graft is a first stent-graft, and wherein the method further comprises:

providing a second stent-graft, which is shaped so as to define a side-facing fenestration;

transvascularly introducing the second stent-graft into the subject; and

positioning the foldable section of the first stent-graft inside the side-facing fenestration,

wherein transitioning comprises transitioning the first stent-graft to the deployment configuration while positioned in the side-facing fenestration, thereby fixing the first stent-graft to the side-facing fenestration.

22. The method according to claim 14, wherein providing the stent-graft comprises providing the stent-graft in which the stent-graft further includes a plurality of circumferentially-disposed radiopaque markers.

23. The method according to claim 22,

wherein the first subsection has first and second longitudinal edges,

wherein the second subsection has third and fourth longitudinal edges,

wherein the third subsection has fifth and sixth longitudinal edges,

wherein the second edge joins the third edge,

wherein the fourth edge joins the fifth edge,

wherein providing the stent-graft comprises providing the stent-graft in which a first subset of the radiopaque markers are disposed near the first edge of the first subsection, and a second subset of radiopaque markers are disposed near the fifth edge of the third subsection, and

wherein transitioning the stent to the deployment configuration comprises ascertaining that the foldable section has fully assumed the longitudinally-folded state by observing that the first and the second subsets of the radiopaque markers are longitudinally aligned with each other.

24. The method according to claim 14, wherein transvascularly introducing comprises transvascular introducing the stent-graft into the blood vessel while the stent-graft is initially disposed, in the delivery configuration, between a tubular external shaft and an internal shafts of the elongated delivery tool, in a vicinity of a distal end of the external shaft.

25. The method according to claim 24,

wherein the delivery tool further includes a stopper member fixed to the internal shaft,

wherein transvascularly introducing comprises transvascularly introducing the stent-graft while the stopper member is initially disposed proximally adjacent the stent-graft, and

wherein transitioning the stent-graft to the deployment configuration comprises withdrawing the external shaft proximally relative to the internal shaft, such that the stopper member prevents proximal movement of the stent-graft inside the delivery tool.

26. The method according to claim 14, wherein transitioning the stent-graft to the deployment configuration in the blood vessel comprises providing blood-flow sealing between the longitudinally-folded foldable section and a wall of the blood vessel, so as to reduce a risk of type I endoleak.