Stent-graft with fixation elements that are radially confined for delivery

• US 9,770,350 B2
• Filed: 05/15/2012
• Issued: 09/26/2017
• Est. Priority Date: 05/15/2012
• Status: Active Grant

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US14/400,699
• Publication Number:
  US 20150142096A1
• Time in Patent Office: 1,960 Days
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8483 Barbs

Abstract

An endovascular stent-graft is provided that includes a flexible stent member, which includes a plurality of struts, which are shaped so as to define a generally circumferential section; a tubular fluid flow guide, which includes a graft material, and which is attached to the stent member; and at least one fixation member shaped so as to define a base at a first end thereof and a sharp tip at a second end thereof. The base is coupled to one of the struts that are shaped so as to define the generally circumferential section. When the stent-graft is in a radially-expanded deployment state, the fixation member protrudes radially outward. When the stent-graft is in a radially-compressed delivery state, at least a portion of the fixation member between the base and the sharp tip is convex as viewed from outside the stent-graft, such that the sharp tip points radially inward.

Claims

1. Apparatus comprising an endovascular stent-graft, which is configured to assume a radially-compressed delivery state and a radially-expanded deployment state, and which comprises:

a flexible stent member, which comprises a plurality of struts, which are shaped so as to define a generally circumferential section;

a tubular fluid flow guide, which comprises a graft material, and which is attached to the stent member; and

at least one fixation member shaped so as to define a base at a first end thereof and a sharp tip at a second end thereof, wherein the base is coupled to one of the struts that are shaped so as to define the generally circumferential section,

wherein, when the stent-graft is in the radially-expanded deployment state, the fixation member protrudes radially outward, and

wherein, when the stent-graft is in the radially-compressed delivery state, at least a portion of the fixation member between the base and the sharp tip is convex as viewed from outside the stent-graft, such that the sharp tip points radially inward.

2. The apparatus according to claim 1,

wherein the stent member is shaped so as to define a generally circumferential band, which includes the circumferential section, and

wherein the plurality of struts that are shaped so as to define the generally circumferential section include (a) the one of the struts to which the base is coupled and (b) a second strut, which are coupled at a peak of the circumferential band.

3. The apparatus according to claim 1, wherein the circumferential section is at least partially not covered by the fluid flow guide at least when the stent-graft is in the radially-expanded deployment state.

4. The apparatus according to claim 1,

wherein, when the stent-graft is in the radially-compressed delivery state, the sharp tip is positioned more radially inward than is the one of the struts to which the base is coupled.

5. The apparatus according to claim 1, wherein, when the stent-graft is in the radially-expanded deployment state, a portion of the fixation member between the base and the sharp tip is convex as viewed from outside the stent-graft.

6. A method comprising:

providing an endovascular stent-graft in a radially-expanded deployment state, which stent-graft includes (a) a flexible stent member, which includes a plurality of struts, which are shaped so as to define a generally circumferential section, (b) a tubular fluid flow guide, which includes a graft material, and which is attached to the stent member, and (c) at least one fixation member shaped so as to define a base at a first end thereof and a sharp tip at a second end thereof, wherein the base is coupled to one of the struts that are shaped so as to define the generally circumferential section, and wherein, when the stent-graft is in the deployment state, the fixation members protrudes radially outward; and

loading the stent-graft into an external delivery sheath of a delivery catheter, such that the stent-graft assumes a radially-compressed delivery state, in which at least a portion of the fixation member between the base and the sharp tip is convex as viewed from outside the stent-graft, such that the sharp tip points radially inward.

7. The method according to claim 6, wherein providing the stent-graft comprises providing the stent-graft in which the circumferential section is at least partially not covered by the fluid flow guide at least when the stent-graft is in the radially-expanded deployment state.

8. The method according to claim 6,

wherein providing the stent-graft comprises providing the stent-graft in which the stent member is shaped so as to define a generally circumferential band, which includes the circumferential section, and

wherein the plurality of struts that are shaped so as to define the generally circumferential section include (a) the one of struts to which the base is coupled and (b) a second strut, which are coupled at a peak of the circumferential band.

9. The method according to claim 6,

wherein loading comprises loading the stent-graft into the external delivery sheath such that the stent-graft assume the radially-compressed delivery state, in which the sharp tip is positioned more radially inward than is the one of the struts to which the base is coupled.

10. The method according to claim 6, wherein providing the stent-graft comprises providing the stent-graft in the radially-expanded deployment state in which a portion of the fixation member between the base and the sharp tip is convex as viewed from outside the stent-graft.

11. A method comprising:

providing an endovascular stent-graft, which is configured to assume a radially-compressed delivery state and a radially-expanded deployment state, and which includes (a) a flexible stent member, which includes a plurality of struts, which are shaped so as to define a generally circumferential section, (b) a tubular fluid flow guide, which includes a graft material, and which is attached to the stent member, and (c) at least one fixation member shaped so as to define a base at a first end thereof and a sharp tip at a second end thereof, wherein the base is coupled to one of the struts that are shaped so as to define the generally circumferential section;

transvascularly introducing the stent-graft into a blood vessel of a human subject while the stent-graft is in the radially-compressed delivery state, in which at least a portion of the fixation member between the base and the sharp tip is convex as viewed from outside the stent-graft, such that the sharp tip points radially inward; and

thereafter, transitioning the stent-graft to the radially-expanded deployment state in the blood vessel, such that the fixation member protrudes radially outwardly.

12. The method according to claim 11, wherein providing the stent-graft comprises providing the stent-graft in which the circumferential section is at least partially not covered by the fluid flow guide at least when the stent-graft is in the radially-expanded deployment state.

13. The method according to claim 11, wherein providing the stent-graft comprises providing the stent-graft in which (a) the stent member is shaped so as to define a generally circumferential band, which includes the circumferential section, and (b) the plurality of struts that are shaped so as to define the generally circumferential section include (i) the one of the struts to which the base is coupled and (ii) a second strut, which are coupled at a peak of the circumferential band.

14. The method according to claim 11,

wherein transvascularly introducing the stent-graft comprises transvascularly introducing the stent-graft into the blood vessel while the stent-graft is in the radially-compressed delivery state, in which the sharp tip is positioned more radially inward than is the one of the struts to which the base is coupled.

15. The method according to claim 11, wherein transitioning comprises transitioning the stent-graft to the radially-expanded deployment state in the blood vessel, such that a portion of the fixation member between the base and the sharp tip is convex as viewed from outside the stent-graft.