Stent system with radial-expansion locking

• US 10,603,197 B2
• Filed: 11/06/2014
• Issued: 03/31/2020
• Est. Priority Date: 11/19/2013
• Status: Active Grant

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Marmur, Yaniv, Zigelboim, Or, Nae, Nir Shalom
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US15/037,804
• Publication Number:
  US 20160302950A1
• Time in Patent Office: 1,972 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• 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 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2250/006 modular

Abstract

A deployment system (10, 410) includes an inner shaft (36, 436), removably disposed in a self-expanding stent-graft (40), and shaped so as to define (a) at least one conduit therealong (50, 450), which is (i) not coaxial with the inner shaft (36, 436), and (ii) shaped so as to define at least first (52, 452) and second enclosed longitudinal segments (54, 454), and (b) a restraining longitudinal portion (56, 456) that is longitudinally disposed between the first (52, 452) and second enclosed longitudinal segments (54, 454). The deployment system (10, 410) is configured such that (a) when a restraining wire (60, 460) thereof is removably disposed in the first (52, 452) and second enclosed longitudinal segments (54, 454), a portion (62, 463) of the restraining wire (60, 460) disposed alongside the restraining longitudinal portion (56, 456) prevents full radial expansion of a longitudinal portion (70, 470) of the stent-graft (40) by physically engaging the stent-graft longitudinal portion (70, 470), and (b) when the restraining wire (60, 460) has been withdrawn from at least the first enclosed longitudinal segment (52, 452), the restraining wire (60, 460) does not prevent the full radial expansion of the stent-graft longitudinal portion (70, 470).

Claims

1. A method for treating a blood vessel suffering from an aneurysm or a dissection, the method comprising:

advancing an inner shaft of a deployment system through a body lumen of a subject to the blood vessel, while the inner shaft is removably disposed in a self-expanding stent-graft that is shaped so as to define one or more lateral fenestrations, wherein the inner shaft is shaped so as to define one or more conduits therealong, which conduits are not coaxial with the inner shaft, wherein advancing comprises advancing the inner shaft while one or more restraining wires of the deployment system (a) are at least partially removably disposed in the conduits, and (b) prevent full radial expansion of one or more longitudinal portions of the self-expanding stent-graft by physically engaging the one or more longitudinal portions of the self-expanding stent-graft;

introducing one or more guidewires into a proximal end of the self-expanding stent-graft, out of the one or more lateral fenestrations, respectively, and into one or more branching blood vessels, respectively, wherein the one or more branching blood vessels branch from the blood vessel;

aligning the one or more fenestrations with respective ostia of the one or more branching arteries;

after aligning the one or more fenestrations, at least partially withdrawing the one or more restraining wires, such that the one or more restraining wires do not prevent the full radial expansion of the one or more longitudinal portions of the self-expanding stent-graft;

introducing one or more branching stent-grafts over the one or more guidewires, respectively, into the proximal end of the self-expanding stent-graft, out of the one or more lateral fenestrations, respectively, and into the one or more branching blood vessels, respectively; and

radially expanding the one or more branching stent-grafts so that the one or more branching stent-grafts form respective blood-tight seals with the one or more lateral fenestrations, respectively,

wherein the one or more restraining wires include first and second restraining wires, and the one or more longitudinal portions of the self-expanding stent-graft include first and second longitudinal portions of the self-expanding stent-graft,

wherein advancing the inner shaft comprises advancing the inner shaft while;

the inner shaft is removably disposed in the self-expanding stent-graft,

the first restraining wire (a) physically engages the first longitudinal portion of the self-expanding stent-graft, thereby preventing full radial expansion of the first longitudinal portion, and (b) does not engage the second longitudinal portion of the self-expanding stent-graft, which second longitudinal portion does not longitudinally overlap the first longitudinal portion, and

the second restraining wire (a) physically engages the second longitudinal portion of the self-expanding stent-graft, thereby preventing full radial expansion of the second longitudinal portion, and (b) does not engage the first longitudinal portion of the self-expanding stent-graft,

wherein at least partially withdrawing the one or more restraining wires comprises at least partially withdrawing the first restraining wire,

wherein the method further comprises;

after at least partially withdrawing the first restraining wire, adjusting a disposition of the second longitudinal portion of the self-expanding stent-graft; and

thereafter, at least partially withdrawing the second restraining wire, and

wherein the deployment system further includes a control handle, which (a) includes a withdrawal actuator, which includes a spool to which a proximal portion of a spool-coupled restraining wire is coupled, and (b) is shaped so as to define one or more lumens open to an external surface of the control handle, through which lumen an externally-accessible restraining wire passes, wherein the spool-coupled restraining wire is one of the first and the second restraining wires and the externally-accessible restraining wire is the other of the first and the second restraining wires,

wherein at least partially withdrawing the first and the second restraining wires comprises rotating the spool to at least partially withdraw the spool-coupled restraining wire in a proximal direction, and pulling on the externally-accessible restraining wire from outside the control handle.

2. The method according to claim 1,

wherein each of the one or more conduits is shaped so as to define (a) at least first and second enclosed longitudinal segments, each of which has a length of at least 30 mm, and (b) a restraining longitudinal portion that is longitudinally disposed between the first and the second enclosed longitudinal segments, and

wherein advancing comprises advancing the inner shaft while one of the restraining wires is removably disposed in the first and the second enclosed longitudinal segments, and a portion of the one restraining wire disposed alongside the restraining longitudinal portion of the inner shaft prevents the full radial expansion of one of the one or more longitudinal portions of the self-expanding stent-graft by physically engaging the one longitudinal portion of the self-expanding stent-graft.

3. The method according to claim 2, wherein the deployment system further includes:

a first ring, which is longitudinally fixed to and surrounds the inner shaft at a first longitudinal border between the first enclosed longitudinal segment and the restraining longitudinal portion defined by the one or more conduits; and

a second ring, which is longitudinally fixed to and surrounds the inner shaft at a second longitudinal border between the second enclosed longitudinal segment and the restraining longitudinal portion defined by the one or more conduits.

4. The method according to claim 1, wherein the second longitudinal portion is disposed more distal than the first longitudinal portion.

5. The method according to claim 1,

wherein withdrawing the one or more restraining wires comprises withdrawing the one or more restraining wires in the proximal direction, and

wherein advancing the inner shaft comprises applying no tensile force or less than 10 N of tensile force to respective proximal portions of the one or more restraining wires while advancing the inner shaft.

6. The method according to claim 1, wherein the one or more restraining wires terminate at respective free distal ends thereof.

7. The method according to claim 1, wherein each of the one or more restraining wires has at least one property selected from the group consisting of:

a moment of inertia of at least 0.0002 mm⁴, and a Young'"'"'s modulus of at least 60 GPa.

8. The method according to claim 1, wherein advancing the inner shaft comprises:

advancing the inner shaft while the inner shaft is removably disposed in the self-expanding stent-graft, and while one or more longitudinal portions of the self-expanding stent-graft are held in respective first radially-compressed states within an outer sheath, and

proximally withdrawing the outer sheath from the self-expanding stent-graft, such that the outer sheath no longer holds the one or more longitudinal portions in the respective first radially-compressed states, and allows partial radial expansion of the one or more longitudinal portions to respective second radially-compressed states in which the one or more longitudinal portions are less radially compressed than in the first radially-compressed states.

9. The method according to claim 1,

wherein the one or more lateral fenestrations include three lateral fenestrations,

wherein the one or more branching blood vessels include and a right renal artery, a left renal artery, and a superior mesenteric artery,

wherein introducing the one or more guidewires comprises introducing three guidewires into the proximal end of the self-expanding stent-graft, out of the lateral fenestrations, respectively, and into the right renal artery, the left renal artery, and the superior mesenteric artery, respectively, and

wherein introducing the one or more branching stent-grafts comprises introducing the three branching stent-grafts over the three guidewires, respectively, into the proximal end of the self-expanding stent-graft, out of the three lateral fenestrations, respectively, and into the right renal artery, the left renal artery, and the superior mesenteric artery, respectively.

10. The method according to claim 1, wherein aligning comprises aligning, after introducing the one or more guidewires, the one or more fenestrations with the respective ostia of the one or more branching arteries.

11. The method according to claim 1, further comprising:

after introducing the one or more guidewires, advancing one or more cannulae over the guidewires, respectively, into the proximal end of the self-expanding stent-graft, out of the one or more lateral fenestrations, respectively, and into the one or more branching blood vessels, respectively,

using the one or more cannulae to help accurately position the one or more lateral fenestrations, respectively, opposite the respective ostia of the one or more branching blood vessels, and

after at least partially withdrawing the one or more restraining wires and before introducing the one or more branching stent-grafts, withdrawing the one or more cannulae from the body over the one or more respective guidewires.