Stent-valve, delivery apparatus and method of use

Patent metadata

Field	Value
Publication number	US-2016262884-A1
Application number	US-201415033096-A
Country	US
Kind code	A1
Filing date	Oct 28, 2014
Priority date	Oct 28, 2013
Publication date	Sep 15, 2016
Grant date	—

Abstract

A delivery apparatus for delivering a stent-valve for implantation within the body, the delivery apparatus configured for introduction into the body through an arterial introducer of a type having a stem insertable into the body and a mouth section that remains outside the body, the mouth section including a haemostasis valve, and wherein the delivery apparatus comprises: a first constraining sheath at a stent-valve accommodation region of the apparatus at a distal end of the apparatus, and configured for constraining at least a portion of a stent-valve at the accommodation region in a radially collapsed configuration; a delivery introducer captive on the delivery apparatus, and slidable between a first position surrounding at least a portion of the stent-valve accommodation region, and a second position in which the delivery introducer slides proximally of the stent-valve accommodation region; wherein the delivery introducer is insertable at least partly into the mouth of a said arterial introducer, the delivery introducer configured for introducing the stent-accommodation region through the haemostasis valve.

First claim

1 . A system comprising a stent-valve for implantation within a body, and a delivery apparatus therefor, the delivery apparatus configured for introduction into the body through an arterial introducer including a haemostasis valve, the delivery apparatus comprising:
a stent-valve accommodation region at a distal end of the apparatus for accommodating the stent-valve in a radially collapsed configuration; a first constraining sheath at the stent-valve accommodation region and configured for constraining a first portion of the stent-valve, in use, in a radially collapsed configuration; a second constraining sheath at the stent-valve accommodation region and configured for constraining a second portion of the stent-valve, in use, in a radially collapsed configuration, wherein a third portion of the stent-valve between the first and second portions is, in use, non-covered by the first and second constraining sheaths and bulges relative to the first and second portions; and a delivery introducer captive on the delivery apparatus, and slidable between a first position surrounding at least a portion of the stent-valve accommodation region, and a second position in which the delivery introducer slides proximally of the stent-valve accommodation region; wherein in said first position, the delivery introducer is configured for confining the third portion of the stent-valve; and wherein the delivery introducer is insertable at least partly into a mouth of said arterial introducer, the delivery introducer configured for introducing the stent-accommodation region through the haemostasis valve.

2 . The system of claim 1 , wherein the delivery introducer comprises a region having an internal diameter for confining the third portion of the stent-valve to a diameter not substantially larger than the outer diameter of the sheaths.

3 . The system of claim 1 , wherein the delivery introducer has a shape that forms an interference fit with at least one component of the stent-valve accommodation region such that: (i) the interference fit retains the delivery introducer captive on the delivery apparatus, and/or (ii) the interference fit mechanically transfers an insertion force applied from the delivery introducer to the stent-valve accommodation region.

4 . The system of claim 1 , wherein the third portion of the stent-valve is a region at which inner and outer skirts of the stent-valve overlap and/or are sutured together.

5 . The system of claim 1 , wherein the third portion of the stent-valve is a region comprising an unconnected apex of a cell of a lattice structure.

6 . A delivery apparatus for delivering a stent-valve for implantation within a body, the delivery apparatus configured for introduction into the body through an arterial introducer of a type having a stem insertable into the body and a mouth section that remains outside the body, the mouth section including a haemostasis valve, and wherein the delivery apparatus comprises:
a first constraining sheath at a stent-valve accommodation region of the apparatus at a distal end of the apparatus, and configured for constraining at least a portion of the stent-valve at the accommodation region in a radially collapsed configuration; a delivery introducer captive on the delivery apparatus, and slidable between a first position surrounding at least a portion of the stent-valve accommodation region, and a second position in which the delivery introducer slides proximally of the stent-valve accommodation region; wherein the delivery introducer is insertable at least partly into the mouth of said arterial introducer, the delivery introducer configured for introducing the stent-valve accommodation region through the haemostasis valve.

7 . The delivery apparatus of claim 6 , wherein the delivery introducer is configured to be insertable at least partly into the mouth of said introducer at least in said first position of the delivery introducer.

8 . The delivery apparatus of claim 6 , wherein the first constraining sheath is configured in use to cover only a first portion of the stent-valve accommodation region, the apparatus further comprising a second sheath for covering a second portion of the stent-valve accommodation region leaving a third portion non-covered, in use, by the first and second sheaths, and wherein the delivery introducer is configured to cover the third portion when the delivery introducer is in said first position.

9 . The delivery apparatus of claim 6 , wherein the delivery introducer has a shape that forms an interference fit with at least one component of the stent-valve accommodation region such that: (i) the interference fit retains the delivery introducer captive on the delivery apparatus, and/or (ii) the interference fit mechanically transfers an insertion force applied from the delivery introducer to the stent-valve accommodation region

10 . (canceled)

11 . (canceled)

12 . (canceled)

13 . A method, comprising:
providing a stent-valve delivery apparatus comprising
a stent-valve accommodation region at a distal end,
first and second sheathes translatable at the stent-valve accommodation region, and
a delivery introducer slidable between a first position at least partly surrounding the stent-valve accommodation region, and second position in which the delivery introducer is slid proximally away from the stent-valve accommodation region;
closing the first and second sheathes over respective first and second portions of a stent-valve, to load the stent-valve in a radially compressed condition at the stent-valve accommodation region of the delivery apparatus, leaving uncovered a third portion of the stent-valve between the first and second portions; and advancing distally the delivery introducer from the second position to the first position, wherein in the first position the delivery introducer surrounds at least the third portion of the stent-valve.

14 . A method, comprising:
providing a stent-valve delivery apparatus comprising
a stent-valve accommodation region at a distal end,
a first constraining sheath at the stent-valve accommodation region, and
a delivery introducer captive on the delivery apparatus, and slidable between a first position surrounding at least a portion of the stent-valve accommodation region, and a second position in which the delivery introducer slides proximally of the stent-valve accommodation region;
providing an arterial introducer of a type having a stem insertable into a body and a mouth section that remains outside the body, the mouth section including a haemostasis valve; loading a stent-valve into the stent-valve accommodation region; sliding the delivery introducer to the first position; inserting the distal end of the delivery apparatus with the delivery introducer in the first position, into the mouth section of the arterial introducer, to pass the distal end of the delivery apparatus through the haemostasis valve; and advancing the delivery apparatus distally, such that the distal end of the delivery apparatus passes into the stem, while the delivery introducer remains at the mouth section.

Assignees

• Symetis Sa

Inventors

• Lombardi Fabien
• Essinger Jacques
• Delaloye Stéphane
• Hefti Jean-Luc
• Mantanus Luc
• Biadillah Youssef
• Simonin Pierre

Classifications

• A61F2/9522

  Means for mounting a stent or stent-graft onto or into a placement instrument · CPC title

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title