Stent valve, delivery apparatus and method therefor

• US 9,414,915 B2
• Filed: 09/26/2011
• Issued: 08/16/2016
• Est. Priority Date: 09/24/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Symetis SA (Boston Scientific Corporation)
• Inventors: Lombardi, Fabien, Essinger, Jacques, Delaloye, Stephane, Hefti, Jean-Luc, Mantanus, Luc, Biadillah, Youssef
• Primary Examiner(s): Eastwood, David C
• Assistant Examiner(s): MANNAN, MIKAIL A
• Application Number:
  US13/825,219
• Publication Number:
  US 20130274870A1
• Time in Patent Office: 1,786 Days
• Field of Search: 623/2.11, 623/1.36, 623/2.36, 623/2.37, 623/1.11, 606/151
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61M 2039/0666 Flap-valve

Abstract

A delivery catheter (12) for a stent valve (10), the delivery catheter having a distal portion (14) insertable into an anatomy, the distal portion comprising an accommodation region (18) for accommodating a stent-valve for delivery into the anatomy, the delivery catheter further comprising at least one sheath (20; 22) that is translatable between a closed position for at least partly closing the accommodation region and an open position for at least partly opening the accommodation region.

Claims

1. A transcatheter aortic valve implantation system, comprising:

an aortic stent-valve comprising a stent component and valve leaflets supported by the stent component, the stent component having an inflow end and an outflow end and being self-expandable from a compressed condition for delivery towards an expanded functional condition, the stent component comprising outflow structure at the outflow end, a crown intermediate the inflow and outflow ends, the crown having a free extremity intermediate the inflow and outflow ends and directed towards the outflow end, and the stent-component further comprising a fixation section between the crown and the inflow end;

a delivery catheter having a distal portion insertable into the anatomy, the distal portion comprising a stent-valve accommodation region for accommodating the stent-valve in the compressed condition for delivery, a first sheath for covering at least a portion of the fixation section at the accommodation region to constrain the fixation section compressed, and a second sheath for covering at least a portion of the outflow structure and at least a portion of the crown at the accommodation region to constrain the outflow structure and the crown compressed, the second sheath being translatable in a proximal direction to uncover the crown and the outflow structure for deployment, and the first sheath being translatable in a distal direction to uncover the fixation section for deployment;

wherein in a condition in which the stent-valve is loaded at the accommodation region and the system is ready for introduction into the anatomy, the first and second sheaths are spaced apart from each other in an axial direction such that a portion of the stent-valve is not covered by either sheath.

2. The system of claim 1, wherein the outflow structure comprises a plurality of arches having apexes at the outflow end of the stent component.

3. The system of claim 1, wherein translation of the second sheath deploys the crown followed by the stabilization arches to permit axial seating of the crown against native leaflets and generation of axial alignment forces by the arches contacting the ascending aorta, and translation of the first sheath deploys the fixation section to anchor the stent-valve.

4. The system of claim 1, wherein the stent-valve is configured such that, when the first sheath covers at least a portion of the fixation section, and the second sheath is translated proximally to uncover the crown and the outflow structure, the stent component defines a partly deployed substantially flared shape from the portion of the fixation section constrained by the first sheath, towards the free extremity of the crown, the flared shape permitting universal seating of the crown against native leaflets.

5. The system of claim 4, wherein the partly deployed substantially flared shape corresponds to the crown being partly deployed in a form smaller than its fully deployed shape.

6. The system of claim 1, wherein the stent-valve further comprises an inner skirt covering a portion of an inner surface of the stent component, and an outer skirt covering a portion of an exterior surface of the stent component, the inner skirts including a region of partial overlap, and wherein the space between the first and second spaced apart sheaths is in register with at least a portion of the region of partial overlap of the inner and outer skirts.

7. The system of claim 1, configured for transvascular delivery of the stent-valve to the heart.

8. The system of claim 1, wherein the first sheath is shorter than the second sheath.

9. The system of claim 1, wherein the first sheath and the second sheath are non-overlapping and/or have a same diameter as each other.

10. The system of claim 1, wherein the delivery catheter further comprises an interface member at the accommodation region, the interface member being deployable upon translation of at least one of the sheaths, the interface member providing a guide surface for aiding withdrawal of the delivery catheter from the anatomy after the stent valve is deployed.

11. The system of claim 1, wherein the delivery catheter comprises a flexible stem portion extending between the distal portion and a control handle at a proximal portion of the delivery catheter, the stem portion comprising a plurality of flexible slidable tubes nested one within another for controlling translation of the sheaths in response to operation of the control handle, wherein the control handle comprises an actuator for applying pre-tension to at least one of the tubes for biasing the first sheath in a proximal direction.