Two-part prosthetic valve system

• US 9,561,101 B2
• Filed: 11/26/2013
• Issued: 02/07/2017
• Est. Priority Date: 06/20/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton J., Maisano, Francesco, Meiri, Oded
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US14/091,239
• Publication Number:
  US 20140088694A1
• Time in Patent Office: 1,169 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 2017/32004 having a laterally movable cutting member at its most distal end which remains within the contours of said end
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A prosthetic valve system for replacing a native aortic valve exhibiting regurgitation may include a support structure and a transcatheter heart valve (THV) that is separate from the support structure. The support structure may be radially collapsible and expandable, and deployable on an outflow side of the native aortic valve, circumscribing the native leaflets of the aortic valve. The THV may be radially collapsible and expandable, and deployable in an annulus of the native aortic valve to frictionally engage the native leaflets between an interior surface of the support structure and the THV.

Claims

1. A prosthetic aortic valve system for replacing a native aortic valve, the native aortic valve comprising an aortic valve annulus, a plurality of native leaflets, a plurality of valve commissures, an inflow side, and an outflow side within an aorta, the prosthetic aortic valve system comprising a support structure, a transcatheter heart valve, and a balloon catheter:

the support structure comprising a radially collapsible and self-expanding, nitinol annular body and a plurality of retaining arms extending from the annular body, the annular body comprising an interior surface, an exterior surface, and three peaks and three valleys in a z-direction, an expanded size of the annular body dimensioned for deployment within the aorta on the outflow side of the native aortic valve with the interior surface circumscribing the native leaflets and the three peaks oriented adjacent to the valve commissures, the retaining arms extending from the annular body to a support structure delivery system and forming a releasable connection with the support-structure delivery system, the support structure radially collapsible to a diameter suitable for delivery using the support-structure delivery system; and

the transcatheter heart valve radially compressible to a compressed size suitable for delivery using the balloon catheter and radially balloon-expandable from the compressed size to a fully expanded size, wherein the expanded size of the annular body is equal to or less than the fully expanded size of the transcatheter heart valve for frictionally engaging the native leaflets between the interior surface of the annular body and the transcatheter heart valve when the support structure is deployed within the aorta on the outflow side of the native aortic valve with the interior surface of the annular body circumscribing the native leaflets and the transcatheter heart valve is expanded within the aortic valve annulus,

wherein the support structure is deliverable separately from the transcatheter heart valve, further wherein the support structure is positionable and repositionable adjacent the aortic valve annulus independent of the transcatheter heart valve when the annular body is in the fully expanded size; and

the balloon catheter comprises an elongate catheter and an expansion balloon disposed at a distal end-portion thereof, wherein the transcatheter heart valve is mounted on the expandable balloon in the radially compressed configuration.

2. The valve system of claim 1, wherein the support structure and the transcatheter heart valve are sized such that when the support structure and the transcatheter heart valve are implanted, the leaflets are compressed between the support structure and the transcatheter heart valve along the entire length of the portions of the leaflets that are between the support structure and the transcatheter heart valve.

3. The valve system of claim 1, wherein the annular body of the support structure is configured to expand inside a patient'"'"'s body to the fully expanded size while the support structure remains connected to the support-structure delivery system by the retaining arms to permit position and repositioning of the support structure relative to the aortic valve annulus through movement of the support-structure delivery system.

4. A prosthetic aortic valve system for replacing a native aortic valve, the native aortic valve comprising an aortic valve annulus, a plurality of native leaflets, a plurality of valve commissures, an inflow side, and an outflow side within an aorta, the prosthetic aortic valve system comprising a support structure, a transcatheter heart valve, a support structure catheter, and a valve catheter:

the support structure comprising a radially collapsible and expandable annular body, the annular body comprising an interior surface and an exterior surface, an expanded size of the annular body dimensioned for deployment within the aorta on the outflow side of the native aortic valve with the interior surface circumscribing the native leaflets, the support structure radially collapsible to a diameter suitable for delivery to the native aortic valve using the support structure catheter; and

the transcatheter heart valve radially compressible to a compressed size suitable for delivery to the native aortic valve using the valve catheter and radially expandable from the compressed size to a fully expanded size, wherein the expanded size of the annular body is equal to or less than the fully expanded size of the transcatheter heart valve for frictionally engaging the native leaflets between the interior surface of the annular body and the transcatheter heart valve when the support structure is deployed within the aorta on the outflow side of the native aortic valve with the interior surface of the annular body circumscribing the native leaflets and the transcatheter heart valve is expanded within the aortic valve annulus,

wherein the support structure is deployable separately from the transcatheter heart valve;

wherein the transcatheter heart valve is mounted on the valve catheter in the compressed size; and

wherein the support structure catheter is configured to position and reposition the support structure adjacent the aortic valve annulus when the annular body is in the fully expanded size, independent of the transcatheter heart valve and prior to implantation of the transcatheter heart valve, and the valve catheter is configured to deploy the transcatheter heart valve within the support structure after the support structure is deployed within the aorta.

5. The valve system of claim 4, wherein the support structure is self-expanding.

6. The valve system of claim 5, wherein the annular body is nitinol.

7. The valve system of claim 4, wherein the annular body comprises a plurality of peaks and valleys in a z-direction.

8. The valve system of claim 7, wherein the annular body has a sinusoidal shape.

9. The valve system of claim 7, wherein the annular body comprises three peaks and three valleys.

10. The valve system of claim 7, wherein the support structure is configured for the peaks to be oriented adjacent to the valve commissures.

11. The valve system of claim 7, wherein the support structure is configured for the valleys to be oriented adjacent to the valve commissures.

12. The valve system of claim 4, wherein the support structure comprises a plurality of retaining arms extending from the annular body, the plurality of retaining arms configured for releasably coupling the support structure to the support-structure catheter.

13. The valve system of claim 4, wherein the transcatheter heart valve is balloon expandable.

14. The valve system of claim 13, further comprising an introducer sheath, wherein the valve catheter comprises an elongate catheter and an expandable balloon disposed at a distal end-portion thereof, the introducer sheath dimensioned to slidably receive therein the valve catheter and transcatheter heart valve when the transcatheter heart valve is mounted on the expandable balloon in the radially compressed configuration.

15. A prosthetic aortic valve system for replacing a native aortic valve, the native aortic valve comprising an aortic valve annulus, a plurality of native leaflets, a plurality of valve commissures, an inflow side, and an outflow side within an aorta, the prosthetic aortic valve system comprising a support structure, a transcatheter heart valve and a support-structure delivery system:

the support structure comprising a radially collapsible and expandable annular body, the annular body comprising an interior surface and an exterior surface, an expanded size of the annular body dimensioned for deployment within the aorta on the outflow side of the native aortic valve with the interior surface circumscribing the native leaflets, the support structure radially collapsible to a diameter suitable for delivery using a catheter; and

the transcatheter heart valve radially compressible to a compressed size suitable for delivery using a catheter and radially expandable from the compressed size to a fully expanded size, wherein the expanded size of the annular body is equal to or less than the fully expanded size of the transcatheter heart valve for frictionally engaging the native leaflets between the interior surface of the annular body and the transcatheter heart valve when the support structure is deployed within the aorta on the outflow side of the native aortic valve with the interior surface of the annular body circumscribing the native leaflets and the transcatheter heart valve is expanded within the aortic valve annulus;

wherein the support structure is deliverable separately from the transcatheter heart valve and the support structure is positionable and repositionable adjacent the aortic valve annulus independent of the transcatheter heart valve and prior to implantation of the transcatheter heart valve;

further wherein the support structure comprises a plurality of retaining arms extending from the annular body, the plurality of retaining arms configured for releasably coupling the support structure to the support-structure delivery system;

wherein the support-structure delivery system comprises an elongate guide catheter comprising a proximal end and a distal end, the guide catheter dimensioned to receive the support structure in the radially compressed state therein;

a stent delivery catheter slidably disposed within the guide catheter, the stent delivery catheter comprising an elongate shaft and an outer fork disposed on a distal end of the elongate shaft thereof; and

an inner catheter slidably disposed within the stent delivery catheter, the inner catheter comprising an elongate shaft and an inner fork disposed on a distal end of the elongate shaft thereof;

the outer fork comprising a plurality of outer prongs, each outer prong comprising an aperture dimensioned to receive one of the retaining arms of the support structure therein, the inner fork comprising a plurality of inner prongs, each inner prong removably insertable through an aperture in each retaining arm when the retaining arms are received in the apertures of the outer prongs of the outer fork, the outer fork and inner fork relatively movable axially to releasably secure the support structure to the support-structure delivery system.