Heart valves prostheses and methods for percutaneous heart valve replacement

• US 10,456,243 B2
• Filed: 10/09/2015
• Issued: 10/29/2019
• Est. Priority Date: 10/09/2015
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Robertson, Scott, Howard, Elliot
• Primary Examiner(s): Schillinger, Ann
• Application Number:
  US14/879,861
• Publication Number:
  US 20170100236A1
• Time in Patent Office: 1,481 Days
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0028 Shapes in the form of latin or greek characters
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

Prosthetic heart valve devices and associated methods for percutaneous heart valve replacement are disclosed herein. A transcatheter valve prosthesis configured in accordance herewith includes a frame having a valve support and one or more support arms coupled thereto. The one or more support arms are configured to extend from the second end of the valve support toward the first end when the valve prosthesis is in an expanded configuration. When deployed in the expanded configuration, the one or more support arms have a curvilinear shape, such as a substantially S-shape, that at least partially engages tissue at the native heart valve.

Claims

1. A heart valve prosthesis having a compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve in a patient, comprising:

a frame including

a valve support having a first end and a second end, the valve support being configured to hold a prosthetic valve component therein, and

a plurality of support arms extending from the second end of the valve support, wherein when the heart valve prosthesis is in the expanded configuration,

the plurality of support arms are configured to extend toward the first end of the valve support for engaging a subannular surface of the native heart valve and

one or more of the plurality of support arms comprises a curvilinear-shaped support arm, the curvilinear-shaped support arm having

a first arcuate region being formed to curve toward the valve support proximate the second end,

a second arcuate region being formed to curve away from the valve support proximate the first end, and

a straight region being formed to slant toward the valve support in an upward and inward direction relative to a longitudinal axis of the valve support as the straight region extends from a first transitional point with the first arcuate region to a second transitional point with the second arcuate region,

wherein the second arcuate region defines a first curved segment that generally curves in an outward and upstream direction from the second transitional point to reach an apex of the curvilinear-shaped support arm and defines a second curved segment that extends in an outward direction from the apex of the curvilinear-shaped support arm and curves slightly downward toward a free-end of the curvilinear-shaped support arm,

wherein a landing zone configured to atraumatically engage tissue at the native heart valve is defined at the apex of the curvilinear-shaped support arm, the landing zone having a width that is greater than a width of the remainder of the curvilinear-shaped support arm.

2. The heart valve prosthesis of claim 1, wherein the landing zone includes one or more tissue gripping features.

3. The heart valve prosthesis of claim 1, wherein the frame further comprises a radially-extending segment that radially extends from the first end of the valve support when the heart valve prosthesis is in the expanded configuration for engaging a supra-annular surface of the native heart valve, and wherein the radially-extending segment is longitudinally spaced from and opposed to the landing zone of the curvilinear-shaped support arm when the heart valve prosthesis is in the expanded configuration for securing the heart valve prosthesis to the native heart valve.

4. The heart valve prosthesis of claim 3, wherein when the heart valve prosthesis is in the expanded configuration the landing zones of the plurality of support arms are configured to oppose the radially-extending segment such that a compressive force is exerted on an annulus at the native valve region by the landing zones and the radially-extending segment so as to inhibit movement of the heart valve prosthesis.

5. The heart valve prosthesis of claim 4, wherein the native valve region is a mitral valve and the annulus is a mitral valve annulus and wherein the landing zones of the plurality of support arms are longitudinally spaced from the radially-extending segment such that the mitral valve annulus may be positioned therebetween.

6. The heart valve prosthesis of claim 3, further comprising:

a sealing material extending over the radially-extending segment, the valve support, or both, wherein the sealing material is configured to inhibit paravalvular leaks.

7. The heart valve prosthesis of claim 1, wherein the first arcuate region of the curvilinear-shaped support arm has a first radius of curvature and the second arcuate region of the curvilinear-shaped support arm has a second radius of curvature that is substantially equal to the first radius of curvature.

8. The heart valve prosthesis of claim 1, wherein the first arcuate region of the curvilinear-shaped support arm has a first radius of curvature and the second arcuate region of the curvilinear-shaped support arm has a second radius of curvature that is greater than the first radius of curvature.

9. The heart valve prosthesis of claim 1, wherein the first arcuate region of the curvilinear-shaped support arm has a first radius of curvature and the second arcuate region of the curvilinear-shaped support arm has a second radius of curvature that is less than the first radius of curvature.

10. The heart valve prosthesis of claim 1, wherein the native heart valve is a mitral valve having an annulus, and wherein the second arcuate region of the curvilinear-shaped support arm is configured to engage a subannular surface of the annulus of the mitral valve and a wall of a left ventricle.

11. The heart valve prosthesis of claim 1, wherein the second transitional point is positioned closer to the valve support than the first transitional point.

12. A heart valve prosthesis for treating a native mitral valve of a patient, the prosthesis comprising:

a cylindrical support having an upstream portion, a downstream portion and a first cross-sectional dimension, wherein the cylindrical support is configured to hold a prosthetic valve component that inhibits retrograde blood flow;

a plurality of S-shaped support arms extending from the downstream portion of the cylindrical support, wherein when the heart valve prosthesis is in an expanded configuration the S-shaped support arms are aligned substantially in parallel with a longitudinal axis of the cylindrical support as the S-shaped support arms extend in an upstream direction and are configured to extend in the upstream direction to engage cardiac tissue on or below an annulus of the native mitral valve, the S-shaped support arms having a first arcuate region being formed to curve toward the cylindrical support proximate the downstream portion, a second arcuate region being formed to curve away from the cylindrical support proximate the upstream portion, and a straight region being formed to slant toward the cylindrical support in an upward and inward direction relative to a longitudinal axis of the cylindrical support as the straight region extends from a first transitional point with the first arcuate region to a second transitional point with the second arcuate region, wherein the second arcuate region defines a first curved segment that generally curves in an outward and upstream direction from the second transitional point to reach an apex of the S-shaped support arm and defines a second curved segment that extends in an outward direction from the apex of the S-shaped support arm and curves slightly downward toward a free-end of the S-shaped support arm, wherein a landing zone configured to atraumatically engage tissue at the native mitral valve is defined at the apex of the S-shaped support arm, the landing zone having a width that is greater than a width of the remainder of the S-shaped support arm; and

a radially-extending segment extending from the upstream portion of the cylindrical support and having a second cross-sectional dimension greater than the first cross-sectional dimension, wherein when the heart valve prosthesis is in the expanded configuration the radially-extending segment is configured to radially extend from the upstream portion of the cylindrical support for engaging cardiac tissue on or above the annulus of the native mitral valve.

13. The heart valve prosthesis of claim 12, wherein when the heart valve prosthesis is in the expanded configuration and deployed at the native mitral valve, the landing zones of the S-shaped support arms are configured to oppose the radially-extending segment to exert a compressive force on the annulus therebetween.

14. The heart valve prosthesis of claim 13, wherein the landing zones are configured to atraumatically engage cardiac tissue on or below the annulus of the native mitral valve.