Prosthetic valve with separably-deployable valve body and tissue anchors

• US 10,463,488 B2
• Filed: 07/23/2018
• Issued: 11/05/2019
• Est. Priority Date: 02/05/2015
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Hariton, Ilia, Harari, Boaz
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US16/042,129
• Publication Number:
  US 20180338831A1
• Time in Patent Office: 470 Days
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements

Abstract

Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, a method of implanting a prosthetic valve within a native mitral valve may be provided. The method may include delivering the prosthetic valve into a heart chamber. The prosthetic valve may be constrained in a contracted delivery configuration. The prosthetic valve may include an annular valve body with a plurality of ventricular anchors and a plurality of atrial anchors attached thereto. The method may also include unconstraining the plurality of ventricular anchors and the plurality of atrial anchors while maintaining the valve body in the contracted delivery configuration. The method may also include unconstraining the valve body from the contracted delivery configuration while the unconstrained atrial anchors are positioned within an atrium and while the unconstrained ventricular anchors are positioned within a ventricle.

Claims

1. A method of implanting a prosthetic valve within a native mitral valve, the method comprising:

delivering the prosthetic valve into a heart chamber while the prosthetic valve is constrained in a radially-contracted delivery configuration, wherein the prosthetic valve includes;

an annular valve body comprising an annular outer frame and an inner frame situated at least partially within the outer frame,

a plurality of ventricular anchors configured to extend from the outer frame, and

a plurality of atrial anchors configured to extend from the inner frame,

wherein the outer frame and the inner frame are secured against relative axial movement by at least one connector;

unconstraining the plurality of ventricular anchors and the plurality of atrial anchors while maintaining the valve body in the radially-contracted delivery configuration; and

unconstraining the valve body from the radially-contracted delivery configuration while the unconstrained atrial anchors are positioned within an atrium and while the unconstrained ventricular anchors are positioned within a ventricle, wherein unconstraining the valve body decreases a longitudinal distance between terminal ends of the unconstrained ventricular anchors and terminal ends of the unconstrained atrial anchors, such that native mitral valve tissue is clamped between the ventricular anchors and atrial anchors.

2. The method of claim 1,

wherein the plurality of ventricular anchors includes a plurality of ventricular anchoring legs, each ventricular anchoring leg having a respective terminal end, and

wherein unconstraining the plurality of ventricular anchors causes the terminal ends of the ventricular anchoring legs to deflect radially outward relative to the outer frame.

3. The method of claim 1,

wherein the plurality of atrial anchors includes a plurality of atrial anchoring arms, each atrial anchoring arm having a respective terminal end, and

wherein unconstraining the plurality of atrial anchors causes the terminal ends of the atrial anchoring arms to deflect radially outward relative to the inner frame.

4. The method of claim 1, wherein the outer frame and the inner frame expand radially outward when the valve body is unconstrained.

5. The method of claim 1, wherein unconstraining the valve body causes the plurality of ventricular anchors and the plurality of atrial anchors to grasp tissue therebetween to secure the prosthetic valve to the native mitral valve.

6. The method of claim 1, further comprising:

prior to unconstraining the valve body, moving the unconstrained ventricular anchors so that they engage tissue on a ventricular side of the native mitral valve.

7. The method of claim 1, further comprising:

prior to unconstraining the valve body, moving the unconstrained atrial anchors so that they engage tissue on an atrial side of the native mitral valve.

8. The method of claim 1, wherein the plurality of ventricular anchors is unconstrained prior to unconstraining the plurality of atrial anchors.

9. The method of claim 1, wherein the plurality of atrial anchors is unconstrained prior to unconstraining the plurality of ventricular anchors.

10. The method of claim 1, wherein the unconstrained ventricular anchors and the unconstrained atrial anchors enable motion of leaflets of the native mitral valve in response to beating of the heart, prior to unconstraining the valve body.

11. The method of claim 1, wherein the inner frame extends in an upstream direction beyond an upstream end of the outer frame.

12. The method of claim 1, wherein the outer frame and the inner frame are constrained in the contracted delivery configuration during unconstraining of the plurality of ventricular anchors and the plurality of atrial anchors.

13. The method of claim 1, wherein unconstraining the valve body shifts points of connection between the plurality of ventricular anchors and the outer frame radially outward.

14. The method of claim 1, wherein unconstraining the valve body shifts points of connection between the plurality of atrial anchors and the inner frame radially outward.

15. The method of claim 1, wherein the plurality of ventricular anchors and the plurality of atrial anchors are unconstrained in at least one of the atrium and the ventricle.

16. The method of claim 1, wherein the at least one connector securing the outer frame and inner frame against relative axial movement comprises at least one of:

a mechanical connector extending between the outer frame and the inner frame, solder, or a weld.

17. The method of claim 1, wherein the outer frame is formed at least partially of struts intersecting at a plurality of outer frame junctions, the ventricular anchors extending from outer frame junctions that are spaced apart from an upstream end of the outer frame and a downstream end of the outer frame.

18. A method of implanting a prosthetic valve within a native mitral valve, the method comprising:

delivering the prosthetic valve into a heart chamber while the prosthetic valve is constrained in a contracted delivery configuration, wherein the prosthetic valve includes an annular valve body with a plurality of ventricular anchors and a plurality of atrial anchors attached thereto;

unconstraining the plurality of ventricular anchors while maintaining the plurality of atrial anchors and the valve body in the contracted delivery configuration;

repositioning the unconstrained ventricular anchors prior to unconstraining the plurality of atrial anchors such that at least one unconstrained ventricular anchor contacts tissue of the native mitral valve;

unconstraining the plurality of atrial anchors while the at least one unconstrained ventricular anchor contacts the tissue of the native mitral valve and while the valve body is maintained in the contracted delivery configuration; and

unconstraining the valve body from the contracted delivery configuration while the unconstrained atrial anchors are positioned within an atrium and while the unconstrained ventricular anchors are positioned within a ventricle, wherein unconstraining the valve body decreases a longitudinal distance between terminal ends of the unconstrained ventricular anchors and terminal ends of the unconstrained atrial anchors, such that native mitral valve tissue is clamped between the ventricular anchors and atrial anchors.

19. The method of claim 18, wherein repositioning the unconstrained ventricular anchors comprises:

moving the unconstrained ventricular anchors in an upstream direction until the at least one unconstrained ventricular anchor contacts a ventricular-facing side of a leaflet of the native mitral valve.

20. The method of claim 18, wherein the valve body comprises:

an annular outer frame;

an inner frame situated at least partially within the outer frame; and

at least one connector configured to secure the outer frame and the inner frame against relative axial movement,

wherein the plurality of ventricular anchors extend from the outer frame and the plurality of atrial anchors extend from the inner frame.

21. A method of implanting a prosthetic valve within a native mitral valve, the method comprising:

delivering the prosthetic valve into a heart chamber while the prosthetic valve is constrained in a contracted delivery configuration,

wherein the prosthetic valve includes an annular valve body with a plurality of ventricular anchors and a plurality of atrial anchors attached thereto, the valve body comprising;

an annular outer frame, and

an inner frame situated at least partially within the outer frame,

wherein the plurality of ventricular anchors extend from the outer frame and the plurality of atrial anchors extend from the inner frame, and

wherein the plurality of ventricular anchors are configured to be substantially flush with the inner frame when the plurality of ventricular anchors is in the contracted delivery configuration;

unconstraining the plurality of ventricular anchors and the plurality of atrial anchors while maintaining the valve body in the contracted delivery configuration; and

unconstraining the valve body from the contracted delivery configuration while the unconstrained atrial anchors are positioned within an atrium and while the unconstrained ventricular anchors are positioned within a ventricle.