Prosthetic valve with aligned inner and outer frames

• US 10,357,360 B2
• Filed: 05/14/2018
• Issued: 07/23/2019
• 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:
  US15/978,494
• Publication Number:
  US 20180256323A1
• Time in Patent Office: 435 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, an expandable prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may be expandable from a radially contracted state to a radially expanded state. The prosthetic valve may include an expandable outer frame and an inner frame with tissue anchors extending therefrom. The outer and inner frames may be configured and interconnected such that ventricular ends of the inner and outer frames are substantially aligned when the frames are in the radially expanded state and are not substantially aligned when the frames are in the radially contracted state.

Claims

1. An expandable prosthetic valve for implantation within a native mitral valve, the prosthetic valve being expandable from a radially contracted state to a radially expanded state, the prosthetic valve comprising:

an expandable annular outer frame having an atrial end and a ventricular end;

an expandable inner frame situated at least partially within the annular outer frame and having an atrial end and a ventricular end, the inner frame further including one or more tissue anchors extending therefrom; and

one or more tissue anchors extending from the annular outer frame,

wherein the annular outer frame and the inner frame are configured and interconnected in a manner such that radial expansion of the prosthetic valve from the radially contracted state to the radially expanded state decreases a distance between the ventricular end of the annular outer frame and the ventricular end of the inner frame, and

wherein a connection between the inner frame and the annular outer frame is located at a portion of the prosthetic valve spaced apart from the atrial and ventricular ends of the inner frame and from the atrial and ventricular ends of the annular outer frame.

2. The prosthetic valve of claim 1,

wherein the one or more tissue anchors extending from the annular outer frame are configured to engage ventricular tissue of the native mitral valve, and

wherein the one or more tissue anchors extending from the inner frame are configured to engage atrial tissue of the native mitral valve.

3. The prosthetic valve of claim 1,

wherein the annular outer frame further includes an intermediate portion extending between the atrial end of the annular outer frame and the ventricular end of the annular outer frame;

and

wherein at least one tissue anchor extending from the annular outer frame extends from the intermediate portion of the annular outer frame.

4. The prosthetic valve of claim 1,

wherein the inner frame further includes an intermediate portion extending between the atrial end of the inner frame and the ventricular end of the inner frame;

and

wherein at least one tissue anchor extending from the inner frame extends from the intermediate portion of the inner frame.

5. The prosthetic valve of claim 1,

wherein the annular outer frame has no connections to the inner frame along the ventricular end of the annular outer frame, and

wherein the inner frame has no connections to the annular outer frame along the ventricular end of the inner frame.

6. The prosthetic valve of claim 1, wherein the inner frame has a greater axial length than an axial length of the annular outer frame.

7. The prosthetic valve of claim 1, wherein when the annular outer frame and the inner frame are both in the radially contracted state, the inner frame extends beyond the ventricular end of the annular outer frame in a ventricular direction and beyond the atrial end of the annular outer frame in an atrial direction.

8. The prosthetic valve of claim 1, wherein when the annular outer frame and the inner frame are both in the radially contracted state, at least one tissue anchor extending from the inner frame is configured for radially outward deployment.

9. The prosthetic valve of claim 1, wherein when the annular outer frame and the inner frame are both in the radially contracted state, at least one tissue anchor extending from the inner frame extends in a direction substantially parallel to a longitudinal axis of the prosthetic valve.

10. The prosthetic valve of claim 1, wherein a distance between the ventricular end of the annular outer frame and the ventricular end of the inner frame is smaller than a distance between the atrial end of the annular outer frame and the atrial end of the inner frame.

11. The prosthetic valve of claim 1, wherein the prosthetic valve is configured to be retained within a delivery device when the prosthetic valve is in the radially contracted state.

12. An expandable prosthetic valve for implantation within a native mitral valve, the prosthetic valve being expandable from a radially contracted state to a radially expanded state, the prosthetic valve comprising:

an expandable annular outer frame having an atrial end and a ventricular end;

an expandable inner frame situated at least partially within the annular outer frame and having an atrial end and a ventricular end, the inner frame further including one or more tissue anchors extending therefrom; and

one or more tissue anchors extending from the annular outer frame,

wherein the annular outer frame and the inner frame are configured and interconnected in a manner such that radial expansion of the prosthetic valve from the radially contracted state to the radially expanded state decreases a distance between the ventricular end of the annular outer frame and the ventricular end of the inner frame, and

wherein the prosthetic valve is configured such that upon implantation,

an entire length of at least one tissue anchor extending from the annular outer frame extends toward an atrium, and

a portion of at least one tissue anchor extending from the inner frame extends toward a ventricle.

13. An expandable prosthetic valve for implantation within a native mitral valve, the prosthetic valve being expandable from a radially contracted state to a radially expanded state, the prosthetic valve comprising:

an expandable annular outer frame having an atrial end and a ventricular end;

an expandable inner frame situated at least partially within the annular outer frame and having an atrial end and a ventricular end, the inner frame further including one or more tissue anchors extending therefrom; and

one or more tissue anchors extending from the annular outer frame,

wherein the annular outer frame and the inner frame are configured and interconnected in a manner such that radial expansion of the prosthetic valve from the radially contracted state to the radially expanded state decreases a distance between the ventricular end of the annular outer frame and the ventricular end of the inner frame, and

wherein an axial distance between the tissue anchors extending from the annular outer frame and the ventricular end of the annular outer frame remains constant between the radially expanded state of the annular outer frame and the radially contracted state of the annular outer frame.

14. A prosthetic valve for implantation within a native heart valve, the prosthetic valve configured to expand from a radially contracted state to a radially expanded state, the prosthetic valve comprising:

an annular outer frame having an atrial end and a ventricular end; and

an inner frame situated at least partially within the annular outer frame and having a ventricular end,

wherein a location of connection between the annular outer frame and the inner frame is spaced apart from the atrial end of the annular outer frame and from the ventricular end of the annular outer frame,

wherein the annular outer frame and the inner frame are configured and interconnected in a manner such that radial expansion of the annular outer frame and of the inner frame decreases a distance between the ventricular end of the annular outer frame and the ventricular end of the inner frame, and

wherein the annular outer frame and the inner frame are secured against relative movement at the location of connection during radial expansion of the annular outer frame and of the inner frame.

15. The prosthetic valve of claim 14, further comprising a plurality of tissue anchors extending from the inner frame, wherein at least one tissue anchor extends from a portion of the inner frame spaced from an atrial end of the inner frame and from the ventricular end of the inner frame.

16. The prosthetic valve of claim 14, wherein the location of connection between the annular outer frame and the inner frame is spaced apart from the ventricular end of the inner frame.