Prosthetic valve with flexible tissue anchor portions

• US 10,390,952 B2
• Filed: 05/31/2018
• Issued: 08/27/2019
• 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:
  US15/994,022
• Publication Number:
  US 20180271654A1
• Time in Patent Office: 453 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 annular valve body may include a plurality of atrial anchoring arms and ventricular anchoring legs extending radially outward therefrom. At least one atrial anchoring arm may include a rigid portion and a flexible portion positioned radially outwards from the rigid portion. At least part of the flexible portion may be configured for placement at a location radially outward from an outer diameter defined by terminal ends of the ventricular anchoring legs.

Claims

1. An expandable prosthetic valve for implantation within a native mitral valve, the prosthetic valve comprising:

an expandable annular valve body;

a plurality of ventricular anchoring legs, each ventricular anchoring leg configured to extend radially outward from the expandable annular valve body to respective terminal leg ends; and

a plurality of atrial anchoring arms, each atrial anchoring arm configured to extend radially outward from the expandable annular valve body,

wherein the expandable prosthetic valve is configured to assume;

a radially compressed state in which the prosthetic valve is configured to be contained at least partially within a prosthetic valve delivery device, and

a radially expanded state in which the expandable prosthetic valve is configured to be anchored within the native mitral valve,

wherein at least one atrial anchoring arm includes;

a rigid portion,

a flexible portion including a structure with multiple curves,

a first opening situated between the structure with multiple curves and a terminal end of the at least one atrial anchoring arm, and

a second opening situated between the structure with multiple curves and a location of connection between the at least one atrial anchoring arm and the expandable annular valve body,

wherein the structure with multiple curves does not extend to the terminal end of the at least one atrial anchoring arm, and

wherein when the expandable prosthetic valve is in the radially expanded state, the at least one atrial anchoring arm is configured to be arranged such that a part of the flexible portion situated outside a circumference defined by the terminal leg ends has a greater length than a part of the flexible portion situated inside the circumference defined by the terminal leg ends.

2. The prosthetic valve of claim 1, wherein when the expandable prosthetic valve is in the radially expanded state, a radially inner end of the flexible portion of the at least one atrial anchoring arm and the terminal leg ends are configured to be substantially equidistant from a longitudinal axis extending through the center of the annular valve body.

3. The prosthetic valve of claim 1,

wherein each atrial anchoring arm of the plurality of atrial anchoring arms includes the rigid portion and the flexible portion, and

wherein when the expandable prosthetic valve is in the radially expanded state, radially inner ends of the flexible portions of the atrial anchoring arms alternate with the terminal leg ends around the circumference defined by the terminal leg ends.

4. The prosthetic valve of claim 1, wherein when the expandable prosthetic valve is in the radially expanded state, the rigid portion of the at least one atrial anchoring arm is situated between a longitudinal axis extending through the center of the annular valve body and the flexible portion of the at least one atrial anchoring arm.

5. The prosthetic valve of claim 1, wherein when the expandable prosthetic valve is in the radially expanded state, a radially inner end of the structure with multiple curves and the terminal leg ends are configured to be substantially equidistant from a longitudinal axis extending through the center of the annular valve body.

6. The prosthetic valve of claim 1, wherein the structure with multiple curves includes a serpentine pattern.

7. The prosthetic valve of claim 1, wherein the flexible portion of the at least one atrial anchoring arm is configured for placement at a location radially inward from the circumference defined by the terminal leg ends when the expandable prosthetic valve is in the radially compressed state.

8. The prosthetic valve of claim 1, wherein each atrial anchoring arm extends from a single location on the annular valve body and each ventricular anchoring leg extends from a single location on the annular valve body.

9. The prosthetic valve of claim 1, wherein beyond locations of connection between the atrial anchoring arms and the annular valve body, no connection is made between any of the plurality of atrial anchoring arms.

10. The prosthetic valve of claim 1,

wherein each ventricular anchoring leg is positioned adjacent to two atrial anchoring arms, and

wherein each atrial anchoring arm is positioned adjacent to two ventricular anchoring legs.

11. The prosthetic valve of claim 1,

wherein the ventricular anchoring legs are substantially equal in length, and

wherein the atrial anchoring arms are substantially equal in length.

12. The prosthetic valve of claim 1, wherein the expandable annular valve body comprises:

an annular outer frame; and

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

wherein the atrial anchoring arms extend from the outer frame and the ventricular anchoring legs extend from the inner frame.

13. The prosthetic valve of claim 12, wherein the inner frame has a greater axial length than the annular outer frame.

14. The prosthetic valve of claim 12, wherein the entire flexible portion of the at least one atrial anchoring arm is configured to be positioned in an upstream direction relative to an upstream end of the annular outer frame.

15. The prosthetic valve of claim 1, wherein a joining point between the rigid portion and flexible portion of the at least one atrial anchoring arm is situated within a portion of the at least one atrial anchoring arm that is configured to extend from the annular valve body in a downstream direction when the expandable prosthetic valve is in the radially expanded state.

16. The prosthetic valve of claim 1, wherein the rigid portion of the at least one atrial anchoring arm is substantially straight.

17. An expandable prosthetic valve for implantation within a native mitral valve, the prosthetic valve comprising:

an expandable annular valve body;

a plurality of ventricular anchoring legs extending from the annular valve body to respective terminal leg ends; and

a plurality of atrial anchoring arms extending from the annular valve body, each atrial anchoring arm including;

a proximal arm end secured to the annular valve body,

a terminal arm end opposite from the proximal arm end,

a first arm section configured to extend from the annular valve body in a downstream direction, and

a second arm section situated between the first arm section and the terminal arm end, the second arm section configured to extend from the annular valve body in an upstream direction,

wherein the expandable prosthetic valve is configured to assume;

a radially compressed state in which the prosthetic valve is configured to be contained at least partially within a prosthetic valve delivery device, and

a radially expanded state in which the expandable prosthetic valve is configured to be anchored within the native mitral valve,

wherein at least one atrial anchoring arm includes;

a rigid portion situated at least partially within the first arm section,

a flexible portion, situated at least partially within the second arm section, including a structure with multiple curves,

a first opening situated between the structure with multiple curves and a terminal end of the at least one atrial anchoring arm, and

a second opening situated between the structure with multiple curves and a location of connection between the at least one atrial anchoring arm and the expandable annular valve body,

wherein the structure with multiple curves does not extend to the terminal end of the at least one atrial anchoring arm, and

wherein when the expandable prosthetic valve is in the radially expanded state, the second arm section of the at least one atrial anchoring arm is configured to be situated outside a circumference defined by the terminal leg ends.

18. The prosthetic valve of claim 17, wherein when the expandable prosthetic valve is in the radially expanded state, a radially inner end of the flexible portion of the at least one atrial anchoring arm and the terminal leg ends are configured to be substantially equidistant from a longitudinal axis extending through the center of the annular valve body.

19. The prosthetic valve of claim 17, wherein the expandable annular valve body comprises:

an annular outer frame; and

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

wherein the atrial anchoring arms extend from the outer frame and the ventricular anchoring legs extend from the inner frame.