Prosthetic valve with pivoting tissue anchor portions

• US 10,682,227 B2
• Filed: 06/01/2018
• Issued: 06/16/2020
• 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:
  US15/995,725
• Publication Number:
  US 20180271655A1
• Time in Patent Office: 746 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 annular valve body may include a plurality of atrial anchoring arms and ventricular anchoring legs configured to extend therefrom. The anchoring arms and anchoring legs may be configured to assume a delivery configuration in which they are substantially parallel to a longitudinal axis of the valve body, and a deployed configuration, in which they may deflect radially outward. The anchoring arms may include a pivoting portion configured to extend in a non-ventricular direction when the arm is in the delivery configuration and in a ventricular direction when the arm is in the deployed configuration. The entire length of each leg may be configured to extend in a non-ventricular direction when the legs are in both the delivery and deployed configurations.

Claims

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

an annular valve body having an upstream end and a downstream end opposite from the upstream end, wherein the downstream end of the annular valve body is configured for implantation within a ventricle adjacent to the native mitral valve;

a plurality of atrial anchoring arms configured to extend from the annular valve body, each atrial anchoring arm having a proximal arm end secured to the annular valve body and a terminal arm end opposite from the proximal arm end; and

a plurality of ventricular anchoring legs configured to extend from the annular valve body, each ventricular anchoring leg having a proximal leg end secured to the annular valve body and a terminal leg end opposite from the proximal leg end,

wherein the atrial anchoring arms and the ventricular anchoring legs are configured to assume;

a delivery configuration in which the atrial anchoring arms and ventricular anchoring legs are configured to be contained at least partially within a prosthetic valve delivery device and are arranged substantially parallel to a longitudinal axis of the annular valve body, and

a deployed configuration in which the atrial anchoring arms and the ventricular anchoring legs deflect radially outward from the delivery configuration, wherein the terminal arm end of at least one atrial anchoring arm is configured to be the outermost portion of the at least one atrial anchoring arm, relative to the longitudinal axis of the annular valve body, when the at least one atrial anchoring arm is in the deployed configuration;

wherein each atrial anchoring arm includes a pivoting portion configured to extend from the annular valve body in an upstream direction when the atrial anchoring arm is in the delivery configuration and to extend from the annular valve body in a downstream direction when the atrial anchoring arm is in the deployed configuration, wherein the terminal arm end of the at least one atrial anchoring arm is configured to be situated upstream of the pivoting portion of the at least one atrial anchoring arm when the at least one atrial anchoring arm is in the deployed configuration; and

wherein a length of each ventricular anchoring leg extending from the proximal leg end to the terminal leg end is configured to extend from the annular valve body in an upstream direction when the ventricular anchoring legs are in both the delivery configuration and the deployed configuration.

2. The prosthetic valve of claim 1, wherein the terminal arm ends of the atrial anchoring arms are configured to be situated at the same axial position along the longitudinal axis of the annular valve body when the atrial anchoring arms are in the deployed configuration.

3. The prosthetic valve of claim 1, wherein the pivoting portion of the at least one atrial anchoring arm is situated in closer proximity to the proximal arm end of the at least one atrial anchoring arm than to the terminal arm end of the at least one atrial anchoring arm.

4. The prosthetic valve of claim 1, wherein the at least one atrial anchoring arm includes:

an upstanding portion configured to extend in an upstream direction when the at least one atrial anchoring arm is in the deployed configuration, wherein the upstanding portion includes the terminal arm end of the at least one atrial anchoring arm.

5. The prosthetic valve of claim 1, wherein the atrial anchoring arms are configured to be spaced at a regular interval about a circumference of the annular valve body.

6. The prosthetic valve of claim 1, wherein the ventricular anchoring legs are configured to be spaced at a regular interval about a circumference of the annular valve body.

7. The prosthetic valve of claim 1, wherein the length of at least one ventricular anchoring leg extending from the proximal leg end to the terminal leg end is configured to extend in an upstream direction when the at least one ventricular anchoring leg is in both the delivery configuration and the deployed configuration.

8. The prosthetic valve of claim 1, wherein the length of at least one ventricular anchoring leg extending from the proximal leg end to the terminal leg end is configured to be arranged substantially parallel to the longitudinal axis of the annular valve body when the at least one ventricular anchoring leg is in the delivery configuration.

9. The prosthetic valve of claim 1, wherein at least one ventricular anchoring leg is configured to abut a portion of the annular valve body when the at least one ventricular anchoring leg is in the delivery configuration.

10. The prosthetic valve of claim 1, wherein the terminal leg end of at least one ventricular anchoring leg is configured to be flush with the annular valve body when the at least one ventricular anchoring leg is in the delivery configuration.

11. The prosthetic valve of claim 1, wherein the annular valve body includes:

an annular outer frame; and

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

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

12. The prosthetic valve of claim 11, wherein at least one ventricular anchoring leg is configured to abut a portion of the inner frame when the at least one ventricular anchoring leg is in the delivery configuration.

13. The prosthetic valve of claim 11, wherein the terminal leg end of at least one ventricular anchoring leg is configured to be flush with the inner frame when the at least one ventricular anchoring leg is in the delivery configuration.

14. The prosthetic valve of claim 1,

wherein at least one ventricular anchoring leg extends from a single portion of the annular valve body, and

wherein none of the plurality of ventricular anchoring legs share a common connection point to the annular valve body.

15. The prosthetic valve of claim 1,

wherein the annular valve body is configured to assume a delivery configuration and a deployed configuration, and

wherein at least one ventricular anchoring leg is configured to assume the deployed configuration of the at least one ventricular anchoring leg while the annular valve body remains in the delivery configuration of the annular valve body.

16. The prosthetic valve of claim 1, wherein when the plurality of ventricular anchoring legs and the plurality of atrial anchoring arms are in their respective deployed configurations, the plurality of ventricular anchoring legs and the plurality of atrial anchoring arms are configured to apply opposing grasping forces upon tissue of the native mitral valve.

17. The prosthetic valve of claim 1,

wherein the annular valve body is configured to assume a delivery configuration and a deployed configuration, and

wherein the at least one atrial anchoring arm is configured to assume the deployed configuration of the at least one atrial anchoring arm while the annular valve body remains in the delivery configuration of the annular valve body.

18. A prosthetic valve for implantation within a native mitral valve, the prosthetic valve comprising:

an annular valve body having an upstream end and a downstream end opposite from the upstream end, wherein the downstream end of the annular valve body is configured for implantation within a ventricle adjacent to the native mitral valve;

a plurality of atrial anchoring arms configured to extend from the annular valve body, each atrial anchoring arm having a proximal arm end secured to the annular valve body and a terminal arm end opposite from the proximal arm end; and

a plurality of ventricular anchoring legs configured to extend from the annular valve body, each ventricular anchoring leg having a proximal leg end secured to the annular valve body and a terminal leg end opposite from the proximal leg end,

wherein the atrial anchoring arms and the ventricular anchoring legs are configured to assume;

a delivery configuration in which the atrial anchoring arms and ventricular anchoring legs are configured to be contained at least partially within a prosthetic valve delivery device and are arranged substantially parallel to a longitudinal axis of the annular valve body, and

a deployed configuration in which the atrial anchoring arms and the ventricular anchoring legs deflect radially outward from the delivery configuration, wherein the terminal arm end of at least one atrial anchoring arm is configured to be the outermost portion of the at least one atrial anchoring arm, relative to the longitudinal axis of the annular valve body, when the at least one atrial anchoring arm is in the deployed configuration,

wherein each atrial anchoring arm includes a pivoting portion configured;

to extend from the annular valve body in a direction away from the downstream end of the annular valve body when the atrial anchoring arm is in the delivery configuration, and

to extend from the annular valve body in a direction towards the downstream end of the annular valve body when the atrial anchoring arm is in the deployed configuration,

wherein the terminal arm end of the at least one atrial anchoring arm is configured to be situated upstream of the pivoting portion of the at least one atrial anchoring arm when the at least one atrial anchoring arm is in the deployed configuration, and

wherein a length of each ventricular anchoring leg extending from the proximal leg end to the terminal leg end is configured to extend from the annular valve body in a direction away from the downstream end of the annular valve body when the ventricular anchoring legs are in both the delivery configuration and the deployed configuration.

19. The prosthetic valve of claim 18, wherein the length of at least one ventricular anchoring leg extending from the proximal leg end of the at least one ventricular anchoring leg to the terminal leg end of the at least one ventricular anchoring leg is configured to extend away from the downstream end of the annular valve body when the at least one ventricular anchoring leg is in both the delivery configuration and the deployed configuration.

20. A prosthetic valve for implantation within a native mitral valve, the prosthetic valve comprising:

an annular valve body having an upstream end and a downstream end opposite from the upstream end, wherein the downstream end of the annular valve body is configured for implantation within a ventricle adjacent to the native mitral valve;

a plurality of atrial anchoring arms configured to extend from the annular valve body, each atrial anchoring arm having a proximal arm end secured to the annular valve body and a terminal arm end opposite from the proximal arm end; and

a plurality of ventricular anchoring legs configured to extend from the annular valve body, each ventricular anchoring leg having a proximal leg end secured to the annular valve body and a terminal leg end opposite from the proximal leg end,

wherein the atrial anchoring arms and the ventricular anchoring legs are configured to assume;

a delivery configuration in which the atrial anchoring arms and ventricular anchoring legs are configured to be contained at least partially within a prosthetic valve delivery device and are arranged substantially parallel to a longitudinal axis of the annular valve body, and

a deployed configuration in which the atrial anchoring arms and the ventricular anchoring legs deflect radially outward from the delivery configuration, wherein the terminal arm end of at least one atrial anchoring arm is configured to be the outermost portion of the at least one atrial anchoring arm, relative to the longitudinal axis of the annular valve body, when the at least one atrial anchoring arm is in the deployed configuration,

wherein each atrial anchoring arm includes a pivoting portion configured to;

extend from the annular valve body in an upstream direction when the atrial anchoring arm is in the delivery configuration, and

to extend from the annular valve body in a downstream direction when the atrial anchoring arm is in the deployed configuration,

wherein the terminal arm end of the at least one atrial anchoring arm is configured to be situated upstream of the pivoting portion of the at least one atrial anchoring arm when the at least one atrial anchoring arm is in the deployed configuration,

wherein a length of each ventricular anchoring leg extending from the proximal leg end to the terminal leg end is configured to extend from the annular valve body in an upstream direction when the ventricular anchoring legs are in both the delivery configuration and the deployed configuration, and

wherein a portion of at least one ventricular anchoring leg and a portion of the annular valve body are configured to be situated at the same axial position along the longitudinal axis of the annular valve body when the at least one ventricular anchoring leg is in the delivery configuration.