Prosthetic valve with radially-deflectable tissue anchors

• US 10,722,360 B2
• Filed: 09/03/2019
• Issued: 07/28/2020
• 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:
  US16/559,365
• Publication Number:
  US 20190388223A1
• Time in Patent Office: 329 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

Prosthetic valves and methods of using prosthetic valves may be provided. In one implementation, an expandable annular valve body may include a plurality of atrial anchoring arms and ventricular anchoring legs extending therefrom. The anchoring arms and anchoring legs may be configured to assume a delivery configuration in which they are radially constrained, such as within a delivery device, such that at least one atrial anchoring arm extends in a first upstream direction from the annular valve body, and a deployed configuration, in which they may deflect radially outward. In the deployed configuration, a first arm portion may be configured to deflect radially outward to extend in a downstream direction, and a second arm portion may be configured to deflect radially outward to extend in a second upstream direction, the first upstream direction being angled relative to the second upstream direction.

Claims

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

an expandable annular valve body;

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

a proximal arm end secured to the annular valve body,

a terminal arm end opposite from the proximal arm end,

a first arm portion situated between the proximal arm end and the terminal arm end, and

a second arm portion situated between the first arm portion and the terminal arm end,

wherein the proximal arm end and terminal arm end of at least one atrial anchoring arm are configured to be situated at the same circumferential position about the annular valve body; and

a plurality of ventricular anchoring legs extending from the annular valve body,

wherein at least one ventricular anchoring leg is configured to assume;

a leg delivery configuration in which the at least one ventricular anchoring leg is configured to be radially constrained within a delivery device, and

a deployed-leg configuration in which the at least one ventricular anchoring leg is configured to pivot radially outward by an angle of less than 90°

from the leg delivery configuration about a connection point between the at least one ventricular anchoring leg and the annular valve body,

wherein the at least one atrial anchoring arm is configured to assume;

an arm delivery configuration in which the at least one atrial anchoring arm is configured to be radially constrained within the delivery device such that the at least one atrial anchoring arm extends in a first upstream direction from the annular valve body, and

a deployed-arm configuration in which;

the first arm portion of the at least one atrial anchoring arm is configured to deflect radially outward from the arm delivery configuration to extend in a downstream direction from the annular valve body, and

the second arm portion of the at least one atrial anchoring arm is configured to deflect radially outward from the arm delivery configuration to extend from the annular valve body in a second upstream direction, the first upstream direction being angled relative to the second upstream direction, and

wherein when the at least one atrial anchoring arm is arranged in the deployed-arm configuration, the at least one atrial anchoring arm is configured to extend radially outward from the annular valve body such that the terminal arm end of the at least one atrial anchoring arm;

is situated upstream from the rest of the at least one atrial anchoring arm, and

forms an outer-most portion of the at least one atrial anchoring arm, relative to a longitudinal axis extending through the center of the annular valve body.

2. The prosthetic valve of claim 1, wherein the first upstream direction is substantially parallel to the longitudinal axis of the annular valve body.

3. The prosthetic valve of claim 1, wherein the terminal arm end of the at least one atrial anchoring arm is configured to be situated upstream from the rest of the prosthetic valve when the at least one atrial anchoring arm is arranged in the deployed-arm configuration.

4. The prosthetic valve of claim 1, wherein the second arm portion of the at least one atrial anchoring arm is configured to be positioned radially outwards from the first arm portion of the at least one atrial anchoring arm when the at least one atrial anchoring arm is in the deployed-arm configuration.

5. The prosthetic valve of claim 1, wherein the at least one atrial anchoring arm is configured to deflect radially outwards independently of radial deflection of the other atrial anchoring arms.

6. The prosthetic valve of claim 5, wherein the at least one atrial anchoring arm is devoid of connection to the other atrial anchoring arms beyond the proximal arm end thereof.

7. The prosthetic valve of claim 1,

wherein the plurality of atrial anchoring arms are spaced at a regular interval about a circumference of the annular valve body;

and

wherein the plurality of ventricular anchoring legs are spaced at a regular interval about a circumference of the annular valve body.

8. The prosthetic valve of claim 1,

wherein the annular valve body comprises:

an annular outer frame, and

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

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

9. The prosthetic valve of claim 8, wherein at least a portion of the at least one ventricular anchoring leg is configured to be substantially flush with the inner frame when the at least one ventricular anchoring leg is in the leg delivery configuration.

10. The prosthetic valve of claim 1,

wherein the at least one ventricular anchoring leg extends from a single connection point to the expandable annular valve body, and

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

11. An expandable prosthetic valve configured for implantation within a native heart valve, the prosthetic valve comprising:

an expandable annular valve body;

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

a proximal arm end secured to the annular valve body,

a terminal arm end opposite from the proximal arm end,

a first arm portion situated between the proximal arm end and the terminal arm end, and

a second arm portion situated between the first arm portion and the terminal arm end; and

a plurality of ventricular anchoring legs extending from the annular valve body,

wherein at least one ventricular anchoring leg is configured to assume;

a leg delivery configuration in which the at least one ventricular anchoring leg is configured to be radially constrained within a delivery device, and

a deployed-leg configuration in which the at least one ventricular anchoring leg is configured to pivot radially outward by an angle of less than 90°

from the leg delivery configuration about a connection point between the at least one ventricular anchoring leg and the annular valve body,

wherein the entire length of the at least one ventricular anchoring leg is configured to extend upstream from the annular valve body when the at least one ventricular anchoring leg is arranged in the leg delivery configuration and in the deployed-leg configuration

wherein at least one atrial anchoring arm is configured to assume;

an arm delivery configuration in which the at least one atrial anchoring arm is configured to be radially constrained within the delivery device such that the at least one atrial anchoring arm extends in a first upstream direction from the annular valve body, and

a deployed-arm configuration in which;

the first arm portion of the at least one atrial anchoring arm is configured to deflect radially outward from the arm delivery configuration to extend in a downstream direction from the annular valve body, and

the second arm portion of the at least one atrial anchoring arm is configured to deflect radially outward from the arm delivery configuration to extend from the annular valve body in a second upstream direction, the first upstream direction being angled relative to the second upstream direction, and

wherein when the at least one atrial anchoring arm is arranged in the deployed-arm configuration, the at least one atrial anchoring arm is configured to extend radially outward from the annular valve body such that the terminal arm end of the at least one atrial anchoring arm;

is situated upstream from the rest of the at least one atrial anchoring arm, and

forms an outer-most portion of the at least one atrial anchoring arm, relative to a longitudinal axis extending through the center of the annular valve body.

12. The prosthetic valve of claim 11, wherein the at least one ventricular anchoring leg is configured to extend upstream from the annular valve body in a direction substantially parallel to the longitudinal axis of the expandable annular valve body when the at least one ventricular anchoring leg is arranged in the leg delivery configuration.

13. An expandable prosthetic valve configured for implantation within a native heart valve, the prosthetic valve comprising:

an expandable annular valve body, a longitudinal axis extending through the center of the annular valve body;

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

a proximal arm end secured to the annular valve body,

a terminal arm end opposite from the proximal arm end,

a first arm portion situated between the proximal arm end and the terminal arm end, and

a second arm portion situated between the first arm portion and the terminal arm end,

wherein at least one atrial anchoring arm includes a single point of connection to the annular valve body; and

a plurality of ventricular anchoring legs extending from the annular valve body,

wherein at least one ventricular anchoring leg is configured to assume;

a leg delivery configuration in which the at least one ventricular anchoring leg is configured to be radially constrained within a delivery device, and

a deployed-leg configuration in which the at least one ventricular anchoring leg is configured to pivot radially outward by an angle of less than 90°

from the leg delivery configuration about a connection point between the at least one ventricular anchoring leg and the annular valve body, and

wherein the at least one atrial anchoring arm is configured to assume;

an arm delivery configuration in which the at least one atrial anchoring arm is configured to be radially constrained within the delivery device such that the at least one atrial anchoring arm extends upstream from the annular valve body in an arm delivery direction, the arm delivery direction being parallel to a longitudinal axis through a center of the annular valve body, and

a deployed-arm configuration in which;

the first arm portion of the at least one atrial anchoring arm is configured to deflect radially outward from the arm delivery configuration to extend downstream from the annular valve body in a first arm portion direction, wherein the first arm portion direction forms a first arm angle with the longitudinal axis, and

the second arm portion of the at least one atrial anchoring arm is configured to deflect radially outward from the arm delivery configuration to extend from the annular valve body in a second arm portion direction, wherein the second arm portion direction forms a second arm angle with the longitudinal axis,

wherein the second arm angle is smaller than the first arm angle.

14. The prosthetic valve of claim 13, wherein the second arm portion of the at least one atrial anchoring arm is configured to extend upstream from the annular valve body in the second arm portion direction when the at least one atrial anchoring arm is arranged in the deployed-arm configuration.

15. The prosthetic valve of claim 13, wherein when the at least one atrial anchoring arm is arranged in the deployed-arm configuration, the at least one atrial anchoring arm is configured to extend radially outward from the annular valve body such that the terminal arm end of the at least one atrial anchoring arm:

is situated upstream from the rest of the at least one atrial anchoring arm, and

forms an outer-most portion of the at least one atrial anchoring arm, relative to the longitudinal axis of the annular valve body.

16. The prosthetic valve of claim 15, wherein the terminal arm end of the at least one atrial anchoring arm is configured to be situated upstream from the rest of the prosthetic valve when the at least one atrial anchoring arm is arranged in the deployed-arm configuration.

17. The prosthetic valve of claim 13,

wherein the arm delivery direction is substantially parallel to the longitudinal axis of the annular valve body, and

wherein the first arm portion direction is configured to form an angle of at least 90°

with the second arm portion direction when the at least one atrial anchoring arm is arranged in the deployed-arm configuration.

18. The prosthetic valve of claim 13, wherein the second arm portion of the at least one atrial anchoring arm is configured to be positioned radially outwards from the first arm portion of the at least one atrial anchoring arm when the at least one atrial anchoring arm is in the deployed-arm configuration.

19. The prosthetic valve of claim 13, wherein the at least one atrial anchoring arm is configured to deflect radially outwards independently of radial deflection of the other atrial anchoring arms.

20. The prosthetic valve of claim 19, wherein the at least one atrial anchoring arm is devoid of connection to the other atrial anchoring arms beyond the proximal arm end thereof.