Prosthetic valve with S-shaped tissue anchors

• US 10,667,908 B2
• Filed: 07/20/2018
• Issued: 06/02/2020
• 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:
  US16/041,208
• Publication Number:
  US 20180338829A1
• Time in Patent Office: 683 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 prosthetic valve may include an annular valve body and a plurality of ventricular anchoring legs configured to extend radially outward from the annular valve body. At least one ventricular anchoring leg may include a first concave portion situated between the valve body and a terminal end of the leg, and a second concave portion situated between the first concave portion and the terminal end of the leg. The first concave portion may face radially outward, while the second concave portion may face radially inward. At least one of the first concave portion and the second concave portion may be angularly aligned with a point of connection between the at least one leg and the valve body.

Claims

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

an annular valve body; and

a plurality of ventricular anchoring legs, each ventricular anchoring leg comprising;

a proximal leg end secured to the annular valve body, and

a terminal leg end opposite from the proximal leg end,

wherein a length of each ventricular anchoring leg that extends between the proximal and terminal leg ends thereof is configured to extend radially outward from the annular valve body,

wherein at least one ventricular anchoring leg includes;

a first surface extending between the proximal leg end and terminal leg end of the at least one ventricular anchoring leg, the first surface having a first curved leg portion situated between the proximal leg end and the terminal leg end, wherein the first curved leg portion is configured to have a convex arrangement with respect to a longitudinal axis of the annular valve body, and

a second surface extending between the proximal leg end and terminal leg end of the at least one ventricular anchoring leg, the second surface being situated on an opposite side of the ventricular anchoring leg from the first surface and having a second curved leg portion situated between the first curved leg portion and the terminal leg end, wherein the second curved leg portion is configured to have a concave arrangement with respect to the longitudinal axis of the annular valve body,

wherein at least one of the first curved leg portion and the second curved leg portion of the at least one ventricular anchoring leg is situated at the same angular position about the longitudinal axis of the annular valve body as the proximal leg end of the at least one ventricular anchoring leg, and

wherein a portion of the annular valve body situated downstream from the proximal leg end of the at least one ventricular anchoring leg is configured to remain in a radially-reduced configuration while the at least one ventricular anchoring leg extends radially outward from the annular valve body.

2. The prosthetic valve of claim 1, wherein the at least one ventricular anchoring leg additionally includes at least one of:

a first linear portion extending between the proximal leg end and the first curved leg portion of the at least one ventricular anchoring leg;

a second linear portion extending between the first curved leg portion and the second curved leg portion of the at least one ventricular anchoring leg; and

a third linear portion extending between the second curved leg portion and the terminal leg end of the at least one ventricular anchoring leg.

3. The prosthetic valve of claim 1,

wherein the terminal leg end of the at least one ventricular anchoring leg includes a widened tissue-engaging flange having an opening therein and is configured to be situated radially outward from the second curved leg portion of the at least one ventricular anchoring leg, with respect to the longitudinal axis of the annular valve body.

4. The prosthetic valve of claim 1, further comprising:

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

a proximal arm end secured to the annular valve body, and

a terminal arm end opposite from the proximal arm end.

5. The prosthetic valve of claim 4, wherein the proximal leg ends and the proximal arm ends are situated at different angular positions about the longitudinal axis of the annular valve body.

6. The prosthetic valve of claim 4, wherein when the prosthetic valve is in a radially-expanded configuration, at least one atrial anchoring arm is configured to extend radially outward beyond the terminal leg end of the at least one ventricular anchoring leg.

7. The prosthetic valve of claim 1, wherein when the prosthetic valve is in a radially-expanded configuration, the length of the at least one ventricular anchoring leg that extends between the proximal and terminal leg ends thereof is configured to extend in an upstream direction.

8. The prosthetic valve of claim 1, wherein the second surface of the at least one ventricular anchoring leg is configured to engage a ventricular portion of the native mitral valve upon implantation of the prosthetic valve.

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

an annular valve body;

a plurality of ventricular anchoring legs, each ventricular anchoring leg comprising;

a proximal leg end secured to the annular valve body, and

a terminal leg end opposite from the proximal leg end,

wherein a length of each ventricular anchoring leg that extends between the proximal and terminal leg ends thereof is configured to extend radially outward from the annular valve body; and

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

a proximal arm end secured to the annular valve body, and

a terminal arm end opposite from the proximal arm end,

wherein at least one ventricular anchoring leg includes;

a first surface extending between the proximal leg end and terminal leg end of the at least one ventricular anchoring leg, the first surface having a first curved leg portion situated between the proximal leg end and the terminal leg end, wherein the first curved leg portion is configured to have a convex arrangement with respect to a longitudinal axis of the annular valve body, and

a second surface extending between the proximal leg end and terminal leg end of the at least one ventricular anchoring leg, the second surface being situated on an opposite side of the ventricular anchoring leg from the first surface and having a second curved leg portion situated between the first curved leg portion and the terminal leg end, wherein the second curved leg portion is configured to have a concave arrangement with respect to the longitudinal axis of the annular valve body,

wherein at least one of the first curved leg portion and the second curved leg portion of the at least one ventricular anchoring leg is situated at the same angular position about the longitudinal axis of the annular valve body as the proximal leg end of the at least one ventricular anchoring leg, and

wherein at least one atrial anchoring arm includes;

a first curved arm portion situated between the proximal arm end and the terminal arm end of the at least one atrial anchoring arm, the first curved arm portion configured to face in a downstream direction when the prosthetic valve is in a radially-expanded configuration; and

a second curved arm portion situated between the first curved arm portion and the terminal arm end of the at least one atrial anchoring arm, the second curved arm portion configured to face in an upstream direction when the prosthetic valve is in the radially-expanded configuration.

10. The prosthetic valve of claim 9, wherein the at least one atrial anchoring arm additionally includes at least one of:

a first linear portion extending between the first curved arm portion and the second curved arm portion; and

a second linear portion extending between the second curved arm portion and the terminal arm end of the at least one atrial anchoring arm.

11. The prosthetic valve of claim 10, wherein when the prosthetic valve is in the radially-expanded configuration:

the first linear portion of the at least one atrial anchoring arm is configured to

extend in a downstream direction, and the second linear portion of the at least one atrial anchoring arm is configured to extend in an upstream direction.

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

an annular valve body;

a plurality of ventricular anchoring legs, each ventricular anchoring leg comprising;

a proximal leg end secured to the annular valve body, and

a terminal leg end opposite from the proximal leg end,

wherein a length of each ventricular anchoring leg that extends between the proximal and terminal leg ends thereof is configured to extend radially outward from the annular valve body; and

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

a proximal arm end secured to the annular valve body, and

a terminal arm end opposite from the proximal arm end,

wherein at least one ventricular anchoring leg includes;

a first surface extending between the proximal leg end and terminal leg end of the at least one ventricular anchoring leg, the first surface having a first curved leg portion situated between the proximal leg end and the terminal leg end, wherein the first curved leg portion is configured to have a convex arrangement with respect to a longitudinal axis of the annular valve body, and

a second surface extending between the proximal leg end and terminal leg end of the at least one ventricular anchoring leg, the second surface being situated on an opposite side of the ventricular anchoring leg from the first surface and having a second curved leg portion situated between the first curved leg portion and the terminal leg end, wherein the second curved leg portion is configured to have a concave arrangement with respect to the longitudinal axis of the annular valve body,

wherein at least one of the first curved leg portion and the second curved leg portion of the at least one ventricular anchoring leg is situated at the same angular position about the longitudinal axis of the annular valve body as the proximal leg end of the at least one ventricular anchoring leg, and

wherein when the prosthetic valve is in a radially-expanded configuration, a portion of the at least one ventricular anchoring leg is configured to be situated at the same position along the longitudinal axis of the annular valve body as a portion of at least one atrial anchoring arm.

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

an annular valve body; and

a plurality of ventricular anchoring legs, 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, at least one ventricular anchoring leg including;

a first concave portion situated between the proximal leg end and the terminal leg end of the at least one ventricular anchoring leg, the first concave portion configured to face radially outward, and

a second concave portion situated between the first concave portion and the terminal leg end of the at least one ventricular anchoring leg, the second concave portion configured to face radially inward,

wherein at least one of the first concave portion and the second concave portion of the at least one ventricular anchoring leg is angularly aligned with the proximal leg end of the at least one ventricular anchoring leg,

wherein the at least one ventricular anchoring leg is configured to move between a compressed state and a fully-expanded state,

wherein a length of the at least one ventricular anchoring leg that extends between the proximal and terminal leg ends thereof is configured to extend radially outward from the annular valve body and in an upstream direction when the at least one ventricular anchoring leg is arranged in the compressed state and in the fully-expanded state, and

wherein a portion of the annular valve body situated downstream from the proximal leg end of the at least one ventricular anchoring leg is configured to remain in a radially-reduced configuration while the at least one ventricular anchoring leg extends radially outward from the annular valve body.

14. The prosthetic valve of claim 13,

wherein each ventricular anchoring leg has a single point of connection to the annular valve body, and

wherein each ventricular anchoring leg connects with the annular valve body at a different portion of the annular valve body.

15. The prosthetic valve of claim 13, wherein the portion of the annular valve body situated downstream from the proximal leg end of the at least one ventricular anchoring leg is configured to remain in the radially-reduced configuration while the at least one ventricular anchoring leg is in the fully-expanded state.

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

a valve body including an annular outer frame and an inner frame situated at least partially within the outer frame;

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

a proximal arm end secured to the inner frame, and

a terminal arm end opposite from the proximal arm end; and

a plurality of ventricular anchoring legs configured to extend radially outward from the valve body, the prosthetic valve comprising at least as many ventricular anchoring legs as atrial anchoring arms, each ventricular anchoring leg comprising;

a proximal leg end secured to the outer frame, and

a terminal leg end opposite from the proximal leg end,

wherein at least one ventricular anchoring leg includes;

a first surface extending between the proximal leg end and terminal leg end of the at least one ventricular anchoring leg, the first surface having a first curved leg portion situated between the proximal leg end and the terminal leg end, wherein the first curved leg portion is configured to have a convex arrangement with respect to a longitudinal axis of the valve body, and

a second surface extending between the proximal leg end and terminal leg end of the at least one ventricular anchoring leg, the second surface being situated on an opposite side of the ventricular anchoring leg from the first surface and having a second curved leg portion situated between the first curved leg portion and the terminal leg end, wherein the second curved leg portion is configured to have a concave arrangement with respect to the longitudinal axis of the valve body.

17. The prosthetic valve of claim 16, wherein when the prosthetic valve is in a radially-expanded configuration, the second curved leg portion of the at least one ventricular anchoring leg is configured to be situated in an upstream direction from an upstream end of the outer frame.

18. The prosthetic valve of claim 16, wherein a point of connection between the at least one ventricular anchoring leg and the outer frame is spaced apart from an upstream end of the outer frame and a downstream end of the outer frame.

19. The prosthetic valve of claim 16,

wherein at least one atrial anchoring arm includes:

a first arm portion situated between the proximal arm end and the terminal arm end, the first arm portion being configured to extend in an upstream direction when the prosthetic valve is in a radially-expanded configuration, and

a second arm portion situated between the proximal arm end and the first arm portion, the second arm portion being configured to extend in a downstream direction when the prosthetic valve is in the radially-expanded configuration.

20. The prosthetic valve of claim 16, wherein the ventricular anchoring legs and the atrial anchoring arms alternate at a regular interval about a circumference of the valve body.

21. The prosthetic valve of claim 16, wherein when the prosthetic valve is in a radially-expanded configuration, a length of the at least one ventricular anchoring leg that extends between the proximal and terminal leg ends thereof is configured to extend in an upstream direction.