Prosthetic valve with aligned inner and outer frames

• US 10,695,177 B2
• Filed: 12/30/2019
• Issued: 06/30/2020
• 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:
  US16/730,090
• Publication Number:
  US 20200129294A1
• Time in Patent Office: 183 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 heart valves and methods of use of prosthetic heart valves may be provided. In one implementation, a prosthetic heart valve may include an annular outer frame, an inner frame, and at least one connector configured to secure the outer frame to the inner frame. The connector may be spaced apart from at least one of the downstream end of the outer frame or the downstream end of the inner frame. The prosthetic heart valve may be configured to maintain a greater distance between the downstream ends of the outer and inner frames when the prosthetic heart valve is radially compressed than when the prosthetic heart valve is radially expanded.

Claims

1. A prosthetic heart valve configured to transition between a radially compressed configuration and a radially expanded configuration, the prosthetic heart valve comprising:

an annular outer frame having a lumen extending between an upstream end of the outer frame and a downstream end of the outer frame;

an inner frame situated at least partially within the lumen of the annular outer frame, the inner frame having an upstream end and a downstream end;

at least one connector configured to secure the annular outer frame to the inner frame, the at least one connector being spaced apart from at least one of the downstream end of the annular outer frame or the downstream end of the inner frame; and

a plurality of tissue anchors configured to extend radially outward from at least one of the annular outer frame or the inner frame,

wherein the prosthetic heart valve is configured to maintain a first distance between the downstream ends of the annular outer frame and inner frame when the prosthetic heart valve is in the radially compressed configuration and a second distance between the downstream ends of the annular outer frame and inner frame when the prosthetic heart valve is in the radially expanded configuration, the first distance being greater than the second distance.

2. The prosthetic heart valve of claim 1, wherein the at least one connector comprises a plurality of connectors that are spaced apart with respect to a circumference of the prosthetic heart valve.

3. The prosthetic heart valve of claim 1, wherein the at least one connector is configured to secure the annular outer frame and inner frame against relative axial movement and comprises at least one of:

a mechanical connector extending between the annular outer frame and the inner frame, solder, or a weld.

4. The prosthetic heart valve of claim 1, wherein the at least one connector is arranged between the plurality of tissue anchors and the downstream ends of the annular outer frame and inner frame.

5. The prosthetic heart valve of claim 1, wherein the at least one connector is situated at the same circumferential position around the prosthetic heart valve as at least one of the tissue anchors.

6. The prosthetic heart valve of claim 1, wherein expansion of the prosthetic heart valve decreases a distance between the at least one connector and at least one of the tissue anchors.

7. The prosthetic heart valve of claim 1, wherein each of the annular outer frame and inner frame includes a plurality of struts intersecting at junctions to form closed cells, the annular outer frame having closed cells of a first shape and the inner frame having closed cells of a second shape different than the first shape.

8. The prosthetic heart valve of claim 1, wherein the plurality of tissue anchors comprises:

a plurality of ventricular tissue anchors extending from the annular outer frame; and

a plurality of atrial tissue anchors extending from the inner frame.

9. The prosthetic heart valve of claim 1, wherein the annular outer frame comprises:

an intermediate portion extending between the upstream end of the annular outer frame and the downstream end of the annular outer frame,

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

10. The prosthetic heart valve of claim 1, wherein the inner frame comprises:

an intermediate portion extending between the upstream end of the inner frame and the downstream end of the inner frame,

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

11. The prosthetic heart valve of claim 1, wherein an axial length of the inner frame is greater than an axial length of the annular outer frame.

12. The prosthetic heart valve of claim 11, wherein the inner frame is configured to extend beyond the downstream end of the annular outer frame in a downstream direction and beyond the upstream end of the annular outer frame in an upstream direction.

13. The prosthetic heart valve of claim 1, wherein a distance between the upstream end of the annular outer frame and the upstream end of the inner frame is greater than at least one of the first distance or second distance between the downstream ends of the annular outer frame and inner frame.

14. The prosthetic heart valve of claim 1, wherein the prosthetic heart valve is configured to be retained within a delivery device when the prosthetic heart valve is in the radially compressed configuration.

15. A prosthetic heart valve configured to transition between a radially compressed configuration and a radially expanded configuration, the prosthetic heart valve comprising:

an annular outer frame having a lumen extending between an upstream end of the outer frame and a downstream end of the outer frame;

an inner frame situated at least partially within the lumen of the annular outer frame, the inner frame having an upstream end and a downstream end;

a plurality of connectors configured to secure the annular outer frame and inner frame against relative axial movement, the plurality of connectors being spaced apart with respect to a circumference of the prosthetic heart valve; and

a plurality of tissue anchors configured to extend radially outward from at least one of the annular outer frame or the inner frame,

wherein the prosthetic heart valve is configured to maintain a first distance between the downstream ends of the annular outer frame and inner frame when the prosthetic heart valve is in the radially compressed configuration and a second distance between the downstream ends of the annular outer frame and inner frame when the prosthetic heart valve is in the radially expanded configuration, the first distance being greater than the second distance.

16. The prosthetic heart valve of claim 15, wherein the plurality of connectors comprises at least one of:

a mechanical connector extending between the annular outer frame and the inner frame, solder, or a weld.

17. The prosthetic heart valve of claim 15, wherein expansion of the prosthetic heart valve decreases a distance between the plurality of connectors and at least one of the tissue anchors.

18. The prosthetic heart valve of claim 15, wherein each of the annular outer frame and inner frame includes a plurality of struts intersecting at junctions to form closed cells, the annular outer frame having closed cells of a first shape and the inner frame having closed cells of a second shape different than the first shape.

19. The prosthetic heart valve of claim 15, wherein the plurality of tissue anchors comprises:

a plurality of ventricular tissue anchors extending from the annular outer frame; and

a plurality of atrial tissue anchors extending from the inner frame.

20. The prosthetic heart valve of claim 15, wherein an axial length of the inner frame is greater than an axial length of the annular outer frame.