Prosthetic valve with aligned inner and outer frames

• US 10,524,903 B2
• Filed: 07/10/2019
• Issued: 01/07/2020
• 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:
  US16/507,357
• Publication Number:
  US 20190328519A1
• Time in Patent Office: 181 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 use of prosthetic valves may be provided. In one implementation, an expandable prosthetic valve may be configured for implantation within a native heart valve. The prosthetic valve may include an expandable outer frame formed at least partially of outer frame struts. The prosthetic valve may also include an inner frame with tissue anchors extending therefrom, the inner frame being formed at least partially of inner frame struts. The struts along the downstream ends of the outer and inner frames may be arranged in undulating configurations to extend between peaks and troughs. A trough of the outer frame may be configured to be situated downstream from a peak of the inner frame.

Claims

1. An expandable prosthetic valve for implantation within a native heart valve, the prosthetic valve being configured for expansion from a radially-contracted state to a radially-expanded state, wherein the prosthetic valve comprises:

an expandable annular outer frame formed at least partially of outer frame struts intersecting at outer frame junctions, the annular outer frame comprising a downstream end and an upstream end opposite from the downstream end, wherein the outer frame struts along the downstream end of the annular outer frame are arranged in a first undulating configuration in which the outer frame struts extend between a first plurality of peaks and a first plurality of troughs positioned downstream from the first plurality of peaks; and

an expandable inner frame situated at least partially within the annular outer frame and formed at least partially of inner frame struts intersecting at inner frame junctions, the inner frame comprising a downstream end and an upstream end opposite from the downstream end,

wherein a plurality of inner frame tissue anchors are configured to extend radially-outward from the inner frame, and

wherein the inner frame struts along the downstream end of the inner frame are arranged in a second undulating configuration in which the inner frame struts extend between a second plurality of peaks and a second plurality of troughs positioned downstream from the second plurality of peaks,

wherein the annular outer frame and the inner frame are configured and interconnected in a manner such that radial expansion of the prosthetic valve from the radially-contracted state to the radially-expanded state decreases a distance between the downstream end of the annular outer frame and the downstream end of the inner frame, and

wherein at least one of the first plurality of troughs is configured to be situated downstream from at least one of the second plurality of peaks.

2. The prosthetic valve of claim 1, wherein the at least one of the first plurality of troughs is configured to be situated downstream from the at least one of the second plurality of peaks when the prosthetic valve is in the radially-expanded state.

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

a plurality of outer frame tissue anchors configured to extend radially-outward from the annular outer frame,

wherein the inner frame tissue anchors are configured to engage atrial tissue of the native heart valve and the outer frame tissue anchors are configured to engage ventricular tissue of the native heart valve.

4. The prosthetic valve of claim 3, 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 outer frame tissue anchor extends from the intermediate portion of the annular outer frame.

5. The prosthetic 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 inner frame tissue anchor extends from the intermediate portion of the inner frame.

6. The prosthetic valve of claim 1,

wherein the downstream end of the annular outer frame is devoid of connections to the inner frame, and

wherein the downstream end of the inner frame is devoid of connections to the annular outer frame.

7. The prosthetic valve of claim 1, wherein the inner frame has a greater axial length than an axial length of the annular outer frame.

8. The prosthetic valve of claim 1, wherein when the annular outer frame and the inner frame are both in the radially-contracted state, 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.

9. The prosthetic valve of claim 1, wherein when the annular outer frame and the inner frame are both in the radially-contracted state, at least one inner frame tissue anchor is configured to extend in a direction substantially parallel to a longitudinal axis of the prosthetic valve.

10. The prosthetic valve of claim 1, wherein a distance between the downstream end of the annular outer frame and the downstream end of the inner frame is smaller than a distance between the upstream end of the annular outer frame and the upstream end of the inner frame.

11. The prosthetic valve of claim 1,

wherein the outer frame struts are configured to intersect at outer frame junctions to form a plurality of closed outer frame cells having a first cell shape, and

wherein the inner frame struts are configured to intersect at inner frame junctions to form a plurality of closed inner frame cells having a second cell shape different from the first cell shape.

12. The prosthetic valve of claim 1,

wherein the outer frame struts are configured to intersect at outer frame junctions to form a plurality of closed outer frame cells, and

wherein the closed outer frame cells adjacent to the downstream end of the outer frame are configured to be chevron shaped.

13. The prosthetic valve of claim 1, wherein the outer frame junctions along the upstream end of the outer frame are offset from the first plurality of troughs, relative to a circumferential direction of the prosthetic valve.

14. The prosthetic valve of claim 1, wherein the prosthetic valve is configured to be retained within a delivery device when the prosthetic valve is in the radially-contracted state.

15. A prosthetic valve configured for implantation within a native heart valve, the prosthetic valve comprising:

an expandable annular outer frame formed at least partially of outer frame struts intersecting at outer frame junctions, the annular outer frame comprising a downstream end and an upstream end opposite from the downstream end, wherein the outer frame struts along the downstream end of the annular outer frame are arranged in a first undulating configuration in which the outer frame struts extend between a first plurality of peaks and a first plurality of troughs positioned downstream from the first plurality of peaks; and

an expandable inner frame situated at least partially within the annular outer frame and formed at least partially of inner frame struts intersecting at inner frame junctions, the inner frame comprising a downstream end and an upstream end opposite from the downstream end, wherein the inner frame struts along the downstream end of the inner frame are arranged in a second undulating configuration in which the inner frame struts extend between a second plurality of peaks and a second plurality of troughs positioned downstream from the second plurality of peaks,

wherein the inner frame has a greater axial length than an axial length of the annular outer frame,

wherein the annular outer frame and the inner frame are configured and interconnected in a manner such that radial expansion of the annular outer frame and of the inner frame decreases a distance between the downstream end of the annular outer frame and the downstream end of the inner frame, and

wherein when the prosthetic valve is in a radially-expanded state, at least one of the first plurality of troughs is configured to be situated downstream from at least one of the second plurality of peaks.

16. The prosthetic valve of claim 15, further comprising:

a plurality of inner frame tissue anchors configured to extend radially-outward from the inner frame; and

a plurality of outer frame tissue anchors configured to extend radially-outward from the annular outer frame,

wherein the inner frame tissue anchors are configured to engage atrial tissue of the native heart valve and the outer frame tissue anchors are configured to engage ventricular tissue of the native heart valve.

17. The prosthetic valve of claim 15,

wherein the downstream end of the annular outer frame is devoid of connections to the inner frame, and

wherein the downstream end of the inner frame is devoid of connections to the annular outer frame.

18. The prosthetic valve of claim 15, 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.

19. The prosthetic valve of claim 15,

wherein the outer frame struts are configured to intersect at outer frame junctions to form a plurality of closed outer frame cells having a first cell shape, and

wherein the inner frame struts are configured to intersect at inner frame junctions to form a plurality of closed inner frame cells having a second cell shape different from the first cell shape.

20. The prosthetic valve of claim 15, wherein the outer frame junctions along the upstream end of the outer frame are offset from the first plurality of troughs, relative to a circumferential direction of the prosthetic valve.