Retaining mechanisms for prosthetic valves

Patent metadata

Field	Value
Publication number	US-12257150-B2
Application number	US-202418625047-A
Country	US
Kind code	B2
Filing date	Apr 2, 2024
Priority date	Jul 23, 2010
Publication date	Mar 25, 2025
Grant date	Mar 25, 2025

Abstract

Prosthetic heart valve assemblies and methods, apparatus, and systems used to deliver a prosthetic heart valve assembly. A prosthetic heart valve assembly includes an inner frame, a prosthetic leaflet section disposed within the inner frame extending between in inflow row of cells and an outflow row of cells of the inner frame, and an outer support stent. The inner frame is disposed within the outer support stent, and the outer support stent is coupled and/or fastened to the inner frame. The outer support stent includes a plurality leaflet capturing arms for capturing native leaflets between the leaflet capturing arms and a portion of the prosthetic heart valve assembly when the prosthetic heart valve assembly is implanted in a native valve. For example, the native leaflets can be frictionally secured between the leaflet capturing arms of the support stent and the inner frame.

First claim

What is claimed is:

1. A prosthetic heart valve assembly comprising:
an annular inner frame comprising a plurality of interconnected struts that form a plurality of rows of cells including an inflow row of cells and an outflow row of cells;
a prosthetic leaflet section disposed within the inner frame between the inflow row of cells and the outflow row of cells; and
an annular outer support stent coupled to the inner frame, the outer support stent comprising one or more leaflet capturing arms, wherein the inner frame is disposed within the outer support stent;
wherein the leaflet capturing arms are sized and shaped to capture native leaflets between the leaflet capturing arms and a portion of the prosthetic heart valve; and
wherein each of the leaflet capturing arms comprises a downstream portion that is oriented toward the outflow end portion of the prosthetic heart valve assembly, an upstream portion that is oriented toward an inflow end portion of the prosthetic heart valve assembly, and an intermediate portion extending from the downstream portion to the upstream portion, wherein each of the leaflet capturing arms is shape set such that, when the prosthetic heart valve assembly is in a radially expanded state, the intermediate portion bends relative to the downstream portion at a first inflection point to define a concave region along an outer surface of the leaflet capturing arm and the upstream portion bends relative to the intermediate portion at a second inflection point to define a convex region along the outer surface of the leaflet capturing arm.

2. The prosthetic heart valve assembly of claim 1 , wherein an intermediate portion of the inner frame comprises an outwardly bowed portion, and wherein the outer support stent comprises a contour complementary to the outwardly bowed portion of the inner frame.

3. The prosthetic heart valve assembly of claim 1 , wherein the inner frame comprises a flared end portion at an inflow end portion of the prosthetic heart valve assembly.

4. The prosthetic heart valve assembly of claim 1 , wherein the outer support stent comprises an intermediate portion and an inflow end portion, wherein the inflow end portion of the outer support stent has a diameter that is greater than the intermediate portion of the outer support stent.

5. The prosthetic heart valve assembly of claim 1 , wherein the outer support stent comprises interconnected struts that form a plurality of alternating peaks and valleys.

6. The prosthetic heart valve assembly of claim 1 , wherein the one or more leaflet capturing arms comprise a plurality of leaflet capturing arms, and wherein the upstream portion of each of the leaflet capturing arms includes a protrusion extending therefrom.

7. The prosthetic heart valve assembly of claim 6 , wherein each of the protrusions comprises an aperture extending therethrough.

8. The prosthetic heart valve assembly of claim 6 , wherein the protrusions are configured to frictionally secure the native leaflets between the protrusions and the inner frame.

9. The prosthetic heart valve assembly of claim 1 , wherein the inner frame comprises a plurality of axially extending retaining arms, and wherein the retaining arms are sized and shaped to be coupled to a delivery apparatus for positioning of prosthetic heart valve assembly at a native heart valve.

10. The prosthetic heart valve assembly of claim 9 , wherein each of the retaining arms axially extends from the outflow row of cells.

11. The prosthetic heart valve assembly of claim 1 , further comprising a plurality of covers, each of the covers extending over an interior surface and an exterior surface of one of the leaflet capturing arms.

12. The prosthetic heart valve assembly of claim 11 , wherein each of the covers comprises a padding.

13. The prosthetic heart valve assembly of claim 1 , wherein the inner frame and the outer support stent are configured to capture the native leaflets between the leaflet capturing arms and the inner frame such that the leaflet capturing arms are on a first side of the native leaflets and the inner frame is on a second side of the native leaflets opposite to the first side of the native leaflets.

14. The prosthetic heart valve assembly of claim 1 , wherein the inner frame and the outer support stent are configured such that, during implantation, the outer support stent is radially expandable prior to radial expansion of the inner frame.

15. The prosthetic heart valve assembly of claim 1 , wherein the prosthetic heart valve assembly is configured for implantation in a native mitral valve.

16. The prosthetic heart valve assembly of claim 1 , wherein the inner frame and the outer support stent are connected to each other with fasteners prior to loading the prosthetic heart valve assembly into a delivery apparatus.

17. The prosthetic heart valve assembly of claim 16 , wherein the fasteners comprise clips.

18. The prosthetic heart valve assembly of claim 16 , wherein the inner frame and the outer support stent are connected to each other with the fasteners adjacent outflow ends of the inner frame and the outer support stent.

19. The prosthetic heart valve assembly of claim 1 , wherein the prosthetic leaflet section extends from the inflow row of cells to the outflow row of cells.

20. A prosthetic heart valve assembly comprising:
an inner frame comprising a plurality of interconnected struts that form a plurality of rows of cells including an inflow row of cells and an outflow row of cells, wherein the inner frame comprises a flared end portion at an inflow end portion of the prosthetic heart valve assembly, an intermediate outwardly bowed portion downstream of the flared end portion, and an inwardly bowed region formed between the flared end portion and the intermediate outwardly bowed portion;
a prosthetic leaflet section disposed within the inner frame, the prosthetic leaflet section extending from the inflow row of cells to the outflow row of cells;
an outer support stent fastened to the inner frame, the outer support stent comprising one or more leaflet capturing arms each formed by one or more struts of the outer support stent, wherein the inner frame is disposed within the outer support stent;
wherein the one or more leaflet capturing arms each comprise an upstream portion that is oriented toward the inflow end portion of the prosthetic heart valve assembly and an intermediate portion connected to the upstream portion; and
wherein each of the leaflet capturing arms is shape set such that, when the prosthetic heart valve assembly is in a radially expanded state and implanted in a native valve, the leaflet capturing arms apply an inward radial force on native leaflets at a location along the inwardly bowed region of the inner frame;
wherein the inner frame and the outer support stent are connected to each other with fasteners prior to loading the prosthetic heart valve assembly into a delivery apparatus.

21. The prosthetic heart valve assembly of claim 20 , wherein an intermediate portion of the outer support stent comprises a contour complementary to the intermediate outwardly bowed portion of the inner frame, and wherein an inflow end portion of the outer support stent has a diameter that is greater than the intermediate portion of the outer support stent.

22. The prosthetic heart valve assembly of claim 20 , wherein each of capturing arms includes a cover extending over an interior surface and an exterior surface thereof, and wherein each of the covers

Assignees

• Edwards Lifesciences Corp

Inventors

• Olson Christopher J
• Rabito Glen T
• Armer Dustin P
• Ma Minh T
• Marr Devin H
• Huang Cheng-Tung
• Okabe Hiroshi
• Stewart Kevin M
• Curtis Alison S
• Corso Jr Philip P

Classifications

• A61F2230/0076

  ellipsoidal or ovoid · CPC title

• A61F2230/0054

  V-shaped · CPC title

• A61F2220/005

  using adhesives · CPC title

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title