Prosthetic valve having a multi-part frame

Patent metadata

Field	Value
Publication number	US-12409031-B2
Application number	US-202418811644-A
Country	US
Kind code	B2
Filing date	Aug 21, 2024
Priority date	Dec 4, 2009
Publication date	Sep 9, 2025
Grant date	Sep 9, 2025

Abstract

A prosthetic heart valve includes a multi-part frame having a first annular body and an anchor component that includes a second annular body circumscribing the first annular body. The first annular body includes a plurality of struts arranged in a lattice pattern and defining a lumen. The anchor component further includes one or more ventricular anchors extending from the second annular body toward an inflow end portion of the first annular body. A fabric layer is disposed on an inner surface of the first annular body and sutured to the struts. A valve structure including three leaflets is disposed within the lumen and inlet ends of the leaflets are sutured to the fabric layer. The multi-part frame is radially compressible for delivery within a sheath of a delivery catheter and is self-expandable for deployment within an annulus of a native valve.

First claim

We claim:

1. A prosthetic heart valve for implantation at a native valve of a heart, the prosthetic heart valve comprising:
a multi-part frame comprising:
a first annular body comprising a plurality of struts arranged in a lattice pattern and defining a lumen, wherein the first annular body has an inflow end portion and an outflow end portion; and
an anchor component comprising a second annular body circumscribing the first annular body and one or more ventricular anchors extending from the second annular body toward the inflow end portion of the first annular body, wherein the one or more ventricular anchors are configured to be positioned behind native valve leaflets;

a fabric layer disposed on an inner surface of the first annular body and sutured to the struts;
a valve structure comprising three leaflets made from pericardium, wherein the valve structure is disposed within the lumen and inlet ends of the leaflets are sutured to the fabric layer; and
wherein the multi-part frame is radially compressible for delivery within a sheath of a delivery catheter and is self-expandable for deployment within an annulus of the native valve.

2. The prosthetic heart valve of claim 1 , wherein the multi-part frame further comprises an atrial anchor that extends radially outward from the inflow end portion of the first annular body, wherein the atrial anchor is shaped for placement on an atrial side of the native valve when the prosthetic heart valve is implanted therein.

3. The prosthetic heart valve of claim 2 , wherein the atrial anchor extends radially outward from the inflow end portion of the first annular body and then axially upward relative to the inflow end portion of main body.

4. The prosthetic heart valve of claim 2 , further comprising a fabric layer extending over the atrial anchor forming an atrial sealing member that is shaped to contact tissue on an atrial side of the native valve when the prosthetic heart valve is implanted therein for forming a seal.

5. The prosthetic heart valve of claim 1 , wherein the second annular body comprises a circumferentially extending row of angled struts.

6. The prosthetic heart valve of claim 5 , wherein the one or more ventricular anchors comprises a plurality of ventricular anchors and the row of angled struts includes angled struts that are located circumferentially between locations where the ventricular anchors are connected to the second annular body.

7. The prosthetic heart valve of claim 6 , wherein the ventricular anchors are connected to the second annular body at locations between adjacent ends of adjacent angled struts.

8. The prosthetic heart valve of claim 7 , wherein the second annular body is connected to the first annular body via a locking mechanism.

9. The prosthetic heart valve of claim 1 , wherein the lattice pattern of the first annular body comprises a first row of cells defining an inflow end of the first annular body and a second row of cells defining an outflow end of the first annular body, wherein the valve structure is mounted within the lumen entirely between the inflow end and the outflow end.

10. The prosthetic heart valve of claim 1 , wherein the one or more ventricular anchors are covered with fabric.

11. The prosthetic heart valve of claim 1 , wherein the second annular body is connected to the first annular body at locations on the first annular body intermediate inflow and outflow ends of the first annular body.

12. A prosthetic heart valve for implantation at a native valve of a heart, the prosthetic heart valve comprising:
a multi-part frame comprising:
a valve frame comprising:
a first annular body comprising a plurality of struts arranged in a lattice pattern and defining a lumen, wherein the first annular body has an inflow end portion and an outflow end portion;
an atrial anchor shaped to engage native tissue on an atrial side of the native valve, wherein the atrial anchor extends radially outward from the inflow end portion of the first annular body; and

an anchor component comprising:
a second annular body; and
a plurality of ventricular anchors that extend from the second annular body toward the inflow end portion of the first annular body,
wherein the second annular body extends completely around the first annular body,
wherein the ventricular anchors are configured to be positioned behind native valve leaflets;

a valve structure comprising three leaflets made from pericardium, wherein the valve structure is mounted within the lumen; and
a first fabric layer disposed on an inner surface of the first annular body and sutured to the struts, wherein inlet ends of the leaflets are sutured to the first fabric layer along U-shaped seams;
wherein the multi-part frame is radially compressible for delivery within a sheath of a delivery catheter and is self-expandable for deployment within an annulus of the native valve.

13. The prosthetic heart valve of claim 12 , wherein the second annular body is connected to the first annular body with a locking mechanism.

14. The prosthetic heart valve of claim 12 , wherein the second annular body is sewn to the first annular body.

15. The prosthetic heart valve of claim 12 , wherein the second annular body comprises a circumferentially extending row of angled struts.

16. The prosthetic heart valve of claim 15 , wherein the ventricular anchors are longer than the angled struts.

17. The prosthetic heart valve of claim 12 , wherein the valve frame and the anchor component are made of Nitinol.

18. The prosthetic heart valve of claim 12 , wherein the ventricular anchors are covered with fabric.

19. The prosthetic heart valve of claim 12 , wherein the ventricular anchors comprise six or more ventricular anchors that can engage multiple locations on the native valve leaflets and/or native commissures.

20. A prosthetic heart valve for implantation at a native valve of a heart, the prosthetic heart valve comprising:
a first annular frame that is radially expandable from a radially compressed state to a radially expanded state, the first annular frame comprising a plurality of struts arranged in a lattice pattern and defining a lumen, wherein the first annular frame has an inflow end portion and an outflow end portion;
an atrial anchor shaped to engage native tissue on an atrial side of the native valve, wherein the atrial anchor extends radially outward from the inflow end portion of the first annular frame and then axially upward relative to the inflow end portion of the first annular frame;
a second annular frame that is radially expandable from a radially compressed state to a radially expanded state, wherein the second annular frame comprises a circumferentially extending row of angled struts that extends around the first annular frame;
a plurality of ventricular anchors that extend from the second annular frame toward the inflow end portion of the first annular frame,
wherein the ventricular anchors are configured to be positioned behind native valve leaflets;
a valve structure comprising three leaflets made from pericardium, wherein the valve structure is mounted within the lumen; and
a fabric layer disposed on an inner surface of the first annular frame and sutured to the struts of the first annular frame, wherein inlet ends of the leaflets are sutured to the fabric layer along U-shaped seams.

21. The prosthetic heart valve of claim 20 , wherein the fabric layer extends over the atrial anchor.

Assignees

• Edwards Lifesciences Corp

Inventors

• Chau Mark
• Patterson Marlowe E
• Yi Seung-Beom
• Geist Stephen C
• Oba Travis Zenyo

Classifications

• A61F2230/0069

  cylindrical · CPC title

• A61F2220/0016

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

• A61F2/2445

  Annuloplasty rings in direct contact with the valve annulus · CPC title

• A61F2/2409

  Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442) · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title