Granted Patent B2

US 12,458,497 · App. 16/908,366 · Granted Nov 4, 2025

Inventors: Avraham Zakay (Tel Aviv-Jaffa, IL); David Mishaly (Shoham, IL); Dan Rottenberg (Haifa, IL); David Alon (Zichron Yaacov, IL)

Assignee: Edwards Lifesciences AG

A61F2/246A61B17/00234A61F2/2466A61B2017/00783A61B2017/00867A61B17/12013A61F2/2412A61F2210/0014A61F2210/0061A61F2210/0066

Abstract

Claims (42)

1 . A method of treating a native mitral valve without open-heart surgery, the method comprising:

loading a valve prosthesis within a delivery catheter, the prosthesis including an anchoring cage and an occluding member for preventing blood flow in one direction;

advancing the delivery catheter into an atrium;

positioning the anchoring cage within the atrium; and

allowing the anchoring cage to self-expand into contact with a wall of the atrium, wherein the anchoring cage has a substantially spherical shape for conforming to a geometry of the atrium and for uniformly distributing anchoring forces along the wall of the atrium;

wherein the anchoring cage maintains the occluding member in a fixed position relative to the native valve and wherein the occluding member prevents blood from flowing from a ventricle to the atrium during systole;

wherein the anchoring cage comprises a plurality of struts arranged to form a plurality of circumferentially extending rows of cells, including a first row of cells and a second row of cells that is closer to an upper end of the anchoring cage than the first row of cells.

2 . The method of claim 1 , wherein the occluding member comprises at least two pieces of flexible material, each piece of material having a rounded arch-shaped top portion and a straight bottom portion, wherein the pieces of flexible material are oriented generally vertically such that each piece of flexible material extends from the arch-shaped top portion to the straight bottom portion in a direction of a flow of blood from the atrium to the ventricle.

3 . The method of claim 2 , wherein the flexible material is pericardial tissue.

4 . The method of claim 1 , wherein the valve prosthesis further comprises support arms for connecting the anchoring cage to the occluding member.

5 . The method of claim 1 , wherein the anchoring cage is formed by laser cutting a metal tube.

6 . The method of claim 5 , wherein the metal tube is made of a shape memory material.

7 . The method of claim 1 , wherein the leaflets of the native valve are capable of opening and closing after the valve prosthesis has been deployed.

8 . The method of claim 1 , wherein the occluding member is secured to a bottom portion of the anchoring cage.

9 . The method of claim 1 , wherein the occluding member includes bovine tissue, polyurethane, fabric, biological material, or artificial material.

10 . A method of treating a native valve without open-heart surgery, the method comprising:

loading a valve prosthesis within a delivery catheter, the prosthesis including an anchoring cage and an occluding member for preventing blood flow in one direction;

advancing the delivery catheter into an atrium;

positioning the anchoring cage within the left atrium; and

allowing the anchoring cage to self-expand into contact with a wall of the atrium, wherein the anchoring cage has a substantially spherical shape for conforming to a geometry of the atrium and for uniformly distributing anchoring forces along the wall of the atrium;

wherein the anchoring cage maintains the occluding member in a fixed position relative to the native valve and wherein the occluding member prevents blood from flowing from a ventricle to the atrium during systole, wherein leaflets of the native valve continue to move toward and away from each other after the anchoring cage is expanded;

wherein the valve prosthesis includes a metal support portion connected to a lower end of the anchoring cage, wherein the occluding member is connected to the support portion.

11 . The method of claim 10 , wherein the entire anchoring cage is positioned within the left atrium after being expanded.

12 . The method of claim 10 , wherein the anchoring cage and the support portion are laser cut from a single Nitinol tube.

13 . The method of claim 10 , wherein the native leaflets of the native valve move toward and contact the valve prosthesis during systole to prevent regurgitation.

14 . A method of treating a native valve without open-heart surgery, the method comprising:

loading a valve prosthesis within a delivery catheter, the prosthesis including an anchoring cage and an occluding member for preventing blood flow in one direction, wherein the occluding member comprises at least two pieces of pericardial tissue, each piece of pericardial tissue having a rounded arch-shaped top portion and straight bottom portion;

advancing the delivery catheter into an atrium;

positioning the anchoring cage within the left atrium; and

allowing the anchoring cage to self-expand into contact with a wall of the atrium, wherein the anchoring cage has a substantially spherical shape for conforming to a geometry of the atrium and for uniformly distributing anchoring forces along the wall of the atrium;

wherein the anchoring cage maintains the occluding member in a fixed position relative to the native valve and wherein the occluding member prevents blood from flowing from a ventricle to the atrium during systole;

wherein the anchoring cage is laser cut from a Nitinol tube to define a plurality of struts arranged to define a plurality of diamond-shaped cells.

15 . The method of claim 14 , wherein leaflets of the native valve continue to move toward and away from each other after the anchoring cage is expanded.

16 . The method of claim 15 , wherein the entire anchoring cage is positioned within the atrium after being expanded.

17 . A method of treating a native valve without open-heart surgery, the method comprising:

loading a valve prosthesis within a delivery catheter, the prosthesis including an anchoring cage and an occluding member for preventing blood flow in one direction;

advancing the delivery catheter into an atrium;

positioning the anchoring cage within the atrium; and

allowing the anchoring cage to self-expand into contact with a wall of the atrium, wherein the anchoring cage has a substantially spherical shape for conforming to a geometry of the atrium and for uniformly distributing anchoring forces along the wall of the atrium;

wherein the anchoring cage maintains the occluding member in a fixed position relative to the native valve and wherein the occluding member prevents blood from flowing from a ventricle to the atrium during systole, wherein leaflets of the native valve continue to move toward and away from each other after the anchoring cage is expanded;

wherein the anchoring cage is laser cut from a Nitinol tube to define a plurality of struts arranged to define a plurality of diamond-shaped cells.

18 . The method of claim 17 , wherein the anchoring cage includes a circular ring at a central upper portion of the anchoring cage, wherein the circular ring is connected to adjacent diamond-shaped cells.

Assignments (2)

Continuity (8)

References Cited (400)