DEVICE AND METHOD FOR TREATMENT OF HEART VALVE REGURGITATION

• US 20150202043A1
• Filed: 03/30/2015
• Published: 07/23/2015
• Est. Priority Date: 09/14/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Zakai, Avraham, Mishaly, David, Rottenberg, Dan, Alon, David
• Granted Patent: US 9,861,480 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2210/0066 shrinkable

Abstract

A method of treating a mitral valve without open-heart surgery is disclosed. An expandable prosthesis comprises an anchoring portion and an occluding member coupled to the anchoring portion. The prosthesis is loaded into a distal end of a delivery catheter and advanced through a femoral vein and through a pre-made puncture in an atrial septum. The occluding member is then positioned in the mitral valve and the anchoring portion is positioned in the left atrium for maintaining the occluding member between the leaflets of the mitral valve. After deployment, the occluding member prevents blood from flowing from the left ventricle to the left atrium during systole.

Claims

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

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

advancing the delivery catheter through a femoral vein and into a right atrium;

passing the delivery catheter through a pre-made puncture in an atrial septum and into the left atrium;

advancing the delivery catheter toward a mitral valve;

positioning the occluding member between leaflets of the mitral valve; and

deploying a portion of the anchoring portion in a left atrium for maintaining the position of the occluding member between the leaflets of the mitral valve, the anchoring portion contacting a mitral annulus;

wherein the occluding member prevents blood from flowing from the left ventricle to the left atrium during systole.

2. The method of claim 1, wherein the occluding member comprises an expandable pocket member, the expandable pocket member configured to expand during systole to block blood flow from the left ventricle to the left atrium and configured to collapse during diastole for permitting blood to flow from the left atrium to the left ventricle.

3. The method of claim 1, wherein the occluding member has a width that is substantially smaller than a length for conforming to the opening in the mitral valve.

4. The method of claim 1, wherein the occluding member comprises pericardial tissue.

5. The method of claim 1, wherein the prosthesis further comprises a support structure constructed to provide the occluding member with a cross-sectional profile in which the width of the occluding member is smaller than the length of the occluding member for conforming to the opening of the mitral valve.

6. The method of claim 1, wherein the support structure is made of a shape memory material.

7. The method of claim 1, wherein the anchoring portion is made of a shape memory material.

8. The method of claim 7, wherein the anchoring portion conforms to a shape of the left atrium.

9. The method of claim 1, wherein the anchoring portion comprises a plurality of loops.

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

loading a prosthesis within a delivery catheter, the prosthesis including an expandable anchoring portion and an expandable occluding member;

advancing the delivery catheter through a femoral vein and into a right atrium;

passing the delivery catheter through a pre-made puncture in an atrial septum and into a left atrium;

advancing the delivery catheter toward a mitral valve;

ejecting the prosthesis from a distal portion of the delivery catheter such that the occluding member is positioned between leaflets of the mitral valve; and

deploying a portion of the anchoring portion within the left atrium and securing the anchoring portion to heart tissue, the occluding member being supported by the anchoring portion for maintaining the occluding member between the leaflets of the mitral valve.

11. The method of claim 10, wherein the anchoring portion engages a mitral annulus.

12. The method of claim 10, wherein the anchoring portion contacts the atrial septum.

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

providing a prosthesis comprising an anchoring portion and a occluding member coupled to the anchoring portion;

compressing the prosthesis;

loading the prosthesis into a distal end of an elongate delivery catheter;

advancing the delivery catheter through a femoral vein and into a right atrium;

passing the delivery catheter through a puncture in an atrial septum and into the left atrium;

advancing the delivery catheter toward a mitral valve;

ejecting the prosthesis from a distal portion of the delivery catheter;

positioning the occluding member between leaflets of the mitral valve; and

expanding the anchoring portion for securing the anchoring portion to a heart wall and thereby maintaining the occluding member between the leaflets of the mitral valve;

wherein the occluding member prevents blood from flowing from the left ventricle to the left atrium during systole and permits blood to flow from the left atrium to the left ventricle during diastole.

14. The method of claim 13, wherein the occluding member comprises pericardial tissue.

15. The method of claim 13, wherein the anchoring portion is made of a shape memory material.

16. The method of claim 13, wherein the anchoring portion contacts a mitral annulus after expansion.

17. The method of claim 16, wherein the anchoring portion further contacts the atrial septum after expansion.