DEVICE FOR MITIGATING OR PREVENTING PARAVALVULAR LEAKS

• US 20140155993A1
• Filed: 12/04/2013
• Published: 06/05/2014
• Est. Priority Date: 12/04/2012
• Status: Abandoned Application

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Kapadia, Samir
• Application Number:
  US14/096,047
• Publication Number:
  US 20140155993A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2250/006 modular

Abstract

One aspect of the present disclosure relates to a device for preventing or mitigating paravalvular leakage associated with a valve replacement procedure. The device can include a first ring, a second ring axially spaced apart from the first ring, at least one pad section extending between the first and second rings, and a plurality of centering wires attached to at least one of the first and second rings.

Claims

1. A device for preventing or mitigating paravalvular leakage associated with a valve replacement procedure, the device comprising:

a first ring;

a second ring that is axially spaced apart from the first ring;

at least one pad section extending between the first and second rings; and

a plurality of centering wires attached to at least one of the first and second rings.

2. The device of claim 1, wherein the first ring is substantially parallel to, and coaxial with, the second ring.

3. The device of claim 1, wherein the first ring and the second ring are each configured to expand into contact with, and apply pressure to, a native valve annulus upon deployment of the device.

4. The device of claim 1, wherein two or more pad sections are circumferentially spaced apart from one another.

5. The device of claim 3, wherein the at least one pad section is disposed about the first and second rings so that the at least one pad section substantially aligns with a commissure of the native valve annulus upon deployment of the device.

6. The device of claim 1, wherein each of the centering wires has a first end that is directly attached to a point on the first ring near a location at which the at least one pad section is located.

7. The device of claim 1, wherein each of the centering wires has a second end that is directly attached to a different centering wire at a central point that is spaced apart from the first and second rings.

8. The device of claim 1, wherein the first and second rings are configured to securely receive a prosthetic valve.

9. The device of claim 1, further including a prosthetic valve secured therein.

10. The device of claim 9, wherein the prosthetic valve is a stented prosthetic valve.

11. A device for preventing or mitigating paravalvular leakage associated with an aortic valve replacement procedure, the device comprising:

a first ring;

a second ring that is axially spaced apart from the first ring;

three pad sections extending between the first and second rings, each of the pad sections having a commissure engaging surface;

a plurality of centering wires attached to at least one of the first and second rings.

12. A method for preventing or mitigating paravalvular leakage during a procedure to replace a diseased heart valve having a valve annulus and at least two commissures, the method comprising the steps of:

providing a device that includes a first ring, a second ring that is axially spaced apart from the first ring, at least one pad section extending between the first and second rings, and a plurality of centering wires attached to at least one of the first and second rings;

deploying the device in the valve annulus so that the at least one pad section engages at least one commissure to form a seal therebetween and thereby reduce or prevent paravalvular leakage; and

deploying a prosthetic valve within the device.

13. The method of claim 12, wherein the step of deploying the device further includes:

positioning the device, in a collapsed configuration, within the valve annulus;

partially expanding the device so that the first and second ring members firmly engage the valve annulus and pin the native valve leaflets against the valve annulus; and

manipulating the centering wires until each of the pad sections is positioned directly adjacent the commissures of the diseased heart valve.

14. The method of claim 12, wherein the prosthetic valve is a stented valve.