Heart Valve Sealing Devices

• US 20140067054A1
• Filed: 08/27/2013
• Published: 03/06/2014
• Est. Priority Date: 09/06/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Oba, Travis, Delgado, Sergio, Taft, Robert C., Rowe, Stanton J., Cooper, Alexander H.
• Granted Patent: US 9,510,946 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

This disclosure pertains generally to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices. In some cases, a spacer having a single anchor can be implanted within a native heart valve. In some cases, a spacer having dual anchors can be implanted within a native heart valve. In some cases, devices can be used to extend the effective length of a native heart valve leaflet.

Claims

1. A prosthetic device for treating heart valve regurgitation comprising:

a main body portion having a connection portion and a free end portion, wherein;

the connection portion is configured to be coupled to a first one of the two native mitral valve leaflets such that the device is implanted within a native mitral valve orifice; and

when the device is implanted within the native mitral valve orifice, the free end portion moves laterally toward a second one of the two native mitral valve leaflets during systole, thereby helping to seal the orifice and reduce mitral regurgitation during systole, and the free end portion moves laterally away from the second native mitral valve leaflet during diastole to allow blood to flow from the left atrium to the left ventricle during diastole.

2. The device of claim 1, wherein the connection portion of the main body is thicker than the free end portion.

3. The device of claim 1, wherein the main body portion further comprises an atrial portion that contacts the native mitral valve annulus within the left atrium adjacent to the first native mitral valve leaflet.

4. The device of claim 1, further comprising a ventricular anchor that clips around a lower end of the first native mitral valve leaflet, thereby securing the device to the first native mitral valve leaflet.

5. The device of claim 4, wherein the anchor comprises a paddle shape with a broad upper end portion and a relatively narrow neck portion, wherein the neck portion couples the upper end portion to the main body.

6. A prosthetic device for treating heart valve regurgitation comprising:

a radially compressible and radially expandable body having a first end, a second end, and an outer surface extending from the first end to the second end; and

a first anchor coupled to the body and configured to capture the anterior native mitral valve leaflet between the first anchor and the body to secure the device to the anterior leaflet; and

a second anchor coupled to the body and configured to capture the posterior native mitral valve leaflet between the second anchor and the body to secure the device to the posterior leaflet, wherein when the first and second anchors capture the anterior and posterior leaflets, the body is situated within a mitral valve orifice between the anterior and posterior leaflets, thereby decreasing a size of the orifice.

7. The device of claim 6, wherein the body is radially compressible to a collapsed delivery configuration suitable for delivering the device to the native mitral valve, and radially expandable from the collapsed delivery configuration to an expanded, operational configuration suitable for operation in the native mitral valve.

8. The device of claim 7, wherein the body is formed from Nitinol and is radially self-expandable from the collapsed configuration to the expanded configuration.

9. The device of claim 6, further comprising a sheet of blood impermeable fabric covering the body.

10. The device of claim 6, wherein the body has an elliptical cross-sectional shape.

11. The device of claim 6, wherein the body has a crescent cross-sectional shape.

12. The device of claim 6, wherein the body comprises a prosthetic valve.

13. The device of claim 6, wherein the body is configured to prevent blood from flowing through the body in a direction extending from the first end to the second end and in a direction from the second end to the first end.

14. A method of implanting a prosthetic sealing device at a native mitral valve of a heart, the method comprising:

advancing a delivery system to a native mitral valve region of a heart from a left ventricle of the heart, the delivery system housing the prosthetic sealing device in a radially compressed configuration;

proximally retracting an outer sheath of the delivery system such that anchors of the prosthetic sealing device are not confined within the delivery system;

advancing the delivery system toward the left atrium of the heart such that native mitral valve leaflets are positioned between the anchors of the prosthetic sealing device and the delivery system;

proximally retracting an inner sheath of the delivery system such that a body of the prosthetic sealing device is not confined within the delivery system, wherein the body comprises a sealing device that prevents blood from flowing through the body during systole and during diastole; and

removing the delivery system from the native mitral valve region of the heart.

15. The method of claim 14, wherein advancing the delivery system to the native mitral valve region from the left ventricle comprises inserting the delivery device into the left ventricle through an incision in an apex of the left ventricle.

16. The method of claim 14, wherein when the delivery system is advanced to the native mitral valve region of the heart, the anchor is held in a substantially straightened position within the delivery catheter extending distally along a side of the body of the prosthetic sealing device.

17. A method of implanting a prosthetic sealing device at a native mitral valve of a heart, the method comprising:

advancing a delivery system to a native mitral valve region of a heart from a left atrium of the heart, the delivery system housing the prosthetic sealing device in a radially compressed configuration;

proximally retracting an outer sheath of the delivery system such that anchors of the prosthetic sealing device are not confined within the delivery system;

retracting the delivery system toward the left atrium of the heart such that native mitral valve leaflets are positioned between the anchors of the prosthetic sealing device and the delivery system;

proximally retracting an inner sheath of the delivery system such that a body of the prosthetic sealing device is not confined within the delivery system, wherein the body comprises a sealing device that prevents blood from flowing through the body during systole and during diastole; and

removing the delivery system from the native mitral valve region of the heart.

18. The method of claim 17, wherein advancing the delivery system to the native mitral valve region from the left atrium comprises advancing the delivery system through an incision in a portion of a septum between the left atrium and a right atrium.

19. The method of claim 17, wherein when the delivery system is advanced to the native mitral valve region of the heart, the anchor is held in a substantially straightened position within the delivery catheter extending proximally from body of the prosthetic sealing device.