Heart valve sealing devices

• US 9,907,652 B2
• Filed: 07/07/2016
• Issued: 03/06/2018
• Est. Priority Date: 09/06/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Oba, Travis Zenyo, Delgado, Sergio, Taft, Robert C.
• Primary Examiner(s): Yabut, Diane
• Assistant Examiner(s): HERBERMANN, ERICH G.
• Application Number:
  US15/204,874
• Publication Number:
  US 20160317290A1
• Time in Patent Office: 607 Days
• Field of Search: 606200, 623 236, 623 211, 623 2372
• 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 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

an anchor having a connection portion and a leaflet capture portion, wherein;

the connection portion is coupled to the body such that the leaflet capture portion is biased against the outer surface of the body when the body is in a radially expanded state;

the prosthetic device is configured to capture a leaflet of a native heart valve between the leaflet capture portion of the anchor and the outer surface of the body;

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 extending from the second end to the first end;

the anchor and the body are configured to be anchored to only one of the native leaflets and can move with the captured leaflet toward and away from another native leaflet during a cardiac cycle.

2. The device of claim 1, wherein:

the body is radially compressible to a compressed state in which a leaflet-receiving gap exists between the body and the leaflet capture portion of the anchor; and

the body is resiliently radially self-expandable to the radially expanded state.

3. The device of claim 1, wherein the anchor comprises a first clip portion and a second clip portion, and wherein the device is configured to capture the leaflet between the first and second clip portions.

4. The device of claim 1, wherein the body comprises a metallic frame and a blood-impermeable fabric mounted on the frame.

5. The device of claim 1, wherein the body is configured to allow blood to flow around the body between the body and a non-captured leaflet during diastole, and configured to allow the non-captured leaflet to close around the body to prevent mitral regurgitation during systole.

6. The device of claim 1, wherein:

the anchor is coupled to the first end of the body; and

the device further comprises an atrial stabilizing member extending from the second end of the body.

7. The device of claim 1, wherein an atrial end portion of the body comprises a tapered shoulder that reduces in diameter moving toward the atrial end portion the body.

8. The device of claim 1, wherein the body comprises a crescent cross-sectional shape.

9. 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

an anchor having a connection portion and a leaflet capture portion, wherein;

the connection portion is coupled to the body such that the leaflet capture portion is biased against the outer surface of the body when the body is in a radially expanded state;

the prosthetic device is configured to capture a leaflet of a native heart valve between the leaflet capture portion of the anchor and the outer surface of the body;

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 extending from the second end to the first end;

the outer surface of the body comprises a first side against which the anchor is biased and a second side opposite the first side; and

the connection portion of the anchor is coupled to the body on the second side of the body.

10. The device of claim 9, wherein:

the anchor comprises an elongated member that is coupled to the second side of the body at a connection location; and

the elongated member comprises a ventricular portion that extends from the connection location across the first end of the body.

11. The device of claim 10, wherein the ventricular portion comprises first and second ventricular portions and the first ventricular portion is substantially parallel to the second ventricular portion.