Heart valve sealing devices

• US 9,510,946 B2
• Filed: 08/27/2013
• Issued: 12/06/2016
• 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.
• Primary Examiner(s): Sevilla, Christian
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US14/011,598
• Publication Number:
  US 20140067054A1
• Time in Patent Office: 1,197 Days
• Field of Search: 623/1.11
• US Class Current: 1/1
• 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 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, the delivery system housing the prosthetic sealing device in a radially compressed configuration, the prosthetic sealing device comprising a main body and anchors extending from the main body, the main body comprising a radially expandable and compressible annular metal frame having an upstream end, a downstream end, and a lumen extending from the upstream end to the downstream end, the main body further comprising a blood impermeable fabric covering the frame;

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

positioning the delivery system 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 the main body of the prosthetic sealing device is not confined within the delivery system and expands from the radially compressed configuration to a radially expanded configuration and is held between the native mitral valve leaflets by the anchors, which clamp portions of the native leaflets against the main body, wherein the fabric prevents blood from flowing through the lumen of the metal frame during systole and during diastole, wherein non-clamped portions of the native mitral valve leaflets can move away from the main body of the prosthetic device during diastole to allow blood from the left atrium to flow past the prosthetic device into the left ventricle, and the non-clamped portions of the native mitral valve leaflets can seal against the main body of the prosthetic device during systole to minimize mitral regurgitation; and

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

wherein an upstream end of the prosthetic sealing device is located downstream of the native mitral valve annulus when implanted.

2. The method of claim 1, wherein advancing the delivery system to the native mitral valve region comprises inserting the delivery device into a left ventricle through an incision in an apex of the left ventricle.

3. The method of claim 1, wherein when the delivery system is advanced to the native mitral valve region of the heart, the anchors are held in a substantially straightened position within the delivery catheter extending distally along a side of the body of the prosthetic sealing device.

4. The method of claim 1, wherein the main body comprises an upstream end portion and a downstream end portion, wherein the upstream end portion is tapered.

5. The method of claim 4, wherein the tapered upstream end portion supports a tapered polymeric nose cone defining a guide wire lumen.

6. The method of claim 1, wherein the upstream end of the metal frame defines an opening and the fabric blocks blood in the left atrium from flowing into the lumen of the frame during diastole.

7. The method of claim 1, further comprising, after retracting the outer sheath, applying an expansion force to the anchors to cause the anchors to splay apart from the main body so that the anchors can be placed behind the native leaflets.

8. The method of claim 7, further comprising, after the main body is expanded, removing the expansion force to allow the anchors to pivot radially inwardly under their own resiliency to clamp the leaflets against the main body.

9. The method of claim 7, wherein the expansion force is applied by expanders that are actuated by a user to cause the anchors to splay apart.

10. The method of claim 9, wherein the expanders are levers.

11. The method of claim 1, wherein advancing the delivery system to the native mitral valve region comprises advancing the delivery system via a trans-septal delivery approach in which the delivery system is advanced through an opening made in a septum between the a left atrium and a right atrium of the heart.

12. The method of claim 1, wherein the fabric comprises a knitted lofty cloth.

13. The method of claim 1, wherein the metal frame comprises a plurality of interconnected struts defining a plurality of openings that are covered by the fabric covering.

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, the delivery system housing the prosthetic sealing device in a radially compressed configuration, the prosthetic sealing device comprising a main body and anchors extending from the main body, the main body having an upstream end and a downstream end;

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

applying an expansion force to the anchors to cause the anchors to splay apart from the main body so that the anchors can be placed behind the native leaflets;

positioning the delivery system 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 ft the main body of the prosthetic sealing device is not confined within the delivery system and expands from a radially compressed configuration to a radially expanded configuration;

removing the expansion force to allow the anchors to pivot radially inwardly under their own resiliency to clamp the leaflets against the main body, thereby anchoring the main body between the native mitral valve leaflets, wherein the main body is impermeable to blood so as to prevent blood from flowing through the main body from the upstream end to the downstream end 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 comprises advancing the delivery system into a right atrium of the heart, through an incision in a portion of a septum between a left atrium and the right atrium, and into the left atrium.

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

17. The method of claim 14, wherein the main body comprises an upstream end portion and a downstream end portion, wherein the upstream end portion is tapered.

18. The method of claim 14, wherein the main body comprises a radially expandable and compressible annular metal frame defining the upstream end and the downstream end of the main body, the frame having a lumen extending from the upstream end to the downstream end, the main body further comprising a blood impermeable fabric covering the frame that prevents blood from flowing through the lumen during systole and diastole.

19. The method of claim 18, wherein the fabric comprises a knitted lofty cloth.

20. The method of claim 14, wherein the expansion force is applied by expanders that are actuated by a user to cause the anchors to splay apart.

21. The method of claim 20, wherein the expanders are levers.

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

23. The method of claim 14, wherein an upstream end of the prosthetic sealing device is located below the native mitral valve annulus when implanted.