Method for treating a mitral valve

• US 9,579,199 B2
• Filed: 12/08/2015
• Issued: 02/28/2017
• Est. Priority Date: 06/01/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Hauser, David L., Solem, Jan O., Alon, David
• Primary Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US14/963,149
• Publication Number:
  US 20160089239A1
• Time in Patent Office: 448 Days
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• 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 2002/0835 with deformation of anchor parts, e.g. expansion of dowel by set screw
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A method of using a device to improve the function of a heart valve is disclosed. In one preferred embodiment, the method includes positioning a prosthetic insert member between leaflets of mitral valve. The insert member has an elongated cross-sectional profile for conforming to gap between leaflets of a mitral valve. The device also includes an anchoring member for attachment to heart tissue for maintaining the insert member in the mitral valve. The insert member is used to plug the gap between the leaflets of the mitral valve and thereby reduce undesirable regurgitation while allowing the leaflets to function in a substantially normal manner. An anchoring member secures the prosthetic insert member to a heart wall. The anchoring member preferably includes a plurality of tissue penetrating hooks or prongs.

Claims

1. A method for treating a mitral valve, the method comprising:

inserting a delivery sheath through an incision through cardiac tissue along an apex of a heart into a left ventricle;

advancing an insert member in a collapsed configuration through the delivery sheath into the left ventricle, the insert member including a biocompatible fabric outer layer, a passageway extending therethrough along a longitudinal axis extending from a left atrium to the left ventricle, and a valve member disposed within the passageway, the valve member including one or more flap members defining a one-way valve;

allowing the insert member to expand to an expanded configuration;

aligning a cross-sectional profile of the insert member to conform to a curvature of native mitral valve leaflets;

positioning the insert member between native leaflets of a mitral valve such that the native leaflets create a tight seal against a layer of fabric disposed over an outer surface of the insert member;

extending a first end of an anchoring member through the incision, the anchoring member including a second end coupled to an outflow end of the insert member, an elongate body portion and a first end including a penetration member, the penetration member extending through the cardiac tissue;

contacting a plate with an outer surface of the heart; and

locking the plate to the penetration member.

2. The method of claim 1, wherein advancing the insert member comprises advancing an insert member including a crescent-shaped transverse cross-sectional profile.

3. The method of claim 1, wherein extending the first end of the anchoring member including the elongate body portion comprises extending a first end of an anchoring member including an elongate, elastic body portion.

4. The method of claim 1, wherein the plate is a first plate, the method further comprising contacting a second plate with an inner surface of the heart, and locking the second plate to the penetration member.

5. The method of claim 1, wherein advancing the insert member comprises advancing an insert member including at least one of plastic or metal.

6. A method for treating a mitral valve, the method comprising:

advancing an insert member in a collapsed configuration through a heart wall and into a left ventricle, the insert member including a passageway extending therethrough along a longitudinal axis extending from a left atrium to the left ventricle, a one-way valve member disposed within the passageway;

allowing the insert member to expand to an expanded configuration;

positioning the insert member between native leaflets of a mitral valve such that the native leaflets create a tight seal against an outer surface of the insert member;

extending a first end portion of an anchoring member through the heart wall, the anchoring member including a second end portion coupled to an outflow end of the insert member;

locking a plate to the first end portion of the anchoring member on an exterior wall of the heart.

7. The method of claim 6, wherein advancing the insert member comprises advancing the insert member through an incision through cardiac tissue along an apex of a heart into a left ventricle.

8. The method of claim 6, wherein advancing the insert member comprises advancing the insert member through a delivery sheath.

9. The method of claim 6, wherein advancing the insert member comprises advancing an insert member including a biocompatible fabric outer layer.

10. The method of claim 6, wherein advancing the insert member comprises advancing an insert member including a biological tissue outer layer.

11. The method of claim 6, wherein advancing the insert member comprises advancing an insert member including at least one of plastic or metal.

12. The method of claim 6, wherein advancing the insert member comprises advancing an insert member including a crescent-shaped transverse cross-sectional profile.

13. The method of claim 6, wherein positioning the insert member further comprises aligning a cross-sectional profile of the insert member to conform to a curvature of native mitral valve leaflets.

14. The method of claim 6, wherein extending the first end portion of the anchoring member comprises extending a first end portion of an anchoring member including an elongate, elastic body portion.

15. The method of claim 6, wherein locking the plate to the first end portion of the anchoring member further comprises contacting the plate with an outer surface of the heart.

16. The method of claim 6, wherein the plate is a first plate, and wherein locking a plate to the first end portion of the anchoring member comprises locking the first plate to the first end portion of the anchoring member on the exterior wall of the heart and locking a second plate to the first end portion of the anchoring member on an inner surface of the heart.