Method for replacing mitral valve

• US 10,226,334 B2
• Filed: 12/29/2014
• Issued: 03/12/2019
• Est. Priority Date: 05/01/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton J., Chau, Mark, Nguyen, Son V.
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US14/584,903
• Publication Number:
  US 20150127096A1
• Time in Patent Office: 1,534 Days
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2/90 characterised by a net-like or mesh-like structure
• 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
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Abstract

A method of implanting a prosthetic mitral valve assembly using a transapical procedure is disclosed. An incision is formed in the chest in the apex of the patient'"'"'s heart. A delivery catheter containing the prosthetic mitral valve assembly is advanced over a guidewire into the patient'"'"'s heart. The prosthetic mitral valve assembly is deployed from the delivery catheter into the native mitral valve. The prosthetic mitral valve assembly comprises a stent having a lower portion for placement between the leaflets of a native mitral valve and an upper portion having a flared end for placement above the annulus. The prosthetic mitral valve includes a valve portion having leaflets formed of pericardial tissue. A plurality of upwardly bent prongs are provided along an outer surface of the stent for preventing upward migration of the prosthetic mitral valve assembly after deployment.

Claims

1. A prosthetic mitral valve assembly, comprising:

a self-expanding stent comprising an upper portion defining an inlet end of the stent having a first diameter, a lower portion defining an extreme outlet end of the stent having a second diameter, and an intermediate portion between the upper portion and the lower portion, the intermediate portion having a third diameter, the stent tapering from the inlet end to the intermediate portion and further tapering from the intermediate portion to the extreme outlet end such that the third diameter is less than the first diameter, and the second diameter is less than the third diameter, wherein the inlet end comprises a flared end sized to be positioned above an annulus of the native mitral valve, wherein the flared end is defined by a circumferentially extending row of struts that extends continuously around the entire extent of a circumference of the upper portion, wherein the flared end is sized such that when implanted, an atrial-most end of the prosthetic mitral valve assembly contacts supra-annular tissue continuously around the entire extent of a circumference of the upper portion;

a tether having a first end portion and a second end portion, the first end portion coupled to the lower portion of the stent, the tether being sized to extend through the left ventricle with the second end portion extending through a wall of the left ventricle at the apex of the heart; and

a tissue anchor connected to the second end portion of the tether and configured to be implanted against an outer surface of the left ventricle at the apex such that when the prosthetic mitral valve assembly is implanted, the tether resists migration of the stent in a direction toward the left atrium and the flared end of the stent resists migration of the stent in a direction toward the left ventricle;

wherein the prosthetic mitral valve assembly is held in place without clamping onto tissue of the annulus of the native mitral valve;

wherein the prosthetic mitral valve assembly is adapted to be advanced in a radially compressed state along a distal end of the delivery catheter for insertion through the wall of the heart.

2. The prosthetic mitral valve assembly of claim 1, wherein the stent has a truncated conical shape.

3. The prosthetic mitral valve assembly of claim 1, wherein the stent is made of nitinol.

4. The prosthetic mitral valve assembly of claim 1, wherein the tether comprises a bioresorbable material.

5. The prosthetic mitral valve assembly of claim 1, wherein the stent has a substantially D-shape cross-section for conforming to the native mitral valve.

6. The prosthetic mitral valve assembly of claim 1, further comprising a valve portion having three prosthetic leaflets formed of porcine pericardium and mounted within an interior portion of the stent, the valve portion having leaflets for occluding blood flow in one direction and replacing the function of the native mitral valve.

7. The prosthetic mitral valve assembly of claim 6, wherein the valve portion is mounted within the lower portion of the stent.

8. The prosthetic mitral valve assembly of claim 1, wherein the tissue anchor comprises an enlarged head portion.

9. The prosthetic mitral valve assembly of claim 1, wherein the stent has a length between 15 and 50 mm.

10. The prosthetic mitral valve assembly of claim 1, wherein the stent has a continuous taper.