METHOD FOR REPLACING MITRAL VALVE

• US 20150127096A1
• Filed: 12/29/2014
• Published: 05/07/2015
• 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.
• Granted Patent: US 10,226,334 B2
• Time in Patent Office: Days
• US Class Current: 623/2.14
• 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 radially-expandable stent including a lower portion sized to held between leaflets of a native mitral valve and an upper portion having a flared end, the upper portion sized for deployment within the annulus of the mitral valve with a pressure fit, the flared end configured to extend above the annulus, the stent comprising a tubular portion, wherein the tubular portion of the stent tapers from the upper portion to the lower portion with a reduced diameter, the stent having a substantially D-shape cross-section for conforming to the native mitral valve, the D-shape cross-section providing a substantially straight portion configured to extend along an anterior side of the native mitral valve and a substantially curved portion configured to extend along a posterior side of the native mitral valve; and

a valve portion formed of pericardial tissue 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.

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

3. The prosthetic mitral valve assembly of claim 1, wherein the valve portion comprises three leaflets.

4. The prosthetic mitral valve assembly of claim 1, wherein the valve portion is a bicuspid valve having only two leaflets.

5. The prosthetic mitral valve assembly of claim 4, wherein the two leaflets differ in size.

6. The prosthetic mitral valve assembly of claim 1, wherein the stent is formed with intercrossing bars.

7. The prosthetic mitral valve assembly of claim 1, further including tension members extending between the leaflets and the stent.

8. The prosthetic mitral valve assembly of claim 7, wherein the tension members are coupled at different heights, relative to one another, along a length of the stent.

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

10. The prosthetic mitral valve assembly of claim 1, wherein an upper portion of the stent is scalloped.

11. The prosthetic mitral valve assembly of claim 1, wherein the prosthetic mitral valve assembly is held in place without clamping onto tissue.

12. The prosthetic mitral valve assembly of claim 1, wherein the stent includes external prongs to assist in holding the prosthetic mitral valve assembly in place.

13. The prosthetic mitral valve assembly of claim 1, wherein the stent and the valve portion are collapsible to a reduced diameter for insertion into the heart on a delivery catheter for implantation.

14. The prosthetic mitral valve assembly of claim 1, further including a tether coupled to the stent on one end thereof, the tether being configured to couple the stent to a portion of the heart remote from the stent.

15. The prosthetic mitral valve assembly of claim 1, wherein the valve portion further includes tension members coupled to the prosthetic leaflets for preventing the prosthetic leaflets from everting and reducing stresses induced by ventricular contraction.

16. The prosthetic mitral valve assembly of claim 15, wherein the tension members are coupled to the prosthetic leaflets at a first end of the tension members and coupled at an opposite end to the stent or to a patient'"'"'s heart.

17. The prosthetic mitral valve assembly of claim 15, wherein the tension members are coupled to the stent at a first end of the tension members and coupled at an opposite end to a portion of the patient'"'"'s heart.