DEVICE AND METHOD FOR REPLACING MITRAL VALVE

• US 20090276040A1
• Filed: 05/01/2008
• Published: 11/05/2009
• Est. Priority Date: 05/01/2008
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Nguyen, Son V., Rowe, Stanton
• Application Number:
  US12/113,418
• Publication Number:
  US 20090276040A1
• Time in Patent Office: Days
• US Class Current: 623/2.180
• 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 prosthetic mitral valve assembly and method of inserting the same is disclosed. In certain disclosed embodiments, the prosthetic mitral valve assembly has a flared upper end and a tapered portion to fit the contours of the native mitral valve. The prosthetic mitral valve assembly can include a stent or outer support frame with a valve mounted therein, The assembly can be adapted to expand radially outwardly and into contact with the native tissue to create a pressure fit. One embodiment of a method includes positioning the mitral valve assembly below the annulus such that the annulus itself can restrict the assembly from moving in an upward direction towards the left atrium. The mitral valve assembly is also positioned so that the leaflets of the mitral valve hold the assembly to prevent downward movement of the assembly towards the left ventricle.

Claims

1. A prosthetic mitral valve assembly, comprising:

a radially-expandable stent including a first portion sized to be held in place by leaflets of a native mitral valve and a second portion having a flared end, the flared end sized to implant above or below an annulus of the mitral valve with a pressure or friction fit, wherein the stent tapers from the flared end to an opposite end of the stent; and

a valve portion coupled to the stent

2. The prosthetic mitral valve assembly of claim 1, wherein the mitral valve assembly is adapted to expand into contact with the native mitral valve tissue to create the pressure or friction fit and secure the mitral valve assembly in a fixed position in the heart.

3. The prosthetic mitral valve assembly of claim 1, wherein the valve portion includes a bicuspid or tricuspid valve.

4. The prosthetic mitral valve assembly of claim 3, wherein the bicuspid valve includes two leaflets that differ in size.

5. The prosthetic mitral valve assembly of claim 4, further including tension members coupled between the leaflets and the stent.

6. The prosthetic mitral valve assembly of claim 5, wherein the tension members are coupled at different heights, relative to one another, along a length of the stent.

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

8. The prosthetic mitral valve assembly of claim 1 wherein the stent includes a non-uniform, cross-sectional shape conforming to the native mitral valve.

9. The prosthetic mitral valve assembly of claim 1, wherein the flared end is scalloped.

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

11. 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.

12. 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.

13. 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.

14. The prosthetic mitral valve assembly of claim 11 wherein the valve portion further includes prosthetic leaflets and further including tension members coupled to the prosthetic leaflets for preventing the prosthetic leaflets from everting and reducing stresses induced by ventricular contraction.

15. The prosthetic mitral valve assembly of claim 14, 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.

16. The prosthetic mitral valve assembly of claim 14, 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.

17. A method of implanting a prosthetic mitral heart valve, comprising:

inserting a prosthetic mitral valve assembly in a collapsed state into a heart using a delivery catheter;

expanding the mitral valve assembly; and

positioning the mitral valve assembly within a native valve so that solely pressure exerted radially outward by the mitral valve assembly holds the mitral valve assembly in position;

wherein positioning the mitral valve assembly includes pulling the mitral valve assembly from the left atrium so that a flared end of the mitral valve assembly sits below an annulus of the native mitral valve and wherein the mitral valve assembly is held in place solely through radial outward pressure from the mitral valve assembly and contact between the native mitral valve leaflets and the outer surface of the valve assembly.

18. The method of claim 17, wherein inserting includes inserting the catheter through an apex of the heart into the left ventricle, through the mitral valve and into the left atrium.

19. An apparatus for replacement of a mitral valve, comprising:

a stent having an upper end, a lower end, and an aperture there through extending from the upper to the lower end;

a valve having a plurality of leaflets mounted within the stent; and

at least one tension member connected at one end to at least one of the leaflets and connected at another end to the stent to lessen the amount of stress transferred to the at least one leaflet.

20. The apparatus of claim 19, wherein the stent has prongs on an outer surface thereof to assist in securing the stent when in contact with native tissue.

21. The apparatus of claim 19, wherein the valve is bicuspid or tricuspid.

22. The apparatus of claim 19, wherein the bicuspid valve includes leaflets of different sizes.

23. The apparatus of claim 19, wherein the upper end of the stent is scalloped.

24. The apparatus of claim 19, wherein the stent and the valve are collapsible for insertion into the heart on a catheter.

25. The apparatus of claim 19, wherein the at least one tension member comprises a plurality of tension members, each having a first end connected to one of the leaflets and a second end connected to the valve.