Transcatheter prosthetic heart valve and delivery system

• US 10,531,951 B2
• Filed: 11/26/2015
• Issued: 01/14/2020
• Est. Priority Date: 11/26/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Spargias, Konstantinos
• Primary Examiner(s): Nguyen, Vi X
• Application Number:
  US15/526,810
• Publication Number:
  US 20170333186A1
• Time in Patent Office: 1,510 Days
• 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 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 2250/0063 Nested prosthetic parts

Abstract

A prosthetic heart valve for an endoprosthesis used in the treatment of a stenotic heart valve and/or a heart valve insufficiency. The prosthetic heart valve comprises a plurality of leaflets (3,4,5) which are able to switch between their open and close position in response to the blood flow through the heart. The leaflets are attached into a collapsible wire valve frame involving a stent part (1) and a wire mesh part (2) that complement each other in many ways. The prosthetic valve comprises additional elements (6) for its correct positioning and stabilization.

Claims

1. A prosthetic mitral valve for transcatheter delivery comprising:

a collapsible and self-expandable interior stent having an atrial end and a ventricular end, the interior stent having a sealing skirt and defining a lumen supporting a plurality of valve leaflets; and

a collapsible and self-expandable exterior wire mesh surrounding the interior stent, the exterior wire mesh extending along substantially an entire length of the interior stent, the exterior wire mesh having a lower radial strength than the interior stent for conforming to a native mitral valve, the exterior wire mesh attached at least to at the atrial end and forming a body around the stent, the exterior wire mesh having a first portion with an enlarged diameter sized for placement above a mitral annulus for sealing and stabilizing the prosthetic mitral valve on an atrial side, the exterior wire mesh having a second portion with a reduced diameter for contacting the mitral annulus and for extending to a ventricular side of the mitral annulus;

wherein the stent forms at its ventricular end a plurality of native leaflet capturing elements, the capturing elements extending in a ventricular direction beyond a ventricular end of the exterior wire mesh and then turning in an atrial direction such that the capturing elements are positioned radially outwardly from the exterior wire mesh, the capturing elements adapted for trapping native mitral leaflets against the wire mesh and for anchoring the prosthetic mitral valve on a ventricular side.

2. The prosthetic mitral valve according to claim 1, wherein the wire mesh extends longitudinally towards the ventricular end of the stent forming a body around the stent.

3. The prosthetic mitral valve according to claim 2, wherein the wire mesh reaches the ventricular end of the stent.

4. The prosthetic mitral valve according to claim 2, wherein the wire mesh extends beyond the ventricular end of the stent.

5. The prosthetic mitral valve according to claim 1, wherein sizes of the native leaflet capturing elements vary between them.

6. The prosthetic mitral valve according to claim 1, wherein shapes of the native leaflet capturing elements vary between them.

7. The prosthetic mitral valve according to claim 1, wherein the wire mesh comprises a sealing material.

8. The prosthetic mitral valve according to claim 7, wherein the sealing material is a fabric.

9. The prosthetic mitral valve according to claim 1, wherein the wire mesh comprises at its outer surface barbs or spikes.

10. The prosthetic mitral valve according to claim 1, wherein the stent is made of collapsible nitinol, or stainless steel.

11. The prosthetic mitral valve according to claim 1, wherein the wire mesh is made of collapsible nitinol or stainless steel.

12. A catheter for delivery of the prosthetic mitral valve according to claim 1, further comprising a capsule, a shaft and a handle.