Prosthetic mitral valve and delivery method

• US 9,744,036 B2
• Filed: 04/02/2015
• Issued: 08/29/2017
• Est. Priority Date: 10/31/2012
• Status: Active Grant

• Current Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Inventors: Duffy, Niall, Kenny, Gavin, Bartolozzi, Fabio
• Primary Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US14/676,926
• Publication Number:
  US 20150209143A1
• Time in Patent Office: 880 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 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0464 for soft tissue
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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 2210/0057 stretchable
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0012 for adjusting elasticity, flexibility, spring rate or mechanical tension
• CPC Class Codes: A61F 2250/0039 : differing in diameter

Abstract

A valve prosthesis and methods for implanting the prosthesis are provided. The prosthesis generally includes a self-expanding frame and two or more engagement arms. A valve prosthesis is sutured to the self-expanding frame. Each engagement arm corresponds to a native mitral valve leaflet. At least one engagement arm immobilizes the native leaflets, and holds the native leaflets close to the main frame. The prosthetic mitral valve frame also includes two or more anchor attachment points. Each anchor attachment point is attached to one or more anchors that help attach the valve prosthesis to the heart.

Claims

1. A method of treating a mitral valve disorder in a patient'"'"'s heart, comprising:

a) inserting a delivery device into the left ventricle of the heart;

b) advancing a mitral valve prosthesis via the delivery device into the left ventricle of the heart, wherein the mitral valve prosthesis comprises;

1) an expandable inflow region formed of a plurality of cells and configured to expand within and support against the walls of the left atrium, wherein the expandable inflow region has a cross-sectional diameter larger than the annulus of the native mitral valve;

2) an expandable outflow region formed of a plurality of cells and configured to expand within and support against the native mitral valve annulus, wherein the expandable outflow region comprises;

at least one anchor attachment point; and

3) a prosthetic valve;

c) advancing the delivery device into the native mitral valve;

d) attaching the mitral valve prosthesis to the heart via at least one anchor that is attached to the at least one anchor attachment point, wherein the at least one anchor is attached to the heart via an anchoring element, the anchoring element including a lock having a first position that permits adjustment of tension in the anchor and a second position that locks the at least one anchor at a desired tension, wherein the anchoring element is a clip and wherein the lock of the anchoring element is comprised of opposing jaw portions of the clip; and

e) adjusting tension on the anchor to prevent PVL.

2. The method of claim 1, wherein at least one anchor attachment point is attached to a proximal end of at least one anchor prior to (b).

3. The method of claim 2, wherein a distal end of the anchor is attached to the clip.

4. The method of claim 1, wherein the anchoring element is configured to attach to the wall of the left ventricle.

5. The method of claim 1, wherein the anchoring element is configured to attach to a papillary muscle of the heart.

6. The method of claim 1, wherein the clip is attached to the heart prior to (b).

7. The method of claim 6, wherein a proximal end of the anchor is attached to the anchor attachment point on the mitral valve prosthesis.

8. The method of claim 1, wherein the anchor comprises a biocompatible material.

9. The method of claim 1, wherein the anchor is configured to function as an artificial chordae.

10. The method of claim 1, wherein the expandable outflow region further comprises at least two commissural sealing members.

11. The method of claim 1, wherein the expandable outflow region further comprises two or more commissure posts, wherein ends of the engagement arms are each coupled to one of the commissure posts.

12. The method of claim 1, wherein the delivery device is inserted transfemorally into the left ventricle of the heart.

13. The method of claim 1, wherein the delivery device is inserted transseptally into the left ventricle of the heart.

14. The method of claim 1, wherein the delivery device is inserted transapically into the left ventricle of the heart.