Device and method for mitral valve regurgitation treatment

• US 10,426,605 B2
• Filed: 11/09/2017
• Issued: 10/01/2019
• Est. Priority Date: 10/05/2013
• Status: Active Grant

• Current Assignee: SINO Medical Sciences Technology Inc.
• Original Assignee: SINO Medical Sciences Technology Inc.
• Inventors: Ma, Jianlu, Huo, Yong, Li, Tianzhu, Zhao, Jinhong, Ma, Jianxiang, Meng, Lei
• Primary Examiner(s): Ganesan, Suba
• Application Number:
  US15/808,822
• Publication Number:
  US 20180071084A1
• Time in Patent Office: 691 Days
• Field of Search: None
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 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 2220/005 using adhesives
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0052 T-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A mitral valve replacement device is adapted to be deployed at a mitral valve position in a human heart. The device has an atrial flange defining an atrial end of the device, a ventricular portion defining a ventricular end of the device, the ventricular portion having a height ranging between 2 mm to 15 mm, and an annulus support that is positioned between the atrial flange and the ventricular portion. The annulus support includes a ring of anchors extending radially therefrom, with an annular clipping space defined between the atrial flange and the ring of anchors. A plurality of leaflet holders positioned at the atrial end of the atrial flange, and a plurality of valve leaflets secured to the leaflet holders, and positioned inside the atrial flange at a location above the native annulus.

Claims

1. A mitral valve replacement device adapted to be deployed at a mitral valve position in a human heart, comprising:

an atrial flange defining an atrial end of the device, the atrial flange having a ventricular end that extends horizontally in a radial direction;

a ventricular portion defining a ventricular end of the device;

a neck positioned between the atrial flange and the ventricular portion;

an annulus support that is positioned between the ventricular portion and the neck, the annulus support including a ring of anchors, each anchor extending radially from the neck and ending in a rounded tip that bends in a circumferential direction, each anchor further including a segment that extends radially outwardly from the tip, then bends longitudinally toward the ventricular end, and then bends radially inwardly, with an annular clipping space defined between the atrial flange and the ring of anchors;

a plurality of leaflet holders positioned at the atrial end of the atrial flange; and

a plurality of valve leaflets secured to the leaflet holders, and positioned inside the atrial flange at a location above the native annulus.

2. The device of claim 1, wherein at least a portion of one or more of the atrial flange, the annulus support and the ventricular portion is covered with tissue, fabric, or both tissue and fabric.

3. The device of claim 1, further including at least one tail extending from the ventricular end of the ventricular portion.

4. The device of claim 1, wherein at least a portion of one or more of the atrial flange, the annulus support and ventricular portion is coated with a biocompatible adhesive.

5. The device of claim 1, wherein the ventricular portion has a height ranging between 2 mm to 15 mm.

6. The device of claim 1, wherein the atrial flange includes a plurality of tabs arranged in an annular manner.

7. The device of claim 1, wherein the ventricular portion comprises a plurality of V-shaped tabs.