Device and Method for Mitral Valve Regurgitation Treatment

• US 20160235529A1
• Filed: 10/03/2014
• Published: 08/18/2016
• Est. Priority Date: 10/05/2013
• Status: Active Grant

• Current Assignee: Sinomed Cardiovita Technology Incorporated
• Original Assignee: SINO Medical Sciences Technology Inc.
• Inventors: Li, Tianzhu, Zhao, Jinhong, Ma, Jianxiang, Meng, Lei, Ma, Jianlu, Huo, Yong
• Granted Patent: US 9,839,511 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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;

a ventricular portion defining a ventricular end of the device, the ventricular portion having a height ranging between 2 mm to 15 mm;

an annulus support that is positioned between the atrial flange and the ventricular portion, the annulus support including a ring of anchors extending radially therefrom, with an clipping annular 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, further including at least one tail extending from the ventricular end of the valve body.

3. The device of claim 1, further including a neck positioned between the atrial flange and the annulus support.

4. The device of claim 1, wherein at least a portion of one or more of the atrial flange, the annulus support and valve body is covered with tissue.

5. The device of claim 1, wherein at least a portion of one or more of the atrial flange, the annulus support and valve body is covered with fabric.

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

7. The device of claim 6, wherein at the tissue and fabric and comprised of a layer of combined tissue and fabric.

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

9. A method of deploying a mitral valve replacement device at a native mitral valve position in a human heart, comprising:

providing a mitral valve replacement device comprising;

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;

an annulus support that is positioned between the atrial flange and the ventricular portion, the annulus support including 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;

seating the atrial flange in the atrium above a native mitral valve annulus in a human heart in a manner where the plurality of leaflets are positioned above the native annulus; and

positioning the native mitral annulus and/or the native mitral valve leaflet(s) in the clipping space.

10. The method of claim 9, wherein the mitral valve replacement device includes at least one tail extending from the ventricular end of the valve body, the method further including:

attaching a wire or line to the at least one tail; and

manipulating the wire or line to adjust the position of the mitral valve replacement device at the native mitral valve position.

11. The method of claim 9, further including:

providing at least one clip extending from the annulus support; and

clipping the native mitral valve leaflets with the at least one clip.