Device and method for mitral valve regurgitation treatment
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.
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 plurality of tabs, each tab extending radially outwardly to a bend, where the tab bends in a longitudinal direction toward the atrial end, and then extends radially inwardly to an end of the tab;
a ventricular portion defining a ventricular end of the device;
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 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 ventricular portion.
3. The device of claim 1 , further including a neck positioned between the atrial flange and the annulus support.
4. The device of claim 3 , wherein each anchor extends radially from the neck and ends in a rounded tip that bends in a circumferential direction.
5. 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 covered with tissue.
6. 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 covered with fabric.
7. The device of claim 1 , wherein at least a portion of one or more of the atrial flange, the annulus support and portion is covered with tissue and fabric.
8. The device of claim 7 , wherein the tissue and fabric are comprised of a layer of combined tissue and fabric.
9. 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.
10. The device of claim 1 , wherein the ventricular portion has a height ranging between 2 mm to 15 mm.
11. The device of claim 1 , wherein the plurality of tabs is arranged in an annular manner to form the atrial flange.
12. The device of claim 1 , wherein the ventricular portion comprises a plurality of V-shaped tabs.
13. A method of deploying a mitral valve replacement device at a native mitral valve position that includes a native mitral annulus and native mitral valve leaflets in a human heart, comprising:
providing a mitral valve replacement device comprising:
an atrial flange defining an atrial end of the device, the atrial flange having a plurality of tabs, each tab extending radially outwardly to a bend, where the tab bends in a longitudinal direction toward the atrial end, and then extends radially inwardly to an end of the tab;
a ventricular portion defining a ventricular end of the device;
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.
14. The method of claim 13 , wherein the mitral valve replacement device includes at least one tail extending from the ventricular end of the ventricular portion, 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.
15. The method of claim 13 , further including providing the ventricular portion with a height ranging between 2 mm to 15 mm.
16. The method of claim 13 , further including arranging the plurality of tabs in an annular manner to form the atrial flange.
17. The method of claim 13 , wherein the ventricular portion comprises a plurality of V-shaped tabs.
18. The method of claim 13 , wherein the mitral valve replacement device further comprises a neck positioned between the atrial flange and the annulus support, and wherein each anchor extends radially from the neck and ends in a rounded tip that bends in a circumferential direction.