Device and method for mitral valve regurgitation treatment

• US 9,839,511 B2
• Filed: 10/03/2014
• Issued: 12/12/2017
• Est. Priority Date: 10/05/2013
• Status: Active Grant

• Current Assignee: Sinomed Cardiovita Technology Incorporated
• Original Assignee: SINO Medical Sciences Technology Inc.
• Inventors: Ma, Jianlu, Huo, Yong, Li, Tianzhu, Zhao, Jinhong, Ma, Jianxiang, Meng, Lei
• Primary Examiner(s): Prone, Christopher D
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US15/025,008
• Publication Number:
  US 20160235529A1
• Time in Patent Office: 1,166 Days
• 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 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.