Device and Method for Mitral Valve Regurgitation Treatment

• US 20150196390A1
• Filed: 05/16/2014
• Published: 07/16/2015
• Est. Priority Date: 01/15/2014
• Status: Active Grant

• Current Assignee: Sinomed Cardiovita Technology Incorporated
• Original Assignee: SINO Medical Sciences Technology Inc.
• Inventors: Ma, Jianlu, Huo, Yong
• Granted Patent: US 9,393,111 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/005 using adhesives

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 valve body defining a ventricular end of the device, and an annulus support that connects the atrial flange and the valve body, the annulus support including a ring of tabs extending radially therefrom and adapted to engage the native mitral annulus and/or the native leaflet(s) of the human heart. The atrial flange can be seated in the atrium above the native mitral valve annulus in a human heart, and the ring of tabs can engage the native mitral annulus in a manner where the atrial flange and tabs provide a clipping effect to secure the mitral valve replacement device at the native mitral valve position

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 valve body defining a ventricular end of the device;

an annulus support that connects the atrial flange and the valve body, the annulus support including a ring of tabs extending radially therefrom;

wherein the atrial flange has a diameter greater than the diameter of the valve body, and the annulus support has a diameter between that of the diameter of the atrial flange and the diameter of the valve body.

2. The device of claim 1, further including a leaflet structure positioned at the valve body.

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

4. The device of claim 1, the annulus support further includes a ring of U-shaped sections extending radially outwardly and alternating with the tabs.

5. The device of claim 4, further including a neck positioned between the atrial flange and the ring of U-shaped sections.

6. The device of claim 1, further including at least one clip extending from the annulus support.

7. 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.

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 covered with fabric.

9. 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.

10. The device of claim 9, wherein at the tissue and fabric and comprised of a layer of combined tissue and fabric.

11. 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.

12. 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 valve body defining a ventricular end of the device; and

an annulus support that connects the atrial flange and the valve body, the annulus support including a ring of tabs extending radially therefrom;

seating the atrial flange in the atrium above a native mitral valve annulus in a human heart; and

engaging the native mitral annulus and/or the native mitral valve leaflet(s) with the ring of tabs in a manner where the atrial flange and tabs provide a clipping effect to secure the mitral valve replacement device at the native mitral valve position.

13. The method of claim 12, 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.

14. The method of claim 12, 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.

15. A heart valve, comprising:

a valve body; and

a leaflet structure attached to the valve body, the leaflet structure comprising three leaflets, each leaflet having radial edges and outer edges, and wherein each outer edge of a leaflet is sewn to an outer edge of an adjacent leaflet along a longitudinal stitch line, and each radial edge of a leaflet is sewn to a radial edge of an adjacent leaflet along a radial stitch line, with the radial stitch line along one of radial edges extending from the longitudinal stitch lines towards a central point, wherein the leaflet structure further includes three inner stitch lines that originate from an apex that is offset from the central point, and which extend for a short distance towards the longitudinal stitch lines and merge with the longitudinal stitch lines, with the inner stitch lines forming an umbrella-shaped configuration for the combined three leaflets.