Device and Method for ReShaping Mitral Valve Annulus

• US 20090076586A1
• Filed: 11/26/2008
• Published: 03/19/2009
• Est. Priority Date: 09/09/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Bobo, Donald E. JR., Hauser, David L., Solem, Jan Otto
• Granted Patent: US 7,803,187 B2
• Time in Patent Office: Days
• US Class Current: 623/1.120
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2478 Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0004 Rounded shapes, e.g. with rounded corners

Abstract

Devices and methods for reshaping a mitral valve annulus are provided. One preferred device is configured for deployment in the right atrium and is shaped to apply a force along the atrial septum. The device causes the atrial septum to deform and push the anterior leaflet of the mitral valve in a posterior direction for reducing mitral valve regurgitation. Another preferred device is deployed in the left ventricular outflow tract at a location adjacent the aortic valve. The device is expandable for urging the anterior leaflet toward the posterior leaflet. Another preferred device comprises a tether configured to be attached to opposing regions of the mitral valve annulus.

Claims

1. A method of reducing mitral valve regurgitation, comprising:

delivering an expandable body into the left ventricular outflow tract, wherein the expandable body has an expanded condition sized for applying a lateral force to the anterior leaflet of the mitral valve for moving the anterior leaflet toward the posterior leaflet, thereby improving coaption of the anterior and posterior leaflets of the mitral valve.

2. The method of claim 1, wherein the expandable body comprises a radially expandable stent.

3. The method of claim 2, wherein the radially expandable stent is configured to be implanted beneath the aortic valve and includes an unobstructed lumen extending longitudinally therethrough.

4. The method of claim 2, wherein the radially expandable stent is self-expandable.

5. The method of claim 2, wherein the radially expandable stent is balloon expandable.

6. The method of claim 2, wherein the radially expandable stent further comprises a protrusion along a wall for increasing the lateral force applied to the anterior leaflet.

7. The method of claim 1, wherein the expandable body is a prosthetic valve configured for deployment within the aortic valve annulus, the prosthetic valve comprising an expandable stent portion and a valvular structure, the stent portion being sized to extend into the left ventricular outflow tract and having a flared lower portion configured for applying a lateral force to the anterior leaflet of the mitral valve for reducing mitral valve regurgitation.

8. A method of improving mitral valve function, comprising:

providing an implant having a first expandable anchor, a second expandable anchor and a curved pusher member extending between the first and second anchors;

deploying the first expandable anchor in the superior vena cava;

deploying the second expandable anchor in the inferior vena cava; and

pushing the anterior leaflet of the mitral valve toward the posterior leaflet by applying a lateral force along the atrial septum with the pusher member;

wherein the lateral force is sufficient to improve the coaption of the mitral valve leaflets, thereby improving mitral valve function.

9. The method of claim 8, wherein the first and second expandable anchors comprise first and second expandable stents.

10. The method of claim 9, wherein the first and second expandable stents are self-expandable.

11. The method of claim 9, wherein the first and second expandable stents are balloon expandable.

12. A method of improving mitral valve function, comprising:

providing a U-shaped member sized for deployment in the right ventricle; and

deploying the U-shaped member at a location in the right ventricle adjacent to the tricuspid valve;

wherein the U-shaped member is configured to urge the ventricular septum outward for reshaping the mitral valve annulus.