METHODS FOR REPLACING A CARDIAC VALVE

• US 20140039613A1
• Filed: 10/08/2013
• Published: 02/06/2014
• Est. Priority Date: 02/18/2005
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Navia, Jose L., Oberti, Carlos, Navia, Jose A.
• Granted Patent: US 10,583,001 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped

Abstract

A method for replacing a cardiac valve includes an expandable support member having oppositely disposed first and second ends, a main body portion extending between the ends, and a prosthetic valve within the main body portion. The main body portion has an annular shape for expanding into position in the annulus of the valve. The first and second ends include a plurality of upper and lower wing members movable from a collapsed condition into an extended condition for respectively engaging a first section of cardiac tissue surrounding the valve and for: engaging a portion of the native valve leaflets to pin the leaflets back against the annulus. The second end further includes at least two strut members spaced apart from each other. A respective one of the strut members is attached to at least one commissural section of the prosthetic valve to prevent prolapse of the valve leaflets.

Claims

1. A method for replacing a cardiac valve having at least two native valve leaflets, said method comprising the steps of:

providing a prosthetic valve that includes an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends, a plurality of upper wing members that extend from a one end of the main body portion, and a plurality of lower wing members that extend from an opposite end of the main body portion, the second end of the support member further including at least two strut members, the prosthetic valve having at least two valve leaflets joined at two or more commissural sections, each of the commissural sections being attached to a strut member to prevent prolapse of the valve leaflets;

placing the main body portion of the prosthetic valve within the annulus of the cardiac valve to be replaced;

expanding the main body portion into engagement with the annulus of the cardiac valve to secure the prosthetic valve in the annulus;

deploying the upper wing members from a radially collapsed condition into a radially extended condition to engagement with a first section of cardiac tissue surrounding one side of the cardiac valve; and

deploying the lower wing members from a radially collapsed condition into a radially extended condition to engage a portion of the native valve leaflets to pin the leaflets back against the annulus of the native cardiac valve.

2. The method of claim 1 wherein said step of placing the main body portion of the prosthetic valve within the annulus of the cardiac valve to be replaced further comprises the steps of:

placing the support member around an inflatable balloon in a secured manner;

inserting the balloon and support member into an atrial chamber;

advancing the balloon until the support member is positioned within the annulus of the cardiac valve to be replaced; and

expanding the support member with the balloon so that the support member engages the annulus of the cardiac valve to secure the support member in the annulus.

3. The method of claim 2 wherein the balloon has an hourglass shape defined by first and second bulb sections connected by a center section having a smaller diameter than the bulb sections, said step of placing the support member around the balloon further comprising the step of positioning the support member about the center section.

4. The method of claim 3 wherein said step of advancing the balloon until the support member is positioned within the valve annulus further includes the step of positioning the first bulb section within the leaflets of the native valve.

5. The method of claim 2 wherein said step of expanding the support member with the balloon so that the support member engages the annulus of the cardiac valve includes the step of conforming the main body portion to the shape of the valve annulus.

6. The method of claim 1 wherein each of the plurality of wing members include at least one attachment mechanism for embedding into cardiac tissue.

7. The method of claim 6 wherein the attachment mechanism includes at least one barb extending from each of the wing members, said method further including the step of embedding the at least one barb into cardiac tissue.

8. The method of claim 7 wherein each of the wing members has a concave cross-sectional shape for conforming to the convex shape of the valve annulus, said method further comprising the step of pulling the wing members into a flatter cross-sectional shape with a constraining wire for placement of the support member, the at least one barb extending generally radially when the wing members are being held by the constraining wire.

9. The method of claim 8 further comprising the step of releasing the constraining wire after said step of expanding the support member with the balloon so that the upper wing members spring radially outward to engage the first section of cardiac tissue, and the lower wing members spring radially outward to engage a portion of the native valve leaflets.

10. The method of claim 9 wherein said step of releasing the constraining wire causes the at least one barb to embed into cardiac tissue in the distal direction.

11. The method of claim 1 wherein said step of inserting the balloon and the prosthetic valve into the heart chamber is done percutaneously via an intravascular catheter.

12. The method of claim 11 wherein said step of inserting the balloon and the prosthetic valve into the heart chamber is done via a minimally invasive approach.

13. The method of claim 1 wherein said step of inserting the balloon and the prosthetic valve into the heart chamber is done via an open-chest procedure.

14. The method of claim 1 wherein at least a portion of the support member is treated with a therapeutic agent for eluting into cardiac tissue, the method further comprising the step of allowing the therapeutic agent to elute into the cardiac tissue.