Prosthetic heart valve devices and methods of valve replacement

• US 8,323,336 B2
• Filed: 04/23/2009
• Issued: 12/04/2012
• Est. Priority Date: 04/23/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hill, Alexander J., Clague, Cynthia T., Eberhardt, Carol Elsa, Menk, Ana R., Capps, Mark J., Millwee, Billie J., Shay, Janice Lynn, Taitague, Debra Ann, Morrow, Joseph C., Redmond, Jerald
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): STRASZHEIM, REBECCA L
• Application Number:
  US12/429,054
• Publication Number:
  US 20090281618A1
• Time in Patent Office: 1,321 Days
• Field of Search: None
• US Class Current: 623/2.14
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0045 Omega-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A stented valve of two or more leaflets made of pericardium or other material having a relatively thin profile at the annulus. The leaflet surfaces are attached via chords to a stent frame, where the chords are positioned to mimic the native valve anatomy and functionality. In particular, the valves of one exemplary embodiment of the invention are sized to replace a mitral valve and therefore the chords are arranged to prevent prolapse of the leaflets into the atrium. The stented valve has a relatively short height at its annulus due to the positioning of the chords. In addition, the stented valve is capable of being crimped to a small enough size that it can be delivered to the implantation site via transcatheter delivery systems and methods.

Claims

1. A stented valve comprising:

a stent frame comprising;

an annular portion comprising first and second ends, and a central longitudinal axis,

an atrial portion extending from the first end of the annular portion, wherein the atrial portion flares radially outward relative to the longitudinal axis of the annular portion, and

a ventricular portion extending from the second end of the annular portion, wherein the ventricular portion flares radially outward relative to the longitudinal axis of the annular portion;

a prosthetic valve comprising a first leaflet and a second leaflet attached within an interior area of the stent frame, the first leaflet and the second leaflet being movable between an open position and a closed position, the first leaflet and the second leaflet coapting at the closed position; and

at least one chord attached to a body of the first leaflet and the ventricular portion of the stent frame, the at least one chord being arranged to prevent prolapse of the first leaflet.

2. The stented valve of claim 1, wherein the prosthetic valve further comprises at least one chord attached to a body of the second leaflet and the ventricular portion of the stent frame, the at least one chord attached to the second leaflet being arranged to prevent prolapse of the second leaflet.

3. The stented valve of claim 1, wherein the first leaflet and the second leaflet have a thin profile.

4. The stented valve of claim 1, wherein the at least one chord is adhered to the first leaflet.

5. The stented valve of claim 1, wherein a first end and a second end of the at least one chord extend from the same side of the first leaflet.

6. The stented valve of claim 5, wherein the first and second ends of the at least one chord are attached to the ventricular portion of the stent frame.

7. The stented valve of claim 1, wherein the at least one chord extends from a first side of the first leaflet to a second side of the first leaflet.

8. The stented valve of claim 1, wherein the first leaflet and second leaflet comprise pericardial material.

9. The stented valve of claim 1, wherein the at least one chord comprises a synthetic material.

10. The stented valve of claim 1, wherein the prosthetic valve is a prosthetic mitral valve, and wherein the first and second leaflets comprise anterior and posterior leaflets of the mitral valve, respectively.

11. The stented valve of claim 1, wherein the stent frame is compressible and expandable for percutaneous delivery and implantation into a body lumen.

12. The stented valve of claim 1, wherein at least one of the annular portion, the atrial portion, and the ventricular portion comprises a shape memory material.

13. The stented valve of claim 1, wherein the prosthetic valve further comprises a third leaflet attached within the interior area of the stent frame, the third leaflet being movable between the open position and the closed position, the third leaflet coapting with the first leaflet and the second leaflet at the closed position;

and

at least one chord attached to a body of the third leaflet and the ventricular portion of the stent frame, the at least one chord attached to the third leaflet being arranged to prevent prolapse of the third leaflet.

14. The stented valve of claim 1, further comprising a covering material attached to at least a portion of at least one of the annular portion, the atrial portion, and the ventricular portion.

15. The stented valve of claim 1, wherein the at least one chord comprises a first end attached to a tab member, wherein the tab member is adjacent to a first surface of the first leaflet.