PROSTHETIC VALVE FOR REPLACING MITRAL VALVE

• US 20140222136A1
• Filed: 02/03/2014
• Published: 08/07/2014
• Est. Priority Date: 02/04/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Geist, Stephen C., Taft, Robert C., Oba, Travis, Sok, Sam, Chau, Mark, Yi, Seung-Beom, Peterson, Matthew A., Golemo, Kevin M.
• Granted Patent: US 9,439,763 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 6/4441 the rigid structure being a C-arm or U-arm
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• 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 2220/0016 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

Embodiments of prosthetic valves for implantation within a native mitral valve are provided. One embodiment of a prosthetic valve includes a radially compressible main body and a one-way valve member. In some cases, the prosthetic valves also include ventricular anchors and/or an atrial portion coupled to and disposed outside of the main body. Methods, devices, and systems for delivering such prosthetic valves to the native mitral valve and implanting them therein are also provided.

Claims

1. An implantable prosthetic valve comprising:

a radially collapsible and radially expandable annular frame comprising;

an annular main body defining a lumen therethrough;

at least one ventricular anchor coupled to a ventricular end portion of the main body; and

an atrial portion coupled to the main body and extending radially away from the main body, wherein the atrial portion comprises a plurality of radially extending arms, wherein at least one of the arms comprises a serpentine or coiled segment; and

a valve member supported within an interior of the frame.

2. The implantable prosthetic valve of claim 1, wherein the at least one of the arms comprises a serpentine segment comprising a plurality of substantially straight, parallel segments.

3. The implantable prosthetic valve of claim 1, wherein the at least one of the arms comprises a serpentine segment comprising a plurality of substantially curved portions.

4. The implantable prosthetic valve of claim 1, wherein the at least one of the arms comprises a serpentine segment comprising a plurality of substantially straight, parallel segments at a portion of the arm proximate to the main body and a plurality of substantially curved portions at a terminal portion of the arm.

5. The implantable prosthetic valve of claim 1, wherein the at least one of the arms comprises a serpentine segment having a thickness which increases from a terminal end portion of the arm to a portion of the arm proximate the main body.

6. The implantable prosthetic valve of claim 1, wherein the plurality of arms are connected to the main body independently of each other without metal segments interconnecting adjacent arms.

7. The implantable prosthetic valve of claim 1, wherein each arm has a free end portion comprising a curved or rounded element.

8. The prosthetic valve of claim 7, wherein the curved or rounded element comprises a horseshoe shaped element comprising two terminal end portions pointing radially inward toward the main body.

9. The prosthetic valve of claim 8, wherein each of the two terminal end portions comprise a loop having a hole formed therethrough.

10. The prosthetic valve of claim 1, wherein each arm comprises a single metal wire or coil that is flexible relative to the main body and to adjacent arms.

11. The prosthetic valve of claim 1, wherein the at least one of the arms comprises a coiled segment.

12. A method for implanting a prosthetic apparatus at the native mitral valve region of a heart, the native mitral valve having posterior and anterior native valve leaflets, the method comprising:

delivering the prosthetic apparatus to the native mitral valve region within a distal end portion of a delivery apparatus;

retracting an outer sheath of the delivery apparatus to expose a ventricular anchor of the prosthetic apparatus;

forcibly expanding the ventricular anchor radially away from the delivery apparatus;

advancing the prosthetic apparatus through the native mitral valve so the ventricular anchor moves behind a native mitral valve leaflet;

contracting the ventricular anchor radially toward the delivery apparatus; and

retracting an inner sheath of the delivery apparatus, thereby allowing a main body of the prosthetic apparatus to radially expand within the native mitral valve.

13. The method of claim 12, wherein the act of retracting the outer sheath exposes an anchor spreader which forcibly expands the anchor.

14. The method of claim 13, wherein the anchor spreader is coupled to the inner sheath and the act of retracting the outer sheath allows the anchor spreader to resiliently extend radially from the inner sheath, thereby forcibly expanding the anchor.

15. The method of claim 12, wherein the act of retracting the inner sheath comprises partially retracting the inner sheath, thereby allowing an atrial portion of the prosthetic apparatus to radially expand prior to the main body being expanded.

16. The method of claim 15, wherein the act of retracting the inner sheath further comprises completely retracting the inner sheath, thereby allowing the main body portion of the prosthetic apparatus to radially expand.

17. A method comprising:

introducing an orientation device to the native mitral valve region of a patient'"'"'s heart;

deploying an echogenic arm of the orientation device;

viewing the echogenic arm of the orientation device within the native mitral valve region using echocardiography;

orienting the arm of the orientation device to align with the A2 and P2 regions of the native mitral valve;

aligning a fluoroscope axis of a fluoroscope along a line extending through the orientation device when the arm is aligned with the A2 and P2 regions;

removing the orientation device from the patient'"'"'s heart;

introducing a prosthetic apparatus to the native mitral valve region; and

positioning an anchor of the prosthetic apparatus behind one of the native mitral valve leaflets at one of the A2 or P2 regions, the anchor being visible on the fluoroscope.

18. The method of claim 17, wherein the echogenic arm comprises two echogenic arms extending radially away from a distal end portion of a shaft of the orientation device.

19. The method of claim 18, wherein:

the distal end portion of the shaft further comprises a fluoroscopic marker band having first and second apertures disposed therein; and

the act of aligning the fluoroscope axis comprises aligning the fluoroscope axis with a line extending from the first to the second aperture.