PROSTHETIC MITRAL VALVE

• US 20150173897A1
• Filed: 05/20/2013
• Published: 06/25/2015
• Est. Priority Date: 05/20/2012
• Status: Active Grant

• Current Assignee: Tel Hashomer Medical Research Infrastructure And Services Ltd.
• Original Assignee: MitralHeal Ltd., Tel Hashomer Medical Research Infrastructure And Services Ltd.
• Inventors: Orlov, Boris, Harari, Boaz, Meiri, Oded, Raanani, Ehud, Rozitsky, Lichen
• Granted Patent: US 10,292,816 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular

Abstract

A prosthetic mitral valve with a frame comprises at least one arm shaped to deploy among a region of chordae tendineae of the native mitral valve to deflect these chords in order to pull the native valve leaflets around the frame to avoid paravalvular leaks. The frame may be made from two parts that are connected by sutures. The prosthetic valve may be deployed by a catherer comprising a deployment clamp attached to the valve frame where the deployment clamp is actuable to induce rotation of the frame.

Claims

1. A prosthetic mitral valve suitable to be deployed in a mammalian heart, comprising:

a valve frame;

a frame aperture defined by the valve frame, said frame aperture sized to;

circumferentially enclose a prosthetic heart valve mechanism and fit within the mitral valve aperture between the heart left ventricle and atrium; and

at least one arm attached to the valve frame on the ventricular side of said frame aperture;

said at least one arm having a chord receiving surface sized and shaped to deploy among a region of chords of the native mitral valve and deflect the shape of chords contacted, pulling least one native mitral valve leaflet at least partially around said frame aperture.

2. The prosthetic mitral valve of claim 1, wherein said chord receiving surface defines a chord capturing region, is shaped to guide encountered chords into said capturing region, and is shaped to bar chords entering said capturing region from exiting.

3. The prosthetic mitral valve of claim 2, wherein said chord receiving surface is oriented with respect to a rotation direction and has at least one slope that guides chords encountered while moving in said rotation direction into said chord capturing region.

4. The prosthetic mitral valve of claim 3, wherein said chord receiving surface is oriented with respect to a rotation direction and has at least one hooked portion that prevents chords moving in opposition to said rotation direction from exiting said chord capturing region.

5. The prosthetic mitral valve of claim 1, wherein said at least one native mitral valve leaflet prevents the flow of blood between itself and said valve frame, at least in the direction passing from the left ventricle to the left atrium.

6. The prosthetic mitral valve of claim 1, wherein a portion of said valve frame on the atrial side of said frame aperture is too wide to pass through the mitral valve aperture.

7. The prosthetic mitral valve of claim 1, wherein said deflection of the shape of at least one chord is maintained after deployment at least by opposing force generated by contact of the frame with tissue of the heart on the atrial side of said frame aperture.

8. The prosthetic mitral valve of claim 1, wherein said deflection of the shape of at least one chord is maintained after deployment at least by opposing force generated by contact of the frame with tissue of the heart on the ventricular side of said frame aperture.

9. The prosthetic mitral valve of claim 1, wherein said deflection of the shape of at least one chord is maintained after deployment at least by opposing force generated by contact of the frame with at least one native mitral valve leaflet.

10. The prosthetic mitral valve of claim 1, wherein said deflection of the shape of at least one chord is maintained after deployment at least by opposing force generated by contact of the frame with at least one other chord which it deflects the shape of.

12. The prosthetic mitral valve of claim 1, wherein said frame is in a compact configuration upon delivery to the heart, and expands at least radially during deployment.

11. (canceled)

13-35. -35. (canceled)

36. A catheter deployment system for deploying a prosthetic mitral valve comprising:

a distal end with a central axis;

a prosthetic mitral valve in a compact configuration disposed around said central axis;

said prosthetic valve including at least a ventricular frame part; and

a deployment clamp attached to the ventricular part, the deployment clamp being actuatable to induce rotation at least in said ventricular frame part.

37. The catheter deployment system of claim 36, comprising:

a rotatable shaft; and

a rotation actuator, coupled to the shaft at a distal end;

said shaft being coupled at a distal end to said deployment clamp.

41. The catheter deployment system of claim 36, wherein said deployment clamp comprises at least one sleeve containing at least a portion of said ventricular frame part.

42. The catheter deployment system of claim 41, wherein said deployment clamp comprises at least one command wire connected to said at least one sleeve;

and a relative motion of said command wire retracts the sleeve from over said contained portion of said ventricular frame part releases said ventricular frame part.

43. The catheter deployment system of claim 37, wherein:

a coupling mechanism couples said shaft to said rotation actuator;

said coupling mechanism comprises a catch member and a detente;

said catch member being caught by the detente; and

one of said catch member and said detente being fixedly coupled to the rotation actuator, and the other of said catch member and said detente being fixedly coupled to said shaft.

44. The catheter deployment system of claim 43, wherein said catch is removed from capture by said detente upon said rotation actuator exerting a torque on said coupling mechanism which exceeds a predetermined threshold.

38-40. -40. (canceled)

45. A method of deploying a prosthetic mitral heart valve in a mammalian heart comprising:

inserting a distal end of a prosthetic mitral heart valve catheter deployment system into the left heart ventricle; and

extending arms attached to the prosthetic mitral valve into one or more regions occupied by chords of the native mitral valve leaflets.

46. The method of claim 45, further comprising rotating the extended arms.

47. The method of claim 45, further comprising locking the extended arms into position.

48. (canceled)