PROSTHETIC VALVE FOR REPLACING A MITRAL VALVE

• US 20150351904A1
• Filed: 06/04/2015
• Published: 12/10/2015
• Est. Priority Date: 06/06/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Cooper, Alexander H., Peterson, Matthew A., Brunnett, William C.
• Granted Patent: US 9,532,870 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

Embodiments of a prosthetic heart valve comprise an annular main body, an atrial cap extending radially outwardly from the atrial end of the main body, and a plurality of ventricular anchors extending outwardly from the ventricular end of the main body. Each ventricular anchor can have a proximal end portion connected to the ventricular end, an intermediate portion extending away from the atrial end and then back toward the atrial so as to define a first bend, and a free distal end portion that extends from the intermediate portion. The distal end portion can comprise a first section, a second section, and a second bend between the first and second sections, the first section extending from the intermediate portion in a direction toward the atrial end and radially away from the main body.

Claims

1. A prosthetic device for implanting at a native mitral or tricuspid valve region of the heart, the native valve region having a native valve annulus and native leaflets, the prosthetic device comprising:

a main body configured for placement within the native valve annulus, the main body having a lumen extending between an atrial end and a ventricular end;

an atrial cap that extends radially outwardly from the atrial end; and

a plurality of ventricular anchors spaced angularly around a circumference of the main body, each ventricular anchor having a proximal end portion connected to the main body proximate the ventricular end, an intermediate portion extending away from the atrial end and then back toward the atrial end so as to define a first bend, and a distal end portion extending from the intermediate portion, the distal end portion comprising a first section, a second section, and a second bend between the first and the second section, the first section extending from the intermediate portion in a direction toward the atrial end and radially away from the main body.

2. The prosthetic device of claim 1, wherein at least one of the ventricular anchors comprises a pattern of repeating turns.

3. The prosthetic device of claim 2, wherein the pattern of repeating turns comprises a serpentine, coiled, or helical pattern.

4. The prosthetic device of claim 1, wherein the atrial cap comprises a plurality of atrial anchors spaced angularly around a circumference of the main body, each atrial anchor having a proximal end portion connected to the atrial end and a free distal end portion.

5. The prosthetic device of claim 1, wherein the plurality of ventricular anchors is radially compressible to a radially compressed state for delivery into the heart, wherein each anchor is linearly extended in the radially compressed state, such that the proximal end portions and distal end portions are axially aligned, parallel to the axis of the main body.

6. The prosthetic device of claim 1, wherein the plurality of ventricular anchors is connected to the main body independently of each other without frame segments interconnecting adjacent ventricular anchors.

7. The prosthetic device of claim 1, wherein the distal end portions of the ventricular anchors each comprise a curved or rounded head portion.

8. The prosthetic device of claim 1, wherein the first sections of the distal end portions extend away from a longitudinal axis of the main body and the second sections of the distal end portions extend substantially parallel to the longitudinal axis.

9. The prosthetic device of claim 1, wherein the second sections of the distal end portions curve toward the atrial end and back toward the ventricular end.

10. The prosthetic device of claim 1, wherein the atrial cap comprises a plurality of atrial anchors, each comprising a proximal end portion connected to the atrial end, an intermediate portion that extends away from the ventricular end and then curves back toward the ventricular end, and a distal end portion that curves away from the intermediate portion.

11. The prosthetic device of claim 1, wherein the proximal end portion of each ventricular anchor is connected to the main body at only a single location on the main body.

12. The prosthetic device of claim 1, wherein the ventricular anchors have varying lengths and/or the atrial anchors have varying lengths.

13. A method of implanting a prosthetic heart valve at a native atrioventricular valve region having a native valve annulus and a plurality of native leaflets, comprising:

delivering a prosthetic heart valve to a native valve region, the prosthetic heart valve contained within an interior of a sheath of a delivery apparatus, the prosthetic heart valve comprising an annular main body and a plurality of ventricular anchors extending from the main body, the ventricular anchors being connected to the main body independently of each other without frame segments interconnecting adjacent anchors; and

deploying the prosthetic heart valve from the sheath such that main body expands within the native annulus and the plurality of ventricular anchors extend behind the native leaflets, each ventricular anchor having a proximal end portion extending in a direction away from the atrial end, an intermediate portion extending back toward the atrial end, and a distal end portion extending toward the atrial end and radially away from the main body.

14. The method of claim 13, wherein the native valve annulus is the mitral valve annulus and the prosthetic heart valve is delivered to the annulus via the left atrium.

15. The method of claim 13, wherein a distal end portion of one or more of the plurality of ventricular anchors projects upward to contact a ventricular surface of the native valve annulus.

16. The method of claim 13, further comprising wrapping one or more of the ventricular anchors behind the native leaflets.

17. The method of claim 13, wherein deployment of the main body causes the distal end portions of the ventricular anchors to pivot inward toward the main body.

18. The method of claim 13, wherein following deployment, the prosthetic heart valve and the native valve annulus move in a generally synchronous manner during cardiac cycling.

19. The method of claim 13, further comprising retracting the outer sheath to deploy an atrial sealing cap within the left atrium, the atrial sealing cap blocking the flow of blood between the native leaflets and the outside of the main body.

20. The method of claim 13, further comprising advancing the outer sheath distally to recapture the plurality of ventricular anchors within an interior of the outer sheath.