Valve prostheses

• US 9,138,312 B2
• Filed: 06/06/2014
• Issued: 09/22/2015
• Est. Priority Date: 09/19/2006
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Inventors: Tuval, Yosi, Benary, Raphael, Kilemnik, Ido
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US14/298,306
• Publication Number:
  US 20150005875A1
• Time in Patent Office: 473 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• 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 2220/005 using adhesives
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A cardiac valve prosthesis for implantation at a native valve having leaflets includes a distal fixation member configured to be implanted downstream of a native valve and includes engagement arms configured to apply, to a native valve'"'"'s downstream side, a first force directed upstream, when the distal fixation member is implanted. The number of engagement arms matches the number of native valve leaflets. The prosthesis also includes a proximal fixation member configured to be implanted at least partially upstream of the native valve such that the proximal fixation member applies, to a native valve'"'"'s upstream side, a second force directed downstream when the proximal fixation member is implanted. The application of the first and second forces is configured to couple the prosthesis to the native valve. The engagement arms and the proximal fixation member are configured to capture the leaflets of the native valve therebetween.

Claims

1. A cardiac valve prosthesis for implantation at a native valve having leaflets, comprising:

a distal fixation member configured to be implanted downstream of a native valve and comprising engagement arms configured to apply, to a downstream side of the native valve, a first force directed upstream, when the distal fixation member is implanted;

wherein the number of engagement arms matches the number of leaflets of the native valve; and

a proximal fixation member configured to be implanted at least partially upstream of the native valve such that the proximal fixation member applies, to an upstream side of the native valve, a second force directed downstream when the proximal fixation member is implanted;

wherein application of the first and second forces is configured to couple the cardiac valve prosthesis to the native valve; and

wherein the engagement arms and the proximal fixation member are configured to capture the leaflets of the native valve therebetween.

2. The cardiac valve prosthesis of claim 1, wherein the distal fixation member and the proximal fixation member are fabricated as one integrated structure.

3. The cardiac valve prosthesis of claim 1, wherein the proximal fixation member comprises a bulging skirt that is configured to apply the second force.

4. The cardiac valve prosthesis of claim 1, wherein the engagement arms are configured to limit an extent of opening of the leaflets of the native valve when the distal fixation member is implanted.

5. The cardiac valve prosthesis of claim 1, wherein the proximal and distal fixation members are configured to be collapsible and expandable.

6. The cardiac valve prosthesis of claim 5, wherein the proximal and distal fixation members are configured to be collapsible such that the proximal and distal fixation members can be advanced to the native valve using a transaortic approach, a transapical approach, or a transseptal approach.

7. The cardiac valve prosthesis of claim 1, wherein the engagement arms are configured to contact tissue adjacent and surrounding an annulus of the native valve when the distal fixation member is implanted.

8. The cardiac valve prosthesis of claim 7, wherein the tissue adjacent and surrounding the annulus of the native valve is a sinus of the native valve.

9. The cardiac valve prosthesis of claim 1, wherein application of the first and second forces couples the prosthesis to the native valve by sandwiching the native valve from a downstream side and the upstream side thereof

10. The cardiac valve prosthesis of claim 1, wherein the proximal and distal fixation members are configured such that any radial force applied by the proximal and distal fixation members outwardly against an annulus of the native valve is insufficient by itself to chronically maintain the cardiac valve prosthesis in position with respect to the annulus of the native valve under conditions of normal cardiac motion.

11. The cardiac valve prosthesis of claim 1, wherein the proximal and distal fixation members are configured to embrace, without squeezing, leaflets of the native valve.

12. The cardiac valve prosthesis of claim 1, wherein the native valve is selected from the group consisting of a mitral valve, an aortic valve, a pulmonary valve, and a tricuspid valve.

13. The cardiac valve prosthesis of claim 1, wherein the engagement arms and the proximal fixation member are configured to capture leaflets of the native valve therebetween without folding over leaflets of the native valve.

14. The cardiac valve prosthesis of claim 1, wherein the engagement arms each have a V-shape.

15. The cardiac valve prosthesis of claim 1, wherein the proximal fixation member defines a bulging skirt.

16. The cardiac valve prosthesis of claim 1, wherein the proximal fixation member is configured to reduce leakage around the cardiac valve prosthesis.

17. The cardiac valve prosthesis of claim 1, wherein the number of engagement arms is two and the number of leaflets of the native valve is two.

18. The cardiac valve prosthesis of claim 1, wherein the number of engagement arms is three and the number of leaflets of the native valve is three.

19. The cardiac valve prosthesis of claim 1, wherein the proximal fixation member and the distal fixation member are fabricated as separate components that are joined together in situ.

20. The cardiac valve prosthesis of claim 1, wherein the proximal fixation member and the distal fixation member are fabricated as one integrated structure.