Valve prosthetic fixation techniques using sandwiching

• US 8,771,346 B2
• Filed: 07/25/2011
• Issued: 07/08/2014
• 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, Kilemnik, Ido, Benary, Raphael
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US13/190,397
• Publication Number:
  US 20110288634A1
• Time in Patent Office: 1,079 Days
• Field of Search: 623 115- 117, 623/1.24, 623 236- 237, 623/900
• US Class Current: 623/2.17
• 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 prosthesis is provided for implantation at a native semilunar valve of a native valve complex. The prosthesis includes a distal fixation member, configured to be positioned in a downstream artery, and shaped so as to define exactly three proximal engagement arms that are configured to be positioned at least partially within respective ones of semilunar sinuses, and, in combination, to apply, to tissue that defines the semilunar sinuses, a first axial force directed toward a ventricle. The prosthesis further includes a proximal fixation member coupled to the distal fixation member, the proximal fixation member configured to be positioned at least partially on a ventricular side of the native semilunar valve, and to apply, to the ventricular side of the native valve complex, a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex.

Claims

1. A valve prosthesis for implantation at a native valve of a subject, the prosthesis comprising:

a frame expandable from a compressed state to an expanded state, the frame comprising;

a first portion configured to be positioned within an annulus of the native valve upon implantation of the prosthesis;

a second portion configured to be positioned upstream of the annulus of the native valve, wherein the second portion is configured such that, upon implantation of the prosthesis, the second portion extends radially outward from a proximal portion of the frame, wherein the second portion is configured to be positioned around an inflow side of the annulus of the native valve upon implantation of the prosthesis;

a third portion configured to be positioned downstream of the annulus of the native valve, the third portion comprising leaflet engagement members extending from a distal portion of the frame and circumferentially spaced apart to define gaps therebetween, wherein the leaflet engagement members, upon implantation of the prosthesis, are rotationally aligned with leaflets of the native valve and the gaps are rotationally aligned with commissures of the native valve, the gaps being configured to span the width of the commissures of the native valve, the leaflet engagement members being configured such that at least a portion of each leaflet engagement member contacts a downstream side of a leaflet of the native valve upon implantation of the prosthesis; and

a prosthetic valve positioned inside and coupled to the frame.

2. The prosthesis according to claim 1, wherein the leaflet engagement members each comprise a portion that is bent proximally.

3. The prosthesis according to claim 1, wherein the prosthesis is configured, upon implantation thereof, to embrace, without squeezing, the leaflets of the native valve.

4. The prosthesis according to claim 1, wherein the prosthesis is configured, upon implantation thereof, to capture, without folding over, the leaflets of the native valve.

5. The prosthesis according to claim 1, wherein the leaflet engagement members meet one another at junctures, wherein the leaflet engagement members are shaped so as define peak complexes at the junctures, and trough complexes between the peak complexes, and wherein, upon implantation of the prosthesis, each peak complex is rotationally aligned with one of the commissures of the native valve and each trough complex is rotationally aligned with one of the leaflets of the native valve.

6. The prosthesis according to claim 1, wherein the second portion of the frame defines a bulging skirt.

7. The prosthesis according to claim 1, wherein the second portion of the frame is configured to reduce leakage around the valve prosthesis.

8. The prosthesis according to claim 1, wherein a proximal portion of the frame is wider than a distal portion of the frame.

9. The prosthesis according to claim 1, wherein the third portion is configured to be coupled to the first portion after the first portion is positioned within the annulus of the native valve.

10. The prosthesis according to claim 1, wherein the third portion is configured to be coupled to first portion before the first portion is positioned within the annulus of the native valve.

11. The prosthesis according to claim 1, wherein at least a portion of the third portion is configured to apply a force to tissue on a downstream side of the native valve.

12. The prosthesis according to claim 1, wherein at least a portion of the second portion is configured to apply a force to tissue on an upstream side of the native valve.

13. The prosthesis according to claim 1, wherein the native valve is a mitral valve.

14. The prosthesis according to claim 1, wherein the native valve is an aortic valve.

15. The prosthesis according to claim 1, wherein the native valve is a pulmonary valve.

16. The prosthesis according to claim 1, wherein the native valve is a tricuspid valve.

17. The prosthesis according to claim 1, wherein the native valve comprises two leaflets and two commissures, and wherein the prosthesis comprises two leaflet engagement members.

18. The prosthesis according to claim 1, wherein the native valve comprises three leaflets and three commissures, and wherein the prosthesis comprises three leaflet engagement members.

19. The prosthesis according to claim 1, wherein the frame is fabricated as one integrated structure.

20. The prosthesis according to claim 1, wherein the frame is fabricated as separate components that are joined together.

21. The prosthesis according to claim 1, wherein the frame is fabricated as separate components that are joined together in situ.

22. The prosthesis according to claim 1, wherein the frame is fabricated as separate components that are joined together before implantation.

23. The prosthesis according to claim 1, wherein the frame is self-expandable.

24. The prosthesis according to claim 1, wherein the prosthetic valve comprises pericardial tissue.

25. The prosthesis according to claim 1, wherein the valve prosthesis is implanted using a procedure selected from the group consisting of a transapical procedure, a transaortic procedure, a transseptal procedure, a transarterial procedure, a transcardiac procedure, a percutaneous procedure, and an endovascular procedure.

26. The prosthesis according to claim 1, wherein the second portion comprises a flared portion.

27. The prosthesis according to claim 1, wherein the number of leaflet engagement members is equal to the number of leaflets of the native valve.

28. The prosthesis according to claim 1, wherein the leaflet engagement members each comprise a portion that extends in an upstream direction.

29. The prosthesis according to claim 1, wherein the leaflet engagement members each comprise a portion that curves outward in an upstream direction.