Collapsible valve prosthesis

• US 9,895,225 B2
• Filed: 03/15/2013
• Issued: 02/20/2018
• Est. Priority Date: 03/23/2012
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Rolando, Giovanni, Gaschino, Paolo, Orecchia, Antonella, Achiluzzi, Monica, Ares, Massimiliano
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Diop, Rokhaya
• Application Number:
  US13/835,508
• Publication Number:
  US 20130253643A1
• Time in Patent Office: 1,803 Days
• Field of Search: 623 237, 623 212, 623 214, 623 217, 623 218, 623 238, 623 124, 623 21, 623 213, 623 215, 623 216
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability

Abstract

A collapsible valve prosthesis includes an armature and a set of prosthetic valve leaflets supported by the armature. The armature is expandable from a contracted condition to an expanded condition for anchoring at an annulus of a natural valve site, and includes a tubular intra-annular portion defining a blood flow lumen having an inflow side and an outflow side. The tubular intra-annular portion supports the prosthetic valve leaflets in the blood flow lumen and is provided with outward formations for coupling with the natural valve site. The armature includes an over-annular portion linked to the intra-annular portion to extend collar-like over the annulus of the natural valve site at the inflow side of the blood flow lumen. The armature may also include an under-annular portion to extend collar-like at the outflow side of the blood flow lumen. The prosthesis may permit mitral valve replacement (MVR) without removing the native valve leaflets and the chordae tendineae.

Claims

1. A collapsible valve prosthesis including an armature, the armature expandable from a contracted condition to an expanded condition for anchoring at an annulus of a mitral valve site bounded by a left atrium and a left ventricle, wherein the armature includes:

a tubular intra-annular component to extend substantially entirely below the annulus of the mitral valve site when the armature is anchored at the annulus of the mitral valve site including a frame and defining a blood flow lumen having an inflow side defined by the left atrium and an outflow side defined by the left ventricle, the tubular intra-annular component being provided with outward formations for coupling with the mitral valve site,

at least one extra-annular portion including a frame and linked to the intra-annular component, the intra-annular component and the at least one extra-annular portion being structurally separate components and including a decoupling member situated between and configured to reduce the mechanical stresses transferred between the intra-annular component and the at least one extra-annular portion, the decoupling member confined to an area within the annulus of the mitral valve site, the at least one extra-annular portion including an over-annular portion to extend, in the shape of a collar, over the annulus of the mitral valve site at the inflow side of the blood flow lumen to contact the atrial wall adjacent the annulus of the mitral valve site, and

a set of prosthetic valve leaflets supported by the tubular intra-annular component in the blood flow lumen, the set of prosthetic valve leaflets enabling free flow of fluid through the valve prosthesis from the inflow side to the outflow side and inhibiting free flow of fluid through the valve prosthesis from the outflow side to the inflow side.

2. The prosthesis of claim 1, wherein the at least one extra-annular portion linked to the intra-annular component also includes an under-annular portion to extend, in the shape of a collar, at the outflow side of the blood flow lumen.

3. The prosthesis of claim 1, wherein the intra-annular component and the at least one extra-annular portion are balloon-expandable and self-expandable, respectively.

4. The prosthesis of claim 1, including a sheet member, formed in the shape of a sheet, applied onto the intra-annular component and the at least one extra-annular portion.

5. The prosthesis of claim 4, wherein the intra-annular component and the at least one extra-annular portion are linked by the sheet member.

6. The prosthesis of claim 4, wherein the outward formations of the intra-annular component are carried by the sheet member.

7. The prosthesis of claim 4, wherein the de-coupling member includes a length of the sheet member.

8. The prosthesis of claim 1, wherein the outward formations include barbs.

9. The prosthesis of claim 1, wherein the outward formations include first and second formations pointing towards the inflow and the outflow sides of the prosthesis, respectively.

10. The prosthesis of claim 1, wherein at least one of the intra-annular component and the at least one extra-annular portion includes a mesh structure.

11. The prosthesis of claim 1, wherein the at least one extra-annular portion includes a pattern of radial finger formations.

12. The prosthesis of claim 11, wherein the radial finger formations exhibit differential flexibility by being stiffer at their proximal ends and more flexible at their distal ends.

13. The prosthesis of claim 1, the prosthesis having different axial lengths between the inflow side and the outflow side around the blood flow lumen.

14. The prosthesis of claim 13, wherein the intra-annular component includes annular members coupled via longitudinal connection members.

15. The prosthesis of claim 13, wherein the intra-annular component includes a mesh structure of struts, at least one of the struts having apertures to permit application of valve leaflets onto the armature via stitching.

16. A collapsible valve prosthesis including an armature and a set of prosthetic valve leaflets supported by the armature, the armature expandable from a contracted condition to an expanded condition for anchoring at an annulus of a natural valve site, wherein the armature includes:

a sheath, the sheath at least partially covering the armature,

a tubular balloon-expandable intra-annular component to extend substantially entirely below the annulus of the natural valve site when the armature is anchored at the annulus of the natural valve site including a frame and defining a blood flow lumen having an inflow side and an outflow side, the tubular intra-annular component being provided with outward formations for coupling with the mitral valve site, and the tubular intra-annular component supporting the set of prosthetic valve leaflets in the blood flow lumen, the set of prosthetic valve leaflets enabling free flow of fluid through the valve prosthesis from the inflow side to the outflow side and inhibiting free flow of fluid through the valve prosthesis from the outflow side to the inflow side, and

at least one self-expandable extra-annular portion including a frame and linked to the intra-annular component, the intra-annular component and the at least one extra-annular portion being separate pieces and including a decoupling member situated between and configured to reduce the mechanical stresses transferred between the intra-annular component and the at least one extra-annular portion, the decoupling member confined to an area within the annulus of the mitral valve site, the at least one extra-annular portion including an over-annular portion to extend, in the shape of a collar, over the annulus of the natural valve site at the inflow side of the blood flow lumen to contact and conform to the annulus of the natural valve site.

17. The prosthesis of claim 16, wherein the intra-annular component and the extra-annular portion have substantially the same diameter when the armature is in the contracted condition.

18. The prosthesis of claim 16, wherein the at least one extra-annular portion linked to the intra-annular component also includes an under-annular portion to extend, in the shape of a collar, at the outflow side of the blood flow lumen.

19. The prosthesis of claim 16, wherein the intra-annular component and the at least one extra-annular portion are linked by the sheath.

20. The prosthesis of claim 16, wherein the outward formations include barbs.