Cardiac valve prosthesis

• US 9,895,223 B2
• Filed: 10/20/2016
• Issued: 02/20/2018
• Est. Priority Date: 02/10/2005
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Stacchino, Carla, Bergamasco, Giovanni, Burriesci, Gaetano, Righini, Giovanni
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US15/298,516
• Publication Number:
  US 20170035565A1
• Time in Patent Office: 488 Days
• 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 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: Y10T 29/49833 Punching, piercing or reaming part by surface of second part

Abstract

A prosthesis for implantation at an implantation site proximate a native aortic valve, the implantation site including a valve annulus and a plurality of Valsalva sinuses located distal to the valve annulus. The prosthesis comprises an armature and a valve connected to the armature, wherein the armature includes a proximal portion configured for anchorage to the valve annulus, a distal portion configured to be positioned distal to the Valsalva sinuses when the proximal portion is anchored to the valve annulus, and first, second and third Valsalva sinus anchors each extending between and connecting the proximal and distal portions and arching radially outward between the proximal portion and the distal portion. The Valsalva sinus anchors are positioned so that each can extend into and engage a wall of a different one of the Valsalva sinuses.

Claims

1. A prosthesis for implantation at an implantation site proximate a native aortic valve, the implantation site including a valve annulus and three Valsalva sinuses located distal to the valve annulus, the prosthesis comprising:

an armature and a valve connected to the armature, wherein the armature includes;

a proximal portion configured for anchorage to the valve annulus;

a distal portion configured to be positioned distal to the Valsalva sinuses when the proximal portion is anchored to the valve annulus; and

first, second and third Valsalva sinus anchors each extending between and connecting the proximal and distal portions and arching radially outward between the proximal portion and the distal portion, the Valsalva sinus anchors positioned so that each can extend into and engage a wall of a different one of the Valsalva sinuses.

2. The prosthesis of claim 1, wherein the first, second and third Valsalva sinus anchors each include a pair of anchor members, wherein each of the anchor members extends between and connects the proximal and distal portions and arches radially outward between the proximal portion and the distal portion.

3. The prosthesis of claim 2, wherein each of the anchor members has a generally sinusoidal shape.

4. The prosthesis of claim 1, wherein the first, second and third Valsalva sinus anchors each have a mesh structure.

5. The prosthesis of claim 1, wherein the proximal and distal portions each have a mesh structure.

6. The prosthesis of claim 1, wherein the armature is radially collapsible to a delivery configuration.

7. The prosthesis of claim 1, wherein the armature further includes first, second and third valve support members connected to the proximal portion and extending from the proximal portion toward the distal portion, and wherein the valve is connected to the valve support members.

8. The prosthesis of claim 7, wherein the first, second and third valve support members are each connected to the distal portion.

9. The prosthesis of claim 7, wherein the first valve support member is positioned between the first and second Valsalva sinus anchors, the second valve support member is positioned between the second and third Valsalva sinus anchors, and the third valve support member is positioned between the third and first Valsalva sinus anchors.

10. The prosthesis of claim 1, wherein the proximal portion of the armature has an outwardly-flared proximal end.

11. A prosthesis for implantation at an implantation site proximate a native aortic valve, the implantation site including a valve annulus and a plurality of Valsalva sinuses located distal to the valve annulus, the prosthesis comprising:

an armature and a valve sleeve including a plurality of valve leaflets connected to the armature, wherein the armature includes;

a proximal portion configured for anchorage to the valve annulus;

a distal portion configured to be positioned distal to the Valsalva sinuses when the proximal portion is anchored to the valve annulus; and

a plurality of Valsalva sinus anchors each extending between and connecting the proximal and distal portions and arching radially outward between the proximal portion and the distal portion, the Valsalva sinus anchors positioned so that each can extend into and engage a wall of a different one of the Valsalva sinuses.

12. The prosthesis of claim 11, wherein the Valsalva sinus anchors each include a pair of anchor members, wherein each of the anchor members extends between and connects the proximal and distal portions and arches radially outward between the proximal portion and the distal portion.

13. The prosthesis of claim 12, wherein each of the anchor members has a generally sinusoidal shape.

14. The prosthesis of claim 11, wherein the Valsalva sinus anchors each have a mesh structure.

15. The prosthesis of claim 11, wherein the proximal and distal portions each have a mesh structure.

16. The prosthesis of claim 11, wherein the armature is radially collapsible to a delivery configuration.

17. The prosthesis of claim 11, wherein the armature further includes a plurality of valve support members connected to the proximal portion and extending from the proximal portion toward the distal portion, and wherein the valve sleeve is connected to the valve support members.

18. The prosthesis of claim 17, wherein the valve support members are each connected to the distal portion.

19. The prosthesis of claim 11, wherein the plurality of Valsalva sinus anchors includes a first, a second and a third Valsalva sinus anchor, the plurality of valve support members includes a first, a second and a third valve support member, and wherein the first valve support member is positioned between the first and the second Valsalva sinus anchors, the second valve support member is positioned between the second and the third Valsalva sinus anchors, and the third valve support member is positioned between the third and first Valsalva sinus anchors.

20. The prosthesis of claim 11, wherein the proximal portion of the armature has an outwardly-flared proximal end.