Cardiac valve prosthesis

• US 9,486,313 B2
• Filed: 11/19/2014
• Issued: 11/08/2016
• 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:
  US14/548,013
• Publication Number:
  US 20150148895A1
• Time in Patent Office: 720 Days
• US Class Current: 1/1
• 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 method of repairing a native cardiac valve such as the aortic valve includes positioning a cardiac valve prosthesis at an implantation site proximate the native cardiac valve to be repaired. The cardiac valve prosthesis includes an armature and a plurality of prosthetic valve leaflets, the armature including first and second annular elements, a plurality of anchor members extending between the first and second annular elements, and a plurality of valve support members extending from at least one of the first and second annular elements, the plurality of prosthetic valve leaflets being coupled to and supported by the valve support members. The method further includes radially expanding the cardiac valve prosthesis such that each of the anchor members arches radially outward from the first annular element to the second annular element and engages a wall of a respective one of a plurality of native Valsalva sinuses located distal to the native cardiac valve so as to enable anchorage of the cardiac valve prosthesis at the implantation site.

Claims

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

positioning the prosthesis at the implantation site in a radially collapsed configuration, the prosthesis including an armature and a valve connected to the armature, the armature including a proximal portion, a distal portion, and first, second and third Valsalva sinus anchors each extending between and connecting the proximal and distal portions, wherein positioning the prosthesis includes positioning the prosthesis so that the first, second and third Valsalva sinus anchors are each positioned so that they can project into a respective one of the Valsalva sinuses of the implantation site;

radially expanding the prosthesis such that each of the Valsalva sinus anchors arches radially outward from the proximal portion to the distal portion and extends into and engages a wall of a respective one of the Valsalva sinuses so as to enable anchorage of the prosthesis at the implantation site.

2. The method of claim 1, wherein positioning the prosthesis further includes positioning the proximal portion of the armature at a location proximal to the Valsalva sinuses, and positioning the distal portion of the armature at a location distal to the Valsalva sinuses.

3. The method of claim 2, wherein radially expanding the prosthesis includes radially expanding the proximal portion so that it engages a wall of the valve annulus, and radially expanding the distal portion so that it engages a vessel wall distal to the plurality of Valsalva sinuses.

4. The method of claim 3, wherein the proximal portion has an outwardly-flared proximal end, and wherein radially expanding the proximal portion includes causing the outwardly-flared proximal end to anchor against the valve annulus.

5. The method of claim 1, wherein positioning the prosthesis at the implantation site is performed using a catheter to retain the prosthesis in the radially collapsed configuration.

6. The method of claim 1, wherein the armature is configured to be self-expandable from the radially collapsed configuration to a radially expanded configuration, and wherein radially expanding the prosthesis includes allowing the armature to self-expand toward the radially expanded configuration.

7. The method of claim 6, wherein the armature is made from a material having shape memory properties.

8. The method of claim 6, wherein allowing the armature to self-expand toward the radially expanded configuration includes disengaging the prosthesis from a sheath retaining the prosthesis in the radially collapsed configuration.

9. The method of claim 1, wherein the first, second and third Valsalva sinus anchors each include a pair of anchor members.

10. The method of claim 9, wherein positioning the prosthesis includes positioning the anchor members of each pair of anchor members on opposite sides of a coronary ostium located in one or more of the respective Valsalva sinuses.