Cardiac-valve prosthesis

• US 8,539,662 B2
• Filed: 06/16/2008
• Issued: 09/24/2013
• 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): Bryant, David
• Assistant Examiner(s): CIGNA, JACOB JAMES
• Application Number:
  US12/139,686
• Publication Number:
  US 20080249619A1
• Time in Patent Office: 1,926 Days
• Field of Search: 623/1.24, 294/32
• US Class Current: 29/432
• 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 cardiac-valve prosthesis which can be used, for example, as a valve for percutaneous implantation. The prosthesis includes an armature for anchorage of the valve prosthesis in the implantation site. The armature defines a lumen for passage of the blood flow and supports a set of prosthetic valve leaflets, which, under the action of the blood flow, are able to move into a radially divaricated condition to enable the flow of the blood through the lumen in a first direction and a radially contracted condition, in which the valve leaflets co-operate with one another and block the flow of the blood through the prosthesis in the opposite direction. The armature includes, in one embodiment, two annular elements connected by anchor members having the capacity of projecting radially with respect to the prosthesis, and support members for the set of leaflets, the support members being carried by at least one of the annular elements so as to leave substantially disengaged the aforesaid lumen for passage of the blood.

Claims

1. A method of making a cardiac valve prosthesis comprising:

forming a frame of the prosthesis from a tube, the frame defining a principal axis of the cardiac valve prosthesis and comprising;

first and second annular elements positioned about the principal axis and axially separated from one another along the principal axis,

a plurality of substantially linear valve leaflet supports extending from the first annular element to the second annular element and disposed about and oriented generally parallel to the principal axis; and

a plurality of anchor members extending from the first annular element to the second annular element, each anchor member arching radially outward from the first annular element to the second annular element and including a first end connected to the first annular element and a second end connected to the second annular element; and

mounting a valve onto the frame.

2. The method of claim 1 wherein mounting the valve onto the frame further comprises suturing.

3. The method of claim 2 wherein suturing includes suturing the valve to the leaflet supports.

4. The method of claim 1 further comprising adding a seal to the frame.

5. The method of claim 4 wherein the seal comprises pericardium.

6. The method of claim 1 wherein the tube is made from a shape-memory material.

7. The method of claim 6 wherein the shape-memory material is nitinol.

8. The method of claim 6 wherein the tube has a diameter prior to cutting the frame selected to be between a radially collapsed diameter corresponding to a delivery configuration of the prosthesis and a radially expanded diameter corresponding to an implanted configuration of the prosthesis.

9. The method of claim 8 further comprising forming the frame so as to attain the radially expanded configuration.

10. The method of claim 9 wherein forming the frame includes performing a heat treatment operation.

11. An improved method of making an expandable cardiac valve prosthesis frame from a tube, the method comprising:

cutting first and second axially spaced annular elements into the tube;

cutting substantially linear leaflet supports into the tube, the leaflet supports extending from the first annular element to the second annular element,

cutting Valsalva sinus anchors into the tube, the Valsalva sinus anchors extending from the first annular element to the second annular element, wherein each Valsalva sinus anchor is positioned between two respective leaflet supports, and wherein each Valsalva sinus anchor includes a first end connected to the first annular element and a second end connected to the second annular element; and

performing a series of expansion operations after cutting the first and second annular elements, the leaflet supports and the Valsalva sinus anchors into the tube, including at least one expansion operation causing the Valsalva sinus anchors to arch radially outward from the first annular element to the second annular element.

12. The improved method of claim 11 further comprising surface treating the frame.

13. The improved method of claim 12 wherein surface treating is selected from the group consisting of sandblasting, electropolishing, and carbon coating.

14. The improved method of claim 11 wherein the tube is made from a shape-memory material.

15. The improved method of claim 14 wherein the shape-memory material is nitinol.

16. The improved method of claim 15 further comprising performing at least one heat treatment operation after cutting the leaflet supports and the Valsalva sinus anchors.

17. The improved method of claim 16 wherein the heat treatment operation is performed at a temperature and for a time such that the frame exhibits a super-elastic behavior at about 37°

C.

18. The improved method of claim 11 further comprising performing a heat treatment operation after each of the expansion operations.