Method of Peening Metal Heart Valve Stents

• US 20110146361A1
• Filed: 11/19/2010
• Published: 06/23/2011
• Est. Priority Date: 12/22/2009
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Davidson, James A., Campbell, Louis A.
• Application Number:
  US12/950,799
• Publication Number:
  US 20110146361A1
• Time in Patent Office: Days
• US Class Current: 72/53
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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: C21D 10/005 by laser shock processing
• CPC Class Codes: C21D 2221/00 Treating localised areas of an article
• CPC Class Codes: C21D 7/06 by shot-peening or the like

Abstract

Medical devices, such as percutaneous prosthetic heart valves can include a stent or frame structure component. The stent can be shot peened, laser peened, and/or ultrasonically peened, thereby reducing surface abnormalities, improving surface appearance, and/or increasing fatigue life of the device.

Claims

1. A method of making a prosthetic heart valve comprising:

providing a valve frame, wherein the frame comprises an inner and an outer surface;

peening at least a portion of the outer surface of the frame, thereby improving fatigue resistance of the frame; and

securing valve leaflets to the frame.

2. The method according to claim 1, wherein peening comprises shot peening with biocompatible beads.

3. The method according to claim 1, wherein peening comprises changing the surface roughness of at least a portion of the outer surface of the frame with uniformity sufficient to mask one or more surface scratches, notches, and/or burrs.

4. The method according to claim 1, wherein peening comprises selectively peening only areas of the outer surface of the frame that are subject to tensile stress while in use.

5. The method according to claim 1, wherein peening comprises at least one of laser peening and ultrasonic peening.

6. The method according to claim 1, wherein peening comprises peening substantially the entire outer surface of the frame.

7. The method according to claim 1, wherein peening comprises peening at least a portion of both the inner and outer surfaces of the frame.

8. The method according to claim 1, wherein the frame is made of Nitinol.

9. The method according to claim 1, wherein the frame is a radially expandable and collapsible annular frame.

10. A method of making a prosthetic heart valve, comprising:

providing a radially collapsible and expandable frame for the heart valve, wherein the frame comprises an inner and an outer surface;

peening at least a portion of the outer surface of the frame, thereby altering one or more surface characteristics of the frame; and

mounting valve leaflets to the frame.

11. The method according to claim 10, wherein peening comprises selectively peening only areas of the outer surface of the frame that are subject to tensile stress while in use.

12. The method according to claim 10, wherein peening comprises one or more of shot peening with biocompatible beads, laser peening with a biocompatible overlay layer, and ultrasonic peening.

13. The method according to claim 10, wherein peening comprises changing the surface roughness of at least a portion of the outer surface of the frame with uniformity sufficient to mask one or more surface scratches, notches, and/or burrs.

14. The method according to claim 10, wherein the frame is made of a self-expanding, shape memory material.

15. A method for peening a medical device, comprising:

providing a radially collapsible and expandable annular frame, wherein the frame comprises an inner and an outer surface;

placing the frame on a stabilizing device;

peening at least a portion of the outer surface of the frame, thereby altering one or more surface characteristics of the frame; and

coupling the frame to prosthetic valve leaflets for implantation in a human subject.

16. The method according to claim 15, wherein peening comprises changing the surface roughness of at least a portion of the outer surface of the frame with uniformity sufficient to mask one or more surface scratches, notches, and/or burrs.

17. The method according to claim 15 wherein substantially the entire outer surface of the frame is peened.

18. The method according to claim 15, wherein peening comprises shot peening with biocompatible beads.

19. The method according to claim 15, wherein substantially only the portions of the frame that are subject to the greatest tensile stresses are peened.

20. The method according to claim 15, further comprising peening at least a portion of the inner surface of the frame.