Method for manufacturing high durability heart valve

• US 9,549,816 B2
• Filed: 04/02/2015
• Issued: 01/24/2017
• Est. Priority Date: 04/03/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rodriguez, Rodolfo
• Primary Examiner(s): COZART, JERMIE E
• Application Number:
  US14/677,746
• Publication Number:
  US 20150282929A1
• Time in Patent Office: 663 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: C23C 14/0021 Reactive sputtering or evaporation
• CPC Class Codes: C23C 14/025 Metallic sublayers
• CPC Class Codes: C23C 14/0641 Nitrides C23C14/0617 takes precedence
• CPC Class Codes: C23C 14/16 on metallic substrates or on substrates of boron or silicon
• CPC Class Codes: C23C 14/24 Vacuum evaporation
• CPC Class Codes: C23C 14/325 Electric arc evaporation
• CPC Class Codes: C23C 16/34 Nitrides C23C16/303 takes precedence
• CPC Class Codes: C23C 16/44 characterised by the method of coating C23C16/04 takes precedence
• CPC Class Codes: Y10T 29/49885 with coating before or during assembling
• CPC Class Codes: Y10T 29/49982 Coating

Abstract

An improved heart bioprosthetic device having a metal frame wireform or stent having an outer external surface. The metal frame has a bond layer coating at least a portion of the external surface and a coating layer disposed on at least a portion of the bond layer. The bond layer comprises a metal selected from the group consisting of: chromium, titanium, zirconium, aluminum, platinum, palladium, and niobium. The coating layer is selected from the group consisting of: a metal nitride, a metal oxide, a metal carbide, and combinations thereof. The coating layer may have a thickness of about 10 μm or less and a grain size of about 10 nm to about 15 nm, and may be characterized as polycrystalline with randomly-oriented grains with both cubic and orthorhombic phases. In one embodiment, the bond layer comprises chromium and the coating layer comprises chromium nitride.

Claims

1. A method for manufacturing a prosthetic heart valve to improve the fatigue life of a metal frame thereof, the method comprising:

disposing a bond layer over at least a portion of a metal frame of a prosthetic heart valve, the bond layer comprising at least one elemental metal;

vacuum depositing a coating layer over at least a portion of the bond layer, the coating layer comprising at least one of a metal oxide, a metal nitride, or a metal carbide; and

securing a plurality of leaflets to the metal frame, the plurality of leaflets defining a one-way valve for blood flow therethrough.

2. The method of claim 1, wherein disposing the bond layer comprises disposing a bond layer by at least one of vacuum deposition or by electrochemical deposition.

3. The method of claim 1, wherein the at least one elemental metal is selected from the group consisting of aluminum, titanium, zirconium, hafnium, vanadium, niobium, tantalum, chromium, molybdenum, tungsten, ruthenium, cobalt, rhenium, iridium, palladium, platinum, copper, silver, and gold.

4. The method of claim 1, wherein disposing the bond layer over at least the portion of the metal frame comprises disposing the bond layer over at least a portion of at least one of a stent or a wireform of a heart valve.

5. The method of claim 1, wherein disposing the bond layer over at least the portion of the metal frame comprises disposing the bond layer over at least a portion of a metal frame comprising at least one of stainless steel, cobalt-chromium, titanium alloy, nitinol, a metal alloy, a shape-memory metal, or a super-elastic metal.

6. The method of claim 1, wherein vacuum depositing the coating layer comprises vacuum depositing a coating layer using at least one of physical vapor deposition (PVD), chemical vapor deposition (CVD), or low-temperature arc-vapor deposition (LTAVD).

7. The method of claim 1, wherein vacuum depositing the coating layer comprises vacuum depositing the coating layer at a temperature of about 150°

C. (about 300°

F.) or lower.

8. The method of claim 1, wherein vacuum depositing the coating layer comprises vacuum depositing a coating layer with a thickness of about 10 μ

m or less.

9. The method of claim 1, wherein the at least one of the metal oxide, the metal nitride, or the metal carbide of the coating layer comprises at least one metal selected from the group consisting of aluminum, titanium, zirconium, hafnium, vanadium, niobium, tantalum, chromium, molybdenum, tungsten, ruthenium, cobalt, rhenium, iridium, palladium, and platinum.

10. The method of claim 1, wherein vacuum depositing the coating layer comprises vacuum depositing a coating layer comprising chromium nitride.

11. The method of claim 1, wherein the bond layer and the coating layer include the same metal.

12. The method of claim 1, wherein the at least one elemental is selected from the group consisting of one or more noble metals.

13. The method of claim 1, wherein the coating layer has a grain size of about 20 nm or less.

14. The method of claim 1, wherein the coating layer includes both cubic and orthorhombic phases.

15. The method of claim 1, wherein the bond layer is chromium and the coating material is chromium nitride (CrN).

16. A method for manufacturing a prosthetic heart valve to improve the fatigue life of a metal frame thereof, the method comprising:

disposing a bond layer over at least a portion of a metal frame of a prosthetic heart valve, the bond layer including one or more stable and non-reactive elemental noble metals;

vacuum depositing a coating layer over at least a portion of the bond layer; and

securing a plurality of leaflets to the metal frame, the plurality of leaflets defining a one-way valve for blood flow therethrough.

17. The method of claim 16, wherein vacuum depositing the coating layer comprises vacuum depositing the coating layer using at least one of physical vapor deposition (PVD), chemical vapor deposition (CVD), or low-temperature arc-vapor deposition (LTAVD).

18. The method of claim 16, wherein vacuum depositing the coating layer comprises vacuum depositing a coating layer comprising at least one of a metal oxide, a metal nitride, or a metal carbide.

19. The method of claim 16, wherein the bond layer comprises a combination of at least two stable and non-reactive elemental noble metals.

20. The method of claim 16, wherein disposing the bond layer comprising at least one of vacuum depositing a bond layer or electrochemically depositing a bond layer.

21. The method of claim 16, wherein securing the plurality of leaflets comprises securing a plurality of tissue leaflets.

22. The method of claim 16, wherein the noble metals are selected from the group consisting of ruthenium, palladium, silver, iridium, platinum, and gold.

23. The method of claim 16, wherein the coating layer has a grain size of about 20 nm or less.

24. The method of claim 16, wherein the coating layer includes both cubic and orthorhombic phases.

25. The method of claim 16, wherein the bond layer is chromium and the coating material is chromium nitride (CrN).