Heart valve that includes coating material

Patent metadata

Field	Value
Publication number	US-12472289-B2
Application number	US-202418434290-A
Country	US
Kind code	B2
Filing date	Feb 6, 2024
Priority date	May 31, 2022
Publication date	Nov 18, 2025
Grant date	Nov 18, 2025

Abstract

A prosthetic heart valve that is at least partially coated with an enhancement layer, and a method for inserting the prosthetic heart valve in a patient. The prosthetic heart valve includes an expandable frame, a leaflet structure, and optionally an inner skirt and/or an outer skirt. One or more of the components of the prosthetic heart valve can be partially or fully coated with the enhancement layer. One type of enhancement layer that can be used includes titanium oxynitride or titanium nitride oxide (TiNOx) and/or zirconium oxynitride (ZrNxOy).

First claim

What is claimed:

1 . A prosthetic heart valve that includes a plurality of components; two of said components include a plastically deformable and/or elastically deformable expandable metallic frame and at least one leaflet; said metallic frame is directly or indirectly attached to said at least one leaflet; said at least one leaflet is configured to at least partially control blood flow through said metallic frame when said prosthetic heart valve is positioned in a heart; an outer surface of at least one component of said prosthetic heart valve includes an enhancement coating; said enhancement coating is formulated to promote generation of nitric oxide when said prosthetic heart valve is implanted in the heart; said enhancement coating is formed of a) a coating material of titanium oxynitride and/or zirconium oxynitride that is directly coated on an outer surface of at least a portion of said metallic frame and/or at least a portion of an outer surface of said at least one leaflet, or b) a metallic adhesion layer and said coating material, and wherein said metallic adhesion layer is directly coated on at least a portion of said outer surface of said metallic frame and/or at least a portion an outer surface of said at least one leaflet, and wherein said metallic adhesion layer is a layer of metal of titanium, titanium alloy, zirconium or zirconium alloy, and wherein said coating material is coated on at least a portion of an outer surface of said metallic adhesion layer, and wherein said enhancement coating is coated on or over at least a portion of an outer surface of said metallic frame and said at least one leaflet, and wherein said coating material is titanium oxynitride and/or zirconium oxynitride.

2 . The prosthetic heart valve as defined in claim 1 , wherein said coating material is titanium oxynitride.

3 . The prosthetic heart valve as defined in claim 1 , wherein said coating material is zirconium oxynitride.

4 . The prosthetic heart valve as defined in claim 1 , wherein said coating material has a thickness of at least 10 nanometers.

5 . The prosthetic heart valve as defined in claim 1 , wherein said coating material has an oxygen to nitrogen atomic ratio of 1:10 to 10:1.

6 . The prosthetic heart valve as defined in claim 1 , wherein said enhancement coating is a) a coating of titanium oxynitride that is directly coated on at least a portion of said outer surface of said metallic frame and/or directly coated on at least a portion of said outer surface of said at least one leaflet, or b) said metallic adhesion layer that is directly coated on at least a portion of said outer surface of said metallic frame and/or directly coated on at least a portion of said outer surface of said at least one leaflet, and wherein said metallic adhesion layer is a layer of metal of titanium or titanium alloy, and wherein at least a portion of said outer surface of said metallic adhesion layer is directly coated with titanium oxynitride.

7 . The prosthetic heart valve as defined in claim 1 , wherein said enhancement coating is a) a coating of zirconium oxynitride that is directly coated on at least a portion of said outer surface of said metallic frame and/or directly coated on at least a portion of said outer surface of said at least one leaflet, or b) said metallic adhesion layer that is directly coated on at least a portion of said outer surface of said metallic frame and/or directly coated on at least a portion of said outer surface of said at least one leaflet, and wherein said metallic adhesion layer is a layer of metal of zirconium or zirconium alloy, and wherein at least a portion of said outer surface of said metallic adhesion layer is directly coated with zirconium oxynitride.

8 . The prosthetic heart valve as defined in claim 1 , wherein said metallic adhesion layer has a thickness of at least 1 nanometers.

9 . The prosthetic heart valve as defined in claim 1 , wherein said plurality of components further include one or more of an inner skirt, an outer skirt, and/or sutures.

10 . The prosthetic heart valve as defined in claim 9 , wherein said plurality of components include said frame, said at least one leaflet, said inner skirt, said outer skirt, and said sutures.

11 . The prosthetic heart valve as defined in claim 1 , wherein said enhancement coating includes no more than 0.1 wt. % nickel, no more than 0.1 wt. % chromium, and/or no more than 0.1 wt. % cobalt.

12 . The prosthetic heart valve as defined in claim 10 , wherein said metallic frame includes no more than 0.1 wt. % nickel, no more than 0.1 wt. % chromium, and/or no more than 0.1 wt. % cobalt.

13 . The prosthetic heart valve as defined in claim 9 , wherein said enhancement coating is coated on or over at least a portion of an outer surface of said inner skirt and/or said outer skirt.

14 . The prosthetic heart valve as defined in claim 1 , wherein said metallic frame is formed of a) stainless steel, b) cobalt-chromium alloy, c) titanium-aluminum-vanadium alloy, d) aluminum alloy, e) nickel alloy, f) titanium alloy, g) tungsten alloy, h) molybdenum alloy, i) copper alloy, j) beryllium-copper alloy, k) titanium-nickel alloy, l) refractory metal alloy, or m) metal alloy that includes at least 15 atomic weight percent (awt. %) rhenium.

15 . The prosthetic heart valve as defined in claim 14 , wherein said metallic frame is formed of said refractory metal alloy or said metal alloy that includes at least 15 atomic weight percent (awt. %) rhenium.

16 . A method for repairing a heart valve; said method comprising:
a. providing a prosthetic heart valve that is crimped about a delivery system; said prosthetic heart valve includes a plurality of components; two of said components include a plastically deformable and/or elastically deformable expandable metallic frame and at least one leaflet; said metallic frame is directly or indirectly attached to said at least one leaflet; said at least one leaflet is configured to at least partially control blood flow through said metallic frame when said prosthetic heart valve is positioned in a heart; an outer surface of at least one component of said prosthetic heart valve includes an enhancement coating that has been coated on said outer surface; said enhancement coating is formulated to promote generation of nitric oxide when said prosthetic heart valve is implanted in the heart; said enhancement coating is formed of a) a coating material of titanium oxynitride and/or zirconium oxynitride that is directly coated on an outer surface of at least a portion of said metallic frame and/or at least a portion of an outer surface of said at least one leaflet, or b) a metallic adhesion layer and said coating material, and wherein said metallic adhesion layer is directly coated on at least a portion of said outer surface of said metallic frame and/or at least a portion an outer surface of said at least one leaflet, and wherein said metallic adhesion layer is a layer of metal of titanium, titanium alloy, zirconium or zirconium alloy, and wherein said coating material is coated on at least a portion of an outer surface of said metallic adhesion layer, and wherein said enhancement coating is coated on or over at least a portion of an outer surface of said metallic frame and said at least one leaflet, and wherein said coating material is titanium oxynitride and/or zirconium oxynitride; b. positioning said prosthetic heart valve in a treatment area of said heart; and, c. expanding said metallic frame from a crimped state to an expanded state while said prosthetic heart valve is in said treatment area of said heart; a

Assignees

• Mirus Llc

Inventors

• Bauman Jordan
• Roth Noah
• Yadav Jay
• Gookin S Beckett
• Salim Md Tausif
• Jimenez Jorge
• White Jason

Classifications

• A61F2250/0067

  Means for introducing or releasing pharmaceutical products into the body · CPC title

• A61L2400/12

  Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces · CPC title

• A61L2420/08

  Coatings comprising two or more layers · CPC title

• A61L2300/114

  Nitric oxide, i.e. NO · CPC title

• A61L2430/20

  for reconstruction of the heart, e.g. heart valves · CPC title