ANTI-MICROBIAL DEVICE AND METHOD FOR ITS MANUFACTURE

• US 20170007743A1
• Filed: 09/26/2016
• Published: 01/12/2017
• Est. Priority Date: 03/26/2014
• Status: Active Grant

• Current Assignee: Nanovis, Inc.
• Original Assignee: Nanovis, Inc.
• Inventors: HEDRICK, MATTHEW, YAO, CHANG
• Granted Patent: US 10,576,186 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61L 2202/21 Pharmaceuticals, e.g. medicaments, artificial body parts
• CPC Class Codes: A61L 2300/102 Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
• CPC Class Codes: A61L 2300/104 Silver, e.g. silver sulfadiazine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/61 containing two or more active agents in different layers
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 27/04 Metals or alloys
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: C04B 2235/447 Phosphates or phosphites, e.g. orthophosphate or hypophosphite
• CPC Class Codes: C04B 35/447 based on phosphates , e.g. hydroxyapatite
• CPC Class Codes: C04B 35/62222 obtaining ceramic coatings coating of mortars, concrete, artificial or natural stone or ceramics C04B41/45; laminated ceramic products B32B18/00; coating metallic materials C23; coating of glass C03C17/00, applying ceramic coatings on silicon for semi-conductor purposes H01L
• CPC Class Codes: C09D 1/00 Coating compositions, e.g. paints, varnishes or lacquers, based on inorganic substances
• CPC Class Codes: C09D 5/14 Paints containing biocides, e.g. fungicides, insecticides or pesticides C09D5/16 takes precedence
• CPC Class Codes: C09D 7/61 inorganic
• CPC Class Codes: C23C 22/05 using aqueous solutions
• CPC Class Codes: C23C 22/78 Pretreatment of the material to be coated
• CPC Class Codes: C25D 11/02 Anodisation
• CPC Class Codes: C25D 11/26 of refractory metals or alloys based thereon
• CPC Class Codes: C25D 11/34 : of metals or alloys not provided for in groups C25D11/04 - C25D11/32

Abstract

An antimicrobial medical device that includes a substrate having a metal surface that is made from a metal or metal alloy that may include stainless steel, cobalt, and titanium. Disposed on the metal surface is a first antimicrobial oxide layer that includes an antimicrobial metal that may include silver, copper, and zinc, and combinations thereof. The atoms of antimicrobial metal in the first antimicrobial oxide layer are of a first concentration. The first antimicrobial oxide layer is positioned in a direction opposite that of the metal surface. The device further includes a second antimicrobial oxide layer that includes an antimicrobial metal that may be silver, copper, and zinc, and combinations thereof. The atoms of the antimicrobial metal present in the second antimicrobial oxide layer are of a second concentration. The first concentration and the second concentration are not equal. Methods for making the antimicrobial medical device are also disclosed.

Claims

1. An antimicrobial medical device comprising:

a substrate comprising a metal surface, said metal surface comprising atoms of at least one of a metal or metal alloy comprising one or more of stainless steel, cobalt, and titanium;

wherein on the metal surface, a first antimicrobial oxide layer comprising atoms of the metal or metal alloy and atoms of an antimicrobial metal selected from the group consisting of silver, copper, and zinc, and combinations thereof, the atoms of antimicrobial metal being present in the first antimicrobial oxide layer in a first concentration;

wherein on the first antimicrobial oxide layer, positioned in a direction opposite that of the metal surface, a second antimicrobial oxide layer comprising atoms of an antimicrobial metal selected from the group consisting of silver, copper, and zinc, and combinations thereof, the atoms of antimicrobial metal being present in the second antimicrobial oxide layer in a second concentration; and

wherein the first concentration is not equal to the second concentration.

2. The antimicrobial medical device according to claim 1, wherein the metal surface is fabricated from at least one of titanium, a titanium alloy, stainless steel, and a cobalt-chrome alloy.

3. The antimicrobial medical device according to claim 2, wherein the metal surface is selected from at least one of a Ti6Al4V and a cobalt-chrome alloy.

4. The antimicrobial medical device according to claim 3, wherein the metal surface is Ti6Al4V.

5. The antimicrobial medical device according to claim 1, wherein the first and second antimicrobial oxide layers are distinct layers separated from one another by at least an intermediate layer that does not comprise an antimicrobial metal selected from the group consisting of silver, copper, and zinc, and combinations thereof.

6. The antimicrobial medical device according to claim 5, wherein the intermediate layer comprises atoms of at least one of stainless steel, cobalt, and titanium.

7. The antimicrobial medical device according to claim 1, wherein the oxide in the second antimicrobial oxide layer comprises silver atoms.

8. The antimicrobial medical device according to claim 1, wherein the oxide in the second antimicrobial oxide layer comprises atoms of at least one of stainless steel, cobalt, and titanium.

9. The antimicrobial medical device according to claim 1, wherein the first and second antimicrobial oxide layers are in direct contact with one another.

10. The antimicrobial medical device according to claim 1, wherein the first concentration is greater than the second concentration.

11. The antimicrobial medical device according to claim 1, wherein the first concentration is less than the second concentration.

12. The antimicrobial medical device according to claim 1, wherein the first antimicrobial oxide layer comprises silver atoms.

13. The antimicrobial medical device according to claim 1, wherein the device further comprises a plurality of nanostructures disposed on the metal surface, and wherein said first and second antimicrobial oxide layers are contained within the plurality of nanostructures.

14. The antimicrobial medical device according to claim 13, wherein the nanostructures are nanotubes.

15. The antimicrobial medical device according to claim 13, wherein the nanostructures are amorphous non-crystalline nanostructures.

16. The antimicrobial medical device according to claim 15, wherein the nanostructures are titanium dioxide nanostructures.

17. The antimicrobial medical device according to claim 16, wherein the nanostructures are nanotubes.

18. The antimicrobial medical device according to claim 17, wherein the device is selected from an orthopedic implant and a neurosurgical implant.

19. The antimicrobial medical device according to claim 1, further comprising a ceramic layer, the ceramic layer comprising atoms of an antimicrobial metal selected from the group consisting of silver, copper, and zinc, and combinations thereof.

20. The antimicrobial medical device according to claim 19, wherein the ceramic layer comprises calcium phosphate.

21. The antimicrobial medical device according to claim 1, wherein the device is selected from an orthopedic implant and a neurosurgical implant.

23. The method according to claim 22, for making an antimicrobial medical device according to claim 1.

22. A method for making an antimicrobial medical device, said method comprising:

providing a substrate comprising a metal surface, said metal surface comprising atoms of at least one of a metal or metal alloy comprising one or more of stainless steel, cobalt, and titanium;

forming, on the metal surface, a first antimicrobial oxide layer comprising atoms of the metal or metal alloy and atoms of an antimicrobial metal selected from the group consisting of silver, copper, and zinc, and combinations thereof, the atoms of antimicrobial metal being present in the first antimicrobial oxide layer in a first concentration; and

forming, on the first antimicrobial oxide layer, positioned in a direction opposite that of the metal surface, a second antimicrobial oxide layer comprising atoms of an antimicrobial metal selected from the group consisting of silver, copper, and zinc, and combinations thereof, the atoms of antimicrobial metal being present in the second antimicrobial oxide layer in a second concentration,

wherein the first concentration is not equal to the second concentration.

24. The method according to claim 22, wherein the first antimicrobial oxide layer comprises silver atoms.

25. The method according to claim 22, wherein at least one of forming the first antimicrobial oxide layer and forming the second antimicrobial oxide layer comprises exposing at least a portion of the device to a solution comprising an antimicrobial metal selected from the group consisting of silver, copper, and zinc, and combinations thereof, or to an antimicrobial metal ion thereof

26. The method according to claim 25, wherein the solution comprises silver or silver ions.

27. The method according to claim 26, wherein the solution is an aqueous solution comprising [Ag(NH₃)₂]NO₃.

28. The method according to claim 22, wherein forming the first antimicrobial oxide layer comprises heat treating the metal surface, acid etching the metal surface, or electrochemically oxidizing the metal surface.

29. The method according to claim 22, wherein forming the first antimicrobial oxide layer comprises anodizing the metal surface.

30. The method according to claim 22, comprising forming on the metal surface a plurality of nanostructures, and wherein said first and second antimicrobial oxide layers are contained within the plurality of nanostructures.

31. The method according to claim 30, wherein the plurality of nanostructures are formed by anodization.

32. The method according to claim 22, comprising forming one or more additional antimicrobial oxide layers in addition to the first and second antimicrobial oxide layers.

33. The method according to claim 22, further comprising:

forming, on the first antimicrobial oxide layer, in a direction opposite that of that of the metal surface, and between the first and second antimicrobial oxide layers, an intermediate layer that does not comprise an antimicrobial metal selected from the group consisting of silver, copper, and zinc, and combinations thereof, such that said first and second antimicrobial oxide layers are distinct layers separated from one another by at least the intermediate layer.

34. The method according to claim 22, wherein the antimicrobial medical device is selected from an orthopedic implant and a neurosurgical implant.