Surgical implant

Patent metadata

Field	Value
Publication number	US-9283303-B2
Application number	US-201213486479-A
Country	US
Kind code	B2
Filing date	Jun 1, 2012
Priority date	Jun 3, 2011
Publication date	Mar 15, 2016
Grant date	Mar 15, 2016

Abstract

A surgical implant comprising: a substrate having an exterior surface and a plurality of layers disposed over the substrate exterior surface. The substrate comprises a polymeric material, and the plurality of layers comprises: an activated substrate surface layer; a valve metal layer; and a porous valve metal oxide layer, wherein the valve metal layer is disposed between the activated substrate layer and the porous valve metal oxide layer. The disclosure provides for a method for producing a polymeric surgical implant. The exterior substrate surface is treated by one or more processes comprising: plasma activation; electron beam irradiation; ultraviolet light; and low energy Ar+ ion beam irradiation; producing an activated substrate surface layer. A plurality of layers is applied over the activated substrate surface layer. The surface is converted by a spark-anodization process in an alkaline bath containing Ca and P ions into a layer of porous valve metal oxide.

First claim

We claim:

1. A surgical implant comprising:
a substrate having an exterior surface and a plurality of layers disposed over the substrate exterior surface, wherein the substrate comprises a polymeric material, and
wherein the plurality of layers comprises:
(i) an activated substrate surface layer;
(ii) a valve metal layer;
(iii) a porous valve metal oxide layer, wherein the valve metal layer is disposed between the activated substrate layer and the porous valve metal oxide layer and
a buffer layer, said buffer layer disposed between the activated substrate surface layer and the valve metal layer.

2. The surgical implant of claim 1 , wherein the polymeric material of the substrate is a thermopolymeric material.

3. The surgical implant of claim 1 , wherein the polymeric material is a polyaryletherketone (PAEK) material.

4. The surgical implant according to claim 3 , wherein the polyaryletherketone (PAEK) is independently selected from a group consisting of polyetherketone (PEK), polyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyetheretherketoneketone (PEEKK) and polyetherketoneetherketoneketone (PEKEKK).

5. The surgical implant according to claim 1 , wherein the valve metal layer is formed from a metal independently selected from the group consisting of titanium, tungsten, aluminum, hafnium, niobium, tantalum and zirconium.

6. The surgical implant according to claim 5 , wherein said porous valve metal oxide layer includes an amorphous calcium phosphate composition.

7. The surgical implant according to claim 1 , wherein the buffer layer comprises a plurality of alternating layers of a first material and a second material.

8. The surgical implant according to claim 7 , wherein the first material comprises a metal material and the second material comprises a nitride and/or a carbide of the metal material.

9. The surgical implant according to claim 8 , wherein the first material comprises Ti and Cr and the second material comprises a combination independently selected from the group consisting of TiN, CrN, TiC, CrC and mixtures thereof.

10. The surgical implant according to claim 1 , wherein each alternating layer has a thickness ranging from 10 nm to 100 nm.

11. The surgical implant according to claim 1 , wherein the buffer layer comprises a crystalline or amorphous material.

12. The surgical implant according to claim 11 , wherein the crystalline or amorphous material is independently selected from the group consisting of TiO 2 , Ta 2 O 5 , Nb 2 O 5 , ZrO 2 , SiO 2 , RuO 2 , or MoO 2 , MoO 3 , VO, VO 2 , V 2 O 3 , V 2 O 5 , CrO 2 O 3 , CrO 3 and combinations thereof.

13. The surgical implant according to claim 1 , wherein the buffer layer comprises a plurality of alternating layers of a first material, a second material and a third material.

14. The surgical implant according to claim 13 , wherein the first material is Ta 2 O 5 , the second material is AlN and the third material is Au.

15. The surgical implant according to claim 1 , wherein the buffer layer has a thickness ranging from 100 nm to 1000 nm.

16. The surgical implant according to claim 1 , wherein the substrate comprises a reinforced polyaryletherketone (PAEK).

17. The surgical implant according to claim 1 , wherein the plurality of layers substantially covers the substrate exterior surface.

18. The surgical implant according to claim 1 , wherein the porous valve metal oxide layer is coated with a silver salt layer.

19. The surgical implant according to claim 1 , wherein the substrate comprises a radiopaque material independently selected from the group consisting of Zr, ZrO 2 , ZnO, Ba, BaSO 4 , Ta, Ta 2 O 5 , Au, Nb, Nb 2 O 5 , Bi, Bi 2 O 3 and combinations thereof.

20. The surgical implant according to claim 1 , wherein the plurality of layers further comprises a polysilane layer disposed between the activated substrate surface layer and the valve metal layer.

21. The surgical implant according to claim 1 , wherein said plurality of layers further comprises a conductive layer formed from a conductive, non-oxidizable metal.

22. The surgical implant according to claim 21 , wherein the conductive, non-oxidizable metal is independently selected from the group consisting of Au, Pt, Pd and combinations thereof.

23. The surgical implant according to claim 22 , wherein the conductive layer has a thickness ranging from 100 nm to 1000 nm.

24. The surgical implant according to claim 1 , having a shape independently selected from the group consisting of: screw, pin, rods plates nails bone anchors cable ties plate with pyramids or spikes or keels, anatomical 3D plate, complex bone replacement structure, and scaffold.

25. The surgical implant according to claim 1 , wherein the porous valve metal oxide layer has pores with sizes ranging from about 0.1 μm to about 10 μm; and a pore density ranging from: about 10,000 pores/mm2 to about 500,000 pores/mm2.

26. A surgical implant comprising:
a substrate having an exterior surface and a plurality of layers disposed over the substrate exterior surface, wherein the substrate comprises a polymeric material, and
wherein the plurality of layers comprises:
(i) an activated substrate surface layer;
(ii) a valve metal layer;
(iii) a porous valve metal oxide layer, wherein the valve metal layer is disposed between the activated substrate layer and the porous valve metal oxide layer; and wherein the porous valve metal oxide layer is coated with a silver salt layer.

27. The surgical implant of claim 26 , wherein the polymeric material of the substrate is a thermopolymeric material.

28. The surgical implant of claim 26 , wherein the polymeric material is a polyaryletherketone (PAEK) material.

29. The surgical implant according to claim 28 , wherein the polyaryletherketone (PAEK) is independently selected from a group consisting of polyetherketone (PEK), polyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyetheretherketoneketone (PEEKK) and polyetherketoneetherketoneketone (PEKEKK).

30. The surgical implant according to claim 26 , wherein the valve metal layer is formed from a metal independently selected from the group consisting of titanium, tungsten, aluminum, hafnium, niobium, tantalum and zirconium.

31. The surgical implant according to claim 30 , wherein said porous valve metal oxide layer includes an amorphous calcium phosphate composition.

32. The surgical implant according to claim 26 , further comprising
a buffer layer, said buffer layer disposed between the activated substrate surface layer and the valve metal layer.

33. The surgical implant according to claim 32 , wherein the buffer layer comprises a plurality of alternating layers of a first material and a second material.

34. The surgical implant according to claim 33 , wherein the first material comprises a metal material and the second material comprises a nitride and/or a carbide of the metal material.

35. The surgical implant according to claim 34 , wherein the first material comprises Ti and Cr and the second material comprises a combination independently selected from the group consisting of TiN, CrN, TiC, CrC and mixtures thereof.

36. The surgical implant according to claim 32 , wherein the buffer layer comprises a c

Assignees

• Voisard Cyril
• Gédet Philippe
• Bouduban Nicolas
• Depuy Synthes Products Inc

Inventors

• Voisard Cyril
• Gédet Philippe
• Bouduban Nicolas

Classifications

• A61L27/18 Primary

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds · CPC title

• A61L2430/02

  for reconstruction of bones; weight-bearing implants · CPC title

• A61L31/18

  Materials at least partially X-ray or laser opaque · CPC title

• A61L31/088

  Other specific inorganic materials not covered by A61L31/084 or A61L31/086 · CPC title

• A61L2430/20

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