Implant with composite coating

• US 7,445,640 B2
• Filed: 01/10/2006
• Issued: 11/04/2008
• Est. Priority Date: 05/14/1998
• Status: Expired due to Fees

• Current Assignee: Shalby Advanced Technologies, Inc. (Shalby Ltd.)
• Original Assignee: Hayes Medical Incorporated
• Inventors: Despres, Alfred S. III, Aharonov, Robert R., Elwood, Eugene J., Ehlers, Peter, Andersen, Knut
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/329,273
• Publication Number:
  US 20060178751A1
• Time in Patent Office: 1,029 Days
• Field of Search: 623 2336- 2353, 623/11.11, 623/16.11, 427 236- 237, 427 21- 231, 427 226- 227, 523/22.36
• US Class Current: 623/23.53
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/3662 Femoral shafts
• CPC Class Codes: A61F 2/367 Proximal or metaphyseal parts of shafts trochanteric devices connected to said proximal parts A61F2/30739
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2002/30016 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2002/30906 shot- sand- or grit-blasted
• CPC Class Codes: A61F 2002/30925 etched
• CPC Class Codes: A61F 2002/30929 having at least two superposed coatings
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2002/3097 using laser
• CPC Class Codes: A61F 2002/3611 Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2002/3625 Necks
• CPC Class Codes: A61F 2002/3631 with an integral complete or partial peripheral collar or bearing shoulder at its base
• CPC Class Codes: A61F 2002/365 Connections of heads to necks
• CPC Class Codes: A61F 2250/0019 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00131 : Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00407 : Coating made of titanium or of Ti-based alloys
• CPC Class Codes: A61F 2310/00485 : Coating made of zirconium or Zr-based alloys
• CPC Class Codes: A61F 2310/00491 : Coating made of niobium or Nb-based alloys
• CPC Class Codes: A61F 2310/00538 : Coating made of hafnium or Hf-based alloys
• CPC Class Codes: A61F 2310/00544 : Coating made of tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00574 : Coating or prosthesis-covering structure made of carbon, e.g. of pyrocarbon
• CPC Class Codes: A61F 2310/0058 : Coating made of diamond or of diamond-like carbon DLC
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: A61L 27/306 : Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61P 19/00 : Drugs for skeletal disorders

Abstract

Systems and methods are described for implants with composite coatings to promote tissue in-growth and/or on-growth. An implant includes: a substrate; a structured surface formed on at least a portion of the substrate; and a biocompatible coating deposited on at least a fraction of the structured surface. The systems and methods provide advantages in that the implant has good biocompatibility while the biocompatible coating has good strength.

Claims

1. An osteoconductive process comprising:

providing an implant comprising;

a substrate;

a structured surface formed on at least a portion of the substrate, the structured surface being of the same material as the substrate; and

a biocompatible coating deposited by a selected one of (i) arc evaporation physical vapor deposition and (ii) chemical vapor deposition on at least a fraction of the structured surface, the coating being softer and more biocompatible than the substrate and the structured surface;

testing for the presence of high adhesion between the coating and the structured surface; and

contacting a bone under in vivo conditions with the implant.

2. An osteoconductive process-comprising:

providing a composition for an implant, the composition comprising a biocompatible material coated by a selected one of (i) arc evaporation physical vapor deposition and (ii) chemical vapor deposition on a structured surface defined by a substrate, the coating being softer and more biocompatible than the substrate and the structured surface;

testing for the presence of high adhesion between the coating and the structured surface, and

contacting a bone under in vivo conditions with the composition.

3. A method for orthopedic surgery which comprises:

providing an implant comprising;

a substrate;

a structured surface formed on a portion of the substrate, the structured surface being of the same material as the substrate; and

a biocompatible coating deposited by a selected one of (i) arc evaporation physical vapor deposition and (ii) chemical vapor deposition on at least a fraction of the structured surface, the coating being softer and more biocompatible than the substrate and the structured surface;

testing for the presence of high adhesion between the coating and the structured surface; and

contacting a bone under in vivo conditions with the implant;

wherein the portion of the substrate is fixed with at least one of tissue in-growth and tissue on-growth for stability.

4. An osteoconductive process comprising:

providing an implant, the implant comprising;

a substrate;

a structured surface formed on a portion of the substrate, the structured surface being of the same material as the substrate; and

a biocompatible coating deposited by a selected one of (i) arc evaporation physical vapor deposition and (ii) chemical vapor deposition on at least a fraction of the structured surface, the coating being softer and more biocompatible than the substrate and the structured surface;

testing for the presence of high adhesion between the coating and the structured surface; and

contacting a bone under in vivo conditions with the implant;

wherein the portion of the substrate is fixed with a selected one of tissue in-growth and tissue on-growth for stability.

5. A method of forming a composite coating, the method comprising:

depositing a biocompatible coating on a structured surface that comprises at least a portion of a surface area of a substrate;

wherein depositing the biocompatible coating includes depositing a coating that is more biocompatible than the structured surface;

wherein depositing the biocompatible coating includes depositing a coating that is softer than the structured surface.

6. The method of forming a composite coating according to claim 5, further comprising:

covering the portion of the surface area of the substrate with a mixture including a plurality of particles, the plurality of particles including a first material; and

sintering the plurality of particles to produce a porous structure;

wherein the biocompatible coating includes a second material that is different from the first material.

7. The method of claim 5, wherein depositing the biocompatible coating includes depositing a coating that is more biocompatible than the substrate.

8. The method of claim 5, wherein depositing the biocompatible coating includes depositing a coating that is softer than the substrate.

9. The method of claim 5, wherein the depositing of the biocompatible coating includes forming the biocompatible coating by a thin film technique.

10. The method of claim 9, wherein the thin film technique includes at least one deposition process selected from the group consisting of physical vapor deposition and chemical vapor deposition.

11. The method of claim 5, further comprising, before the step of depositing the biocompatible coating, forming a plurality of undercuts in the structured surface, and wherein depositing the biocompatible coating includes coating the plurality of undercuts in the structured surface.

12. The method of claim 11, wherein forming a plurality of undercuts includes forming interconnected pores beneath the structured surface, and wherein depositing the biocompatible coating includes coating the interconnected pores.

13. The method of claim 5, further comprising, before the step of depositing a biocompatible coating, providing the substrate with at least one material selected from the group consisting of carbon-composite, stainless steel, cobalt-chromium, titanium alloy, tantalum, and ceramic.

14. The method of claim 5, further comprising, before the step of depositing a biocompatible coating, providing the structured surface with a material that includes a plurality of particles that are sintered together to form a continuous porous phase.

15. The method of claim 5, further comprising, before the step of depositing a biocompatible coating, preparing the structured surface by at least one method selected from the group consisting of sintering, flame spraying, acid etching, grit blasting, casting-in, forging-in, laser texturing, and micromachining.

16. The method of claim 5, wherein depositing the biocompatible coating includes depositing at least one material selected from the group consisting of titanium, tantalum, carbon, calcium phosphate, zirconium, niobium, hafnium, hydroxyapatite, and tissue in-growth and/or on-growth facilitating proteins.

17. The method of claim 5, wherein depositing the biocompatible coating includes depositing multi-layers.

18. The method of claim 17, wherein depositing the biocompatible coating includes depositing nano-layers.

19. The method of claim 5, further comprising, after the step of depositing a biocompatible coating, treating another portion of the surface area with ion bombardment.