System and method for attaching soft tissue to annodized metal implant

• US 8,399,008 B2
• Filed: 08/20/2009
• Issued: 03/19/2013
• Est. Priority Date: 11/12/2004
• Status: Active Grant

• Current Assignee: Purdue Research Foundation (The Trustees of Purdue University (d/b/a Purdue University))
• Original Assignee: Purdue Research Foundation (The Trustees of Purdue University (d/b/a Purdue University))
• Inventors: Webster, Thomas J., Perla, Venu
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US12/544,575
• Publication Number:
  US 20100178312A1
• Time in Patent Office: 1,307 Days
• Field of Search: None
• US Class Current: 424/423
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61F 2/30 Joints
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30064 Coating or prosthesis-covering structure made of biodegradable material
• CPC Class Codes: A61F 2002/3084 Nanostructures
• CPC Class Codes: A61F 2002/3092 having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/30929 having at least two superposed coatings
• CPC Class Codes: A61F 2002/3093 for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61F 2310/00982 Coating made of collagen
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2300/624 Nanocapsules
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 2400/18 : Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2430/02 : for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/04 : Metals or alloys
• CPC Class Codes: A61L 27/32 : Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• CPC Class Codes: A61L 27/50 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/022 : Metals or alloys
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 19/02 : for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/04 : for non-specific disorders of the connective tissue
• CPC Class Codes: C25D 11/02 : Anodisation
• CPC Class Codes: C25D 5/34 : Pretreatment of metallic surfaces to be electroplated
• CPC Class Codes: Y10T 428/24355 : Continuous and nonuniform or irregular surface on layer or component [e.g., roofing, etc.]

Abstract

One embodiment of the present invention is directed to compositions and methods for enhancing attachment of soft tissues to a metal prosthetic device. In one embodiment a construct is provided comprising a metal implant having a porous metal region, wherein said porous region exhibits a nano-textured surface, and a biocompatible polymer matrix coating the nano-textured surface. The polymer matrix coating comprises a naturally occurring extracellular matrix with biocompatible inorganic materials distributed within the matrix, or a biocompatible polymer and an osteoinductive agent.

Claims

1. A method of inducing the growth of fibrocartilage tissue and/or bone on a metal implant to enhance the attachment of the metal implant to a patient'"'"'s tissues, said method comprising

implanting said implant, comprising a metal surface displaying nanosurface roughness produced from anodization of the metal surface, in contact with said patient'"'"'s tissues to induce the growth of fibrocartilage tissue and/or bone on said metal implant.

2. The method of claim 1, wherein the anodization of the metal surface is performed by

pretreating the metal surface of said implant with an acid;

and

anodizing said pretreated metal surface at low voltage for at least 1 minute.

3. The method of claim 2, wherein the pretreated metal surface is anodized at low voltage for 1 to 5 minutes.

4. The method of claim 2, wherein the metal surface displaying nanosurface roughness comprises titanium or a titanium alloy, and wherein

said pretreating step comprises immersing the metallic implant and a cathode in an acidic electrolyte solution comprising hydrofluoric acid;

and

said anodizing step comprises applying an electrical potential between the metallic implant and the cathode.

5. The method of claim 4 wherein the electrical potential is about 20 volts that is maintained for 1, 3 or 5 minutes.

6. The method of claim 5 wherein the acidic electrolyte solution comprises 1% hydrofluoric acid.

7. The method of claim 5 wherein the acidic electrolyte solution comprises 1% hydrofluoric acid and 2% HNO₃.

8. The method of claim 1 wherein said metal surface displaying nanosurface roughness comprises a plurality of surface structures having an average height of from about 20 nm to about 200 nm.

9. The method of claim 8 wherein said surface structures have an average height of less than 100 nm.

10. The method of claim 8 wherein the distance between said surface structures ranges from about 25 nm to about 500 nm.

11. The method of claim 1 wherein said implant further comprises a calcified material layer coating the metal surface displaying nanosurface roughness.

12. The method of claim 11 wherein the calcified material layer comprises hydroxyapatite.

13. The method of claim 11 wherein the calcified material layer further comprises a bioactive agent.

14. The method of claim 13 wherein the bioactive agent is a therapeutic drug selected from the group consisting of antibiotics, antimicrobials, steroidal and non-steroidal analgesic and anti-inflammatory drugs, immune-suppressants and anti-cancer drugs.

15. The metallic implant of claim 13 wherein the bioactive agent is a growth factor.

16. A method of inducing the growth of fibrocartilage tissue and/or bone on a metal implant to enhance the attachment of the metal implant to a patient'"'"'s tissues, said method comprising

providing an implant comprising a metal component;

pretreating the metal component of said implant with an acid;

anodizing said pretreated metal component at low voltage for at least 1 minute; and

implanting the anodized implant in contact with said patient'"'"'s tissues, wherein said anodized implant comprises a metal component displaying nanosurface roughness produced from said anodizing step, to induce the growth of fibrocartilage tissue and/or bone on said metal implant.

17. The method of claim 16 wherein said metal component displaying nanosurface roughness comprises a plurality of surface structures having an average height of less than 100 nm.

18. The method of claim 17 wherein the distance between said surface structures ranges from about 25 nm to about 500 nm.

19. The method of claim 17 wherein said implant further comprises a calcified material layer coating the metal component displaying nanosurface roughness.

20. A method of inducing the growth of fibrocartilage tissue and/or bone on a metal implant to enhance the attachment of the metal implant to a patient'"'"'s tissues, said method comprising

providing an implant comprising a titanium or a titanium alloy;

pretreating the metal component of said implant by immersing the metallic implant and a cathode in an acidic electrolyte solution comprising hydrofluoric acid;

anodizing said pretreated metal component by applying an electrical potential between the metallic implant and the cathode; and

implanting the anodized implant in contact with said patient'"'"'s tissues, wherein said anodized implant comprises a metal component displaying nanosurface roughness produced from said anodizing step, to induce the growth of fibrocartilage tissue and/or bone on said metal implant.