Osseointegration and biointegration coatings for bone screw implants

• US 9,095,391 B2
• Filed: 06/11/2008
• Issued: 08/04/2015
• Est. Priority Date: 06/11/2007
• Status: Active Grant

• Current Assignee: Aeolin, LLC
• Original Assignee: Aeolin, LLC
• Inventors: McKinley, Laurence M.
• Primary Examiner(s): SEVILLA, CHRISTIAN ANTHONY
• Application Number:
  US12/137,043
• Publication Number:
  US 20080306554A1
• Time in Patent Office: 2,610 Days
• Field of Search: 606/76
• US Class Current: 1/1
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 17/8605 Heads, i.e. proximal ends projecting from bone
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2002/30067 Coating or prosthesis-covering structure made of thermoplastic material
• CPC Class Codes: A61F 2310/00395 Coating or prosthesis-covering structure made of metals or of alloys
• CPC Class Codes: A61F 2310/00407 Coating made of titanium or of Ti-based alloys
• CPC Class Codes: A61F 2310/0052 Coating made of silver or Ag-based alloys
• CPC Class Codes: A61F 2310/00592 Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
• CPC Class Codes: A61F 2310/00598 Coating or prosthesis-covering structure made of compounds based on metal oxides or hydroxides
• CPC Class Codes: A61F 2310/00616 Coating made of titanium oxide or hydroxides
• CPC Class Codes: A61F 2310/0073 Coating or prosthesis-covering structure made of compounds based on metal carbides
• 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 2310/0085 Coating or prosthesis-covering structure made of compounds based on metal chlorides
• CPC Class Codes: A61F 2310/00856 Coating or prosthesis-covering structure made of compounds based on metal nitrides
• CPC Class Codes: A61F 2310/00928 Coating or prosthesis-covering structure made of glass or of glass-containing compounds, e.g. of bioglass
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 31/08 Materials for coatings

Abstract

Novel orthopaedic bone screws/spinal pedicle screws and implants that include coatings to help promote a structurally stable interface between the implant and the patient'"'"'s bone/tissue, and methods of coating such screws and implants are provided. The implants and methodologies described involve at least a coating that facilitates osseous integration, and additionally at least one coating that either reduces the risk of infection in immunologically suppressed patients and/or for utilization in patients who have infection, but who require stabilization, or coatings that permit the use of dissimilar metals and prevent galvanic corrosive reactions.

Claims

1. An implant screw for permanent use in a patient comprising:

an elongated shafted having a threaded portion for engaging a bone of the patient disposed along a distal portion thereof, an exposed head portion disposed at a proximal end thereof, and a fixture engaging portion disposed between said threaded portion and said exposed head portion;

a porous and non-dissolvable biomimetic coating disposed on at least the portion of the thread configured to engage a bone, the biomimetic coating forming a non-dissolving interfacial binding region between the implant screw and the bone, said interfacial binding region comprising at least the biomimetic coating and bone;

a dielectric coating disposed on at least the exposed head portion and the fixture engaging portion of the implant screw, the dielectric coating insulating the implant from secondary corrosive currents; and

an infection preventative material, selected from one or all of an antimicrobial, an antibacterial or an antiseptic material, such infection preventative material being incorporated into at least the biomimetic coating, said infection preventative material continuously releasing a dose of an infection preventative material above a minimum inhibitory concentration into a region immediately adjacent said implant.

2. The implant screw of claim 1, wherein the infection preventative material is incorporated into both the biomimetic and dielectric coatings.

3. The implant screw of claim 1, wherein the infection preventative material is incorporated into a biodegradable polymer.

4. The implant screw of claim 3, wherein the biodegradable polymer is selected from the group consisting of PLA, PLLA, PDLLA, PGA, phosphate PLA, and PLGA.

5. The implant screw of claim 1, wherein the infection preventative material is selected from the group consisting of acidic antibiotics, and fibrinolytic agents.

6. The implant screw of claim 5, wherein the infection preventative material is an acidic antibiotic selected from the group consisting of fucidin, rifampin, amoxicillin, cephamandol, gentamicin, tobramycin, carbenicillin, cephalothin, and vancomycin.

7. The implant screw of claim 5, wherein the infection preventative material further comprises an ionic silver material selected from the group consisting of metallic silver, silver chlorides, silver oxides or silver nitrates.

8. The implant screw of claim 7, wherein the ionic silver material has a concentration of at least 10,000 parts per million.

9. The implant screw of claim 5, wherein the infection preventative material is a fibrinolytic agent selected from the group consisting of heparin, urokinase-heparin and fibronectin.

10. The implant screw of claim 1, wherein the infection preventative material is a carboxy containing antibiotic.

11. The implant screw of claim 1, wherein the infection preventative material is an antiseptic selected from one of either octenidine or irgasan.

12. The implant screw of claim 1, wherein the biomimetic coating comprises at least a material that is one of either an osteoconductive or osteoinductive substance.

13. The implant screw of claim 12, wherein the biomimetic coating is selected from the group consisting of ceramics, glass ceramics, apatites, plastics, plasmified titaniums, titanium oxides, fluorine, metals, porous metals, metal oxides, metal halides, carbonitrides and calcium phosphates.

14. The implant screw of claim 13, wherein the biomimetic coating is a calcium phosphate material selected from the group consisting of dicalcium phosphates, dihydrates, dihydrides, octacalcium phosphates, beta-tricalcium phosphates, hydroxyapatites, tetracalcium phosphates and monoxides.

15. The implant screw of claim 14, wherein the biomimetic coating is a hydroxyapatite with calcium/phosphorus ratio of about 1.67.

16. The implant screw of claim 12, wherein the biomimetic coating is an apatite material selected from the group consisting of fluoroapatite, crystalline oxyapatite, beta-wollastonite and beta-whitlockite.

17. The implant screw of claim 1, wherein the dielectric material coating disposed thereon is selected from the group consisting of titanium oxide and Parylene.

18. The implant screw of claim 1, wherein at least a portion of an outer surface of the implant screw is treated in accordance with a method selected from the group consisting of laser radiating, electron radiation, shot peening, micro texturing, ion implantation, roughening, degreasing and deburring.

19. The implant screw of claim 1, wherein at least a portion of at least the exposed head is configured to engage a separate metal component, and wherein the portion of the exposed head configured to engage a separate metal component has a dielectric coating disposed thereon.