Multi-functional bioresorbable coatings with biofilm inhibition and optimal implant fixation

Project n NMP3-CT-2006-026501

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The MEDDELCOAT consortium

Project coordinator Industry (SME) Research

LEMI

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Outline
1. Objectives 2. State-of-the-art 3. Innovative substrate materials 4. Innovative coating techniques 5. Advanced characterisation 6. Contact

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1. Objectives
Combinatorial approach: Design and engineer the structure of the implant surface to optimise implant fixation by osteointegration, Promote osteointegration by the application of a bioactive top coating, Incorporate a biofilm formation inhibiting function into the coating. Development of innovative, multi-functional bioactive and anti-inflammatory coatings on Ti6Al4V
Open porosity Metal Bioactive and/or biofilm inhibiting coating Porous coating (Ti + bioactive coating) Implant material (Ti or Ti6Al4V)

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1. Objectives
The project focused on acetabular cups, glenoids and humeral bodies of inverse shoulder implants and dental implants provided by LIMA and HeliPro.

Glenoid

Humeral body

Targeted coating: Porous Bioactive 5 Biofilm inhibiting

Targeted coating: Bioactive Biofilm inhibiting

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2. State-of-the-art
State-of-the-art vacuum plasma sprayed coatings were used as a reference throughout the project. This technique is commercially applied by Alhenia, a leading provider of medical instruments and implants.

500 m

500 m

State-of-the-art Ti vacuum plasma sprayed cup (left), cross-sectional view (middle) and top view (right)

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2. State-of-the-art
An increased surface roughness improves the implant stability, but also increases the risk of biofilm formation. Viable cells (green) tend to spread throughout the porous coating.
SEM top view (left) and CSLM cross-sectional (right) image of staphylococcal biofilm formation on a VPS Ti surface

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3. Innovative substrate materials

A new biomedical grade titanium alloy was developed with advantageous microstructure, excellent biocompatibility, and without aluminium or vanadium!
Negative control TNZ(X)

CSLM top view of human osteogenic cells on a TNZ(X) surface showing enhanced in vitro cell adhesion and proliferation Nanostructured TNZ(X) 8
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4. Innovative coating techniques

Electrophoretic deposition (EPD) EPD of particle stabilised emulsions and/or suspensions followed by classical vacuum sintering or vacuum microwave sintering creates a porous Ti mask with an average porosity of 50% and pores ranging from 10-60 m, improving mechanical interlocking, i.e. biological implant fixation.

100 m

100 m

Porous Ti coating on dental screw and Ti6Al4V cup 9

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4. Innovative coating techniques

Electrophoretic deposition (EPD) EPD of particle stabilised emulsions and/or suspensions followed by classical vacuum sintering or vacuum microwave sintering creates a porous Ti mask with an average porosity of 50% and pores ranging from 10-60 m, improving mechanical interlocking, i.e. biological implant fixation.

100 m

10

SEM image and EDX compositional analysis of the bone ingrowth in a porous Ti coating

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4. Innovative coating techniques

Electrophoretic deposition (EPD) Additional application of bioactive glass enhances the bioactive fixation of the implant

100 m

Hybrid microwave furnace for vacuum sintering (10-6mbar) of Ti alloys

100 m

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Bioactive glass coating on a Ti6Al4V humeral body (left) and Ti dental implant (middle)
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4. Innovative coating techniques

Hydrothermal treatment Provides a bioactive TiO2 layer, which promotes HAp formation, exhibits a photocatalytic effect enabling sterilisation by UV-light and prevents leaching of metal ions into the body.

Hydrothermally treated dental Ti implant

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4. Innovative coating techniques

Micro-arc oxidation (MAO) Creates a titania-based amorphous coating with incorporated calcium phosphates, which acts as a biocompatible top coating for implants with a porous Ti layer for cementless fixation. The highly hydrophylic nature of the coating reduces biofilm formation.

MAO coated cups

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4. Innovative coating techniques

Sol-gel synthesis Sol-gel synthesis of bioactive glass enables coating the internal surface of a porous Ti coating without filling the voids completely (left). As an alternative, the porous structure can be infiltrated with bioactive glass prepared by the particulate sol-gel method (right).

20 m

100 m

SEM images of VPS Ti surfaces impregnated with bioactive glass

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4. Innovative coating techniques

Spraying of anti-microbial coatings An active anti-microbial coating, which releases an antibiotic drug during more than 2 weeks, was sprayed on top to avoid infection and biofilm formation.

SEM image of a VPS Ti surface with anti-microbial coating Submicron CT images of a VPS Ti surface without (left) and with an additional anti-microbial coating (right) revealing no difference in bone ingrowth

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5. Advanced characterisation
Microbial interaction Microbial interaction results in biofilm formation and thus difficult to treat biomaterial-related infections. The influence of various substratecoating systems on biofilm formation was studied. The importance of the composition and physico-chemical properties of the coating like roughness, porosity, interconnective pore channel size and hydrophobicity were analysed.

5 m

1m

SEM pictures of Staphylococcus epidermidis cells adhering on a Ti coating and formation of biofilm

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5. Advanced characterisation
Mechanical characterisation of coating-substrates Constant Depth scratch procedure to measure the shear adhesion stress along thick substrate-coating interfaces (> 30 m). For thin coatings (< 5 m), AFM was successfully incorporated and combined with a mathematical model correlating the force deformation components.

Scratch head with integrated load cell Diaphragm load cell Platform head Specimen

Scratch test setup (left) and micrograph of a scratched specimen (right)

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5. Advanced characterisation
In vitro and in vivo evaluation In vitro evaluation to investigate the biocompatibility and cell/material interactions of powders and various substrate-coating systems to evaluate the osteogenic potential. A short and long term in vivo study was performed, to evaluate the bone response of porous Ti coatings combined with different bioactive and anti-microbial coatings.
Collagen type I expression

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27 days

Gene expression and cytoskeleton and focal adhesion study of human osteogenic cells on a porous Ti coating

Light microscopic image of a stained histological section after 4 weeks of implantation and nano-CT scan of a VPS-Ti coated implant after 12 weeks of implantation showing bone ingrowth

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6. Contact
For further information: Visit www.meddelcoat.eu
Prof. Dr. Ir. Jef Vleugels Katholieke Universiteit Leuven Department of Metallurgy and Materials Engineering (MTM) Kasteelpark Arenberg 44, B-3001 Heverlee (Belgium) Phone: +32 16 32 12 44 Fax: +32 16 32 19 92 E-mail: jozef.vleugels@mtm.kuleuven.be

Project coordinator

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