Project Presentation

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• Project Presentation

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Content

• Aims
• Approach
• Problem statement expected breakthroughs
• Envisaged radical innovations
• Scientific technological objectives
• The Meddelcoat consortium
• Project structure co-operation
• Project work plan
• Project milestones
• Expected impact
• Administrative information contact

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Aims of the MEDDELCOAT project
To develop the next generations of
multifunctional bioactive biocompatible coatings
with biofilm inhibition and optimal implant
fixation, eliminating the currently experienced
need for implant revisions due to implant
loosening and infections.
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Approach of the MEDDELCOAT project
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.

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Problem statement expected breakthroughs
         
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Problem statement expected breakthroughs
         
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Envisaged radical innovations and major
breakthroughs

• Development of new substrate and coating
  materials with enhanced biocompatibility.
• Development of radically new or improvement of
  existing coating techniques for the processing of
  bioactive and biocompatible coatings with a
  graded interface (adhesion strength) and tailored
  porosity (bone in-growth).
• In-depth understanding of the implant
  substrate/coating/bone interfacial structure, the
  design, engineering and control for optimal
  implant fixation.
• Novel knowledge on interactions between new
  coating materials and bacteria and effective
  biofilm avoidance/elimination routes
• Evaluation of new biofilm inhibiting substances
• A formulation for the incorporation of
  anti-infective substances into the coating

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Scientific technological objectives
No Description
O1 The design and manufacturing of state-of-the-art dental, shoulder (glenoid and humeral bodies) and hip (stem and acetabular cup) implants suitable for the envisaged coating procedures. New substrates, such as nanostructured titanium-based alloys, will be developed and evaluated, aiming at a better biocompatibility compared to standard Ti6Al4V. The targeted E-modulus and fatigue strength of the new substrate material are respectively 100-120 GPa and 550 MPa.
O2 The development of bioactive glass (BAG), calcium phosphate and titania based precursors or powders for the processing of new bioactive coatings. The long-term fixation mechanism for the implant will be established by surface structuring or the deposition of porous Ti as an intermediate coating.
O3 Define guidelines for the microstructural, compositional, morphological and mechanical requirements for bioactive coatings with improved mechanical fixation (static coating adhesion strength gt 40 MPa) and biofilm inhibiting functionality. Definition of the selection criteria for the coating/substrate systems to be tested in vivo.
O4 To investigate the possibility to use state-of-the-art techniques such as plasma spraying to engineer the substrate-coating-bone interface in such a way to realise optimal implant fixation in combination with an additional bioactivity and biofilm inhibiting functionality. Nanocoatings deposited by combined metal and bioactive powder spraying will be investigated.
O5 The development of coating techniques which are radically new for implants such as electrophoretic deposition, selective laser sintering and structuring, dip-coating, plasma enhanced chemical vapour deposition and laser assisted microwave processing that would allow to engineer the substrate-coating-bone interface in such a way to realise optimal implant fixation in combination with osteointegration and biofilm inhibiting functionality.
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Scientific technological objectives
No Description
O6 Microstructural characterisation of the BAG, calcium phosphate and titania based advanced multi-functional substrate-coating systems.
O7 Mechanical characterisation of the BAG, calcium phosphate and titania based advanced multi-functional substrate-coating systems. The targeted adhesion strength is gt 20 MPa for calcium phosphates and BAG, and gt 40 MPa for porous Ti. The targeted adhesion strength for the multifunctional coating is 30 MPa
O8 Modelling of thermal residual stresses, thermal treatments and material stability to assist coating design and engineering.
O9 Study the importance of the composition and physicochemical properties of various substrate-coating systems produced by partners in the consortium on biofilm formation. Model micro-organism systems which closely simulate the in vivo or in situ conditions for each device will be used.
O10 To investigate and select the most suitable anti-microbial substances active during a reasonable and optimal period to reduce infection and biofilm formation to a minimum, and to investigate the impregnation and release of these selected anti-infectives from the new substrate-coating biomaterial systems in vitro.
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Scientific technological objectives
No Description
O11 The best anti-infective/biomaterial combination will be tested in the Fisher rat model to confirm the in vitro results to validate the biofilm reactor approach by means of in vivo studies carried out using a unique ex-germ-free Fisher rat model.
O12 Biocompatibility testing of cell cultures of powders, abrasion debris and substrate/coating systems to study the cytotoxicity of raw materials in an early stage of the project, and to evaluate the various substrate/coating systems and their abrasion debris to determine which are most relevant for bone regeneration and repair in order to select the most promising systems.
O13 In vitro bioactivity testing of coating/substrate systems to investigate the bioactivity and bioresorbability of the various coating-substrate systems with and without antibacterial substance, in order to evaluate their osteogenic potential and select the most promising systems for in vivo testing.
O14 In vivo testing of bone bonding of the multifunctional coating/substrate systems using an adult rabbit model
O15 Feasibility study of the upscaling of the coating technologies for the coating of implants
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MEDDELCOAT consortium
LEMI
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Project structure partner co-operation
Selection of implants
(LIMA, Helipro)
Selection of implants (WP1)
(LIMA, Heli Pro)
RTD-activities (WP1-WP5) all
Innovation-related activities (WP6) all
Demonstration activities (WP8) all
LIMA, Helipro,
LIMA, HeliPro, AALTO
Substrates powders (WP1)
Substrates powders
KUL
KUL-MTM, ALHENIA, UoB
ALHENIA, AMES,
Alhenia, AMES,
Coating and sintering technology
Coating and sintering technology (WP2)
KUL
-
MTM, UoB, IJS
KUL-MTM, UoB, IJS
IMMG, KUL
-
MTM,
IMMG, KUL
-
MTM,
Characterisation and evaluation
Characterisation and evaluation (WP2)
UoB, IJS
UoB, IJS
Training activities (WP7) all partners
Coating design Engineering (all partners)
Training activities (all partners)
LIMA, AALTO,
Coating design Engineering (WP2) all partners
Modelling
LIMA, HUT, KUL
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MTM, UoB
Modelling and finite element analysis (WP2)
KUL-MTM, UoB
KUL-REGA, HEMOTEQ
Bacteria
-
material interaction
KUL
-
REGA, OctoPlus
Bacteria
-
material interaction (WP3)
LEMI, HeliPro, IJS, KUL-MTM
Biocompatibility testing
Biocompatibility testing (WP4)
LEMI, Helipro, IJS, KUL
-
MTM
Upscaling feasibility (WP5)
all partners
Dissemination and exploitation (all partners)
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Project work plan overview
WP 3 Bacteria-coating interaction
Task 3.1 Bacteria-coating interaction
investigation Task 3.2 Selection and
incorporation of biofilm inhibitors Task 3.3
Evaluation of biofilm inhibiting coatings
WP 2 Coating of implants
Task 2.2 Coatings for implant fixation Task
2.3 Bioresorbable and bioactive coatings Task
2.4 Thermal treatments Task 2.5 Structural
characterisation of coating/substrate systems
Task 2.6 Mechanical characterisation of
coating/substrate systems Task 2.7 Modelling
and finite element analysis thermodynamic and
kinetic modelling
WP 1 Substrates bioactive powders
Task 1.1 Selection supply of substrates and
implants Task 1.2 Selection supply of
bioactive powders
Task 2.1 Coating engineering design
WP 4 Biocompatibility and activity testing
Task 4.1 Cell culture of powders and coated
implants Task 4.2 Bioactivity and
resorbability testing of coatings Task 4.3
In-vivo testing of bone bonding
WP 5 Upscaling feasibility WP 6 Innovation
related activities WP 7 Demonstration activities
WP 8 Training activities WP 9 Project management
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Project milestones
No Month Description
M0 0 Signed Consortium Agreement (All Partners)
M1 18 Supply of state-of-the-art dental and shoulder implants and hip stems and acetabular cups (HeliPro, LIMA)
M2 12 Development and supply of a range of bioactive powders (Alhenia, KUL-MTM, UoB)
M3 6 Initial composition definition of the graded Ti metal/bioactive material coating (All Partners)
M4 6 State-of-the-art vacuum plasma sprayed calcium phosphate and Ti HA coatings as a reference for biofilm formation investigation (WP 3), coating adhesion testing and biocompatibility and activity investigation (Alhenia)
M5 18 Supply of the first multi-functional (fixation bioactive) substrate-coating combination (KUL-MTM, IJS, UoB, Alhenia)
M6 24 Supply of the first generation of multi-functional (fixation bioactive) substrate-coating combination for each processing route (KUL-MTM, IJS, UoB, Alhenia)
M7 24 Microstructural characterisation of the vacuum plasma sprayed state-of-the-art coatings and the first advanced multi-functional substrate-coating systems (IJS, KUL-MTM, UoB).
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Project milestones
No Month Description
M8 30 Nanoscale microstructural characterisation of the vacuum plasma sprayed state-of-the-art coatings and the first generation of advanced multi-functional substrate-coating systems (IJS).
M9 24 Mechanical characterisation of the first generations of advanced multi-functional substrate-coating systems (IMMG).
M10 18 Micromechanical and finite element model for the evaluation of the thermal residual stresses and thermal treatments of the envisaged substrate/coating systems. (AALTO)
M11 24 Assessment of the physicochemical properties of biomaterials which limit the adherence of micro-organisms to the substrate, and hence, will avoid biofilm formation. (KUL-REGA)
M12 24 Knowledge on the best anti-infective/biomaterial combination and formulation for an efficient prophylactic and therapeutic action (KUL-REGA, HEMOTEQ)
M13 36 Biofilm inhibitor formulation (HEMOTEQ)
M14 45 Biofilm inhibiting coatings evaluated in vivo. (KUL-REGA)
M15 18 Evaluation of cytotoxicity testing of bioactive starting powders and substrates (LEMI)
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Project milestones
No Month Description
M16 30 Evaluation of cytotoxicity testing of the new coating-substrate systems (LEMI)
M17 36 Biocompatibility evaluation of the abrasion wear debris generated in the pin-on-flat tests (LEMI)
M18 24 In vitro bioactivity evaluation of state-of-the-art vacuum plasma sprayed and the first generations of multi-functional coating/substrate systems (LEMI, KUL-MTM).
M19 36 Evaluation of bioactivity testing of the substrate/coating systems (LEMI, KUL-MTM)
M20 45 Evaluation of bone bonding of the multifunctional substrate/coating systems (Heli- Pro, IJS, KUL-MTM)
M21 45 Feasibility study for a continuous microwave heating system for the coating of implants with different geometries (AMES)
M22 42 Feasibility study for the upscaling of the coating processing routes for implants with different geometry (KUL-MTM, IJS, UoB, Alhenia)
M23 24 Critical progress review milestone (all partners)
M24 36 Selection of the multifunctional substrate/coating systems for in vivo bone bonding testing (all Partners).
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Expected impact of the MEDDELCOAT project

• Community societal objectives
• The project aims at a drastic decrease of implant
  failures, concomitantly reducing the number of
  revisions, lowering the pain and suffer of the
  patients and decreasing the medical costs for
  patients and community.
• The implementation of highly reliable implants
  definitely improves the mobility and quality of
  live of those among us who need it because of
  age, illness or accident.
• SME-driven market ! Small and medium size
  companies together make up more than 80 of
  medical technology business entities. This
  industry contributes significantly to saving life
  and improving the quality of life of the citizens
  of Europe.
• SMEs are the main job creators of European
  industry. MEDDELCOAT will enhance the ability of
  the SMEs involved to improve their
  competitiveness, with an immediately positive
  effect in job creation.

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Expected impact of the MEDDELCOAT project

• Contribution to policy developments
• The project addresses the integration of
  nanotechnologies, material science and advanced
  technologies to improve health and quality of
  life of European citizens and creating wealth
  through novel knowledge-based and sustainable
  products (biomaterials) and processes (coatings).
  
• The project will contribute to a dynamic and
  competitive knowledge-based economy (Lisbon
  objective), sustainable development (Göteborg
  objective), and serves the needs of a traditional
  SME-intensive industrial sector.
• The project contributes to the ERA by focussing
  on nanotechnologies, intelligent materials and
  new production processes sustainable
  development genomics and biotechnology for
  health and citizens and governance in the
  European knowledge-based society (4 of the 7
  research priorities for Europe) and especially
  enhances the participation of SMEs in ERA.

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Expected impact of the MEDDELCOAT project

• Biomedical implants are knowledge-based products
  with high added value. At present, about 60 of
  the implant market in Europe is controlled by
  non-EU companies. The development of a
  technology, as envisaged in the IP-SME project,
  would give competitive advantage to European SMEs
  which is of high interest not only to conserve
  employment, but also to create new jobs in
  Europe.
• The proposed research is of strategic importance
  to the EU in view of the massive impact on market
  share which would result from the development of
  the envisaged biomaterials with multifunctional
  bioresorbable biocompatible coatings with biofilm
  inhibition and optimal implant fixation.

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Expected impact of the MEDDELCOAT project

• Gender issues
• The goal within this project is to reach a
  minimum of 25 of female researchers at the
  recruitment stage and encourage greater
  participation at senior level, which is
  significantly higher than the European average of
  15 for industrial research.
• Contribution to standards
• The activities related to the bacteria-material
  interaction investigation, the development and
  evaluation of coating integrated biofilm
  inhibitors, and biocompatibility testing will
  result in an active participation in European and
  international standardisation committees.

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Expected impact of the MEDDELCOAT project

• Economic impact
• The 80B medical device industry continues to
  grow at 9 per year, driven by the aging global
  population and medical advances.
• Less than 5 of the medical device market now
  utilizes surface modification technology of any
  kind. As the demand for better, more advanced
  biomaterials accelerates in step with scientific
  breakthroughs, the market for surface
  modification of existing medical devices is
  expected to grow at approximately 80-90 per year
  for the next 5 years, as the market adopts
  "intelligent" coatings.
• Early adopters will use the coatings to either
  improve device biocompatibility or reduce
  infection later generations of coatings could
  conceivably employ a nearly infinite array of
  therapeutic agents. We anticipate that
  "intelligent" coatings for medical devices and
  biologic implants will become the standard of
  care.

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Administrative information

• Project
• Type IP-SME
• Contract no. NMP3-CT-2006-02651
• www.meddelcoat.eu
• Project duration 01/10/2006 31/3/2011
• No. of person-months 674
• Budget
• Total project budget 4706 k
• EC funding 3300 k
• Project co-ordination K.U.Leuven RD (Leuven,
  Belgium)

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Contact

• For further information
• Visit www.meddelcoat.eu
• Project coordinator

Prof. Dr. ir. Jef VleugelsKatholieke
Universiteit LeuvenDepartement of Metallurgy and
Materials Engineering (MTM)Kasteelpark Arenberg
44, B-3001 Heverlee (Belgium)phone
32-16-321244, fax [phone] E-mail
Jozef.vleugels_at_mtm.kuleuven.be