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Bioceramics activity in the partner regions of Euroceram
1. Biomaterials activities in Tampere region

1.1. Finn-Medi Biocluster

Bioceramics activity in the Tampere Region is part of a larger « biocluster » in the region. The « Finn-Medi » cluster is a pool of medical research and healthcare technology experts and is composed of the following sectors:

1. Research and Education: Hospitals, Universities, Research Centres and Healthcare Institutes (~ 1,000 persons).
2. Product Manufacturers and Service Providers: approx. 50 companies (1,100 persons).
3. Users of Services and Products: representing approx. 10,000 persons.

Finn-Medi Research Ltd. is jointly owned by a number of health, research and local authority bodies. Its role is to merge new medical knowledge and technical expertise with financing and customer’s needs to develop products and technology. Within the biocluster, Finn-Medi Research is responsible for start-ups, commercialisation, R&D services, and the development of innovation and technology transfer systems.

1.2. Biomaterials industry in the region

Three companies in Tampere are active in the field of bioceramics/biomaterials.

Bionx Implants Ltd. is a worldwide leading developer and manufacturer of bioabsorbable surgical implants. The technology base of the company is bioabsorbable polymers, ceramics and their composites, proprietary self-reinforcing technology, and over 150 worldwide patents. The company has commercial and/or clinical R&D products for orthopaedics and sports surgery, for craniomaxillofacial, thoracic, spinal and neurosurgery, for urology and also for tissue engineering. The company has a staff of 90 in Finland with 98% of production for export (60% to the US). Facilities in Tampere include implant manufacturing in clean room conditions and product development.

Inion Ltd. was established in 1999 to develop and manufacture biomaterial based medical devices. The initial target market is craniomaxillofacial (CMF) surgery (launch 2001), followed by orthopaedic surgery, spinal and neurosurgery, as well as hand surgery. The materials of choice are biopolymers and bioceramics, or composites of the two.

Carbogem Oy develops and produces glassy carbon products by carbonisation from a polymer resin. The products include different shapes with the following tailored features and properties: (a) bioinert and chemically stable, (b) variable density, (c) inherent porosity with pores sizes from 0.6 to 8 nm, (d) structures with larger porosity from a few nanometers to micrometers, porosity gradients can be also be constructed, (e) mechanically strong materials.

1.3. Biomaterials research in the Tampere University of Technology

Biomaterial research in the TUT (Tampere University of Technologies) is carried out in the Institute of Biomaterials, the Institute of Materials Science and the Institute of Textile and Fiber Technologies.

Basic research in the Institute of Biomaterials concentrates on the synthesis, structural studies and properties of polymeric and composite biomaterials. Applied research is focussed on the processing technologies of these materials and their interactions with living cells and tissues. Product development is carried out on bioabsorbable surgical implants, surgical instruments and bioabsorbable polymeric drug-release systems. Currently the most important research projects are :

  • Self-reinforcing of bioabsorbable amorphous and partially crystalline polymers with solid state deformation.
  • Processing studies of bioabsorbable polymers.
  • Development of composites of bioabsorbable polymers and bioactive glass fillers and fiber reinforcements.
  • Development of novel bioabsorbable implants for bone to bone and soft tissue to bone fixation.
  • Development of bioabsorbable, self-expanding stents for urological and gastro-enterological applications.
  • The Institute of Materials Science has been involved in bioceramics research projects such as the development, processing and surface modification of porous ceramic structures, thermal spraying of bioglass and HAP, and PVD coatings for dental implants.

    2. Bioceramics activities in the Valencia Region

    2.1. Biomaterials Industry in the Valencia Region

    Two companies in the region, which manufacture metallic orthopaedic prosthesis coat some of their products with zirconia or hydroxyapatite ceramics using thermal spraying.

    Industrias Quirurgicas De Levante, S.L. located near Valencia employs over 100 personnel. The company forms part of the Biomet-Merck Group and manufactures a range of orthopaedic and trauma products including alumina-alumina hip systems and zirconia femoral heads.

    2.2. Biomaterials Research in the Valencia Region

    The Institute of Biomechanics of Valencia (IBV) is a non-profit association interested in the development of biomechanics. The IBV has a staff of 68 persons within three research groups (Medical, Sports and Occupational). Research on Orthopaedic Implants is carried out within the Institute. The IBV presents a complete technological and scientific offer to private and public companies and entities with the purpose of improving competitiveness, innovation and diversification of the different sectors of the industry.

    3. Bioceramics activities in Centro Region

    Bioceramics Research in the Centro Region

    Research on bioceramics is carried out at the Ceramic Materials Research Unit (U.I.M.C) at the University of Aveiro. Currently the most important research projects are:

    1. Development of bioglasses and bioglass-ceramics. Glasses in the CaO-MgO-P2O5-SiO2 system have promise for incorporation in polymer matrices to increase bioactivity and control the elastic constant and are machinable.

    2. Mineralisation of calcium phosphates (substituted HAP and HAP-TCP compositions) in vitro. Use of the natural hydrogen-carbonate buffer (instead of the common tris) remarkably increases the mineralisation kinetics. Microelectrode techniques for monitoring local H+ and Ca2+ concentrations are being developed.

    3. Development of metal-ceramic systems for biomedical applications. (i) bioactive glass-coated Ti for implant anchoring and (ii) bulk Ti-ZrO2 joints (brazed) for the encapsulation of RF-emitting diagnostic circuitry with the goal of substituting commercial brazing alloys by more biocompatible materials.

    4. Processing of HAP-Al2O3 composites by direct coagulation casting.

    5. Optimisation of the conditions of sol-gel synthesis of HAP-Al2O3 composites.

    6. Polymer – HAP composites. Production of nanosized HAP particles to coat the surfaces of interconnected macropores of a polymer. A composite with a porosity gradient in the ceramic phase can be produced.

    4. Bioceramics activities in Limousin Region

    4.1. Bioceramics Industry in the Limousin Region

    M.I.L. (Matériels Implants Limousin) a subsidiary of Crystal, a company which specialises in the distribution of orthopaedic implants and surgical material, is located at the high-tech Limoges Technopole and employs 45 persons. Drawing on the expertise available in the region, the company has developed a range of innovative orthopaedic implants based on advanced methods of ceramisation including plasma, PVD, electrophoresis.

    Traditional Implants

    Although metals are the materials most frequently used for orthopaedic implants, their use is not without problems such as wear, reaction of wear debris with bodily fluids and implant loosening. Ceramic femoral heads (alumina or zirconia) have been on the market for 15 years, but they have not always lived up to their initial promise in terms of reliability. Currently, although all companies offer such heads, only a third of the heads manufactured are ceramic (250,000 units approximately).

    MIL has focussed on marrying the biochemical qualities of ceramics to the mechanical properties of metals through ceramisation of metals. Currently, MIL is the only manufacturer with a range of ceramised implants, all with the CE marking. The company have retained the exclusive exploitation rights of two ceramisation processes for medical applications:

    Carbioceram, PVD technology (all implants)
    Plasmaceram, plasma spraying technology (for friction couples).

    Spinal Column and Bone Substitutes

    New requirements have appeared in the orthopaedic market: spinal column and bone substitutes have allowed bone grafts to be avoided. The available bone substitutes (TCP and HAP) are degradable meaning that bone reconstruction cannot be perfect. MIL produce, under the tradename Ceramil, a range of porous ceramic implants without any human or animal origin which can be recolonised by bone and which is non degradable. These products have generated significant interest from surgeons.

    Some other companies in the region involved in bioceramics include Sorevi, which employs 30 persons and specialises in surface treatment and coatings and Finimetaux, which employs 15 and specialises in cold surface treatment.

    4.2. Bioceramics Research in the Limousin Region

    The « Science des Procédés Céramiques et Traitements de Surface » laboratory at the University of Limoges has researched the field of bioceramics, particularly calcium phosphates (HAP and TCP), for over 12 years.

    Mechanical reinforcement of hydroxyapatite with Al2O3 platelets. The toughness of composites, prepared by slip casting and densified by pressure sintering, depended on the orientation of the stress and in the best case (30% Al2O3), toughness was increased from 1 to > 4 MPa.m½.

    Fabrication of HAP-TCP composites. The synthesis and the chemical and mechanical characterisation of calcium phosphates (general formula Ca10-x(HPO4)x(PO4)6-x(OH)2-x) of Ca/P ratio between 1.50 and 1.71 has been studied. The flexural strength depended strongly on the Ca/P ratio and on the sintering temperature. After sintering the materials contained a mixture of HAP-TCP. The flexural strength increased from 75 MPa for stoichiometric HAP (Ca/P = 1.66) to > 150 MPa for Ca/P = 1.65, which had a b-TCP content of 7.5%.

    Speed of proliferation and differentiation of human trabecular osteoblasts on HAP with or without carbonate ions. Results underline the important role of the carbonate ions and of the surface energy of the material in the adhesion processes. Biocompatibility was measured by the reaction of HAP powder and human synoviocytes.

    Planned future studies include the synthesis, sintering and mechanical properties of TCP and carbonated apatite. Finally the superficial grafting of materials is envisaged.

    These studies were developed through collaborations with: M. Almeida (Aveiro, Portugal), J.L. Beneytout (Limoges), E. Brès (Lille), J. Cournot (Paris), H.J. Kleebe (Colorado, USA), P. Marie (Paris), M. Nardin (Mulhouse), C. Rey (Toulouse), L. Sedel (Paris). For further information contact Didier Bernache-Assollant or Eric Champion.

    5. Bioceramics activities in Shannon Region

    5.1. Bioceramics Industry in the Shannon Region

    Stryker Corporation, a publicly quoted US healthcare company, is a worldwide leader in the medical industry and designs and develops a wide range of surgical and medical products to restore and repair bones and tissues that have deteriorated through disabling diseases such as arthritis and osteoporosis or have been damaged by accidents or injuries. Stryker Corporation employs over 12,000 people worldwide.

    The Howmedica Osteonics division of Stryker was established in 1998 following the acquisition of Howmedica, the orthopaedic division of Pfizer. Stryker Corporation has three manufacturing facilities in Ireland. Two are located at Carrigtohill, Co. Cork. Stryker Howmedica Osteonics produces hip and knee implants mainly for the European, Japanese and South East Asian markets. Having commenced operations in 1998, it currently employs over 80 people. Stryker Instruments employs 65 people in the manufacture of surgical blades, burs and dissection needles used in orthopaedic surgery. The third facility, Stryker Howmedica Osteonics, Limerick, employs 340 people and specialises in the design and manufacture of complex knee implant systems using investment casting technology and manufactures the world leading orthopaedic bone cement product, Simplex.

    Stryker Howmedica Osteonics has an extensive history in the development and manufacturing of hydroxyapatite (HA) coated prostheses. Through system and process development, Howmedica Osteonics has brought HA powder manufacturing and application in-house. This permits strict control over HA parameters such as purity and crystallinity. The clinically successful PureFix™ HA brand is applied using a line-of-sight plasma spray process making it ideal for surface coating an on-growth surface.

    Stryker Howmedica Osteonics also developed PureFix™ Peri-apatite™ (PureFix™ PA); a technologically advanced hydroxyapatite coating that makes it possible to completely coat all areas of a porous in-growth surface. PureFix™ PA is applied using a proprietary low temperature aqueous precipitation process. This process allows a 20 µm thin coating of 100% pure crystalline HA to form around the perimeter of each bead from the surface to the substrate, without blocking the pores facilitating bony in-growth.

    Stryker Howmedica Osteonics offers a diverse range of total hip products. Femoral stems may be implanted with a variety of wear couples including metal on polyethylene, ceramic on polyethylene or ceramic on ceramic. Ceramic on polyethylene systems typically use zirconia ball heads coupled with polyethylene acetabular inserts. This system yields a decrease in the amount of wear debris in the hip joint compared with metal on polyethylene wear couplings. In the ceramic on ceramic bearing hip systems, the acetabular insert and ball head are both manufactured from aluminium oxide. The alumina wear couple represents a substantial decrease in the volume of wear debris exposed to the hip joint and hence the problem of osteolysis.

    5.2. Bioceramics Research at the University of Limerick

    Researchers at the University of Limerick (UL) have responded to the developing area of biomaterials science both within the Department of Materials Science and Technology and the newly-established Materials and Surface Science Institute. Research is currently underway in a variety of key biomaterials including hydro-gels, ceramics, improved plastics for hip-implants and cements used for fixation of implants or for dentistry. A number of research projects specifically on bioceramics are described below.

    1. Ultralow Fusing Dental Porcelains.
    Hydrothermal glasses, developed by Ducera Dental, are low fusing glasses with water incorporated into the silicate glasses producing non-bridging hydroxyl groups. This disrupts the glass network and results in increased thermal stability, reduced glass transition temperature, decreased viscosity and increased thermal expansion. Research at UL has yielded a great deal of data on the structural role of fluorine in glasses. Current research parallels development of hydrothermal porcelains by Ducera, but fluorine is employed to disrupt the glass network rather than hydoxyl groups. Such glasses are capable of bonding to precious metal alloys and are not prone to corrosion.

    2. Tissue Engineered Implants.
    Development of a rapidly resorbing scaffold material based on bioactive glass to aid bone growth. The aim is to produce a hybrid biomaterial where osteoblasts would be incorporated into a porous bioactive glass matrix material. Such a material, in contrast to the growth pattern associated with materials in current use, would promote bone growth throughout the entire scaffold.

    3. Crosslinking of glass ionomer cements (GICs).
    GICs are reaction bonded composites consisting of a poly(carboxylic acid) and an ion leachable glass. Variants are used in applications such as (a) cement for bone fixation, (b) cements for prosthetic fixation, (c) orthopaedic, dental, maxillofacial, other specific applications, (d) bone substitute materials and (e) dental restorative materials. The mechanical, chemical and biological behaviour as a function of composition has been studied. Mechanical properties are dependant on the Mw of the polymer component and this is limited by the Mw that can physically be formed into a cementitious mass.

    4. Composition-structure-property relationships in dental restorative GICs.
    Glass polyalkenoate cements would have considerable potential as a posterior filling material for large class I and II cavities if the fracture toughness and abrasion resistance could be improved. Unlike resin based materials, no polymerisation is involved in the setting process and the materials do not undergo any polymerisation contraction, which is often associated with marginal leakage and ultimately with the development of secondary caries. The release of fluoride ions is beneficial in preventing secondary caries. Furthermore the ability of glass polyalkenoate cements to chemically bond to the apatite phase of enamel and dentine ensures good adaptation and stress transfer in the restored tooth.

    5. Development of machinable ceramics for dental and engineering applications.
    Mica based glass-ceramics formed from melting and crystallisation of magnesium fluoro-alumino-silicate glasses are being studied with the objective of development of readily machinable glass ceramics for dental inlays and industrial engineering ceramics.

    6. Castable glass-ceramic dental restorative systems.
    The objective is to produce readily castable fluoro-alumino-silicate glass ceramics for use as restorative biomaterials in dental crowns and inlays. These glasses crystallise to fluorapatite (FAP) and mullite. FAP is an attractive phase for restorative materials, as it is the mineral phase found in tooth and bone and thus, many advantages exist in its use including biocompatibility and ability to chemically bond to GIC. Factors that give rise to tough wear resistant ceramics, which can subsequently be used as dental crowns and inlays are to investigated.

    6. Bioceramics activities in Nord pas de Calais Region

    Bioceramics Research in Nord Pas de Calais Region

    At the Laboratoire des Matériaux Avancés (LAMAC) of the Université de Valenciennes et du Hainaut Cambrésis (UVHC) a number of projects in bioceramics have been carried out.

    1. Synthesis of pure HAP and b-TCP powders with controlled surface area by co-precipitation of calcium nitrate and di-ammonium hydrogen phosphate. The precipitates are calcined and ground to obtain a powder with adequate specific area for slurry preparation.

    2. Fabrication of macroporous HAP and b-TCP bioceramics with controlled architecture. Various processing routes were developed to obtain a macroporous structure allowing optimal colonisation of the bone substitute by newly formed bone. The optimal processing method is the subject of a patent application.

    3. Synthesis of fluorine and boron bioreactive glasses. The objectives of this study is to decrease the synthesis temperature compared to Hench’s composition 45S5 for coating glass application by substituting CaO by CaF2 and/or SiO2 by B2O3.

              
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