WO1993017976A1 - Verre bioactif utilise comme substitut osseux - Google Patents

Verre bioactif utilise comme substitut osseux Download PDF

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Publication number
WO1993017976A1
WO1993017976A1 PCT/FI1993/000081 FI9300081W WO9317976A1 WO 1993017976 A1 WO1993017976 A1 WO 1993017976A1 FI 9300081 W FI9300081 W FI 9300081W WO 9317976 A1 WO9317976 A1 WO 9317976A1
Authority
WO
WIPO (PCT)
Prior art keywords
glass
bone
granules
infected
glasses
Prior art date
Application number
PCT/FI1993/000081
Other languages
English (en)
Inventor
Juha Kaarlo Peltola
Örjan Helmer ANDERSSON
Original Assignee
Turku Implant Team Oy
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Turku Implant Team Oy filed Critical Turku Implant Team Oy
Priority to AU36338/93A priority Critical patent/AU3633893A/en
Publication of WO1993017976A1 publication Critical patent/WO1993017976A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/12—Phosphorus-containing materials, e.g. apatite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/10—Ceramics or glasses
    • C—CHEMISTRY; METALLURGY
    • C03—GLASS; MINERAL OR SLAG WOOL
    • C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
    • C03C10/00—Devitrified glass ceramics, i.e. glass ceramics having a crystalline phase dispersed in a glassy phase and constituting at least 50% by weight of the total composition
    • C03C10/0009—Devitrified glass ceramics, i.e. glass ceramics having a crystalline phase dispersed in a glassy phase and constituting at least 50% by weight of the total composition containing silica as main constituent
    • C—CHEMISTRY; METALLURGY
    • C03—GLASS; MINERAL OR SLAG WOOL
    • C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
    • C03C3/00—Glass compositions
    • C03C3/04—Glass compositions containing silica
    • C03C3/076—Glass compositions containing silica with 40% to 90% silica, by weight
    • C03C3/078—Glass compositions containing silica with 40% to 90% silica, by weight containing an oxide of a divalent metal, e.g. an oxide of zinc
    • C—CHEMISTRY; METALLURGY
    • C03—GLASS; MINERAL OR SLAG WOOL
    • C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
    • C03C4/00—Compositions for glass with special properties
    • C03C4/0007—Compositions for glass with special properties for biologically-compatible glass
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite

Definitions

  • the present invention describes glasses for replacement of bony tissue in obliteration of bone defects.
  • the described materials have been found to perform successfully in infected sites as well as in non-infected sites.
  • the glass can be used as such or in its partially crystallized form (glass-ceramic) . Glasses of this kind are known in the art, as is their bone bonding behaviour. According to the invention a narrow optimal compositional range has been found wherein the glass can be used as a granulate, i.e. with a large surface area.
  • the granules possess a good ability to conduct bone growth and are used alone or in combination with bulk glass (blocks, plates etc.) or other implants, such as titanium tooth root implants, for filling of bone defects or for stabilizing dental or surgical implants in the bone.
  • the granules are easy to apply and provide for a complete filling of defects of irregular shape.
  • the materials used can be divided into three groups on the basis of their stability in the tissue, i.e. nearly inert materials, resorbable materials and surface reactive or bioactive materials.
  • the first group of materials relies on a mechanical fixation in the tissue. Examples are titanium and alumina. Typically these materials are used as prostheses or for attachment of prostheses in the bone, i.e. not as bone substitutes and fillers.
  • the resorbable materials e.g. tricalcium phosphate, have largely been replaced by the bioactive material hydroxylapatite (HA) in clinical use. The inert and the resorbable materials do not achieve bone bonding and are therefore proned to infection.
  • HA hydroxylapatite
  • HA is used in reconstruction of bony tissue and for example in dental sites which are proned to infection. HA gives a good roentgenological contrast and has, when studied in this way, been considered to achieve extensive bone contact. Still the clinical results have often been unsatisfactory.
  • a bioactive glass that has proved to be a successful candidate for bone replacement is the 45S5 Bioglass ® composition (see e.g. US-patent 4,171,544, column 1), which comprises 45 % by weight Si0 2 , 24.5 % by weight Na 2 0, 24.5 % by weight CaO and 6 % by weight P 0 5 .
  • the 45S5 glass has received FDA approval for use in a middle ear transplant. This glass is, however, not used as granules, but as bulk. In a recent paper (Gatti, A.M. & Zaffe, O. Biomaterials 1991, Vol. 12. pp 345-350)) it was reported that the bone growth around granules of the 45S5 glass is unsatisfactory.
  • the present invention relates to bioactive glass in granular form with a composition to be specified hereinafter, as such or in crystalline form as a glass- ceramic.
  • the invention also relates to the use, in humans and non-humans, of the said materials as a bone substitute for infected and non-infected sites for use in dental and orthopaedic implants.
  • the invention is based on the discovery that too high ion release rates, i.e. reactivity, of the glass may disturb the bone formation around the implant. According to the invention it has now been found that within a fairly narrow range the reactivity of the material is low enough to make it possible for it to be used as a granulate, which application form has many advantages over bulk form, as will be explained later. The invention also contemplates the use of bulk implants together with the granules of the invention.
  • the dissolution or release rate for elements from the implant material must not be too high, since the flux of released ions can interfere with the biological processes as well as with the implant surface chemistry. In the case of glass, too high a dissolution rate can cause the local pH at the glass surface to increase to a biologically unacceptable level. On the other hand, a certain release of ions at the surface might stimulate the healing process and the bone formation. This conclusion can be drawn on basis of studies by us and others, showing that a bioactive glass usually is more rapidly bonded to and surrounded by new bone, than is for example HA. The release of ions from HA is slower than from bioactive glass.
  • bioactive glass in granular form and having - the following composition, wherein percentages are by weight:
  • the material according to the invention may be used as such or in partly crystallized form as glass-ceramics as a bone substitute for the obliteration of bone defects, such as for filling of bone defects and cavities, and for bone augmentation.
  • the glass may be used as such as a granular implant, in the form of a mix with e.g. a physiological saline solution, or together with bulk implants.
  • Specific applications or treatments included in the present invention are the use as dental or surgical implants including granules of controlled reactivity in a variety of sites, such as filling of forehead, sinus, alveolar, bone cysts, and in ozena treatment.
  • the granulate can also be used around metal or ceramic implants for stabilizing purpose. A common feature of all these applications is that granules are needed to achieve a complete filling of the bone defect.
  • granules are thus preferred over bulk specimens since granules can readily be applied in bone pockets of very irregular shape. Granules are also preferred since the size of the filling cannot always be established before the operation. Thus from the point of view of the surgeon and the patient, a granulate is preferred.
  • bioactive glasses have the ability to conduct bone growth along their surfaces. This is known to the art.
  • the material When used as granules, the material however provides an efficient scaffold for the bone growth.
  • the bone can under beneficial circumstances grow from one granule to another, eventually filling up the gap. A gap in the bone can in the absence of a osteoconductive material close only when the width of the gap is not too large.
  • the granulate is produced by mixing the raw materials (e.g. Si0 2 , Na 2 C0 3 , CaC0 3 etc) and heating them at about 1350 °C for several hours. After this the melt is poured on a graphite plate and annealed at about the glass transition temperature of the glass for one to several hours. Alternatively the glass can be quenched and left annealed to facilitate the crushing. The glass is crushed mechanically e.g. in a ball mill and sieved to appropriate grain sizes. Glass-ceramics are produced by heating the base glass to about 650-1000 °C for several hours.
  • the raw materials e.g. Si0 2 , Na 2 C0 3 , CaC0 3 etc
  • the glass defined in the Example 1 (S53P4) is an intermediate reactive glass and thus a fairly large surface area can be tolerated, but if the surface area is very large, this glass will not perform satisfactorily.
  • Our studies show i.a. that grains smaller than about 200 ⁇ m (microns) give a surface area that is too large in relation to the reactivity of the glass. Consequently a glass of even less reactivity is needed if a grain size of less than 200 ⁇ m is to be used.
  • grains ranging from 300 ⁇ m to several millimeters.
  • glass S53P4 can due to its optimized composition and controlled reactivity be used in all practically interesting sizes, i.e. from granules of about 300 ⁇ m up to bulk size, i.e. to about 5 to 10 mm. Larger pieces can be considered as bulk specimens.
  • the 16 glasses were studied by implantation in rabbit tibia.
  • the glasses were classified according to their reaction behaviour as well as according to the type of bone response (i.e. no contact, contact, bonding) .
  • a phenomenological model was developed.
  • the model describes the relationship between the behaviour in vivo and the glass composition.
  • the bioactivity was established on basis if implantation of bulk specimens.
  • the reactivity or ion release rate must not be too high if the glass is to be used not only as bulk but also as granules.
  • compositional range having a low enough reactivity (ion release rate) but a sufficient bone bonding ability was found within the known broader bioactive ranges.
  • the optimized compositional ranges suited for use also as granules, i.e. at high specific surface area, is the composition of the invention given above.
  • composition given in the Example 1 was chosen for extensive testing in vivo and in vitro. It was found that the glass behaves as expected, i.e. that it shows a relatively low solubility/reactivity as compared with composition 45S5 and that its behaviour when implanted is good.
  • Example 1 A glass (S53P4) of the following composition was studied
  • the glass was implanted in rabbit tibia as bulk specimens (cones) and granules and was found to perform well, with a large amount of infiltration of bony tissue.
  • the minimum acceptable grain size for this glass appeared to about 300 ⁇ m. Smaller grain sizes are according to our findings not desirable from the handling point of view. Therefore the above composition performs as desired in the practically interesting grain size, i.e. from about 300 ⁇ m grains up to bulk size.
  • Example 2 A glass having the same composition as in the Example 1 was used. It was used in the same manner as in the Example 1, but in infected, wet sites. Together with antibiotic treatment the result was very good and better than usually achieved with antibiotic treatment together with other implant materials, such as polymers, metals and bone or fat autografts.
  • Example 3 The same glass as in Example 1 was implanted to lift the bottom of the maxilla sinus. Granules and a plate of the glass were used in this application. After 3 months bone had surrounded the granules and thus lifted the bottom of the sinus 12 to 17 mm. A titanium implant was inserted at the time of the operation and thanks to the increased thickness of the the bone, the titanium implant was stable.

Abstract

L'invention concerne des verres bioactifs ou des vitrocéramiques sous forme granulaire utilisés comme substituts osseux pour combler des sites infectés ou non tels que, par exemple, les kystes d'os frontaux, alvéolaires ou de sinus.
PCT/FI1993/000081 1992-03-09 1993-03-09 Verre bioactif utilise comme substitut osseux WO1993017976A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU36338/93A AU3633893A (en) 1992-03-09 1993-03-09 Bioactive glass as a bone substitute

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US84773892A 1992-03-09 1992-03-09
US847,738 1992-03-09

Publications (1)

Publication Number Publication Date
WO1993017976A1 true WO1993017976A1 (fr) 1993-09-16

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/FI1993/000081 WO1993017976A1 (fr) 1992-03-09 1993-03-09 Verre bioactif utilise comme substitut osseux

Country Status (1)

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WO (1) WO1993017976A1 (fr)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0869749A4 (fr) * 1994-06-30 1998-10-14
US5981412A (en) * 1996-05-01 1999-11-09 University Of Florida Research Foundation Bioactive ceramics and method of preparing bioactive ceramics
WO2000035508A1 (fr) * 1998-12-11 2000-06-22 Ylaenen Heimo Nouveau composite et son utilisation
WO2003031356A1 (fr) * 2001-10-02 2003-04-17 Schott Glas Verre bioactif de grande purete et son procede de production
WO2003050053A2 (fr) * 2001-12-12 2003-06-19 Schott Glas Utilisation d'une vitroceramique antimicrobienne pour les soins dentaires et l'hygiene buccale
EP1449815A3 (fr) * 2003-02-21 2004-09-29 Firma Ivoclar Vivadent AG Vitrocéramique bioactive comprenant rhenanite
CN100348525C (zh) * 2004-09-28 2007-11-14 中南大学 一种可切削的生物活性玻璃陶瓷及其制备方法
WO2010063887A1 (fr) * 2008-12-04 2010-06-10 Tampereen Yliopisto, Solu- Ja Kudosteknologiakeskus Regea Régénérat biologique pour utilisation en oblitération
WO2011001028A1 (fr) * 2009-06-29 2011-01-06 Bonalive Biomaterials Oy Verre bioactif destiné à être utilisé dans des pathologies liées aux infections osseuses
US20130095183A1 (en) * 2010-06-25 2013-04-18 Iain Ronald Gibson Bone graft system
US9144631B2 (en) 2003-01-27 2015-09-29 Benedicte Asius Ceramic-based injectable implants which are used to fill wrinkles, cutaneous depressions and scars, and preparation method thereof
CN107872980A (zh) * 2015-06-23 2018-04-03 I.陶瓷公司 胸骨置换植入物

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2606540A1 (de) * 1975-02-20 1976-09-02 Battelle Memorial Institute Biologisch vertraegliche glaskeramik
WO1991012032A1 (fr) * 1990-02-08 1991-08-22 S.E.I.P.I. Società Esportazione Importazione Prodotti Industriali S.P.A. Composition vitree bioactive destinee aux implants osseux, filaments formes a partir de celle-ci et methode

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2606540A1 (de) * 1975-02-20 1976-09-02 Battelle Memorial Institute Biologisch vertraegliche glaskeramik
WO1991012032A1 (fr) * 1990-02-08 1991-08-22 S.E.I.P.I. Società Esportazione Importazione Prodotti Industriali S.P.A. Composition vitree bioactive destinee aux implants osseux, filaments formes a partir de celle-ci et methode

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0869749A1 (fr) * 1994-06-30 1998-10-14 Orthovita, Inc. Particules bioactives destinees a la formation de tissu osseux
EP0869749A4 (fr) * 1994-06-30 1998-10-14
US5981412A (en) * 1996-05-01 1999-11-09 University Of Florida Research Foundation Bioactive ceramics and method of preparing bioactive ceramics
WO2000035508A1 (fr) * 1998-12-11 2000-06-22 Ylaenen Heimo Nouveau composite et son utilisation
WO2003031356A1 (fr) * 2001-10-02 2003-04-17 Schott Glas Verre bioactif de grande purete et son procede de production
WO2003050053A2 (fr) * 2001-12-12 2003-06-19 Schott Glas Utilisation d'une vitroceramique antimicrobienne pour les soins dentaires et l'hygiene buccale
WO2003050053A3 (fr) * 2001-12-12 2003-09-04 Schott Glas Utilisation d'une vitroceramique antimicrobienne pour les soins dentaires et l'hygiene buccale
US9144631B2 (en) 2003-01-27 2015-09-29 Benedicte Asius Ceramic-based injectable implants which are used to fill wrinkles, cutaneous depressions and scars, and preparation method thereof
EP1449815A3 (fr) * 2003-02-21 2004-09-29 Firma Ivoclar Vivadent AG Vitrocéramique bioactive comprenant rhenanite
CN100348525C (zh) * 2004-09-28 2007-11-14 中南大学 一种可切削的生物活性玻璃陶瓷及其制备方法
WO2010063887A1 (fr) * 2008-12-04 2010-06-10 Tampereen Yliopisto, Solu- Ja Kudosteknologiakeskus Regea Régénérat biologique pour utilisation en oblitération
WO2011001028A1 (fr) * 2009-06-29 2011-01-06 Bonalive Biomaterials Oy Verre bioactif destiné à être utilisé dans des pathologies liées aux infections osseuses
EP2448607A1 (fr) * 2009-06-29 2012-05-09 BonAlive Biomaterials Oy Verre bioactif destiné à être utilisé dans des pathologies liées aux infections osseuses
US20120164187A1 (en) * 2009-06-29 2012-06-28 Fredrik Ollila bioactive glass for use in conditions relating to bone infections
US20130095183A1 (en) * 2010-06-25 2013-04-18 Iain Ronald Gibson Bone graft system
US9492591B2 (en) * 2010-06-25 2016-11-15 Sirakoss Limited Bone graft system
CN107872980A (zh) * 2015-06-23 2018-04-03 I.陶瓷公司 胸骨置换植入物

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