FR2823674A1 - Production of high-strength ceramic articles useful in bone surgery comprises impregnating a pre-sintered porous ceramic material with a concentrated suspension of ceramic particles and resintering it - Google Patents

Production of high-strength ceramic articles useful in bone surgery comprises impregnating a pre-sintered porous ceramic material with a concentrated suspension of ceramic particles and resintering it Download PDF

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FR2823674A1
FR2823674A1 FR0105336A FR0105336A FR2823674A1 FR 2823674 A1 FR2823674 A1 FR 2823674A1 FR 0105336 A FR0105336 A FR 0105336A FR 0105336 A FR0105336 A FR 0105336A FR 2823674 A1 FR2823674 A1 FR 2823674A1
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ceramic
wedges
porous ceramic
resintering
production
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FR2823674B1 (en
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LIMOUSINE DE BREVET SOC
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LIMOUSINE DE BREVET SOC
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    • 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
    • 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
    • A61L27/105—Ceramics or glasses containing Al2O3
    • 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
    • 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
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Inorganic Chemistry (AREA)
  • Ceramic Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Dispersion Chemistry (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Production of inert ceramic articles with a porosity of 50-60%, a pore size of 200-600 microns and a compressive strength of 40-50 MPa/cm<2> comprises pre-sintering a porous ceramic material (produced by impregnating a foam with a suspension of ceramic particles and drying the product) at a temperature above 1200 deg C, impregnating it with a concentrated suspension of ceramic particles, and resintering it at a temperature above 1600 deg C.

Description

même diamètre, vertical par rapport au carter (32).same diameter, vertical relative to the housing (32).

DESCRIPTIONDESCRIPTION

Les substituts osseux sont des pro duits très demandés en chirurgie osseuse. Ils sont utilisés en effet dans de nombreux types d'interventions: en traumatologie pour les reconstructions de fractures, en orthopédie en tant qu'éléments de comblement, ou comme implants de fusion intersomatique du rachis, pour des ostéotomies d' addition et pour Bone substitutes are in great demand in bone surgery. They are indeed used in many types of interventions: in traumatology for the reconstructions of fractures, in orthopedics as elements of filling, or as implants of interbody fusion of the spine, for osteotomies of addition and for.

les reconstructions maxillo-faciale... maxillofacial reconstructions ...

Plusieurs matériaux sont utilisés: aujourd'hui dominent, d'une part le métal (alliage de titane) complété généralement par des greffons osseux et, d'autre part, des blocs de céramique biodégradable à base de Several materials are used: today predominate, on the one hand metal (titanium alloy) generally supplemented by bone grafts and, on the other hand, biodegradable ceramic blocks based on

o calcium, comme l'hydroxyapatite et/ou le phosphate tricalcique. o calcium, such as hydroxyapatite and / or tricalcium phosphate.

Les implants en métal sont très utilisés comme cages de fusion intersomatique du rachis. En effet, seul le métal permettait jusqu'alors de résister aux fortes contraintes vertébrales (pressions ou torsions) et de conserver l'espace, ou interligne, inter-osseux requis par le protocole opératoire. Pourtant, ces implants métalliques répondent très mal aux Metal implants are widely used as interbody fusion cages in the spine. In fact, until now, only metal has made it possible to resist strong vertebral stresses (pressures or torsions) and to conserve the interosseous space, or spacing, required by the operating protocol. However, these metal implants respond very poorly to

besoins de comblement: ils ne sont pas dégradables et peu réhabitables. filling needs: they are not degradable and not easily rehabitable.

Le métal ne peut étre utilisé qu'en formes creuses, remplies de greffons osseux sans lesquels la fixation et la fusion intersomatique ne peuvent survenir. Or, le prélèvement des greffons osseux, effectué sur le patient, The metal can only be used in hollow forms, filled with bone grafts without which fixation and interbody fusion cannot occur. However, the removal of bone grafts, carried out on the patient,

o génère des douleurs importantes et rémanentes. o generates significant and persistent pain.

De plus, les implants métalliques, méme s'ils sont recouverts d' hydroxyapatite, présentent de s risques sérieux de métallose et d' impaction dans les parois osseuses. Enfin, la mise en place de ces implants nécessite généralement la pose d'une plaque métallique vissée, In addition, metal implants, even if they are coated with hydroxyapatite, present serious risks of metallosis and impaction in the bone walls. Finally, the installation of these implants generally requires the installation of a screwed metal plate,

rigidifiant les segments osseux entre eux. stiffening the bone segments between them.

C'est pourquoi la recherche s'est orientée vers des éléments bio- This is why research has focused on bio- elements.

résorbables à base de phosphate de calcium, phosphate tricalcique et hydroxyapatite. Ces matériaux sont tout d'abord mis en forme par coulage ou pressage, puis frittés, pour donner des céramiques absorbable based on calcium phosphate, tricalcium phosphate and hydroxyapatite. These materials are first shaped by casting or pressing, then sintered, to give ceramics.

o dégradables, réhabitables et utilisables en comblement et reconstruction. o degradable, rehabitable and usable for filling and reconstruction.

Cependant, sur les faces en contact, la repousse osseuse demeure limitée à moins de 3 mm, méme sur l'os autologue. La partie centrale de l'implant, ne pouvant être réhabitée, demeure molle et peut s'affaisser, entranant l'instabilité de l'assemblage et l' échec de l' opération. Ces substituts procurent donc des résultats limités à terme, tant en However, on the surfaces in contact, bone regrowth remains limited to less than 3 mm, even on autologous bone. The central part of the implant, which cannot be re-inhabited, remains soft and may sag, causing instability of the assembly and failure of the operation. These substitutes therefore provide limited results in the long term, both in terms of

reconstruction qu'en fusion.reconstruction than in fusion.

2 r Enfin, ni le métal, qu'il soit creux ou poreux, ni les matériaux calciques biodégradables ne permettent de réaliser des implants de taille imp ortante destinés, entre autres, aux corporectomies (remplacement d'hémi-vertèbres dans le cas de tumeurs et accidents de la colonne 2 r Finally, neither metal, whether hollow or porous, nor biodegradable calcium materials allow large-scale implants to be produced, intended, among other things, for corporectomies (replacement of hemispheres in the case of tumors and spine accidents

s vertétrale).s vertical).

Quant aux tentatives de mise au point de cales malaxées en ciment orthopédique (résine méthylmétacrylate), elles se sont soldées par un As for the attempts to develop wedges mixed with orthopedic cement (methylmetacrylate resin), they have ended in a

échec en terme de fusion comme de stabilité. failure in terms of both fusion and stability.

.... La présente invention a pour but de produire des substituts osseux et o implants, alliant les qualités du métal et des matériaux biorésortables, sans leurs inconvénients. Plus précisément, la présente invention a pour objet la production industrielle de substituts osseux et implants en céramique, d'origine réellement synthétique, offrant une inertie biochimique et une porosité de 50 à 60% en volume pour des pores de s taille variant de 200 à 600 m, compatibles avec une réhabitation rapide par les ostéocytes et capables de supporter sans rompre, pour des épaisseurs de 5 à 30 mm, des pressions supérieures à 40 MPa au cm2, .... The object of the present invention is to produce bone substitutes and implants, combining the qualities of metal and bio-resistant materials, without their drawbacks. More specifically, the present invention relates to the industrial production of bone substitutes and ceramic implants, of truly synthetic origin, offering biochemical inertia and a porosity of 50 to 60% by volume for pores of size varying from 200 to 600 m, compatible with rapid rehabitation by osteocytes and capable of withstanding without breaking, for thicknesses of 5 to 30 mm, pressures greater than 40 MPa per cm2,

soit une résistance à la compression doublée par rapport au standard. or a compressive strength doubled compared to the standard.

Elle résulte de la modification et de l'amélioration du procédé de o fabrication des céramiques poreuses, ainsi que de son application au It results from the modification and improvement of the manufacturing process o of porous ceramics, as well as its application to the

- domaine médical.- medical domain.

La céramique poreuse était jusqu'alors obtenue en utilisant le procédé de fabrication par imprégnation d'un matériau porogène (type mousse), procédé décrit dans le brevet N 904008430 du 28/03/90, tombé dans le domaine public. La seule application industrielle notoire était Porous ceramic has hitherto been obtained using the manufacturing process by impregnation of a pore-forming material (foam type), a process described in patent No. 904008430 of 03/28/90, which has fallen into the public domain. The only notorious industrial application was

dans le domaine de la filtration.in the field of filtration.

Ce procédé de fabrication comprend quatre phases: tout d'abord, l'imprégnation du matériau porogène par une suspension de particules céramiques (alumine, zircone ou autres matériaux blocompatibles...) so avec différents additifs organiques (phase A), suivie d'un séchage en étuve (phase B); ensuite, l'élimination de la mousse et des constituants organiques de la suspension par un traitement thermique à basse température, inférieure à 700 C (phase C), puis un frittage à une This manufacturing process comprises four phases: first, the impregnation of the pore-forming material with a suspension of ceramic particles (alumina, zirconia or other block-compatible materials, etc.) so with different organic additives (phase A), followed by drying in an oven (phase B); then, the elimination of the foam and the organic constituents of the suspension by a heat treatment at low temperature, below 700 C (phase C), then sintering at a

température supérieure à 1500 C (phase D). temperature above 1500 C (phase D).

Dans la présente invention, après la mise en _uvre des deux premières phases telles que décrites ci-dessus (phases A, B), la pièce céramique poreuse est pré-frittée à une température supérieure à 1200 C, ce qui lui confère une cohésion supérieure (phase C'). Le cycle se In the present invention, after the implementation of the first two phases as described above (phases A, B), the porous ceramic part is pre-sintered at a temperature above 1200 ° C., which gives it greater cohesion. (phase C '). The cycle is

- 2823674- 2823674

. poursuit par un trempage de la pièce dans une suspension plus concentrée en particules céramiques (ph ase E). La viscosité de cette suspension concentrée est contrôlée grâce à divers auxiliaires organiques (liants, plastifiants, dispersant), pour être adaptée à une imprégnation s homogène de la pièce poreuse préfrittée. Après un nouveau séchage en étuve (phase B') et pyrolyse des auxiliaires organiques de la suspension (phase C), la pièce céramique est enfin frittée à une température . continues by soaking the part in a suspension more concentrated in ceramic particles (phase E). The viscosity of this concentrated suspension is controlled using various organic auxiliaries (binders, plasticizers, dispersant), in order to be suitable for homogeneous impregnation of the porous pre-sintered part. After further drying in an oven (phase B ') and pyrolysis of the organic auxiliaries of the suspension (phase C), the ceramic part is finally sintered at a temperature

supérieure à 1600 C suivant un cycle adapté (phase D'). greater than 1600 C following a suitable cycle (phase D ').

Ce procédé de sur-imprégnation, caractéristique de la présente o invention, renforce les propriétés mécaniques de la céramique frittée et multiplie sa résistance par un coefficient 2, notamment la contrainte à la This over-impregnation process, characteristic of the present invention, reinforces the mechanical properties of the sintered ceramic and multiplies its resistance by a coefficient of 2, in particular the stress at the

rupture en compression.compression failure.

Dès lors, l'invention permet de fabriquer et de mettre à la disposition des praticiens des implants en céramique poreuse dont les avantages sont les suivants: À formes: anatomique, sur mesure, ou de série, À matériau: bio-inerte, non dogradable et réhabitable, À porosité: contrôlée, Consequently, the invention makes it possible to manufacture and make available to practitioners porous ceramic implants, the advantages of which are as follows: Shaped: anatomical, made to measure, or as standard, Material: bio-inert, non-dogradable and rehabitable, With porosity: controlled,

À résistance à la compression: supérieure à 40 MPa. Compressive strength: greater than 40 MPa.

L'invention autorise la fabrication de nombreux substituts osseux et implants tels que: À blocs de corporectomie, À cages ou cales intersomatiques du rachis cervical ou lombaire, À cales d'ostéotomie, À cales de dérotation, de rattrapage, de valgisation, À blocs de reconstruction et de comblement, À broches et pivots de fixation et d'arthrodèse, À blocs d'arthrodèse assurant le maintien de l'espace naturel ou interligne intersomatique, À implants spéciaux de reconstruction: plancher et plafond d'orbite, À bouchons de craniotomie, À implants de comblement et plaques de réhabitation maxillo faciale. The invention allows the manufacture of numerous bone substitutes and implants such as: With corporectomy blocks, With cages or intersomatic wedges of the cervical or lumbar spine, With osteotomy wedges, With derotation, recovery, valgization wedges, With blocks for reconstruction and filling, With pins and pins for fixation and arthrodesis, With arthrodesis blocks ensuring the maintenance of the natural space or interbody spacing, With special reconstruction implants: floor and ceiling of the orbit, craniotomy, Filler implants and maxillofacial relocation plates.

Claims (6)

REVENDICATIONS 1. Procédé de fabrication de pièces en céramique inerte (fig. l), d'une porosité en volume de 50 à 60%, de taille de pores de 200 à 600 m (fig.2), d'une résistance à la ropture en compression double du standard, allant de 40 à MPa au cm2, caractérisé en ce que la céramique poreuse, obtenue par imprégnation d'une mousse, est préfrittée à plus de 1200 C, puis surimprégnée par une suspension concentrée de particules céramiques, avant d'être refrittée à 1. Process for manufacturing inert ceramic parts (fig. L), with a porosity by volume of 50 to 60%, pore size from 200 to 600 m (fig. 2), resistance to ropture in double compression of the standard, ranging from 40 to MPa per cm2, characterized in that the porous ceramic, obtained by impregnating a foam, is pre-sintered at more than 1200 C, then over-impregnated with a concentrated suspension of ceramic particles, before d '' be refrittée at plus de 1600 C.over 1600 C. 2. Procédé suivant la revendication 1 caractérisé en ce que la suspension peut être composée de particules céramiques d'alumine, de 2. Method according to claim 1 characterized in that the suspension may be composed of ceramic particles of alumina, of o zircone ou autres matériaux biocompatibles et de différents adjuvants. o zirconia or other biocompatible materials and various adjuvants. 3. Procédé, selon les revendications let 2 caractérisé en ce qu'il 3. Method according to claims let 2 characterized in that it permet de réaliser des implants ou substituts osseux en céramique poreuse pour le rachis: blocs de corporectomie (fig.3), cages et cales allows for bone implants or substitutes in porous ceramic for the spine: corporectomy blocks (fig. 3), cages and wedges intersomatiques cervicales (fig.4 et fig.5) ou lombaires (fig.6). cervical (fig. 4 and fig. 5) or lumbar (fig. 6) interbody fusion. 4. Procédé selon les revendications 1 et 2, caractérisé en ce qu'il 4. Method according to claims 1 and 2, characterized in that it permet de fabriquer des implants en céramique poreuse de reconstruction maxillo-faciale: plaques, blocs de comblement de sinus, bouchons, allows the manufacture of porous ceramic implants for maxillofacial reconstruction: plates, sinus filling blocks, plugs, planchers et plafonds d'orbite (fig. 7 et fig 8)... orbit floors and ceilings (fig. 7 and fig 8) ... 5. Procédé selon les revendications let 2, caractérisé en ce qu'il 5. Method according to claims let 2, characterized in that it o permet de fabriquer des coins d'ostéotomie (fig.9), des cales de valgisation, des cales de dérotation ou de rattrapage (fig.10) o makes it possible to fabricate osteotomy wedges (fig. 9), valgization wedges, derotation or correction wedges (fig. 10) 6. Procédé selon les revendications let 2 caractérisé en ce qu'il 6. Method according to claims let 2 characterized in that it
FR0105336A 2001-04-19 2001-04-19 PROCESS FOR THE MANUFACTURE OF BONE SUBSTITUTES AND IMPLANTABLE ELEMENTS OF VERY HIGH RESISTANCE POROUS CERAMIC Expired - Fee Related FR2823674B1 (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016066660A1 (en) 2014-10-27 2016-05-06 I.Ceram Porous composition filled with an active ingredient
WO2016207255A1 (en) 2015-06-23 2016-12-29 I.Ceram Sternum replacement implant
WO2019106287A1 (en) 2017-11-28 2019-06-06 I.Ceram Antibiotic-grafted ceramic matrix
WO2022189625A1 (en) 2021-03-12 2022-09-15 I.Ceram Sternal reconstruction interface

Citations (6)

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Publication number Priority date Publication date Assignee Title
DE3123460A1 (en) * 1980-06-13 1982-02-04 Mitsubishi Mining & Cement Co. Ltd., Tokyo Process for the production of a porous sintered article made of calcium phosphate
US4371484A (en) * 1980-06-13 1983-02-01 Mitsubishi Mining & Cement Co., Ltd. Process for making porous sintered body of calcium phosphate
EP0335359A2 (en) * 1988-03-31 1989-11-29 Asahi Kogaku Kogyo Kabushiki Kaisha Porous ceramic material and production process thereof
WO1995032008A1 (en) * 1994-05-24 1995-11-30 Implico B.V. A biomaterial and bone implant for bone repair and replacement
FR2744020A1 (en) * 1996-01-31 1997-08-01 S H Ind Synthetic bone product with controlled porosity
WO1998034654A1 (en) * 1997-02-05 1998-08-13 Sofamor Danek Ireland Limited Method for preparing synthetic bone substitutes with controlled porosity

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3123460A1 (en) * 1980-06-13 1982-02-04 Mitsubishi Mining & Cement Co. Ltd., Tokyo Process for the production of a porous sintered article made of calcium phosphate
US4371484A (en) * 1980-06-13 1983-02-01 Mitsubishi Mining & Cement Co., Ltd. Process for making porous sintered body of calcium phosphate
EP0335359A2 (en) * 1988-03-31 1989-11-29 Asahi Kogaku Kogyo Kabushiki Kaisha Porous ceramic material and production process thereof
WO1995032008A1 (en) * 1994-05-24 1995-11-30 Implico B.V. A biomaterial and bone implant for bone repair and replacement
FR2744020A1 (en) * 1996-01-31 1997-08-01 S H Ind Synthetic bone product with controlled porosity
WO1998034654A1 (en) * 1997-02-05 1998-08-13 Sofamor Danek Ireland Limited Method for preparing synthetic bone substitutes with controlled porosity

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016066660A1 (en) 2014-10-27 2016-05-06 I.Ceram Porous composition filled with an active ingredient
US11253633B2 (en) * 2014-10-27 2022-02-22 I.Ceram Porous composition filled with an active ingredient
WO2016207255A1 (en) 2015-06-23 2016-12-29 I.Ceram Sternum replacement implant
FR3037803A1 (en) * 2015-06-23 2016-12-30 I Ceram IMPLANT OF SUBSTITUTION OF STERNUM
CN107872980A (en) * 2015-06-23 2018-04-03 I.陶瓷公司 Breastbone replacement implants
US10729808B2 (en) 2015-06-23 2020-08-04 I.Ceram Sternum replacement implant
WO2019106287A1 (en) 2017-11-28 2019-06-06 I.Ceram Antibiotic-grafted ceramic matrix
WO2022189625A1 (en) 2021-03-12 2022-09-15 I.Ceram Sternal reconstruction interface
FR3120512A1 (en) 2021-03-12 2022-09-16 I.Ceram STERNAL RECONSTRUCTION INTERFACE

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