WO1998034654A1 - Procede d'elaboration de substituts osseux synthetiques de porosite controlee - Google Patents

Procede d'elaboration de substituts osseux synthetiques de porosite controlee Download PDF

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Publication number
WO1998034654A1
WO1998034654A1 PCT/FR1998/000213 FR9800213W WO9834654A1 WO 1998034654 A1 WO1998034654 A1 WO 1998034654A1 FR 9800213 W FR9800213 W FR 9800213W WO 9834654 A1 WO9834654 A1 WO 9834654A1
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WO
WIPO (PCT)
Prior art keywords
particles
organic compound
temperature
ceramic
macro
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/FR1998/000213
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English (en)
French (fr)
Inventor
Olivier Richart
Stephan Szarzynski
Pierre Hardouin
Michel Descamps
Amparo GALLUR
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Ireland Ltd
Original Assignee
Sofamor Danek Ireland Ltd
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 Sofamor Danek Ireland Ltd filed Critical Sofamor Danek Ireland Ltd
Priority to AU62983/98A priority Critical patent/AU6298398A/en
Priority to US09/367,017 priority patent/US6316091B1/en
Priority to JP53387598A priority patent/JP4222633B2/ja
Priority to DK98906978T priority patent/DK0964707T3/da
Priority to DE69801902T priority patent/DE69801902T2/de
Priority to AT98906978T priority patent/ATE206313T1/de
Priority to EP98906978A priority patent/EP0964707B1/fr
Publication of WO1998034654A1 publication Critical patent/WO1998034654A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B35/00—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
    • C04B35/01—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics
    • C04B35/447—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on phosphates, e.g. hydroxyapatite
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    • 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
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    • A61F2/02—Prostheses implantable into the body
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    • 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
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    • 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
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    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y10S623/92—Method or apparatus for preparing or treating prosthetic
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    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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    • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/924—Material characteristic
    • Y10S623/926—Synthetic
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/249921—Web or sheet containing structurally defined element or component
    • Y10T428/249953—Composite having voids in a component [e.g., porous, cellular, etc.]
    • Y10T428/249961—With gradual property change within a component
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y10T428/249953—Composite having voids in a component [e.g., porous, cellular, etc.]
    • Y10T428/249967—Inorganic matrix in void-containing component

Definitions

  • the invention relates to a process for the preparation of a macro-porous synthetic ceramic intended in particular for bone substitution, the ceramic having a controlled dimension of interconnection between the pores, as well as a porosity and a controlled pore size. 10
  • Some methods recommend exerting pressure on the heaped particles, intended to form the pores, in order to control the interconnection diameter.
  • this type of process does not allow effective control of the interconnection, which is homogeneous, easily reproducible and scalable.
  • the value of the mechanical resistances, due to the total non-control of the architectures, is often low, and in particular in compression. It is necessary to limit the mechanical stresses on the implant and consequently, to reduce the size of the parts produced in order to limit the risks of mechanical bankruptcy of the implant-recipient bone system.
  • the invention therefore aims to overcome the drawbacks of the aforementioned prior art.
  • an objective of the process of the invention is in particular to:
  • the invention provides a method of the aforementioned type characterized by the following successive steps: a) construction of a building of pore-forming elements; b) thermoforming of the building so as to ensure controlled coalescence between the pore-forming elements; c) impregnation of the building with a suspension so as to fill the spaces between the pore-forming elements; d) elimination of the pore-forming elements so as to generate the macro-porosity with controlled interconnection diameter.
  • particles of a porogenic organic compound with low thermal expansion are stacked in a reservoir, the particles having a predetermined shape.
  • thermoforming treatment is provided on the particles.
  • the purpose of this operation is to reach the working temperature above the glass transition temperature of the organic compound in order to place it in its rubber plate, in order to achieve a controlled weld between these particles.
  • the generation of controlled bridging between particles, and therefore of the future controlled interconnection between macropores, is due to the regulation of the thermoforming treatment time parameter and the thermoforming treatment temperature parameter.
  • the one-piece structure formed by these interconnected particles is extracted, after the structure has cooled, to place it in a porous mold.
  • the spaces between the particles are sealed with a calcium phosphate powder in suspension in an aqueous medium, in order to constitute the ceramic reinforcement of the material.
  • the product obtained is demolded then heat treated in order to eliminate in a first step the organic compound, and therefore to generate the porosity of the product, then in a second step, to densify the walls of the ceramic.
  • the organic compound is chosen in particular from acrylic resins, such as According to the invention, the organic compound is chosen in particular from acrylic resins, such as in particular polymethylmetacrylate (PMMA), polymetacrylate (PMA), polystyrene, polyethylene, or the like.
  • acrylic resins such as in particular polymethylmetacrylate (PMMA), polymetacrylate (PMA), polystyrene, polyethylene, or the like.
  • the particles have a generally substantially spherical shape.
  • the calcium phosphate is chosen in particular from hydroxyapatite (HA) or tricalcium phosphate (TCP ⁇ ), or the like, or a mixture thereof.
  • the method of the invention thus makes it possible to obtain a macro-porous synthetic ceramic whose interconnection between macro-pores is perfectly controlled and whose pores have controlled dimensions, and are distributed in number and surface in a predetermined manner.
  • the method of the invention allows perfect control of the diameter of the spherical pores, in particular between 100 ⁇ m and 800 ⁇ m with perfectly controlled interconnections in particular between 0.1 and 0.8 times the diameter of the macro-pore involved, and more particularly between 40 and 640 ⁇ m.
  • control of parameters such as temperature, pressure and duration of treatment allows control of the interconnection diameter.
  • ceramics are produced whose interconnection diameter between the macro-pores is greater than 30 ⁇ m. Consequently, for each given particle size class, it is possible to precisely adjust the coalescence and therefore the final interconnection of the product. It is understood that these two parameters are distinct from each other and can be adjusted independently.
  • the invention also makes it possible to obtain ceramics of the aforementioned type of all sizes, whether small or large (several cm) and having a high resistance to mechanical stresses.
  • this process also makes it possible to obtain ceramics, which may be bone substitutes, of complex shape and of constant porosity or not.
  • the invention relates to a use of such a ceramic as a bone substitute.
  • FIG. 1 represents a view in electron microscopy showing the coalescence of polymer particles.
  • FIG. 2 represents a view in electron microscopy of a one-piece structure formed by the interconnected particles.
  • Figures 3 and 4 show electron microscopy views of ceramics with pores of 500 ⁇ m and whose interconnection diameters are 100 ⁇ m and 200 ⁇ m respectively.
  • FIG. 5 represents a view in electron microscopy of particles having undergone a heat treatment at 150 ° C.
  • FIGS. 6a to 6c are schematic perspective views of embodiments of bone substitutes with peripheral mechanical reinforcement.
  • Figures 7a and 7b are schematic perspective views of embodiments of bone substitutes with tubular mechanical reinforcement.
  • Figures 8a to 8d are schematic perspective views of bone substitutes showing possible applications, in particular for an addition tibial osteotomy ( Figures 8a to 8c).
  • FIGS. 9a to 9c are optical micrographs representing the substitute for FIG. 8d, seen respectively from above, side and in longitudinal section.
  • the macro-porous ceramic is prepared from particles of acrylic resins, such as particles of polymethylmethacrylate (PMMA), stacked in a tank.
  • PMMA polymethylmethacrylate
  • thermoplastic polymer suitable for thermoforming.
  • a polymer of at least partially amorphous structure preferably completely amorphous, will be used, in order to avoid an excessive volume increase during the heat treatment.
  • the pore-forming element must be able to degrade at low temperature with a negligible level of residual impurities and non-corrosive decomposition products.
  • PMMA corresponds to a compound exhibiting all of these characteristics.
  • the PMMA particles used are in the form of beads which may have dimensions which are substantially identical to one another or of different dimensions.
  • the spherical shape of the PMMA particles makes it possible in particular to ensure close and various contacts between the particles, to obtain a porosity of homogeneous morphology and to control the final pore volume of the ceramic.
  • PMMA particles have the particularity of being little or no deformable, as indicated above. Therefore, the pores of the substitute obtained have dimensions substantially identical to those of the particles.
  • the PMMA beads used have, in a particular embodiment, a particle size distribution ranging from a few microns to about 850 microns.
  • the PMMA powder is subjected beforehand to mechanical sieving.
  • the PMMA powder is passed between opening sieves of different meshes, so as to obtain batches of powder of relatively narrow particle size classes.
  • particle size classes ranging from 0 to 100 ⁇ m, from 100 to 200 ⁇ m, from 200 to 300 ⁇ m, from 400 to 500 ⁇ m, from 500 to 600 ⁇ m, from 600 to 700 ⁇ m, or from 700 to 850 ⁇ m .
  • narrower particle size classes - for example from 190 to 200 ⁇ m - can be selected.
  • PMMA beads may be hollow.
  • the number, the shape and the distribution of the particles used depends on the shape of the mold and on the ceramic which it is desired to obtain.
  • the reservoir intended to receive the particles of organic compound must be able to withstand at least the temperature of thermal degradation of said compound.
  • this temperature is of the order of 200 ° C.
  • the reservoir is for example metallic, ceramic, or polymeric.
  • thermoforming treatment is carried out on the PMMA particles in order to ensure coalescence between said particles.
  • an amorphous polymer such as in particular PMMA, assumes a rubbery consistency at a temperature higher than the glass transition temperature T v of said polymer.
  • the glass transition temperature of PMMA is of the order of 110 ° C.
  • the polymer undergoes modifications of its macro-molecules to arrive at the rubbery consistency close to the viscous state.
  • the polymer is then easily moldable.
  • the viscosity of the material obtained then gradually increases when the temperature decreases.
  • thermoforming process generally involves heating the particles, taken as a whole or on their surface, to a temperature higher than the glass transition temperature of the organic compound.
  • PMMA thermoforming treatment can be broken down into the following stages:
  • provision can be made not to preheat the vacuum tank but to heat it once filled.
  • thermoforming technique for these pore-forming elements is reproducible and also applicable to large-scale buildings (several tens of square centimeters and large volume (several tens of cubic centimeters).
  • the efficiency of the process for controlling the interconnection diameter is essentially controlled by diffusion, the quality of the weld will depend on the temperature, the time and the intensity of the contact between particles.
  • the PMMA beads are introduced into a metal tank previously heated, for example to the different processing temperatures.
  • These temperatures, higher than the glass transition temperature, are respectively 120 ° C, 150 ° C, 180 ° C, and 200 ° C.
  • This footprint corresponds to the future interconnection between the macropores of the bioceramic.
  • this trace remains discrete and with an estimated diameter of 100 ⁇ m.
  • test temperature of 180 ° C. allows significant bridging between the beads for short treatment times.
  • the thermally formed PMMA particles thus form a one-piece structure comprising a certain number of spaces between the balls (see FIGS. 1 and 2).
  • This one-piece structure is then extracted from the reservoir to place it in a porous mold.
  • This mold is, in the present embodiment, plaster.
  • a ceramic, metal or resin mold, or the like can also consider using a ceramic, metal or resin mold, or the like.
  • the spaces between beads are then filled, impregnated with a dense suspension based on calcium phosphate in an aqueous medium.
  • This suspension, or slip comprises hydroxyapatite (HA) or tricalcium phosphate (TCP ⁇ ), or else their mixture up to 100% each.
  • HA hydroxyapatite
  • TCP ⁇ tricalcium phosphate
  • the suspension thus made up of powder and water, will gradually dry around the one-piece structure thanks to capillary depression phenomena generated by the porosity of the plaster.
  • the mold comprises, in its walls, a reserve containing a sufficient amount of slip.
  • This reserve makes it possible to continuously impregnate the monobloc structure so that all the spaces are perfectly filled, and this, until the slip dries. This reserve is used in combination with the pouring of the slip.
  • a deflocculation step is carried out to achieve optimal deagglomeration of the suspension.
  • the deflocculation of a suspension of calcium phosphate, for example of hydroxyapatite, is ensured by a polyelectrolyte of carboxylate type, widely used in ceramurgy: ammonium polyacrylate (PaA).
  • the viscosities of these slip are then determined at a speed gradient of 100 s -1 .
  • suspensions less concentrated in the dry matter content can be used in particular to reduce the viscosity and facilitate the impregnation of the polymer structure.
  • the "raw” product obtained is then removed from the mold.
  • the temperature of this treatment is less than approximately 300 ° C. This heat treatment will therefore make it possible to eliminate the beads by burning all the organic materials and therefore to generate voids at their location.
  • a macro-porous ceramic with controlled interconnections is thus obtained and can be intended for bone replacement.
  • Figures 3 and 4 illustrate the control and growth of the interconnection diameter (small black holes) for a porosity of 500 ⁇ m.
  • plaster mold can have different shapes, whether simple or complex.
  • it may for example have a substantially parallelepiped or cylindrical shape, being simple shapes.
  • Figures 6a to 9c show examples of complex configuration of the ceramic obtained, and therefore of the mold. It is thus possible to provide dense parts allowing mechanical reinforcement of certain areas of the substitute.
  • the polymeric structure then does not have balls at the place where the dense part (s) is (are) desired.
  • the densest parts D are located at the periphery of the substitute, whether it is parallelepipedic (FIGS. 6a and 6b) or cylindrical (FIG. 6c).
  • FIGS. 7a and 7b show an embodiment of a cylindrical substitute comprising a dense part D, a macro-porous part M and a hollow part C.
  • the dense part D is inserted between the hollow part C and the macro-porous part M, while in FIG. 7b, the dense part is located at the periphery of the substitute.
  • FIGS. 8a to 8c show substitutes of complex shape, called "wedge" shape, where the dense, or micro-porous parts, are represented in D and the macro-porous parts in M.
  • the parts M are inserted between the parts D.
  • Such substitutes can for example be used in cases of addition tibial osteotomy.
  • FIG. 8d as well as FIGS. 9a to 9c, represent a substitute of generally frustoconical shape comprising a dense internal part D of generally cylindrical shape and an outer porous part substantially frustoconical.
  • the dense parts D are obtained for example by generating a lower porosity, for example, by using particles of smaller sizes.
  • the resistance of the substitute - and therefore its density - can also be reinforced by increasing the spaces between the particles, so as to increase the quantity of impregnated slip, or by removing the particles in certain zones and by filling these zones with slip.

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PCT/FR1998/000213 1997-02-05 1998-02-05 Procede d'elaboration de substituts osseux synthetiques de porosite controlee Ceased WO1998034654A1 (fr)

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AU62983/98A AU6298398A (en) 1997-02-05 1998-02-05 Method for preparing synthetic bone substitutes with controlled porosity
US09/367,017 US6316091B1 (en) 1997-02-05 1998-02-05 Method for preparing synthetic bone substitutes with controlled porosity
JP53387598A JP4222633B2 (ja) 1997-02-05 1998-02-05 制御された多孔度を有する合成骨代替物の製造方法
DK98906978T DK0964707T3 (da) 1997-02-05 1998-02-05 Fremgangsmåde til fremstilling af syntetiske knogleerstatninger med en styret porøsitet
DE69801902T DE69801902T2 (de) 1997-02-05 1998-02-05 Verfahren zur herstellung von synthetischen knochenersatzmaterialien mit kontrollierter porosität
AT98906978T ATE206313T1 (de) 1997-02-05 1998-02-05 Verfahren zur herstellung von synthetischen knochenersatzmaterialien mit kontrollierter porosität
EP98906978A EP0964707B1 (fr) 1997-02-05 1998-02-05 Procede d'elaboration de substituts osseux synthetiques de porosite controlee

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FR2823674A1 (fr) * 2001-04-19 2002-10-25 Limousine De Brevet Soc Procede de fabrication de substituts osseux et d'elements implantables en ceramique poreuse a tres haute resistance
KR100426446B1 (ko) * 2001-07-28 2004-04-13 홍국선 직선형 다공성 골 충진재 및 그 제조 방법
DE10063119B4 (de) * 1999-12-22 2005-08-11 Biovision Gmbh Verfahren zur Herstellung eines synthetischen Füllmaterials und temporärer Knochendefektfüller
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DE10063119B4 (de) * 1999-12-22 2005-08-11 Biovision Gmbh Verfahren zur Herstellung eines synthetischen Füllmaterials und temporärer Knochendefektfüller
DE10063119C5 (de) * 1999-12-22 2008-07-31 Biovision Gmbh Verfahren zur Herstellung eines synthetischen Füllmaterials
DE10066312B4 (de) * 1999-12-22 2009-03-05 Biovision Gmbh Verfahren zur Herstellung eines synthetischen Füllmaterials und temporärer Knochendefektfüller
EP1378256A4 (en) * 2001-03-23 2009-09-16 Olympus Corp ARTIFICIAL BONE MATERIAL
FR2823305A1 (fr) * 2001-04-05 2002-10-11 Francine Monchau Procede de controle de la coalescence des particules formant un edifice, notamment destine a etre utilise dans la fabrication de produits a pores interconnectes, par exemple, implant osseux
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KR100426446B1 (ko) * 2001-07-28 2004-04-13 홍국선 직선형 다공성 골 충진재 및 그 제조 방법

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DE69801902T2 (de) 2002-04-25
ATE206313T1 (de) 2001-10-15
FR2758988A1 (fr) 1998-08-07
FR2758988B1 (fr) 2000-01-21
US6316091B1 (en) 2001-11-13
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AU6298398A (en) 1998-08-26
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JP2001510375A (ja) 2001-07-31

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