EP0888096A1 - Procede de fabrication d'un substitut osseux - Google Patents

Procede de fabrication d'un substitut osseux

Info

Publication number
EP0888096A1
EP0888096A1 EP97907038A EP97907038A EP0888096A1 EP 0888096 A1 EP0888096 A1 EP 0888096A1 EP 97907038 A EP97907038 A EP 97907038A EP 97907038 A EP97907038 A EP 97907038A EP 0888096 A1 EP0888096 A1 EP 0888096A1
Authority
EP
European Patent Office
Prior art keywords
channels
ceramic block
substance
polymer
bone substitute
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.)
Withdrawn
Application number
EP97907038A
Other languages
German (de)
English (en)
Inventor
Axel Kirsch
Dietmar Hutmacher
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP0888096A1 publication Critical patent/EP0888096A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • CCHEMISTRY; METALLURGY
    • C04CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04BLIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B41/00After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone
    • C04B41/009After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone characterised by the material treated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L27/46Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with phosphorus-containing inorganic fillers
    • CCHEMISTRY; METALLURGY
    • C04CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04BLIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B38/00Porous mortars, concrete, artificial stone or ceramic ware; Preparation thereof
    • C04B38/0003Porous mortars, concrete, artificial stone or ceramic ware; Preparation thereof containing continuous channels, e.g. of the "dead-end" type or obtained by pushing bars in the green ceramic product
    • CCHEMISTRY; METALLURGY
    • C04CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04BLIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B41/00After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone
    • C04B41/45Coating or impregnating, e.g. injection in masonry, partial coating of green or fired ceramics, organic coating compositions for adhering together two concrete elements
    • C04B41/4505Coating or impregnating, e.g. injection in masonry, partial coating of green or fired ceramics, organic coating compositions for adhering together two concrete elements characterised by the method of application
    • C04B41/4523Coating or impregnating, e.g. injection in masonry, partial coating of green or fired ceramics, organic coating compositions for adhering together two concrete elements characterised by the method of application applied from the molten state ; Thermal spraying, e.g. plasma spraying
    • CCHEMISTRY; METALLURGY
    • C04CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04BLIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B41/00After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone
    • C04B41/80After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone of only ceramics
    • C04B41/81Coating or impregnation
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30965Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30009Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in fibre orientations
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30062(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30065Properties of materials and coating materials thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108Shapes
    • A61F2002/30199Three-dimensional shapes
    • A61F2002/30261Three-dimensional shapes parallelepipedal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30677Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772Apertures or holes, e.g. of circular cross section
    • A61F2002/30784Plurality of holes
    • A61F2002/30785Plurality of holes parallel
    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772Apertures or holes, e.g. of circular cross section
    • A61F2002/30784Plurality of holes
    • A61F2002/30787Plurality of holes inclined obliquely with respect to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772Apertures or holes, e.g. of circular cross section
    • A61F2002/30784Plurality of holes
    • A61F2002/30789Plurality of holes perpendicular with respect to each other
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    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30795Blind bores, e.g. of circular cross-section
    • A61F2002/30807Plurality of blind bores
    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0071Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof thermoplastic
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    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0028Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in fibre orientations
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    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures
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    • A61LMETHODS 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/02Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
    • CCHEMISTRY; METALLURGY
    • C04CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04BLIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B2111/00Mortars, concrete or artificial stone or mixtures to prepare them, characterised by specific function, property or use
    • C04B2111/00474Uses not provided for elsewhere in C04B2111/00
    • C04B2111/00836Uses not provided for elsewhere in C04B2111/00 for medical or dental applications

Definitions

  • the invention relates to methods for producing a bone replacement material, starting from a highly porous ceramic block.
  • the channels are introduced into the ceramic block, the channels are filled with bioabsorbable polymer granules and then the ceramic block with the polymer granules is heated to a temperature above the melting or flow temperature of the polymer granules.
  • the polymer granulate melts in the channels and, when it cools down to room temperature, anchors itself in the form of a supporting structure in the pores of the ceramic block adjacent to the bores, thus ensuring the desired mechanical strength without the majority of the pores in the ceramic being removed from it bioresorbable polymer would be closed.
  • This ensures that when such a polymer-reinforced ceramic block is inserted into the bone, the contact surface with the bone mainly consists of a pure ceramic surface. This is essential for good biocompatibility of the bone replacement material.
  • the temperature to which the ceramic block with the polymer granules is to be heated depends on the selected bioabsorbable polymer. As materials, plastics from the group of polyesters come into question, and from these in particular the Poly ( ⁇ -hydroxyl acids). A temperature range of 180 ° C to 230 ° C is appropriate for this.
  • the fumigation process has proven to be advantageous.
  • This is a process for shaping thermoplastic materials, in which the thermoplastic material is introduced into a mold cavity in free-flowing form or in the form of a preform, and the viscosity of the plastic is reduced with the aid of supercritical substances to such an extent that the plastic becomes flowable and / or can be deformed.
  • the gassing is carried out with one or more gases, possibly also liquefied gases, under high pressure, and they should preferably be in the supercritical state. It can be adjusted in terms of process technology that the polymer takes on a compact or foamed structure within the bores and the adjacent pores.
  • the solubility of gases or liquids in polymers is a function of pressure and temperature. It is known that particularly good solubility parameters are achieved when the gas changes to the supercritical state.
  • Supercritical gases or liquids are known. These include carbon dioxide, ethylene, propane, nitrogen and water. Depending on the supercritical substance used in each case, the gassing process can be carried out at a pressure in a range from 50 to 800 bar (5 ⁇ 10 6 Pa to 8 ⁇ 10 7 Pa).
  • Carbon dioxide is advantageously used for the bone substitute material mentioned, which is preferred for the invention.
  • the suitable pressure range is between 50 to 200 bar (5 x IO 6 pa to 2 x 10 7 Pa;.
  • biologically active agents such as growth factors, antibiotics, pain-relieving agents, agents which influence cell division and vascularization, coagulating or anti-coagulating agents, immunosuppressive or immunostimulating agents, cytokines, chemical attractiveness, enzymes and combinations of which to be introduced into the bone substitute material.
  • biologically active agents such as growth factors, antibiotics, pain-relieving agents, agents which influence cell division and vascularization, coagulating or anti-coagulating agents, immunosuppressive or immunostimulating agents, cytokines, chemical attractiveness, enzymes and combinations of which to be introduced into the bone substitute material.
  • the effectiveness and, above all, the mechanisms of action of the said agents are known to the person skilled in the art.
  • growth factors can serve to stimulate cells in general and, if appropriate, special cell populations to intensify growth in order to fill up the existing tissue or bone defect as quickly as possible.
  • the use of antibiotics is particularly indicated if there are tissue defects that are large or difficult to clean or if the environment in which the bone substitute material is introduced has a high bacterial load.
  • Agents that influence cell division and vascularization also allow rapid regeneration of the tissue or bone defect.
  • the addition of coagulating or, if necessary, anti-coagulating agents can be beneficial.
  • immunosuppressive agents is particularly indicated if, for example, the healing process would otherwise deteriorate as a result of allergic reactions.
  • immunostimulating agents can be advantageous if it is desired to generate an enhanced immune response in the area of the bone replacement material.
  • the immigration of various cell populations means that cytokines and chemical acctance can represent a way of largely controlling the healing process.
  • the addition of enzymes allows a further modification of the regeneration process and can affect the regenerated or regenerating tissue.
  • the gassing process is advantageously carried out at a temperature which is below 37 ° C. Therefore, the addition of thermolabile, biologically active agents is possible without any problems.
  • the channels can be closed on at least one side.
  • Suitable materials for the highly porous ceramic block are synthetic ceramics, glasses and glass ceramics, or ceramics of natural origin.
  • Synthetic ceramics are, for example, hydroxylapatite, ⁇ -tricalcium phosphate and ⁇ -tricalcium phosphate.
  • the ceramics of natural origin are made from cattle bones Algae (Algipore ⁇ ) and corals.
  • a typical chemical formula for a bioactive glass ceramic is Ca0-P2 ⁇ 5-SiC> 2 •
  • Bioresorbable polymer granules which can be used in the present invention are, for example, the poly ( ⁇ -hydroxyl acids) already mentioned above, such as poly (L- Lactide-co-D, L-lactide).
  • FIG. 1 schematically with a highly porous ceramic block
  • FIG. 2 shows the ceramic block from FIG. 1 with polymer granules filled into the channels
  • Figure 3 shows the finished ceramic block
  • Figure 4 shows an example of an arrangement of the channels in a ceramic block according to the invention.
  • Figure 5 shows another example of the arrangement of the
  • channels 20 with a diameter of 2 to 4 mm are drilled in a highly porous ceramic block 10 made of Algipore ⁇ or BioOss * R) .
  • the channels 20 are parallel to one another and arranged in rows, only one such row being indicated schematically in FIG.
  • polymer granules 30 are filled into these channels 20.
  • the ceramic block 10 filled with polymer granules 30 is now heated to 200 ° C. in a heating cabinet.
  • the polymer granulate 30 melts in the channels 20, as illustrated in FIG. 3, and forms the desired mechanical structure 40 in the ceramic block 10 after cooling to room temperature. It has been found that a composite bone replacement molded article produced by the method according to the invention exhibits a 100% to 200% higher mechanical strength than the untreated, highly porous ceramic block.
  • a ceramic block prepared as in Example 1 is filled with free-flowing polymer granules made of poly ( ⁇ -hydroxyl acids). In a pressure chamber, this filled ceramic block is gassed at room temperature in a carbon dioxide atmosphere at 50 to 200 bar. The carbon dioxide dissolves in the polymer and with it creates a foamed structure within the holes and the adjacent pores.
  • channels 20, 24 it can be expedient to design the channels 20, 24 in such a way that they pass through the ceramic block 10 in groups in which the channels each run perpendicular to one another.
  • a first row of channels 20 can be formed extending in the top-down direction in the drawing, while a second row of channels 24 are spaced apart such that the channels 24 run perpendicular to the channels 20.

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  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Ceramic Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Materials Engineering (AREA)
  • Organic Chemistry (AREA)
  • Structural Engineering (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Plasma & Fusion (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Cardiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Composite Materials (AREA)
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Abstract

Ce procédé de fabrication d'un substitut osseux, sur la base d'un bloc céramique hautement poreux (10), est caractérisé en ce que plusieurs canaux (20, 22, 24) sont ménagés dans le bloc céramique (10) et remplis de granulés en polymère biorésorbable (30); le bloc céramique (10) est ensuite chauffé à une température supérieure à la température de fusion ou de fluidité du granulé polymère (30). En outre, ce procédé de fabrication d'un substitut osseux à partir d'un bloc céramique hautement poreux (10) est caractérisé en ce que plusieurs canaux (20, 22, 24) sont ménagés dans le bloc céramique (10) et remplis d'un polymère biorésorbable coulant ou préformé (30); le bloc céramique (10) avec le polymère (30) est ensuite traité avec une substance ou un mélange de substances sous haute pression à l'état hypercritique, de sorte que le matériau synthétique thermoplastique devienne coulant et/ou déformable.
EP97907038A 1996-03-19 1997-01-31 Procede de fabrication d'un substitut osseux Withdrawn EP0888096A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19610715 1996-03-19
DE1996110715 DE19610715C1 (de) 1996-03-19 1996-03-19 Verfahren zum Herstellen eines Knochenersatzmaterials
PCT/DE1997/000198 WO1997034546A1 (fr) 1996-03-19 1997-01-31 Procede de fabrication d'un substitut osseux

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EP0888096A1 true EP0888096A1 (fr) 1999-01-07

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EP (1) EP0888096A1 (fr)
AU (1) AU1923797A (fr)
DE (1) DE19610715C1 (fr)
WO (1) WO1997034546A1 (fr)

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US20040002770A1 (en) * 2002-06-28 2004-01-01 King Richard S. Polymer-bioceramic composite for orthopaedic applications and method of manufacture thereof
DE102004016883A1 (de) * 2004-04-06 2005-10-27 Coripharm Medizinprodukte Gmbh & Co. Kg. Verfahren zur Herstellung eines Knochen-Implantat-materials mit verbesserter mechanischer Beanspruchbarkeit auf der Basis von Formkörpern aus porösem Implantatmaterial sowie nach dem Verfahren hergestelltes Implantatmaterial
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DE19610715C1 (de) 1997-06-26
WO1997034546A1 (fr) 1997-09-25
AU1923797A (en) 1997-10-10

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