WO1998038948A1 - An artefact suitable for use as a bone implant - Google Patents

An artefact suitable for use as a bone implant Download PDF

Info

Publication number
WO1998038948A1
WO1998038948A1 PCT/EP1998/001218 EP9801218W WO9838948A1 WO 1998038948 A1 WO1998038948 A1 WO 1998038948A1 EP 9801218 W EP9801218 W EP 9801218W WO 9838948 A1 WO9838948 A1 WO 9838948A1
Authority
WO
WIPO (PCT)
Prior art keywords
artefact
pores
support structure
porous
bioactive
Prior art date
Application number
PCT/EP1998/001218
Other languages
French (fr)
Inventor
Paul Wilhelm Richter
Michael Edward Thomas
Original Assignee
Implico B.V.
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 Implico B.V. filed Critical Implico B.V.
Priority to AU64998/98A priority Critical patent/AU6499898A/en
Priority to EP98910723A priority patent/EP0900064A1/en
Publication of WO1998038948A1 publication Critical patent/WO1998038948A1/en

Links

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
    • C04B38/00Porous mortars, concrete, artificial stone or ceramic ware; Preparation thereof
    • C04B38/06Porous mortars, concrete, artificial stone or ceramic ware; Preparation thereof by burning-out added substances by burning natural expanding materials or by sublimating or melting out added substances
    • C04B38/061Porous mortars, concrete, artificial stone or ceramic ware; Preparation thereof by burning-out added substances by burning natural expanding materials or by sublimating or melting out added substances by melting out
    • 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
    • A61L27/02Inorganic materials
    • A61L27/12Phosphorus-containing materials, e.g. apatite
    • 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
    • A61L27/42Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix
    • A61L27/425Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix of phosphorus containing material, e.g. apatite
    • 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
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56Porous materials, e.g. foams or sponges
    • 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
    • C04B35/00Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
    • C04B35/01Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics
    • C04B35/447Shaped 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
    • 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
    • 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
    • A61F2/3094Designing or manufacturing processes
    • 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
    • A61F2002/30004Material 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
    • A61F2002/30011Material 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 porosity
    • 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
    • A61F2002/302Three-dimensional shapes toroidal, e.g. rings
    • 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
    • A61F2002/30224Three-dimensional shapes cylindrical
    • 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
    • A61F2002/30224Three-dimensional shapes cylindrical
    • A61F2002/30225Flat cylinders, i.e. discs
    • 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
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • 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
    • 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
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/30968Sintering
    • 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0065Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped
    • 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0069Three-dimensional shapes cylindrical
    • 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
    • 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
    • A61F2250/0023Special 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 porosity
    • 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
    • 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
    • A61F2250/0023Special 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 porosity
    • A61F2250/0024Special 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 porosity made from both porous and non-porous parts, e.g. adjacent parts
    • 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
    • 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
    • A61F2310/00293Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
    • 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
    • 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

  • THIS INVENTION ralates to an artefact suitable for use as a bone implant by implan a on thereof into a subject at a body 3ite where bone growth is required, ⁇ t relates also to a method of making such an artefact.
  • an artefact suitable for use as a bone implant by implantation thereof into a subject at a body site where bone growth is required comprising a porous body of bioactive material, and a support structure supporting the porous body and acting as a mechanical reinforcement for the bioactive body, with the support structure being of a material which is less porous than the body.
  • Ike porous bioactive body or biomaterial thus, in use, permits bone growth into its porous spaces, thereby to secure its incorporation into and osteointegration with the surrounding viable bone at the margins of a bone defect at the site where the artefact is implanted.
  • the bioactive body may thus be ⁇ steoccmductive, ie permitting bone growth into its porous spaces when it i ⁇ in direct contact with viable bone, and/or osteoinductive, ie permitting bone growth into its porous spaces independently of the presence of viable bone in contact with the artefact.
  • the poree should, for good oste ⁇ inductive or osteocon ⁇ uetive capability, comprise from 40 to 80% of the total volume of the bioactive body. At least some of the pores must be connected to the outer or external surface of the body, Thus, between 40 and 100% of the pores may be connected to the external body surface. This connection may be direct, eg by way of an aperture, channel, pathway or the like, from a pore to the surface, and/or even a pore integrated with the surface, eg being in the form of an indentation or concavity in the surface.
  • connection of the pores to the external surface may be indirect, eg by a particular pore being connected to another pore which is connected directly to the external sur ce as described, or connected to a series or sequence of connected pores, at least one of which is directly connected to the surface, as described.
  • the pores may be of substantially spherical shape, and may have diameters or cross-sectional dimensions in the range 200-3000 micron.
  • the bioactive material of the body may be sintered bioactive ceramic or glass material.
  • it may be a calcium phosphate-based ceramic material such as hydroxyl-apatite or tricalcium phosphate.
  • the support structure may comprise at least two interconnected support components or parts.
  • the components or parts may at least partially surround or enclose the body and/or may be at least partially embedded in the body.
  • the body may be of more or less cylindrical or disc form/ with the support structure comprising a pair of rings abutting the respective ends of the body and a plurality of circumferentially spaced connecting members connecting the rings and extending alongside or through the body, with the rings and connecting members thus constituting interconnected support components of the * support structure.
  • the support structure is, as stated, less porous than the body.
  • the proportion of pores will be less than the proportion of pores in the body.
  • the pores in the support structure will comprise 20% or lees of the total volume of the support structure-
  • the support structure may even be of solid material, ie contain substantially no pores.
  • the material of the support structure may al ⁇ o be bioactive, and may then be the same as that of the body, eg it may be faydroxylapatite . instead, however, the material of the support structure may be resorbable. such as tricalcium phosphate; it may be bioinert such as alumina; or it may be pliable such as high density polyethylene.
  • a bone implant by implantation thereof into a subject at a body site where bone growth is required comprises compressing a precursor mixture comprising a bioactive material in particulate form and hea -decomposable particles of a heat-decomposable substance, to form a green body, with the green body having spaces or recesses for a support structure; filling the spaces or recesses with a support structure material in particulate form, to form a non-consolidated green body; compressing the non-consolidated green body to form ⁇ consolidated green body,- heating the consolidated green body, to permit controlled decomposition of the heat-decomposable particles and to sinter the body and the support structure, thereby to form a unitary artefact comprising a porous bioactive body and a less porous support structure supporting the porous bioactive body and acting as a mechanical reinforcement for the porous bioactive body.
  • both the bioactive material and the support structure material may be hydroxylapatite, and the material may initially be in powder form.
  • the heat decomposable particles may be stearic acid spheres, typically having a diameter between £00 and 1000 micron, with pores slightly smaller than this subsequently being formed in the body.
  • the mass ratio of powdered hydroxylapatite to stearic acid spheres will be selected to give a desired porosity to the body, and typically is about 2.3 by mass, to give a body porosity of about 55% to 70%, typically about S5%.
  • the initial compressing may he effected by uniaxially pressing the precursor mixture into the form of a solid cylinder or disc having circumferential recesses in its ends and circu ferentially spaced recesses in its side, or S passageways through it, interconnecting the circumferential recesses .
  • This pressing may be effec ed at low pressure eg at about 5 MPa.
  • the subsequent compressing of the non-consolidated green body may also be in the form of uniaxial pressing, which may be at a higher pressure eg at about 50 MPa.
  • the heating or firing may initially be effected at a first predetermined rate, eg at about 25 ⁇ C/hour, up to a first predetermined temperature, eg about 100*C, to permit controlled melting and decomposition of the stearic acid spheres; thereafter at a second predetermined rate, eg about 50*C/hour, up to a second predetermined temperature, eg to.
  • a first predetermined rate eg at about 25 ⁇ C/hour
  • a first predetermined temperature eg about 100*C
  • a second predetermined rate eg about 50*C/hour
  • a third predetermined rate eg about lOO'C/hour
  • a third predetermined temperature eg about l2S0 ⁇ C
  • this temperature being maintained for a predetermined soak time, eg about 4 hours, to sinter the body and the support structure-
  • the artefact is then allowed to cool to room temperature, while keeping it in the furnace. This cooling is typically effected for about ⁇ hours.
  • reference numeral ID generally indicates the artefact-
  • the artefact 10 includes a solid cylindrical or disc like porous hydroxyiapatite body 12, and a less porous support structure 14 also of hydxoxylapatite supporting the body 12.
  • the body 12 thus comprises circular planar ends 16, 18 and a cylindrical outer surface 20 between the ends 16, 18.' Circumferential recesses 22 are provided in the ends 16, 18, with circumferentially spaced grooves or recesses 24 provided in the surface 20 and connecting the recesses 22.
  • the body 12 typically has a porosity of 40-80%, based on the total volume of the body, with the 3iae of the pores, which are substantially spherical, being in the range 600-1000 microns, 40-100% of the o es are connected to the internal surfaces of the body 12, either directly or indirectly as hereinbefore described.
  • the support structure 14 comprises rings 26 of hydroxylapafcite located in the recesses 22 and integrally bonded or fused with the body 12 by sinterin .
  • the support structure 14 also comprises support members in the form of pillars or pins 28 extending along the recesses or passageways 24 and connecting the rings 2S-
  • the pillars or pints 23 are also integrally sintered with the body 12 and the rings 25.
  • the support structure 14 is of substantially solid hydr ⁇ xylapatite, ie contains substantially no pores.
  • the artefact 10 can be formed by initially preparing a precursor mixture.
  • the precursor mixture comprises hydroxylapatite powder mixed with 600-1000 micron diameters stearic acid spheres in a mass ratio of 2.-3.
  • a cylindrical or disc-like compact is uniaxially pressed at a IDW pressure of 5 MPa from th ⁇ precursor mixture, using a die and pistons (not shown) with inserts (also not shown) in such a way that the recesses 22 and passageways 24 are formed therein.
  • the pistons and inserts are removed from the die, and the recesses and passageways filled with* hydrcxylapatite powder.
  • the resultant non-consolidated green body or assembly is then uniaxially pressed at a higher pressure of 50 MPa, to form a well consolidated green body.
  • the green body is fired in a furnace at an initial heating rate of 50 ⁇ C/hour up to 500 C C to allow controlled melting and decomposition of the stearic acid spheres, thereby forming the voids in the body.
  • the arcefacs is further heated at a heating rate of 100*C/hour up to 1250 ⁇ C, and maintained at this temperature for a soak time of 4 hours, to sinter the body and the support structure 14, and to fuse them together.
  • the resultant artefact thus has its support structure 14 intimately bound to the body 12-
  • the support structure 14 thus provides a mechanical reinforcement for the body 13, thereby rendering it suitable for load bearing applications. More specifically, the support structure 14 imparts strength to the artefact 10, while the porous body 12, in use, encourages bone generation and hone growth, either by osteocondouctivity or osteoinductivity.
  • a high degree of porosity ie a high percentages of pores in the porous body, as well as a large number of pores, ie pores of as small a size as is feasible so as to have a large number of small pores rather than a small number of large pores, are desirable for good bone growth.
  • the spacing between the pores in the body 12 can also be maintained at as email a distance as is practically feasible, eg the pores can coalesce into each other rather than having them interconnected by relatively small channels or passageways which also inhibits hone ingrowth-
  • the Applicant thus believes that the artefact in accordance with the invention will give good results when used as a bone .substitute in load bearing applications due to - its open fully connected approximately spherical pores of 200-3000 micron diameter its high volume fraction of such open porosity, which will permit significant bone ingrowth the rein orcement provided by the support structure 14 which provides adequate mechanical property the absence of foreign intrusions or second phase materials which could inhibit bone ingrowth; however, if desired, the support structure can be of a second phase or different material - is manufactured of hydroxylapatit ⁇ which has intrinsic ⁇ steoinductive capability.
  • the artefact of the present provides over known bone implants
  • the solid ceramic support structure 14 can, as ' described, have the same chemical composition as the .porous bioactive ceramic body or structure 12, thereby 0 minimizing the possibility of unwanted interreact ons between the support structure 14 and the body 12 if desired, however, the solid ceramic support structure 14 Can have a di erent chemical composition to that of the porous bioactive ceramic body 12 eg it 5 can have a closely related but resorbable composition, to allow gradual resorption of the solid support during bone ingrowth in the porous body 12; the solid support' structure 14 thus provides mechanical support end need not necessarily possess bioactive properties 0 - the extent of support and directional properties of the support structure 14 can be readily modified or optimised for particular applications during manufacture, it is possible to extend the solid support structure by protru

Abstract

An artefact (10) suitable for use as a bone implant by implantation thereof into a subject at a body site where bone growth is required, comprises a porous body (12) of bioactive material, and a support structure (14) supporting the porous body (12) and acting as a mechanical reinforcement for the bioactive body (12). The support structure (14) is of a material which is less porous than the body (12).

Description

AN ARTEFACT SUITABLE! FOR USE A3 A BOMB IMPIiAKT
THIS INVENTION ralates to an artefact suitable for use as a bone implant by implan a on thereof into a subject at a body 3ite where bone growth is required, ϊt relates also to a method of making such an artefact.
According to a first aspect of the invention, there is provided an artefact suitable for use as a bone implant by implantation thereof into a subject at a body site where bone growth is required, the artefact comprising a porous body of bioactive material, and a support structure supporting the porous body and acting as a mechanical reinforcement for the bioactive body, with the support structure being of a material which is less porous than the body.
Ike porous bioactive body or biomaterial thus, in use, permits bone growth into its porous spaces, thereby to secure its incorporation into and osteointegration with the surrounding viable bone at the margins of a bone defect at the site where the artefact is implanted. The bioactive body may thus be σsteoccmductive, ie permitting bone growth into its porous spaces when it iε in direct contact with viable bone, and/or osteoinductive, ie permitting bone growth into its porous spaces independently of the presence of viable bone in contact with the artefact.
The poree should, for good osteαinductive or osteoconάuetive capability, comprise from 40 to 80% of the total volume of the bioactive body. At least some of the pores must be connected to the outer or external surface of the body, Thus, between 40 and 100% of the pores may be connected to the external body surface. This connection may be direct, eg by way of an aperture, channel, pathway or the like, from a pore to the surface, and/or even a pore integrated with the surface, eg being in the form of an indentation or concavity in the surface. Instead, or additionally, the connection of the pores to the external surface may be indirect, eg by a particular pore being connected to another pore which is connected directly to the external sur ce as described, or connected to a series or sequence of connected pores, at least one of which is directly connected to the surface, as described.
The pores may be of substantially spherical shape, and may have diameters or cross-sectional dimensions in the range 200-3000 micron.
The bioactive material of the body may be sintered bioactive ceramic or glass material. In particular, it may be a calcium phosphate-based ceramic material such as hydroxyl-apatite or tricalcium phosphate.
The support structure may comprise at least two interconnected support components or parts. The components or parts may at least partially surround or enclose the body and/or may be at least partially embedded in the body. For example, the body may be of more or less cylindrical or disc form/ with the support structure comprising a pair of rings abutting the respective ends of the body and a plurality of circumferentially spaced connecting members connecting the rings and extending alongside or through the body, with the rings and connecting members thus constituting interconnected support components of the* support structure.
The support structure is, as stated, less porous than the body. Thus, when pores are present in the material of the support structure, the proportion of pores will be less than the proportion of pores in the body. Typically, when the body has a porosity of 40-80% as hereinbefore described, the pores in the support structure will comprise 20% or lees of the total volume of the support structure- The support structure may even be of solid material, ie contain substantially no pores.
The material of the support structure may alβo be bioactive, and may then be the same as that of the body, eg it may be faydroxylapatite . instead, however, the material of the support structure may be resorbable. such as tricalcium phosphate; it may be bioinert such as alumina; or it may be pliable such as high density polyethylene.
According to a second aspect of the invention, there is provided a method of making an artefact suitable for use as
A bone implant by implantation thereof into a subject at a body site where bone growth is required, which method comprises compressing a precursor mixture comprising a bioactive material in particulate form and hea -decomposable particles of a heat-decomposable substance, to form a green body, with the green body having spaces or recesses for a support structure; filling the spaces or recesses with a support structure material in particulate form, to form a non-consolidated green body; compressing the non-consolidated green body to form ύ consolidated green body,- heating the consolidated green body, to permit controlled decomposition of the heat-decomposable particles and to sinter the body and the support structure, thereby to form a unitary artefact comprising a porous bioactive body and a less porous support structure supporting the porous bioactive body and acting as a mechanical reinforcement for the porous bioactive body.
As hereinbefore described, both the bioactive material and the support structure material may be hydroxylapatite, and the material may initially be in powder form.
The heat decomposable particles may be stearic acid spheres, typically having a diameter between £00 and 1000 micron, with pores slightly smaller than this subsequently being formed in the body. The mass ratio of powdered hydroxylapatite to stearic acid spheres will be selected to give a desired porosity to the body, and typically is about 2.3 by mass, to give a body porosity of about 55% to 70%, typically about S5%.
The initial compressing may he effected by uniaxially pressing the precursor mixture into the form of a solid cylinder or disc having circumferential recesses in its ends and circu ferentially spaced recesses in its side, or S passageways through it, interconnecting the circumferential recesses . This pressing may be effec ed at low pressure eg at about 5 MPa.
The subsequent compressing of the non-consolidated green body may also be in the form of uniaxial pressing, which may be at a higher pressure eg at about 50 MPa.
The heating or firing may initially be effected at a first predetermined rate, eg at about 25βC/hour, up to a first predetermined temperature, eg about 100*C, to permit controlled melting and decomposition of the stearic acid spheres; thereafter at a second predetermined rate, eg about 50*C/hour, up to a second predetermined temperature, eg to. about 400βC,- and then at a third predetermined rate, eg about lOO'C/hour, up to a third predetermined temperature, eg about l2S0βC, with this temperature being maintained for a predetermined soak time, eg about 4 hours, to sinter the body and the support structure- The artefact is then allowed to cool to room temperature, while keeping it in the furnace. This cooling is typically effected for about β hours.
The invention will now be described, by way of example, with reference to the accompanying drawing which shows a three-dimensional view of &n artefact for use as a bone implant by implantation thereof into a subject at a body site where bone growth is required, according to the invention.
In the drawing, reference numeral ID generally indicates the artefact- The artefact 10 includes a solid cylindrical or disc like porous hydroxyiapatite body 12, and a less porous support structure 14 also of hydxoxylapatite supporting the body 12.
The body 12 thus comprises circular planar ends 16, 18 and a cylindrical outer surface 20 between the ends 16, 18.' Circumferential recesses 22 are provided in the ends 16, 18, with circumferentially spaced grooves or recesses 24 provided in the surface 20 and connecting the recesses 22.
The body 12 typically has a porosity of 40-80%, based on the total volume of the body, with the 3iae of the pores, which are substantially spherical, being in the range 600-1000 microns, 40-100% of the o es are connected to the internal surfaces of the body 12, either directly or indirectly as hereinbefore described.
The support structure 14 comprises rings 26 of hydroxylapafcite located in the recesses 22 and integrally bonded or fused with the body 12 by sinterin . The support structure 14 also comprises support members in the form of pillars or pins 28 extending along the recesses or passageways 24 and connecting the rings 2S- The pillars or pints 23 are also integrally sintered with the body 12 and the rings 25.
The support structure 14 is of substantially solid hydrσxylapatite, ie contains substantially no pores.
The artefact 10 can be formed by initially preparing a precursor mixture. The precursor mixture comprises hydroxylapatite powder mixed with 600-1000 micron diameters stearic acid spheres in a mass ratio of 2.-3. A cylindrical or disc-like compact is uniaxially pressed at a IDW pressure of 5 MPa from thε precursor mixture, using a die and pistons (not shown) with inserts (also not shown) in such a way that the recesses 22 and passageways 24 are formed therein. The pistons and inserts are removed from the die, and the recesses and passageways filled with* hydrcxylapatite powder. The resultant non-consolidated green body or assembly is then uniaxially pressed at a higher pressure of 50 MPa, to form a well consolidated green body. The green body is fired in a furnace at an initial heating rate of 50βC/hour up to 500CC to allow controlled melting and decomposition of the stearic acid spheres, thereby forming the voids in the body. Thereafter, the arcefacs is further heated at a heating rate of 100*C/hour up to 1250βC, and maintained at this temperature for a soak time of 4 hours, to sinter the body and the support structure 14, and to fuse them together. The resultant artefact thus has its support structure 14 intimately bound to the body 12-
In the artefact 10, the support structure 14 thus provides a mechanical reinforcement for the body 13, thereby rendering it suitable for load bearing applications. More specifically, the support structure 14 imparts strength to the artefact 10, while the porous body 12, in use, encourages bone generation and hone growth, either by osteocondouctivity or osteoinductivity.
Generally, in bone substitutes or bone implants of hydroxylapatite or the like, a high degree of porosity, ie a high percentages of pores in the porous body, as well as a large number of pores, ie pores of as small a size as is feasible so as to have a large number of small pores rather than a small number of large pores, are desirable for good bone growth. However, as the number of pores and the porosity increases, the strength of the implant decreases, so that biomaterial comprising only porous hydrαxylapatite, normally cannot be used in load hearing applications, n contrast, with the artefact 10, which incorporates the* support structure 14 having either no pores or a lower porosity and a small number of pores, the required strength for load bearing application is achieved.
In the artefact 10, the spacing between the pores in the body 12 can also be maintained at as email a distance as is practically feasible, eg the pores can coalesce into each other rather than having them interconnected by relatively small channels or passageways which also inhibits hone ingrowth-
The Applicant thus believes that the artefact in accordance with the invention will give good results when used as a bone .substitute in load bearing applications due to - its open fully connected approximately spherical pores of 200-3000 micron diameter its high volume fraction of such open porosity, which will permit significant bone ingrowth the rein orcement provided by the support structure 14 which provides adequate mechanical property the absence of foreign intrusions or second phase materials which could inhibit bone ingrowth; however, if desired, the support structure can be of a second phase or different material - is manufactured of hydroxylapatitε which has intrinsic αsteoinductive capability. Additional advantages which the artefact of the present provides over known bone implants include* it is possible to concentrate the solid support structure in specific regions of the artefact, while S retaining a large volume f action of suitable porosity in the remainder or the artefact, ie in the body 12 the solid ceramic support structure 14 can, as' described, have the same chemical composition as the .porous bioactive ceramic body or structure 12, thereby 0 minimizing the possibility of unwanted interreact ons between the support structure 14 and the body 12 if desired, however, the solid ceramic support structure 14 Can have a di erent chemical composition to that of the porous bioactive ceramic body 12 eg it 5 can have a closely related but resorbable composition, to allow gradual resorption of the solid support during bone ingrowth in the porous body 12; the solid support' structure 14 thus provides mechanical support end need not necessarily possess bioactive properties 0 - the extent of support and directional properties of the support structure 14 can be readily modified or optimised for particular applications during manufacture, it is possible to extend the solid support structure by protrusions such as pins or end 5 cape which can be useful in locating or fixing the position of the implant relative to that of the natural bone or tissue at the defect it is possible to employ minimal mechanical reinforcement, for example to prevent edge chipping or 0 fracture which occur due to bending of porous ceramics, in non-load bearing applications-

Claims

___&___S -
1- An artefact suitable for use as a bone implant by implantation thereof into a subject at a body site where hone growth is required, the artefact comprising a porous body of bioactive material, and a support structure supporting the porous body and acting as a mechanical reinforcement for the bioactive body, with the support structure being of a material which is lees porous than the body-
2. An artefact according to Claim 1, wherein the porous body is osteoconductive and osteoinductive-
3. An artefact according to Claim 1 or Claim 2, wherein the pores of the body comprise from 40% to 80% of the total volume of the body.
4. An artefact according to any one of Claims i to 3 inclusive, wherein from 40% to 100* of the pores of the body are connected to the outer or external surface of the body-
5. An artefact according to Claim 4, wherein the connection of the pores of the body to the external surface of the body is directly by way of apertures, channels or pathways from the pores to the body surface and/or hy way of pores integrated with the external body surf ce lay being in the form of indentations or concavities in the external body surface.
S. An artefact according to Claim 4, wherein the connection of the pores of the body to the external surface of the body is indirectly by means of pores connected to other pores which are connected directly to the external surface of the body and/or by means of pores connected to a series or sequence of connected pores, at least one of which is directly connected to the external surface.
7. An artefact according to any one of Claims l to
6 inclusive, wherein the pores are of substantially spherical shape, and have diameters in the range 200-3000 microns .
8. An artefact according to any one of Claims 1 to
7 inclusive, wherein the bioactive material of the body is hydroxylapatite or tricalcium phosphate.
9, An artefact according to any one of claims 1 to
8 inclusive, wherein the support structure comprises at leas . wo interconnected support components or parts which at least partially surround or enclose th╬╡ body and/or are at least partially embedded in the body.
10. An artefact according to Claim 9, wherein the body is of more or less cylindrical or disc form, with the support structure comprising a pair of rings abutting the respective ends of the body and a plurality of circumferentially spaced connecting members connecting the rings and extending alongside or through the body, with the rings and connecting members thus constituting interconnected support components of the support structure .
11. An artefact according to any one of Claims l to IQ inclusive, wherein pores are present in the material of the support structure, with the proportion of the pores in the material of the support structure being less than the proportion of the pores in the body.
12. An arte act according to any one of Claims 1 to 10 inclusive, wherein the material of the support structure is solid and thus contains substantially no pores.
13- A method of making an artefact suitable for use as a bone implant by implantation thereof into a subject at a body site where bone growth is required, which method comprises compressing a precursor mixture comprising a bioactive material in particulate form and heat-decomposable particles of a heat-decomposable substance, to form a green body, with the green body having spaces or recesses for a support structure? filling the spaces or recesses with a support structure material in particulate form, to form a non-consolidated green body, compressing the non-consolidated green body to form a consolidated green body; heating the consolidated green body, to permit controlled decomposition of the heat-decomposable particles and to sinter the body and the support structure, thereby to form a unitary artefact comprising a porous bioactive body and a less porous support structure supporting the porous bioactive body and acting as a mechanical reinforcement for the porous bioactive body.
14, A method according to laim 13, wherein both the bioactive material and the support structure material are hydroxylapatite, which is initially in powder form.
15- A method according to Claim 14, wherein the heat decomposable particles are stearic acid spheres, having a diameter between 500 and 1000 microns, with pores slightly smaller than this subsequently being formed in the body.
16. A method according to Claim 15, wherein the mass ratio of powdered hydroxylapatite to stearic acid spheres is about 2;3 by mass, to give a body porosity of about 55% to 70%.
17. A method according to Claim 15 or Claim l╬▓, wherein the initial compressing is effected by uniaxially pressing the precursor mixture into the form of a solid cylinder or disc having circumferential recesses in its ends and circumferentially spaced recesses in its side and/or passageways through it and interconnecting the circumferential recesses, with the pressing being effected at a low pressure of about 5 MPa.
18. A method according to Claim 17, wherein the subsequent compressing of the non-consolidated green body is also in the form of uniaxial pressing, which is at a higher pressure of about SO MPa.
19. A method according to any one of Claims 15 to 18 inclusive, wherein the heating or firing of the green body ie initially effected at a first rate, up to a first temperature, to permit controlled melting and decomposition of the stearic acid spheres,- thereafter at a second rate, up to a second temperature,- and then at a third rate, up to a third temperature, with th╬╡ third temperature being maintained for a soak time, fco effect the sintering of the body and the support structure, whereafter the artefact is allowed to cool t╬▒ room temperature.
20- A novel artefact, substantially as described and illustrated herein,
21. A novel method of making an artefact, substantially as described and illustrated herein.
PCT/EP1998/001218 1997-03-04 1998-03-04 An artefact suitable for use as a bone implant WO1998038948A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU64998/98A AU6499898A (en) 1997-03-04 1998-03-04 An artefact suitable for use as a bone implant
EP98910723A EP0900064A1 (en) 1997-03-04 1998-03-04 An artefact suitable for use as a bone implant

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ZA97/1865 1997-03-04
ZA971865 1997-03-04

Publications (1)

Publication Number Publication Date
WO1998038948A1 true WO1998038948A1 (en) 1998-09-11

Family

ID=25586277

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1998/001218 WO1998038948A1 (en) 1997-03-04 1998-03-04 An artefact suitable for use as a bone implant

Country Status (3)

Country Link
EP (1) EP0900064A1 (en)
AU (1) AU6499898A (en)
WO (1) WO1998038948A1 (en)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6126688A (en) * 1998-12-21 2000-10-03 Surgical Dynamics Inc. Apparatus for fusion of adjacent bone structures
GB2356140A (en) * 1999-09-08 2001-05-16 Asahi Optical Co Ltd A sustained release chemical substance carrier
EP1197233A1 (en) * 2000-10-13 2002-04-17 Toshiba Ceramics Co., Ltd. Porous ceramics body for in vivo and in vitro use
WO2001070136A3 (en) * 2000-03-22 2002-05-30 Synthes Usa Plugs for filling bony defects
US6776860B2 (en) 1998-11-30 2004-08-17 Pentax Corporation Ceramic composite and manufacturing method thereof
EP1508311A3 (en) * 2003-08-21 2005-12-21 Yasumasa Akagawa Method for fixing an implant, fixing member for the implant and implant composite
WO2006128904A1 (en) * 2005-06-01 2006-12-07 Ulrich Breckwoldt Bone regeneration element for stabilising artificial tooth roots
US8603184B2 (en) 2002-04-03 2013-12-10 DePuy Synthes Products, LLC Kneadable and pliable bone replacement material
US8840614B2 (en) 2010-11-15 2014-09-23 DePuy Synthes Products, LLC Graft collection and containment system for bone defects

Citations (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2426814A1 (en) * 1973-06-05 1975-01-09 Atomic Energy Commission BONE PROSTHESIS AND METHOD OF MANUFACTURING GRAPHITE
EP0107476A2 (en) * 1982-10-25 1984-05-02 Calcitek, Inc. Bone graft substitute
DE3531144A1 (en) * 1984-09-25 1986-03-27 TDK Corporation, Tokio/Tokyo POROESES HYDROXYAPATITE MATERIAL AND ITS USE
EP0398497A1 (en) * 1989-04-14 1990-11-22 United States Surgical Corporation Method for moulding surgical implants
US5152791A (en) * 1989-12-07 1992-10-06 Olympus Optical Co., Ltd. Prosthetic artificial bone having ceramic layers of different porosity
US5211664A (en) * 1992-01-14 1993-05-18 Forschungsinstitut, Davos Laboratorium Fur Experimentelle Chirugie Shell structure for bone replacement
US5266248A (en) * 1990-05-10 1993-11-30 Torao Ohtsuka Method of producing hydroxylapatite base porous beads filler for an organism
US5290494A (en) * 1990-03-05 1994-03-01 Board Of Regents, The University Of Texas System Process of making a resorbable implantation device
US5296180A (en) * 1992-05-11 1994-03-22 Polyceramics, Inc. Ceramic process
EP0631763A1 (en) * 1993-07-01 1995-01-04 SULZER Medizinaltechnik AG Metallic filler for bone cavities
DE4409836A1 (en) * 1994-03-22 1995-09-28 Draenert Klaus Device for the mechanical protection of an implant or graft when inserted into and / or remaining in a living body
DE9413778U1 (en) * 1994-08-26 1996-01-04 Schaefer Micomed Gmbh Intervertebral implant
US5531794A (en) * 1993-09-13 1996-07-02 Asahi Kogaku Kogyo Kabushiki Kaisha Ceramic device providing an environment for the promotion and formation of new bone
EP0719529A1 (en) * 1994-12-26 1996-07-03 Kyocera Corporation Living body-supporting member and preparation process thereof
US5549123A (en) * 1993-12-29 1996-08-27 Ngk Spark Plug Co., Ltd. Process for producing biocompatible implant material by firing a mixture of a granulated powder and a combustible substance
WO1996028117A1 (en) * 1995-03-13 1996-09-19 Board Of Regents, The University Of Texas System Biodegradable implant for fracture nonunions

Patent Citations (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2426814A1 (en) * 1973-06-05 1975-01-09 Atomic Energy Commission BONE PROSTHESIS AND METHOD OF MANUFACTURING GRAPHITE
EP0107476A2 (en) * 1982-10-25 1984-05-02 Calcitek, Inc. Bone graft substitute
DE3531144A1 (en) * 1984-09-25 1986-03-27 TDK Corporation, Tokio/Tokyo POROESES HYDROXYAPATITE MATERIAL AND ITS USE
EP0398497A1 (en) * 1989-04-14 1990-11-22 United States Surgical Corporation Method for moulding surgical implants
US5152791A (en) * 1989-12-07 1992-10-06 Olympus Optical Co., Ltd. Prosthetic artificial bone having ceramic layers of different porosity
US5290494A (en) * 1990-03-05 1994-03-01 Board Of Regents, The University Of Texas System Process of making a resorbable implantation device
US5266248A (en) * 1990-05-10 1993-11-30 Torao Ohtsuka Method of producing hydroxylapatite base porous beads filler for an organism
US5211664A (en) * 1992-01-14 1993-05-18 Forschungsinstitut, Davos Laboratorium Fur Experimentelle Chirugie Shell structure for bone replacement
US5296180A (en) * 1992-05-11 1994-03-22 Polyceramics, Inc. Ceramic process
EP0631763A1 (en) * 1993-07-01 1995-01-04 SULZER Medizinaltechnik AG Metallic filler for bone cavities
US5531794A (en) * 1993-09-13 1996-07-02 Asahi Kogaku Kogyo Kabushiki Kaisha Ceramic device providing an environment for the promotion and formation of new bone
US5549123A (en) * 1993-12-29 1996-08-27 Ngk Spark Plug Co., Ltd. Process for producing biocompatible implant material by firing a mixture of a granulated powder and a combustible substance
DE4409836A1 (en) * 1994-03-22 1995-09-28 Draenert Klaus Device for the mechanical protection of an implant or graft when inserted into and / or remaining in a living body
DE9413778U1 (en) * 1994-08-26 1996-01-04 Schaefer Micomed Gmbh Intervertebral implant
EP0719529A1 (en) * 1994-12-26 1996-07-03 Kyocera Corporation Living body-supporting member and preparation process thereof
WO1996028117A1 (en) * 1995-03-13 1996-09-19 Board Of Regents, The University Of Texas System Biodegradable implant for fracture nonunions

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6776860B2 (en) 1998-11-30 2004-08-17 Pentax Corporation Ceramic composite and manufacturing method thereof
US6126688A (en) * 1998-12-21 2000-10-03 Surgical Dynamics Inc. Apparatus for fusion of adjacent bone structures
GB2356140A (en) * 1999-09-08 2001-05-16 Asahi Optical Co Ltd A sustained release chemical substance carrier
GB2356140B (en) * 1999-09-08 2004-03-17 Asahi Optical Co Ltd Sustained release chemical substance carrier and method for manufacturing therefor
US6719989B1 (en) 1999-09-08 2004-04-13 Pentax Corporation Sustained release drug carrier, and method of manufacturing sustained release drug carrier
WO2001070136A3 (en) * 2000-03-22 2002-05-30 Synthes Usa Plugs for filling bony defects
EP1197233A1 (en) * 2000-10-13 2002-04-17 Toshiba Ceramics Co., Ltd. Porous ceramics body for in vivo and in vitro use
US6713420B2 (en) 2000-10-13 2004-03-30 Toshiba Ceramics Co., Ltd. Porous ceramics body for in vivo or in vitro use
US8603184B2 (en) 2002-04-03 2013-12-10 DePuy Synthes Products, LLC Kneadable and pliable bone replacement material
US9050390B2 (en) 2002-04-03 2015-06-09 DePuy Synthes Products, LLC Kneadable and pliable bone replacement material
EP1508311A3 (en) * 2003-08-21 2005-12-21 Yasumasa Akagawa Method for fixing an implant, fixing member for the implant and implant composite
US7699612B2 (en) 2003-08-21 2010-04-20 Yasumasa Akagawa Method for fixing an implant, fixing member for the implant and implant composite
WO2006128904A1 (en) * 2005-06-01 2006-12-07 Ulrich Breckwoldt Bone regeneration element for stabilising artificial tooth roots
US8840614B2 (en) 2010-11-15 2014-09-23 DePuy Synthes Products, LLC Graft collection and containment system for bone defects
US9782259B2 (en) 2010-11-15 2017-10-10 DePuy Synthes Products, Inc. Graft collection and containment system for bone defects
US11026795B2 (en) 2010-11-15 2021-06-08 DePuy Synthes Products, Inc. Graft collection and containment system for bone defects

Also Published As

Publication number Publication date
EP0900064A1 (en) 1999-03-10
AU6499898A (en) 1998-09-22

Similar Documents

Publication Publication Date Title
EP1024841B1 (en) Bone substitutes
US7056577B1 (en) Body for providing ingrowth and growth of bone tissue and/or connective tissue and method of making such a body
US9545315B2 (en) Porous and nonporous materials for tissue grafting and repair
US6993406B1 (en) Method for making a bio-compatible scaffold
EP1755697B1 (en) Compressed porous materials suitable for implant
US5496372A (en) Hard tissue prosthesis including porous thin metal sheets
EP0900064A1 (en) An artefact suitable for use as a bone implant
US20150265745A1 (en) Porous and Nonporous Materials for Tissue Grafting and Repair
US6776860B2 (en) Ceramic composite and manufacturing method thereof
US10105207B2 (en) Porous and nonporous materials for tissue grafting and repair
US20220313442A1 (en) Osteogenic and angiogenic implant material
KR100426446B1 (en) Cylindrical Porous Bone Filler and Process for Its Production

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AL AM AT AU AZ BA BB BG BR BY CA CH CN CU CZ DE DK EE ES FI GB GE GH GM GW HU ID IL IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MD MG MK MN MW MX NO NZ PL PT RO RU SD SE SG SI SK SL TJ TM TR TT UA UG US UZ VN YU ZW

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): GH GM KE LS MW SD SZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH DE DK ES FI FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN ML MR NE SN TD TG

WWE Wipo information: entry into national phase

Ref document number: 1998910723

Country of ref document: EP

121 Ep: the epo has been informed by wipo that ep was designated in this application
WWP Wipo information: published in national office

Ref document number: 1998910723

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 09180331

Country of ref document: US

WWW Wipo information: withdrawn in national office

Ref document number: 1998910723

Country of ref document: EP

REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

NENP Non-entry into the national phase

Ref country code: CA

NENP Non-entry into the national phase

Ref country code: JP

Ref document number: 1998538156

Format of ref document f/p: F