EP0994735A1 - Produits ou structures formes pour applications medicales - Google Patents

Produits ou structures formes pour applications medicales

Info

Publication number
EP0994735A1
EP0994735A1 EP98931822A EP98931822A EP0994735A1 EP 0994735 A1 EP0994735 A1 EP 0994735A1 EP 98931822 A EP98931822 A EP 98931822A EP 98931822 A EP98931822 A EP 98931822A EP 0994735 A1 EP0994735 A1 EP 0994735A1
Authority
EP
European Patent Office
Prior art keywords
coral
product
structure according
medical
bone
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Withdrawn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
EP98931822A
Other languages
German (de)
English (en)
Other versions
EP0994735A4 (fr
Inventor
Razi Vago
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.)
Australian Institute of Marine Science
Original Assignee
Australian Institute of Marine Science
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
Priority claimed from AUPO7705A external-priority patent/AUPO770597A0/en
Priority claimed from AUPO7706A external-priority patent/AUPO770697A0/en
Application filed by Australian Institute of Marine Science filed Critical Australian Institute of Marine Science
Publication of EP0994735A1 publication Critical patent/EP0994735A1/fr
Publication of EP0994735A4 publication Critical patent/EP0994735A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0012—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/866—Material or manufacture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/227—Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/005—Ingredients of undetermined constitution or reaction products thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/043—Proteins; Polypeptides; Degradation products thereof
    • A61L31/047—Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8665—Nuts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8695—Washers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A61F2002/2817—Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30224—Three-dimensional shapes cylindrical
    • A61F2002/30235—Three-dimensional shapes cylindrical tubular, e.g. sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The 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
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30405—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by screwing complementary threads machined on the parts themselves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The 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
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/30507—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism using a threaded locking member, e.g. a locking screw or a set screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The 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
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
    • A61F2002/3055—Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting length
    • A—HUMAN NECESSITIES
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30886—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts externally-threaded
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    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4631—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor the prosthesis being specially adapted for being cemented
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    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00341—Coral, e.g. aragonite, porite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

  • This invention relates to shaped products or structures, including prosthetic or implant devices, for medical or related purposes, and in particular to prosthetic or implant devices and other shaped products or structures for use in bone tissue engineering in the fields of human medicine and dentistry, as well as in non-human veterinary fields.
  • Crane et al. (1995) point out that skeletal deficiencies resulting from trauma, tumours or abnormal development frequently require surgical intervention to restore normal tissue function. Even though current surgical treatments are often successful, all have associated problems with limitations.
  • the limited supply of autograft tissue and the potential of pathogen transfer with allografts have inspired surgeons and engineers to search for other methods to repair skeletal defects.
  • Synthetic materials such as metals and bone cements have also been used for many years, but often result in stress-shielding to the surrounding bone and fatigue failure of the implant.
  • scaffolds for cell transplantation must have a high porosity for maximal cell loading, surface characteristics that support cell growth and differentiated function and appropriate pore morphology for bone tissue ingrowth in vivo.
  • conduits relies on their ability to induce surrounding tissue to invade, grow and replace the implanted material.
  • US Patent No. 4,861 ,733 discloses calcium phosphate materials useful as bone substitution material or for the manufacture of prosthetic devices which have been prepared from calcium hydroxyapatite material which has a uniformly permeable microporous structure characterised by a substantially uniform pore volume in the range from about 10 to about 90% and by a pronounced three- dimensional fenestrate structure corresponding to the microstructure of the porous carbonate echinoderm or scleractinian coral skeletal material of marine life, by reacting the calcium hydroxyapatite material which has a calcium to phosphorous atomic ratio of about 1.66 with a phosphate-contributing or phosphorous-contributing moiety or with a calcium-contributing or calcium oxide-contributing moiety so as to alter the calcium to phosphorous Ca/P atomic ratio to yield a calcium phosphate material retaining the above-described microstructure of the porous carbonate echinoderm or scleractinian coral skeletal material but
  • Interpore International discloses synthetic biomaterials useful for onthopedicaneal dental applications which have a base portion of calcium carbonate and a surface layer of a synthetic phosphate such as hydroxyapatite.
  • the base portion may be a calcium carbonate structure having three- dimensional interconnected porosity such as may be found in porous skeletal carbonate of marine life, e.g. coral porites skeletal aragonite, or it may be porous or non-porous granules of calcium carbonate.
  • a shaped product or structure for medical or related purposes characterised in that it is formed from coral, preferably coral of the species Porites or Acropora species, particularly Acropora species such as Acropora grandis.
  • the present invention also provides a device for medical or related purposes which comprises an assembly of shaped products or structures, as broadly described above.
  • a prosthetic or implant device for medical or related purposes, particularly for use in repair of fracture of a long bone or when elongation of a long bone is required.
  • the prosthetic or implant device of this aspect of the invention comprises an assembly of shaped members formed from coral, preferably coral of the species Porites or Acropora, the assembly comprising first and second elongate members each of which is adapted to be fixed at one end to a long bone, the other ends of each of said first and second elongate members being externally and internally threaded, respectively, so that said first member is received by said second member in a threaded inter-engagement to enable the overall length of the device to be adjusted.
  • the threaded inter-engagement of the first and second elongate members of the device of this invention enables the overall length of the device to be adjusted to the length required for the particular use, that is in repair of a fracture or in elongation of a long bone, before the device is fixed in place, for example between the ends of a fractured long bone.
  • an internally-threaded third member is also provided in threaded engagement with the first member to act as a locking nut and lock the second member with respect to the first member at a desired overall length.
  • Coral is the hard deposit consisting principally of calcium carbonate which is built up by minute colonial marine invertebrate animals called coral polyps .
  • the corals of the order Hydrocoralline of the Class Hydrozoa exist as sessile colonies with a massive encrusting or branching exoskeleton with pits in the surface from which the polyps arise.
  • the corals of the orders Alcyonaria and Zoantharia of the Class Anthozoa (Actinozoa) are of different form and habits.
  • Those of the alcyonarians are made up of minute spicules formed within the tissues, occasionally compacted in a hard central rod running through the entire colony and sometimes supplemented by an external covering.
  • Zoantharian corals build up hard deposits externally beneath the basal disk which attaches them to the ocean floor. As new individuals arise from the edge of the living tissue their deposits become continuous with those already laid down and so large colonies produce extensive masses of coral rock. The form of these deposits varies. Some are slender and branching and others rounded and massive. They have received common names such as staghorn coral and brain coral (Van Nostrand's Scientific Encyclopaedia, Eight Edition, Van Nostrand, Reinhold, 1995).
  • Surgical repair of large cortical and other defects, in both humans and non- humans, resulting from traumas or tumour resection presents many challenges. Significant morbidity is associated with autograft harvest sites and the quantity of material available for use in the repair is limited. A bone defect might regenerate more efficiently if a stromal substitute is implanted to provide a framework for organisation of the osteons. By providing a scaffold containing spaces morphologically compatible with osteons and their vascular interconnections, an association between biocomponents and biologic regenerative and repair responses can be promoted.
  • a wide range of metallic, ceramic, polymeric and composite materials have been used in the construction of medical devices for implantation into the human body (Hench and Wilson, 1993).
  • the types of implant can be presented as follows: (1) nearly inert; (2) porous; (3) bioactive; (4) resorbable. Porous structure devices were developed to prevent loosening of the implants.
  • the porous implant is metal, the large interfacial area can provide a focus for corrosion of the implant and loss of metal ions into the tissue.
  • a film of hydroxyapatite (HA) often coats these, for a more rapid bond of the natural bone to the devices (Hench and Wilson, 1993; Lacefield, 1993; Dunn and Maxiian, 1994). The coatings, however, often dissolve with time, which limits their effectiveness.
  • porous implants it is necessary for the pores to be at least 100 micrometers in diameter to allow capillaries to provide a blood supply to the ingrown connective tissue. It is important to note that interfacial stability is crucial for a clinical successful implantation. Resorbable implants are designed to gradually degrade and be replaced with natural tissue, leading to regeneration of tissue instead of its replacement. The difficulty is to meet the requirements of strength and short-term and mechanical performance during the processes.
  • the rationale for using the calcium carbonate structure of coral as a bone substitute material is based on the fact that natural bone is approximately 70% hydroxyapatite by weight and 50% by volume. Porosity and interconnectivity are key factors with respect to the amount and type of ingrowth of tissue into the lattice structure of coral. For example, in highly porous and interconnected implants, tissue ingrowth starts by day three or four. By four weeks, the ingrowth is completed and apposition of bone covering the pore walls has began. In animal models, bone ingrowth may be nearly complete by three months.
  • Particularly preferred for use in the present invention are two species of corals.
  • the first one, Po ⁇ tes is more porous and softer; while the other Acropora is stronger, harder and less porous.
  • the entire skeleton deposited by a single polyp or by a colony is the corallum.
  • the skeletons around an individual polyp are corallites and the upper open or end of a carollities is the calyx.
  • the calices are mostly arranged in a hexagonal closed packed array.
  • Po tes species traditionally have been difficult to distinguish. Confusion results from the fact that some coral species tend to be plastic mainly in response to some environmental parameters such as light intensity, water motion, temperature etc. The plasticity is evidenced by the same species exhibiting a variety of growth forms and colours etc.
  • the void to solid ratios is generally in the range of 0.4 to 0.6, and the void phase completely interconnects, forming a highly regular network that interpenetrates the solid calcium carbonate phase.
  • the micro architecture of the solid and void spaces is nearly identical. The species control regulatory of microstructure characteristics is attractive to material scientists because this uniform and interconnecting architecture has not been matched in man-made, synthetic materials.
  • Porites species are highly porous and possess a regular and uniform micro configuration (structure) of the skeleton. Colonies can grow to 10m in diameter and can be found in the reef slopes and lagoons.
  • the average density for Porites species from the Great Barrier Reef in Australia is ⁇ 1.4 g/cm 3 .
  • the average pore size in species growing at outer edge of the Great Barrier Reef is ⁇ 200 ⁇ but it can vary between the locations.
  • the most common growth form of Acropora is the branched form with Acropora grandis forming staghorn- like colonies. Branches of a typical colony can be very long (a few metres in height) and as thick as 10-15cm. This species grows 20-25cm a year. Since this species is very common and fast growing, samples can be easily collected in sheltered areas of the coral reefs. In addition it is also very easy to culture this species so that collection from the coral reefs can be avoided by use of cultured coral material.
  • the average skeletal density of Acropora grandis is ⁇ 2.7g/cm 3 Because the skeleton of this coral species is dense and strong, it can be easily machined to a variety of configurations of shaped products or structures of different sizes, for example by grinding. This material is particularly suited for use in an implant device, in particular for load bearing bones where strength is an essential property of the implant device.
  • the prosthetic or implant devices and other shaped products or structures of the present invention are provided for medical or related purposes.
  • the term "medical or related purposes" is used throughout this specification to include the fields of human and non-human medicine and dentistry in particular.
  • the shaped products or structures of this invention may be used as bone implants or protheses, or as dental implants or prostheses.
  • the shaped products or structures may be "hardware" items for medical or related purposes including, but not limited to, various cylinders, sleeves, pins, screws, bolts, nuts, spacers, flat or curved plates or the like. Some typical hardware items are shown by way of example only in Figure 1. These shaped products or structures which are "hardware” items are preferably formed from coral of the species Acropora.
  • FIG. 2 shows a typical such device, however it is to be understood that this Figure is included by way of example only and the present invention is not restricted to devices of the type shown in Figure 2.
  • Figure 2 shows an implant device 10 for insertion between the ends 30 and 31 of a long bone (see Fig 2e), for example the ends formed by fracture of the long bone, or when elongation of the bone is needed.
  • Device 10 comprises a threaded male pin 11 (see Fig 2a), an internally threaded female socket 12 (see Fig 2b) and an internally threaded locking nut 13 (see Fig 2c).
  • Fig 2d shows the assembled device 10.
  • male pin 11 (which is optionally hollow as shown at 23) consists of an externally threaded shank portion 21 and a head portion 22 which incorporates a socket 24 of suitable dimensions to receive the end of a long bone, which in use of the device will be fixed into the socket, for example using bone cement or similar material or by use of suitable screws, pins or the like.
  • Female socket 12 is internally threaded as shown at 25, and is similarly provided with a socket 26 to receive the end portion of a long bone.
  • Locking nut 13 is also internally threaded as shown at 27.
  • Fig 2d shows the assembled device 10 that the overall length of the device, and hence the distance between the ends of a long bone into which the device is inserted, can be adjusted by screwing the female socket 12 along the shank portion 21 of the male pin 11 , and then locking the socket 12 in place with the locking nut 13.
  • the various shaped members of the device 10 are preferably formed from coral of the species Porites or Acropora.
  • off-shore coral colonies were collected from the Great Barrier Reef in Australia using lifting bags and baskets.
  • the colonies were immediately soaked in a bleaching solution. Since clearing the residual organic matrix is one of the first tasks in the purification process, the first steps were started immediately following collection of the coral. It has been found that by bleaching the colonies immediately after collection and while the colonies were still wet, the best results and cleanest colonies were obtained.
  • the colonies were then cut into blocks and machined into a variety of configurations as shown by way of example in Figure 1. After the initial bleaching and cleaning processes, samples were oven dried and kept in a semi-sterile, dry environment to avoid humidity and bacterial infections of the cleaned skeletal materials.
  • Special holders were fabricated from soft polyvinyl chloride polymer material to firmly secure the samples to avoid fractures during the machine processing of the samples.
  • Oven dried samples were transferred into an hydrostatic pressure chamber where distilled water was pressurised (150psi) into the skeleton, and particularly the fine cavities. This process reduces the amount of dust particles produced and allows easier machining (eg. grinding) of the samples. As an alternative, it has been found that dipping samples in liquid nitrogen creates a more solid substrate. After dipping in liquid nitrogen for 2 minutes, processing of the samples was easier and the surface produced by the machine processing was smoother.
  • the products or structures may be machined into a variety of configurations for various medical or related purposes, and quite complex shapes such as cylindrical structures and threaded structures may be formed by appropriate machine processing.
  • the shaped products or structures of the present invention may be used to adsorb or bind, and deliver, other therapeutically active substances which assist in the bone repair or regeneration process, or which have other desired therapeutic activity.
  • therapeutically active substances include, by way of example, known synthetic or semisynthetic antibiotics which may be introduced into the pore cavities of the shaped product or structure, or a growth factor such as transforming growth factor or one of the bone morphogenic proteins which can be used to assist or promote bone ingrowth.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Surgery (AREA)
  • Epidemiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Dermatology (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dentistry (AREA)
  • Cardiology (AREA)
  • Urology & Nephrology (AREA)
  • Zoology (AREA)
  • Botany (AREA)
  • Ceramic Engineering (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne une structure ou un produit formé comprenant un implant ou une prothèse pour des applications médicales ou apparentées. Cette structure ou ce produit se caractérise en ce qu'il est formé de corail.
EP98931822A 1997-07-07 1998-07-06 Produits ou structures formes pour applications medicales Withdrawn EP0994735A4 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
AUPO770597 1997-07-07
AUPO7705A AUPO770597A0 (en) 1997-07-07 1997-07-07 Prosthetic or implant device
AUPO770697 1997-07-07
AUPO7706A AUPO770697A0 (en) 1997-07-07 1997-07-07 Shaped products or structures for medical or related purposes
PCT/AU1998/000519 WO1999002200A1 (fr) 1997-07-07 1998-07-06 Produits ou structures formes pour applications medicales

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EP0994735A1 true EP0994735A1 (fr) 2000-04-26
EP0994735A4 EP0994735A4 (fr) 2004-05-26

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JP (1) JP2001509422A (fr)
CA (1) CA2295636A1 (fr)
IL (1) IL133739A (fr)
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WO (1) WO1999002200A1 (fr)

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FR2800267A1 (fr) * 1999-10-29 2001-05-04 Topline Technology Llc Obturateurs neurologiques
FR2863172B1 (fr) * 2003-12-05 2006-07-21 Biocoral Inc Procede de purification du corail
HUE043110T2 (hu) * 2008-11-20 2019-08-28 Cartiheal 2009 Ltd Szilárd formák szövetjavításhoz
DK2442749T3 (da) 2009-06-15 2019-05-27 Cartiheal 2009 Ltd Faste former til reparation af væv
US8361123B2 (en) 2009-10-16 2013-01-29 Depuy Spine, Inc. Bone anchor assemblies and methods of manufacturing and use thereof

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US4011602A (en) * 1975-10-06 1977-03-15 Battelle Memorial Institute Porous expandable device for attachment to bone tissue
US4978348A (en) * 1988-05-26 1990-12-18 Ilizarov Gavriil A Compression-distraction apparatus for osteosynthesis
US5129899A (en) * 1991-03-27 1992-07-14 Smith & Nephew Richards Inc. Bone fixation apparatus

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FR2600246B1 (fr) * 1986-06-23 1990-01-12 Camprasse Georges Racine dentaire de remplacement
US4976731A (en) * 1987-10-19 1990-12-11 Perry Arthur C Device for orbital implant
WO1989006944A1 (fr) * 1988-01-26 1989-08-10 Thierry Rainier Besins Systeme de formation de depots subperiostaux pour restauration faciale
FR2637502A1 (fr) * 1988-10-12 1990-04-13 Duroselle Patrick Materiau de xenogreffe osseuse et procede d'obtention
US4976736A (en) * 1989-04-28 1990-12-11 Interpore International Coated biomaterials and methods for making same
US5071655A (en) * 1990-01-12 1991-12-10 Baylink David J Pharmaceutical combination for treatment of bone-wasting diseases
US5563124A (en) * 1991-04-22 1996-10-08 Intermedics Orthopedics/ Denver, Inc. Osteogenic product and process
FR2679250B1 (fr) * 1991-07-19 1995-07-13 Inoteb Utilisation de carbonate de calcium poreux comme materiau support de culture in vitro de cellules eucaryotes.
FR2681235B1 (fr) * 1991-09-13 1993-11-12 Itac Var Implant Materiel d'osteosynthese a face de contact osseux recouverte par un revetement de surface.
US6376573B1 (en) * 1994-12-21 2002-04-23 Interpore International Porous biomaterials and methods for their manufacture
AU4721696A (en) * 1996-02-29 1997-09-16 T. Sam Lindholm An osteogenic device and a method for preparing the device

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US4011602A (en) * 1975-10-06 1977-03-15 Battelle Memorial Institute Porous expandable device for attachment to bone tissue
US4978348A (en) * 1988-05-26 1990-12-18 Ilizarov Gavriil A Compression-distraction apparatus for osteosynthesis
US5129899A (en) * 1991-03-27 1992-07-14 Smith & Nephew Richards Inc. Bone fixation apparatus

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See also references of WO9902200A1 *

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Publication number Publication date
IL133739A (en) 2005-03-20
NZ502022A (en) 2000-12-22
EP0994735A4 (fr) 2004-05-26
WO1999002200A1 (fr) 1999-01-21
CA2295636A1 (fr) 1999-01-21
JP2001509422A (ja) 2001-07-24
IL133739A0 (en) 2001-04-30

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