SE468502B - POROEST IMPLANT - Google Patents
POROEST IMPLANTInfo
- Publication number
- SE468502B SE468502B SE9101677A SE9101677A SE468502B SE 468502 B SE468502 B SE 468502B SE 9101677 A SE9101677 A SE 9101677A SE 9101677 A SE9101677 A SE 9101677A SE 468502 B SE468502 B SE 468502B
- Authority
- SE
- Sweden
- Prior art keywords
- implant
- range
- pores
- pore size
- implant according
- Prior art date
Links
Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B22—CASTING; POWDER METALLURGY
- B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
- B22F7/00—Manufacture of composite layers, workpieces, or articles, comprising metallic powder, by sintering the powder, with or without compacting wherein at least one part is obtained by sintering or compression
- B22F7/002—Manufacture of composite layers, workpieces, or articles, comprising metallic powder, by sintering the powder, with or without compacting wherein at least one part is obtained by sintering or compression of porous nature
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- 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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
-
- 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
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/025—Other specific inorganic materials not covered by A61L27/04 - A61L27/12
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/56—Porous materials, e.g. foams or sponges
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61C8/0018—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 shape
- A61C8/0037—Details of the shape
- A61C2008/0046—Textured surface, e.g. roughness, microstructure
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- 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
- 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
- A61C8/0016—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 polymeric material
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- 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
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
- A61F2/3662—Femoral shafts
-
- 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
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
- A61F2/3662—Femoral shafts
- A61F2/367—Proximal or metaphyseal parts of shafts
-
- 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
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
- A61F2/3662—Femoral shafts
- A61F2/3672—Intermediate parts of shafts
-
- 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
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material 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
- A61F2002/30011—Material 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
-
- 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
- A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
- A61F2002/30322—The prosthesis having different structural features at different locations within the same prosthesis differing in surface structures
-
- 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
- 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
- A61F2002/30795—Blind bores, e.g. of circular cross-section
- A61F2002/30803—Blind bores, e.g. of circular cross-section inclined obliquely
-
- 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
- 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
- A61F2002/30795—Blind bores, e.g. of circular cross-section
- A61F2002/30807—Plurality of blind bores
- A61F2002/30808—Plurality of blind bores parallel
-
- 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
- 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
- A61F2002/30795—Blind bores, e.g. of circular cross-section
- A61F2002/30807—Plurality of blind bores
- A61F2002/3081—Plurality of blind bores inclined obliquely with respect to each other
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—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
- A61F2002/3082—Grooves
- A61F2002/30823—Grooves having the shape of a reverse dovetail
-
- 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
- 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
- A61F2002/30838—Microstructures
-
- 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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
-
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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
- A61F2/40—Joints for shoulders
- A61F2/4059—Humeral shafts
- A61F2002/407—Intermediate parts of shafts
-
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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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special 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
- A61F2250/0023—Special 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
-
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- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special 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
- A61F2250/0026—Special 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 surface structures
-
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- 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
- A61F2310/00011—Metals or alloys
- A61F2310/00017—Iron- or Fe-based alloys, e.g. stainless steel
-
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- 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
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
-
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- 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
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00059—Chromium or Cr-based alloys
-
- A—HUMAN NECESSITIES
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- 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
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00185—Ceramics or ceramic-like structures based on metal oxides
- A61F2310/00233—Ceramics or ceramic-like structures based on metal oxides containing chromia or chromium oxides CrO, CrO2 or CrO3
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- 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
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00269—Ceramics or ceramic-like structures based on metal carbides
- A61F2310/00281—Ceramics or ceramic-like structures based on metal carbides containing silicon carbide
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- 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
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
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- 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
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00299—Ceramics or ceramic-like structures based on metal nitrides
- A61F2310/00317—Ceramics or ceramic-like structures based on metal nitrides containing silicon nitride
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Description
CA Q 10 15 20 25 30 35 (J1 CD {\) där Y är en geometrisk positions- och formfaktor, of utgör brott- hållfastheten och c anger största tillåtna defekt. CA Q 10 15 20 25 30 35 (J1 CD {\) where Y is a geometric position and shape factor, of constitutes the breaking strength and c indicates the largest permissible defect.
För kända material för implantatapplikationer, tex aluminiumoxid och hydroxylapatit med brottseghetsvärden på 3.0 respektive 1.0 MPaml/2 medför exempelvis en 200 pm stor por en maximal hållfasthetsnivå of av ca 150 respektive 40 MPa, vilket gör båda dessa implantatmaterial tveksamma för mekaniskt högpåkända tillämpningar. Risk föreligger dessutom för långsam spricktillväxt för speciellt hydroxylapatit, vilket medför att tolererbara spänningar lätt understiger angivna värden.For known materials for implant applications, such as alumina and hydroxylapatite with fracture toughness values of 3.0 and 1.0 MPaml / 2, for example, a 200 μm pore entails a maximum strength level of about 150 and 40 MPa, respectively, which makes both these implant materials doubtful for mechanically high stress applications. There is also a risk of slow crack growth, especially for hydroxylapatite, which means that tolerable stresses are easily below the stated values.
Nya konstruktionskeramer, exempelvis baserade på kiselnitrid eller zirkoniumoxid, är mer lämpade för dylika högpåkända tillämpningar. Ett keramiskt material som visat sig kunna behålla en relativt hög håll- fasthet trots närvaro av stor mängd porer är reaktionsbunden kisel- nitrid, Si3N4 (RBSN). Även vid dessa konstruktionskeramer, liksom även vid andra tänkbara implantatmaterial, såsom stål, titan och andra metaller, polymerer liksom vid andra oxidiska eller icke oxidiska keramer måste emellertid en avvägning ske mellan å ena sidan porosite- ten och porernas karaktär och å andra sidan kravet på hållfasthet.New construction ceramics, for example based on silicon nitride or zirconia, are more suitable for such high pressure applications. A ceramic material that has been shown to maintain a relatively high strength despite the presence of a large amount of pores is reaction-bonded silicon nitride, Si3N4 (RBSN). However, even with these structural ceramics, as well as with other conceivable implant materials, such as steel, titanium and other metals, polymers as well as with other oxidic or non-oxidic ceramics, a balance must be struck between the porosity and the nature of the pores and the requirement for strength.
KORT REDOGÖRELSE FÖR UPPFINNINGEN Ändamålet med uppfinningen är att erbjuda ett implantat av i ingressen angivet slag som i sig förenar en hög hållfasthet med höga krav på gynnsam situation för såväl beninväxt som för vävnadsinväxt med inte- grerad mjuk- och hårdvävnadssamverkan jämte möjlighet att åstadkomma reservoarer för i materialet deponerbara ämnen med specifika funk- tioner. Dessa och andra syften kan enligt uppfinningen uppnås däri- genom att kommunicerande porer med en porstorlek inom intervallet 0.1-10 pm upptar 10-80% av den totala porvolymen i nämnda åtminstone ett parti av materialet, att porer med en porstorlek inom intervallet 10-50 um upptar max 5% av den totala porvolymen i nämnda parti av materialet, och att 5-40% av ytan på nämnda åtminstone ett parti av '- implantatet täcks av väsentligen jämnt fördelade porer med en porstor- lek inom intervallet 50-500 um. 10 15 20 25 30 35 Företrädesvis upptar nämnda kommunicerande porer med en porstorlek inom intervallet 0.1-10 pm 25-75%, lämpligen 40-60% av den totala porvolymen i nämnda åtminstone ett parti av implantatmaterialet.BRIEF SUMMARY OF THE INVENTION The object of the invention is to offer an implant of the type stated in the preamble which in itself combines a high strength with high demands on a favorable situation for both bone ingrowth and for tissue ingrowth with integrated soft and hard tissue cooperation and the ability to provide reservoirs. in the material depositable substances with specific functions. These and other objects can be achieved according to the invention in that communicating pores with a pore size in the range 0.1-10 μm occupy 10-80% of the total pore volume in said at least a portion of the material, that pores with a pore size in the range 10-50 μm um occupies a maximum of 5% of the total pore volume in said portion of the material, and that 5-40% of the surface of said at least a portion of the implant is covered by substantially evenly distributed pores with a pore size in the range of 50-500 μm. Preferably, said communicating pores having a pore size in the range 0.1-10 μm occupy 25-75%, preferably 40-60% of the total pore volume in said at least a portion of the implant material.
Företrädesvis har huvuddelen, räknat på volymen, av de ovan nämnda kommunicerande porerna en porstorlek inom intervallet 0.3-8 pm, lämpligen inom intervallet 0.5-5 um.Preferably, the major part, by volume, of the above-mentioned communicating pores has a pore size in the range 0.3-8 μm, suitably in the range 0.5-5 μm.
Företrädesvis täcks ett 10-30%, lämpligen 15-25% av ytan inom nämnda åtminstone ett parti av implantatet av de väsentligen jämnt fördelade porerna med en porstorlek inom intervallet 50-500 pm.Preferably, a 10-30%, preferably 15-25% of the surface within said at least a portion of the implant is covered by the substantially evenly distributed pores with a pore size in the range of 50-500 μm.
Huvuddelen av de stora porerna i ytskiktet har företrädesvis en storlek inom området 75-400 pm, lämpligare storleken 100-300 pm och mest ändamålsenligt inom intervallet 150-250 pm.The majority of the large pores in the surface layer preferably have a size in the range 75-400 μm, more preferably the size 100-300 μm and most expediently in the range 150-250 μm.
De stora porerna förekommer enligt en utföringsform endast i ett ytskikt av implantatet, varmed förstås ett ytskikt som är 3 mm, företrädesvis 2 mm och lämpligen 0.3 mm tjockt.According to one embodiment, the large pores occur only in a surface layer of the implant, by which is meant a surface layer which is 3 mm, preferably 2 mm and preferably 0.3 mm thick.
Genom att materialet väsentligen saknar - eller åtminstone innehåller en mindre andel av - porer i intervallet 10-50 um kan vid måttliga krav på hållfasthet enligt en annan utföringsform av uppfinningen ändock stora porer förekomma i materialets inre. Enligt denna aspekt på uppfinningen upptas 10-80% av totala porvolymen av de större porerna med en porstorlek inom intervallet 50-500 pm, företrädesvis inom intervallet 75-400 pm, lämpligare inom intervallet 100-300 um och lämpligast inom intervallet 150-250 pm.Because the material substantially lacks - or at least contains a smaller proportion of - pores in the range 10-50 μm, with moderate requirements for strength according to another embodiment of the invention, large pores can still occur in the interior of the material. According to this aspect of the invention, 10-80% of the total pore volume of the larger pores is occupied by a pore size in the range of 50-500 μm, preferably in the range of 75-400 μm, more preferably in the range of 100-300 μm and most preferably in the range of 150-250 μm. .
Med porstorlek förstås, när det gäller porer med porstorlekar mindre eller lika med 50 pm, storlekar bestämda med traditionell Hg- porosimetri, där relationen mellan pordiameter (2 r) erhålls ur uttrycket _ 2 s cosF, p där I* 10 15 20 25 30 35 (_71 -cø m: p = trycket s = Hg's ytspänning vid aktuell temperatur F = meniskvinkel (randvinkel) (ref L C Ritter and R L Drake, Ind. Eng. Chem. lz 782 (1945)) För porstorlekar överstigande 50 um förstås storlekar erhållna genom optisk bestämning i ljusmikroskåp på ett tvärsnitt av proverna i ett snitt taget på 0,1 pm djup, respektive i ett snitt vinkelrätt provytan. Vidare förstås med uttrycket "den totala porvolymen i materialet" den porvolym som uppmäts genom vatteninträngning.By pore size is meant, in the case of pores with pore sizes less than or equal to 50 μm, sizes determined by traditional Hg porosimetry, where the relationship between pore diameter (2 r) is obtained from the expression _ 2 s cosF, p where I * 10 15 20 25 30 35 (_71 -cø m: p = pressure s = Hg's surface tension at current temperature F = meniscus angle (edge angle) (ref LC Ritter and RL Drake, Ind. Eng. Chem. Lz 782 (1945)) For pore sizes exceeding 50 μm, of course sizes obtained by optical determination in a light microscope on a cross section of the samples at a section taken at a depth of 0.1 [mu] m and in a section perpendicular to the sample surface, respectively, the term "total pore volume in the material" means the pore volume measured by water penetration.
Uppfinningen kännetecknas alltså av komplexa porstorleksfördelningar, vilket ger möjlighet till optimala kombinationer av hållfasthet och utbildning av mjukvävnad samt gynnsam beninväxt.The invention is thus characterized by complex pore size distributions, which provides the possibility of optimal combinations of strength and training of soft tissue as well as favorable bone growth.
Generellt kan sägas att de stora porerna är gynnsamma för beninväxt, medan de små porerna är gynnsamma för utbildning av mjukvävnad, sam- tidigt som de kan fungera som reservoarer för i materialet deponerade lösliga ämnen med specifika medicinska/biologiska funktioner. För att kunna medge gynnsam beninväxt respektive utbildning av mjukvävnad skall både de stora och de små porerna finnas i implantatets yta, åtminstone i ett parti av ytan där man önskar att nämnda funktioner skall vara verksamma. I hela materialet finns vidare de små porerna i ett kommunicerande porsystem för att kunna verka som nämnda reser- voarer för deponerade ämnen, såsom ämnen vilka innehåller kalcium och/eller P04, företrädesvis i form av kalciumfosfatmaterial, exempelvis hydroxylapatit, bentillväxtstimulerande hormon, antiinflammatoriska ämnen, etc.In general, it can be said that the large pores are favorable for bone growth, while the small pores are favorable for the formation of soft tissue, at the same time as they can function as reservoirs for soluble substances deposited in the material with specific medical / biological functions. In order to allow favorable bone ingrowth and soft tissue formation, respectively, both the large and the small pores must be present in the surface of the implant, at least in a portion of the surface where it is desired that said functions be effective. The whole material also contains the small pores in a communicating pore system in order to act as the said reservoirs for deposited substances, such as substances which contain calcium and / or PO 4, preferably in the form of calcium phosphate material, for example hydroxylapatite, bone growth stimulating hormone, anti-inflammatory substances. etc.
Implantatet framställs enligt uppfinningen av pulver, som konsolideras till en porös kropp, vilket kan utföras enligt någon i och för sig känd teknik, exempelvis konventionell sintring, kallpressníng följd av hetisostatisk pressning, eller genom nitridering eller liknande.The implant is prepared according to the invention from powders which are consolidated into a porous body, which can be carried out according to any technique known per se, for example conventional sintering, cold pressing followed by hetisostatic pressing, or by nitriding or the like.
Sålunda framställs exempelvis ett material av kiselnitrid företrädes-' vis genom nitridering av kiselkorn så att man erhåller så kallad reaktionsbunden kiselnitrid (RBSN), Si3N4. Materialet kan även cv:- n 10 15 20 25 30 35 468 502 innnehålla andra ämnen än Si3N4, men det bör vid val av detta material till åtminstone 80 vikts-% utgöras Si3N4. Bland andra tänkbara material må nämnas kalciumfosfatmaterial, exempelvis hydroxylapatit, Al2O3, titan, SiC, ZrO2, krom, koboltstål, höglegerade rostfria stål, och vissa polymerer. Implantatet kan bestå helt av något av dessa material, eller av blandningar av två eller flera av dessa material, eller huvudsakligen bestå av något av dessa material i kombination med något ytterligare, här icke nämnt material. Det skall vidare nämnas att implantatet kan ha olika sammansättning i olika delar, varvid en del kan vara porös enligt föreliggande uppfinning, medan en annan del kan bestå av ett mer konventionellt material och vara väsentligen porfri. Även kombinationer av partier med olika sammansättning, men var och en porös enligt uppfinningens principer, är också tänkbara.Thus, for example, a material of silicon nitride is preferably prepared by nitriding silicon grains so as to obtain so-called reaction-bonded silicon nitride (RBSN), Si3 N4. The material may also contain substances other than Si3N4, but when selecting this material at least 80% by weight should be Si3N4. Other possible materials include calcium phosphate materials, for example hydroxylapatite, Al 2 O 3, titanium, SiC, ZrO 2, chromium, cobalt steel, high alloy stainless steels, and certain polymers. The implant may consist entirely of any of these materials, or of mixtures of two or more of these materials, or consist essentially of any of these materials in combination with any additional material not mentioned herein. It should further be mentioned that the implant may have different composition in different parts, one part may be porous according to the present invention, while another part may consist of a more conventional material and be substantially pore-free. Combinations of batches of different composition, but each porous according to the principles of the invention, are also conceivable.
Porositeten och porstorleksfördelningen hos materialet kan styras via någon eller några av följande tekniker: 1) genom val av ursprunglig kornstorlek hos råvaran 2) genom reglering av processparametrar, tryck, temperatur och tid vid konsolideringen (densifieringen) 3) genom tillsatser i gas eller i råvaran 4) genom efterbearbetning Sålunda erhålls den finare porfraktionen genom styrning av 1) och 2) ovan. Exempelvis avgör - då det är fråga om ett RBSN-material - storleken hos de ursprungliga Si-kornen finporfraktionens porstorlek och fördelning hos utbildad reaktionsbunden kiselnitrid (RBSN), medan de större porerna i ytan företrädesvis åstadkommas genom efterbear- betning enligt 4) ovan. Om man i stället eller i kombination med större porer framställda genom efterbearbetning av ytan även önskar större porer i materialets huvuddel kan detta åstadkommas genom tillsats i råvaran av fibrer, exempelvis polymer, keram eller metall, som avbränns eller lakas bort före eller efter materialets konsoli- dering. Även glasfibrer kan tillsättas, vilka kan utnyttjas som sintringsmedel eller borttagas före eller efter konsolideringen. För framställning av de större porerna i ytskiktet kan speciellt användas- laser och/eller ultraljudbearbetning eller vattenstråleskärning.The porosity and pore size distribution of the material can be controlled via any of the following techniques: 1) by selecting the original grain size of the raw material 2) by regulating process parameters, pressure, temperature and time during consolidation (densification) 3) by additions in gas or in the raw material 4) by post-processing Thus, the finer pore fraction is obtained by controlling 1) and 2) above. For example, in the case of an RBSN material, the size of the original Si grains determines the pore size of the fine pore fraction and the distribution of formed reactive silicon nitride (RBSN), while the larger pores in the surface are preferably obtained by finishing according to 4) above. If, instead or in combination with larger pores produced by finishing the surface, larger pores in the main part of the material are also desired, this can be achieved by adding to the raw material fibers, for example polymer, ceramic or metal, which are burned or leached away before or after the material dering. Glass fibers can also be added, which can be used as sintering agents or removed before or after consolidation. For the production of the larger pores in the surface layer, laser and / or ultrasonic processing or water jet cutting can be used in particular.
Härigenom kan åstadkommas porer med speciellt gynnsam porprofil, som 10 15 20 25 30 35 begränsar spänningskoncentrationerna vid porerna. Genom en sådan teknik, det vill säga val av ej endast porstorlek och djup, utan även av porprofil, kan implantatmaterialet belastas ännu högre än eljest genom att Y-värdet i det brottmekaniska grunduttrycket 1/2 K :YUC lC storleksordningen 1.2-1.4. ,sänks från det teoretiska max-värdet 1.98 till För material framställda genom konsolidering av pulver av olika metaller eller mycket hållfasta keramiska material kan kombinationer av finporositet och grov (makro) porositet erhållas genom något sintringsförfarande som ej drivs till fullständighet följt av en ytarbetning, exempelvis med någon av ovan beskrivna tekniker, för erhållande av makroytporositet. Aktuella material kan här vara Co-Cr stål, Ti-legeringar och keramer, i första hand oxider av aluminium och zirkon samt icke oxidiska material av kiselnitrid och SiAl0N-typ.In this way pores can be provided with a particularly favorable pore profile, which limits the stress concentrations at the pores. Through such a technique, i.e. selection of not only pore size and depth, but also of pore profile, the implant material can be loaded even higher than otherwise by the Y-value in the basic mechanical expression 1/2 K: YUC lC of the order of 1.2-1.4. , is lowered from the theoretical maximum value of 1.98 to For materials produced by consolidating powders of different metals or very solid ceramic materials, combinations of fine porosity and coarse (macro) porosity can be obtained by any sintering process which is not driven to fullness followed by a surface treatment, e.g. using any of the techniques described above, to obtain macroytic porosity. Relevant materials here can be Co-Cr steel, Ti alloys and ceramics, primarily oxides of aluminum and zircon as well as non-oxidic materials of silicon nitride and SiAlON type.
Ytterligare kännetecken och aspekter på uppfinningen framgår av följande exempel samt av de efterföljande patentkraven.Further features and aspects of the invention appear from the following examples as well as from the appended claims.
KORT FIGURBESKRIVNING I den följande beskrivningen kommer att hänvisas till bifogade ritningsfigurer, av vilka Fig. l visar en axelprotes, med ett parti bestående av ett poröst material enligt uppfinningen, Fíg. 2 visar en höftledprotes, där också ett parti består av ett poröst material enligt uppfinningen, Fig. 3 visar ett dentalt implantat för förankring av tänder i ben, vilket implantat ävenledes uppvisar ett poröst parti enligt uppfinningen, Fig. 4-7 visar schematiskt hur i materialet förekommande ytmakroporerf kan se ut, och. 10 15 20 25 30 35 Fig. 8 utgör ett diagram som visar erforderliga skjuvkraften för utstötning av ett implantat som funktion av inväxttiden.BRIEF DESCRIPTION OF THE DRAWINGS In the following description reference will be made to the accompanying drawing figures, of which Fig. 1 shows a shoulder prosthesis, with a portion consisting of a porous material according to the invention, Figs. Fig. 2 shows a hip joint prosthesis, where also a portion consists of a porous material according to the invention, Fig. 3 shows a dental implant for anchoring teeth in bone, which implant also has a porous portion according to the invention, Figs. 4-7 show schematically how in the surface macroporphs present in the material may look like, and. Fig. 8 is a diagram showing the required shear force for ejection of an implant as a function of the growth time.
BESKRIVNING AV UTFÖRINGSEXEMPEL Exempel 1 Fibrer i form av 1-2 mm långa stycken av en nylonlina med diametern 0.2 mm tillsättes en pulverblandning bestående av zirkoniumoxid innehållande 3 vol-% yttriumoxid. Halten fibrer uppgår till 12 vol-%.DESCRIPTION OF EMBODIMENTS Example 1 Fibers in the form of 1-2 mm long pieces of a 0.2 mm diameter nylon line are added to a powder mixture consisting of zirconia containing 3% by volume of yttrium oxide. The fiber content amounts to 12% by volume.
Blandningen trumlas under 2h i en rullkulkvarn med polymerbehållare och sfäriska malkroppar av zirkoniumoxid. Råpresskroppar framställs genom kallpressning vid ett tryck av 250 MPa. Råpresskropparna värmebehandlas för avdrivning av den organiska komponenten, det vill säga av nylonfibrerna. Vid avdrivningen höjs temperaturen 5°C/h upp till 500°C. Den relativt sköra råpresskropp som erhålls, sintras vid l550°C under 3h. Hg-porosimetri visar på porer med en storlek av ca l pm. Optisk granskning i ljusmikroskåp av ett tvärsnitt visar förekomst av stora porer av storleksordningen av cirka 170 pm.The mixture is tumbled for 2 hours in a roller ball mill with polymer container and spherical grinding bodies of zirconia. Crude bodies are produced by cold pressing at a pressure of 250 MPa. The blank presses are heat treated to drive off the organic component, ie the nylon fibers. During stripping, the temperature is raised 5 ° C / h up to 500 ° C. The relatively brittle crude body obtained is sintered at 150 ° C for 3 hours. Hg porosimetry indicates pores with a size of about 1 μm. Optical examination in light microscope of a cross section shows the presence of large pores of the order of about 170 μm.
Exempel 2 Aluminiumoxidpulver av en kvalitet med beteckningen AKP30 med en specifik yta (BET) av ca 20 ma/g, motsvarande en kornstorlek < 0.1 pm, pressas till en kubisk provkropp med måtten 10 x 10 x 10 mm. Kroppen, inkapslad i glas, densifieras med hjälp av het isostatisk pressning, så kallad HIP-ning. Densifieringen (konsolideringen) utförs vid 1l50°C under 20 min. Maxtrycket vid topptemperaturen uppgår till 160 MPa.Example 2 Alumina powder of a grade with the designation AKP30 with a specific surface area (BET) of about 20 mg / g, corresponding to a grain size <0.1 μm, is pressed into a cubic test body measuring 10 x 10 x 10 mm. The body, encapsulated in glass, is densified by means of hot isostatic pressing, so-called HIP-ning. The densification (consolidation) is carried out at 150 ° C for 20 minutes. The maximum pressure at the peak temperature is 160 MPa.
Porositeten uppmäts genom vatteninträngning till 14.5 vol-%.The porosity is measured by water penetration to 14.5% by volume.
Hg-porosimetri visar att huvuddelen, dvs > 90% av porerna ligger i intervallet 0.4-0.7 pm med en medelporstorlek av 0.6 pm, medan < 3% av den totala porvolymen ligger inom intervallet 10-50 pm.Hg porosimetry shows that the majority, i.e.> 90% of the pores are in the range 0.4-0.7 μm with an average pore size of 0.6 μm, while <3% of the total pore volume is in the range 10-50 μm.
Exempel 3 Till en kiselråvara bestående av kiselpulver av typ Sicomill 4D sättes metylalkohol. Efter lätt trumling avskiljes korn större än 5 pm genom- sedimentering. Resterande kiselråvara består alltså av pulver med kornstorlekar < 5 pm. En råpresskropp med måtten 10 x 5 x 30 mm Cï\ GO 10 15 20 25 30 35 .ÄÃJ framställs genom kall isostatisk pressning med 3 vol-% polyetylen- glykol som presshjälpmedel. Avdrivning av PEG sker genom upphettning ca 10°C/h upp till 400°C. Därefter nitrideras râpresskroppen med kvävgasinnehållande atmosfär i två steg vid l160°C under 5h och vid l400°C under 15h; så att man får en reaktionsbunden kiselnitrid, Si3N4 (RBSN). Den nitriderade kroppen uppvisar 22 vol-% öppen (kommuni- cerande) porositet mätt genom vakuumsugning och vatteninträngning.Example 3 Methyl alcohol is added to a silicon raw material consisting of silicon powder of type Sicomill 4D. After light tumbling, grains larger than 5 μm are separated by sedimentation. The remaining silicon raw material thus consists of powder with grain sizes <5 pm. A crude compact with the dimensions 10 x 5 x 30 mm Cï \ GO 10 15 20 25 30 35 .ÄÃJ is produced by cold isostatic pressing with 3 vol% polyethylene glycol as a pressing aid. Evaporation of PEG takes place by heating approx. 10 ° C / h up to 400 ° C. Thereafter, the crucible is nitrided with a nitrogen-containing atmosphere in two steps at 160 ° C for 5 hours and at 140 ° C for 15 hours; to give a reaction-bonded silicon nitride, Si3N4 (RBSN). The nitrided body has 22% by volume of open (communicating) porosity measured by vacuum suction and water penetration.
Hg-porosimetri visar en mycket snäv porstorleksfördelning med > 90% av den totala porvolymen i intervallet 0.2-1.0 um och med < 3% i inter- vallet 10-50 pm. Av porerna i intervallet 0.2-1.0 um ligger huvuddelen mer bestämt inom intervallet 0.2-0.4 um.Hg porosimetry shows a very narrow pore size distribution with> 90% of the total pore volume in the range 0.2-1.0 μm and with <3% in the range 10-50 μm. Of the pores in the range 0.2-1.0 μm, the main part is more specifically in the range 0.2-0.4 μm.
Exempel 4 10 volym-% glasfibrer av CaAl-silikater limmade till diametern 150 um och med längden 1-2 mm tillsättes en kiselnitridråvara med beteck- ningen UBE E10. Blandningen homogeniseras och råpresskroppar fram- ställs på samma sätt som i exempel l. Provkroppar framställs genom sintring av råpresskropparna vid 1800°C under 2h i kvävgasatmosfär i en pulverbädd av grov kiselnitrid. Totalporositeten i provkropparna uppmäts genom vatteninträngning till 11 vol-%. Optisk utvärdering in ljusmikroskåp visar en grovfraktion porer av storleksordningen 150 um.Example 4 10% by volume of glass fibers of CaAl silicates glued to a diameter of 150 μm and with a length of 1-2 mm, a silicon nitride raw material designated UBE E10 is added. The mixture is homogenized and crude bodies are prepared in the same manner as in Example 1. Samples are prepared by sintering the crude bodies at 1800 ° C for 2 hours in a nitrogen atmosphere in a powder bed of coarse silicon nitride. The total porosity of the specimens is measured by water penetration to 11% by volume. Optical evaluation in light microscope shows a coarse fraction of pores of the order of 150 μm.
Exempel 5 Ur plattor av helt tät kiselnitrid innehållande 2 % yttriumoxid och med densiteten 3.22 g/mms framställd genom hetisostatisk pressning vid 1750°C, 160 MPa, lh, tillverkas 20 provstavar med måtten 3.5 x 4.5 x 40 mm för hållfasthetstestning genom utkapning och kant- brytning (45°). Hälften av provstavarna förses med makroporer på ena sidan genom datorstödd laserskärning som ger en schematisk porprofil enligt Fig 5. Hållfasthetsmätningar visar att med 200 um djupa porer och med profil enligt Fig. 5 erhålls en sänkning av medelhållfastheten bestämd genom 4-punkts böjprov från 680 MPa (utan makroporer) till 350 MPa. Medelvärdet 350 indikerar att Y-värdet i ekvationen (1) är lågt.Example 5 From test strips of completely dense silicon nitride containing 2% yttrium oxide and with a density of 3.22 g / mmm produced by hetisostatic pressing at 1750 ° C, 160 MPa, lh, 20 test rods with the dimensions 3.5 x 4.5 x 40 mm are manufactured for strength testing by cutting and edge refraction (45 °). Half of the test rods are provided with macropores on one side by computer-assisted laser cutting which gives a schematic pore profile according to Fig. 5. Strength measurements show that with 200 μm deep pores and with profile according to Fig. 5 a reduction of the average strength is determined by 4-point bending test from 680 MPa (without macropores) to 350 MPa. The mean value 350 indicates that the Y value in equation (1) is low.
Med uppmätt brottseghetsvärde av 5.0 Maml/2 motsvarar det ett Y-värde på ca 1.2. 10 15 20 25 30 35 468 502 Exempel 6 Råpresskroppar från exempel 3 förses med ytmakroporer av storleks- ordningen 200 um genom att ytan behandlas med en stämpel med tätt fördelade, utstickande nålar av typ "spikmatta". Nålarna med ett centrumavständ av 400 um gör ett intryck med djupet 200 um. Profilen på intrycken framgår av Fig. 7. Därefter nitríderas proverna på samma sätt som i exempel 3.With a measured fracture toughness value of 5.0 Maml / 2, it corresponds to a Y-value of approx. 1.2. Example 15 Raw press bodies from Example 3 are provided with surface macropores of the order of 200 μm by treating the surface with a stamp with tightly distributed, protruding "nail mat" type needles. The needles with a center distance of 400 μm make an impression with a depth of 200 μm. The profile of the impressions is shown in Fig. 7. Thereafter, the samples are nitrided in the same manner as in Example 3.
Medelhållfastheten för det material utan ytmakroporer som framställes genom exempel 3, bestämd genom 4-punkts böjprov, uppgår till 290 MPa.The average strength of the surface macroporous material prepared by Example 3, determined by 4-point bending test, is 290 MPa.
Ett material med ytmakroporer framställt genom exempel 1 har en håll- fasthet av 150 MPa bestämd enligt samma 4-punkt böjprov.A material with surface macropores prepared by Example 1 has a strength of 150 MPa determined according to the same 4-point bending test.
Exempel 7 Detta exempel avser ett sätt att tillverka materialet enligt uppfin- ningen. Prover bestående av sintrad zirkoniumoxid med 3 vol-% yttriumoxid och med densiteten 6.07 g/cm: ytbehandlas med ultraljud, varvid används en borkarbidslamma med kornstorlek ca 30 um. Ultra- ljudsverktyg med olika topografi motsvarande porkonfigurationer enligt Fig. 4 och 6 användes.Example 7 This example relates to a method of manufacturing the material according to the invention. Samples consisting of sintered zirconia with 3% by volume of yttrium oxide and with a density of 6.07 g / cm: surface-treated with ultrasound, using a boron carbide slurry with a grain size of about 30 μm. Ultrasonic tools with different topography corresponding to pore configurations according to Figs. 4 and 6 were used.
Exempel 8 Detta exempel avser några tänkbara applikationer för uppfinningen.Example 8 This example relates to some possible applications of the invention.
Datorstyrd laserskärning kan utnyttjas för applicering av ytmakroporer på tre implantatkomponenter inom områden vilka vid implantatets användning är mekaniskt lågpåkända. Materialet inom dessa områden utgörs av porösa material enligt uppfinningen och har schatterats i Fig. l-3. Dessa komponenter utgörs av - en axelledskomponent, Fig. l - en höftledskomponent (stam), Fig. 2, och - ett dentalimplantat, Fig. 3. Övriga delar av implantaten, dvs de icke schatterade, mer högpåkända partierna, kan bestå av material som är mer konventionella implantatmaterial eller i och för sig av andra okonventionella '- material som uppfyller de specifika krav som ställs på dessa delar av respektive implantat.Computer-controlled laser cutting can be used for applying surface macropores to three implant components in areas which are mechanically low-stressed when the implant is used. The material in these areas consists of porous materials according to the invention and has been estimated in Figs. 1-3. These components consist of - a shoulder joint component, Fig. 1 - a hip joint component (stem), Fig. 2, and - a dental implant, Fig. 3. Other parts of the implants, ie the non-shaded, more stressed parts, can consist of materials such as are more conventional implant materials or per se other unconventional 'materials that meet the specific requirements of these parts of the respective implants.
CT* (10 CD , l 10 Exempel 9 Av material med ytmakroporer beskrivna i exemplen 3, 5, 6 och 7 tillverkas cylindrar med diametern 2.8 mm och längden 7 mm.CT * (10 CD, l 10 Example 9 From materials with surface macropores described in examples 3, 5, 6 and 7, cylinders with a diameter of 2.8 mm and a length of 7 mm are manufactured.
Cylindrarna inopereras i femora på kanin. Efter tre månader offras djuren och erforderliga skjuvkfrafter för utstötning av cylindrarna bestäms med så kallad push-out test. Resultaten finns sammanfattade i tabell 1.The cylinders are implanted in the femora of the rabbit. After three months, the animals are sacrificed and the required shear forces for ejection of the cylinders are determined with a so-called push-out test. The results are summarized in Table 1.
'N Tabell 1 ' Material Skjuvkraft (MPa) Anmärkning RBSN (exempel 3) 2 Utan ytmakroporer RBSN (exempel 6) ll Med ytmakroporer Zirkoníumoxid (exempel 7, porutseende, Fig. 4) 12 Med ytmakroporer Kiselnitrid (exempel 5) 10 Med ytmakroporer Kiselnitrid (referensmaterial) 2 Utan ytmakroporer Exempel 10 Cylindrar med diametern 2.8 mm och längden 7 mm av material enligt exempel 2, det vill säga bestående av finporös aluminiumoxid, ytbehandlas genom laserbearbetning enligt exempel 5 för att skapa komplexa porstorleksfördelningar, nämligen en mikroporös fraktion i hela materialet erhållen vid tillverkningen av cylindrarna och en makroporös ytfraktion. Konfigurationen hos ytmakroporerna överens- stämmer med Fig. 5. I den öppna finporstrukturen utfälls Ca-fosfat genom reaktion mellan kalciumhydroxid och ammoniumvätefosfat. På motsvarande sätt kan andra bentillväxtstimmulerande medel tillsättas i finporstrukturen, t ex bonegrowthfactor eller antíinflammatoriska medel genom t ex frystorkning. De sålunda framställda och behandlade cylindrarna inplanteras i femora i kanin. Djuren offras efter 2, 5 och 8 veckor. Referensmaterial utan deponering av Ca-fosfat. Skjuvkrafter mellan implantat och nybildat ben bestäms genom push-out testning. ' - Resultaten framgår av Fig. 8, som visar skjuvkraften som funktion av inväxttiden (veckor).'N Table 1' Material Shear force (MPa) Note RBSN (Example 3) 2 Without surface macropores RBSN (Example 6) ll With surface macropores Zirconia (Example 7, pore appearance, Fig. 4) 12 With surface macropores Silicon nitride (Example 5) 10 With surface macropores Silicon nitride (reference material) 2 Without surface macropores Example 10 Cylinders with a diameter of 2.8 mm and a length of 7 mm of material according to Example 2, i.e. consisting of fine porous alumina, are surface treated by laser processing according to Example 5 to create complex pore size distributions, namely a microporous fraction in the whole material obtained in the manufacture of the cylinders and a macroporous surface fraction. The configuration of the surface macropores corresponds to Fig. 5. In the open fine pore structure, Ca-phosphate precipitates by reaction between calcium hydroxide and ammonium hydrogen phosphate. Similarly, other bone growth stimulating agents may be added to the fine pore structure, for example bonegrowth factor or anti-inflammatory agents by, for example, lyophilization. The cylinders thus produced and treated are implanted in femora in rabbit. The animals are sacrificed after 2, 5 and 8 weeks. Reference material without deposition of Ca-phosphate. Shear forces between implants and newly formed bone are determined by push-out testing. The results are shown in Fig. 8, which shows the shear force as a function of the growth time (weeks).
U!U!
Claims (10)
Priority Applications (4)
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SE9101677A SE468502B (en) | 1991-06-03 | 1991-06-03 | POROEST IMPLANT |
AU19081/92A AU1908192A (en) | 1991-06-03 | 1992-05-29 | An implant |
PCT/SE1992/000366 WO1992021302A1 (en) | 1991-06-03 | 1992-05-29 | An implant |
AU39637/93A AU3963793A (en) | 1991-06-03 | 1993-03-11 | A process for recovering chemicals and energy from cellulose waste liquor |
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SE9101677A SE468502B (en) | 1991-06-03 | 1991-06-03 | POROEST IMPLANT |
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SE9101677D0 SE9101677D0 (en) | 1991-06-03 |
SE9101677L SE9101677L (en) | 1992-12-04 |
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SE9101677A SE468502B (en) | 1991-06-03 | 1991-06-03 | POROEST IMPLANT |
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SE469653B (en) * | 1992-01-13 | 1993-08-16 | Lucocer Ab | POROEST IMPLANT |
SE504294C2 (en) * | 1993-10-01 | 1996-12-23 | Lucocer Ab | Implants intended to be fixed by contact with newly formed bone tissue |
CA2175660C (en) * | 1993-11-02 | 2005-07-05 | Charles S. Naiman | Control of cell growth |
CA2142636C (en) * | 1994-02-18 | 2005-09-20 | Salvatore Caldarise | Implantable articles with as-cast macrotextured surface regions and method of manufacturing the same |
US5665118A (en) * | 1994-02-18 | 1997-09-09 | Johnson & Johnson Professional, Inc. | Bone prostheses with direct cast macrotextured surface regions and method for manufacturing the same |
US6065476A (en) * | 1994-12-21 | 2000-05-23 | Board Of Regents, University Of Texas System | Method of enhancing surface porosity of biodegradable implants |
AU6423796A (en) * | 1995-08-29 | 1997-03-06 | Johnson & Johnson Professional, Inc. | Bone prosthesis with protected coating for penetrating bone intergrowth |
DE19545470A1 (en) * | 1995-12-06 | 1997-07-31 | Matthias Dr Med Honl | End prosthesis or implant surface |
WO1997046179A1 (en) * | 1996-06-03 | 1997-12-11 | Mathys Medizinaltechnik Ag | Femur component for a hip endoprosthesis |
EP0827726A3 (en) * | 1996-09-04 | 1999-03-03 | Implantech Medizintechnik Ges.m.b.H. | Implant, especially prosthetic joint implant |
AT405236B (en) * | 1997-07-18 | 1999-06-25 | Implantech Medizintechnik Ges | IMPLANT, IN PARTICULAR JOINT PROSTHESIS IMPLANT |
WO1998016267A1 (en) * | 1996-10-15 | 1998-04-23 | University College Dublin | Bone replacement materials with interconnecting pore system |
DE10060036C1 (en) * | 2000-12-02 | 2002-08-08 | Dot Gmbh | Inorganic resorbable bone substitute material |
EP1159935A1 (en) * | 2000-05-31 | 2001-12-05 | SAY, Wen-Ching | Orthopedic implant having a porous surface and method of making same |
FR2827155B1 (en) * | 2001-07-16 | 2004-03-12 | Biomet Merck France | FEMALE ROD FOR HIP PROSTHESIS |
GB0119652D0 (en) * | 2001-08-11 | 2001-10-03 | Stanmore Implants Worldwide | Surgical implant |
GB0128729D0 (en) * | 2001-11-30 | 2002-01-23 | Depuy Int Ltd | Femoral component of hip joint prosthesis |
EP1358859A1 (en) * | 2002-04-29 | 2003-11-05 | Politecnico Di Milano | Bone prostheses having multilayer interface |
DE10328892A1 (en) * | 2003-06-26 | 2005-05-12 | Curasan Ag | Bone building agent and manufacturing process |
NL1030364C2 (en) * | 2005-11-07 | 2007-05-08 | Ft Innovations Fti B V | Implant and method for manufacturing such an implant. |
US8524265B2 (en) * | 2006-08-17 | 2013-09-03 | Warsaw Orthopedic, Inc. | Medical implant sheets useful for tissue regeneration |
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US4834756A (en) * | 1982-02-18 | 1989-05-30 | Pfizer Hospital Products Group, Inc. | Bone prosthesis with porous coating |
CA1227002A (en) * | 1982-02-18 | 1987-09-22 | Robert V. Kenna | Bone prosthesis with porous coating |
NL8402158A (en) * | 1983-07-09 | 1985-02-01 | Sumitomo Cement Co | POROUS CERAMIC MATERIAL AND METHOD FOR THE PREPARATION THEREOF. |
-
1991
- 1991-06-03 SE SE9101677A patent/SE468502B/en not_active IP Right Cessation
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1992
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WO1992021302A1 (en) | 1992-12-10 |
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