FI83729B - SURGICAL IMPLANTS. - Google Patents

SURGICAL IMPLANTS. Download PDF

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Publication number
FI83729B
FI83729B FI875223A FI875223A FI83729B FI 83729 B FI83729 B FI 83729B FI 875223 A FI875223 A FI 875223A FI 875223 A FI875223 A FI 875223A FI 83729 B FI83729 B FI 83729B
Authority
FI
Finland
Prior art keywords
surface layer
implant
tissue
fixation
core layer
Prior art date
Application number
FI875223A
Other languages
Finnish (fi)
Swedish (sv)
Other versions
FI83729C (en
FI875223A0 (en
FI875223A (en
Inventor
Pertti Toermaelae
Seppo Vainionpaeae
Pentti Rokkanen
Matti Mero
Original Assignee
Biocon Oy
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biocon Oy filed Critical Biocon Oy
Priority to FI875223A priority Critical patent/FI83729C/en
Publication of FI875223A0 publication Critical patent/FI875223A0/en
Priority to JP50945188A priority patent/JPH02502612A/en
Priority to AU27119/88A priority patent/AU2711988A/en
Priority to PCT/FI1988/000191 priority patent/WO1989004674A1/en
Priority to EP19880910043 priority patent/EP0351424A1/en
Publication of FI875223A publication Critical patent/FI875223A/en
Application granted granted Critical
Publication of FI83729B publication Critical patent/FI83729B/en
Publication of FI83729C publication Critical patent/FI83729C/en

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Classifications

    • 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
    • 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
    • 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
    • A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/005—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters containing a biologically active substance, e.g. a medicament or a biocide
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • 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
    • 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
    • A61F2/34—Acetabular cups
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3662—Femoral shafts
    • A61F2/3676—Distal or diaphyseal 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
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • A61F2002/30064—Coating or prosthesis-covering structure made of biodegradable material
    • 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
    • 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
    • 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
    • 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
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30968—Sintering
    • 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
    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3611—Heads or epiphyseal parts of femur
    • 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
    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3625—Necks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
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    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • 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
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
    • 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
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • A61L2300/406—Antibiotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0056—Catheters; Hollow probes characterised by structural features provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir

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  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Dermatology (AREA)
  • Materials Engineering (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Description

8372983729

Kirurginen implantaattiSurgical implant

Keksinnön kohteena on patenttivaatimuksen 1 johdannossa lähemmin määritelty kirurginen implantaatti.The invention relates to a surgical implant as further defined in the preamble of claim 1.

Erityisesti keksinnön kohteena ovat ns. ulkoisen fik-5 saatiovälineen yhteydessä käytettävät piikkiosat.In particular, the invention relates to the so-called spike parts used in connection with the external fik-5 means.

Ulkoisten fiksaatiovälineiden kirurgisessa käytössä suurimpana haittatekijänä on korkea infektioprosent-ti. Tyypillisesti noin 4-30% leikkauksista johtaa in-10 fektion muodostumiseen (kts. esim. L.D.Anderson, W.C. Hudchins et ai., Clin. Orthop. 105:179, 1979; F.Bunny "Hoffman External Hart Frame Fixation: Current Con cepts of External Fixation of Fractures", Springer-Werlag, Berlin, BRD, 1982). Suuri infektioprosentti 15 aiheutuu mm. siitä, että mikro-organismit pääsevät johtumaan elimistöön sen ulkopuolelta fiksaatiopiik-kejä pitkin ihohaavauman kautta, joka piikin ympärillä esiintyy fiksoidussa raajassa.The major drawback in the surgical use of external fixation devices is the high infection rate. Typically, about 4-30% of surgeries result in in-10 infection formation (see, e.g., LDAnderson, WC Hudchins et al., Clin. Orthop. 105: 179, 1979; F. Bunny, Hoffman External Hart Frame Fixation: Current Con cepts of External Fixation of Fractures ", Springer-Werlag, Berlin, BRD, 1982). A high infection rate of 15 is caused e.g. that microorganisms enter the body from outside it along fixation peaks through a skin ulcer present in the fixed limb around the peak.

20 Tässä keksinnössä on todettu yllättäen, että kun pa tenttivaatimuksen 1 tunnusmerkkiosan mukaisesti ulkoisen fiksaatiovälineen ydinkerroksen muodostavat, pehmytkudoksen lävistävät f iksaatiopiikit 4 pinnoi-tetaan ainakin pehmytkudokset lävistävältä osaltaan 25 orgaanisella pintakerroksella, joka sisältää pinta kerroksesta kudosolosuhteissa vapautuvaa antimikro-bioaalista ainetta tai aineyhdistelmää, kuten antibioottia tai antibioottiseosta, pystytään infektio-prosenttia ulkoisessa fiksaatiossa merkittävästi 30 pienentämään. Tämä aiheutuu siitä, että keksinnön mukaisten välineiden piikkien pinnalta vapautuva an-: timikrobiaalinen aine estää tehokkaasti mikro-orga- - nismien siirtymisen ja etenemisen ihon pinnalla ole- 2 83729 vasta haavaumasta syvemmälle kudoksiin. Samoin kyseinen antimikrobiaalinen aine estää tehokkaasti implan-taatissa olevien mikro-organismien tai sen mukana leikkauksessa haavaan joutuvien mikrobien infektoivaa 5 vaikutusta.In the present invention, it has surprisingly been found that when, according to the characterizing part of claim 1, the soft tissue piercing fixation peaks 4 forming the core layer of the external fixation means are coated on at least the or a mixture of antibiotics, the percentage of infection in external fixation can be significantly reduced. This is due to the fact that the antimicrobial agent released from the surface of the spikes of the devices according to the invention effectively prevents the migration and propagation of microorganisms from the ulcer deeper into the tissues. Likewise, said antimicrobial agent effectively inhibits the infectious effect of the microorganisms present in the implant or the microbes entering the wound during surgery.

Keksinnön mukaisten ulkoisten fiksaatiovälineiden piikit voivat myös olla pintarakenteeltaan huokoisia, muodostuen esim. metallisesta ydinmateriaalista. 10 Piikkien pinnan avoin huokoisuus on tällöin edulli sesti täytetty ainakin osittain kudosolosuhteissa vapautuvalla antimikrobiaalisella aineella tai jollakin orgaanisella tai epäorgaanisella aineella, joka sisältää antimikrobiaalista ainetta, joka vapautuu 15 kudoksiin. Tällaisia välineitä käytettäessä saadaan kudokseen vapautuvan antimikrobiaalisen aineen avulla tehokas infektiota estävä efekti aikaan.The spikes of the external fixation means according to the invention may also have a porous surface structure, consisting, for example, of a metallic core material. The open porosity of the surface of the peaks is then preferably filled at least in part with an antimicrobial agent released under tissue conditions or with an organic or inorganic substance containing an antimicrobial agent which is released into the tissues. When such devices are used, the antimicrobial agent released into the tissue provides an effective anti-infective effect.

Keksintöä ja sen lisäetuja on lähemmin havainnollis-20 tettu seuraavassa selityksessä sekä esimerkeissä, joissa viitataan oheisten piirustusten esittämiin sovellutusesimerkkeihin. Piirustuksissa, kuva la esittää kaavamaisesti sääriluunmurtuman 25 ulkoisen fiksaatiovälineen osaa asennettuna, kuva Ib esittää kaavamaisesti esim. ranteen alueella käytettävää ulkoista fiksaatiovalinettä asennettuna, 30 kuva 2 esittää kaavamaisesti keksinnön mukaista ulkoisen fiksaatiovälineen piikkiä, kuva 3 esittää esimerkin 1 mukaista fiksaatiota.The invention and its further advantages are further illustrated in the following description and in the examples, which refer to the application examples shown in the accompanying drawings. In the drawings, Fig. 1a schematically shows a part of an external fixation means for a tibial fracture 25 installed, Fig. Ib schematically shows an external fixation device for use in the wrist area, Fig. 2 schematically shows a spike of an external fixation means according to the invention, Fig. 3 shows a fixation according to Example 1.

3 837293,83729

Luunmurtumien ulkoisissa fiksaatiovälineissä voidaan keksintöä soveltaa mm. seuraavasti. Ulkoiset fiksaa-tiovälineet muodostuvat a) pehmytkudoksen läpi luuhun kiinnitettävistä fiksaatiopiikeistä eli pinneistä ja 5 b) kehon ulkopuolella sijaitsevista tukirakennelmis-ta, joihin piikit kiinnitetään. Tällaisia tunnettuja ulkoisia fiksaatiovälineitä on esitetty kaavamaisesti kuvissa la ja Ib. Kuva la esittää pituusleikkauksena kaavamaisesti osaa esim. sääriluunmurtuman 1 fiksaa-10 tiossa käytettävää ulkoista fiksaatiovälinettä, joka muodostuu sääriluun 2 ja sitä ympäröivän pehmytkudoksen 3 läpäisevistä fiksaatiopiikeistä 4, jotka on molemmista päistään kiinnitetty raajan ulkopuolella sijaitseviin tukirakennelmiin 5. Fiksaatiopiikkejä 4 on 15 tyypillisesti kolme kappaletta murtuman molemmin puolin. Niiden määrä voi vaihdella murtumatyypin mukaan. Kuvassa Ib on esitetty kaavamaisesti esim. ranteen alueella käytettävä ulkoinen fiksaatioväline, jossa fiksaatiopiikit 4 läpäisevät pehmytkudokset 3 vain 20 toisesta päästään ja ovat kiinnitetyt yhteen tukirakenteeseen 5.In external fixation means for fractures, the invention can be applied e.g. as follows. The external fixation means consist of a) fixation spikes, i.e. pins, attached to the bone through the soft tissue, and 5 b) out-of-body support structures to which the spikes are attached. Such known external fixation means are shown schematically in Figures 1a and Ib. Fig. 1a shows schematically in longitudinal section a part of, for example, an external fixation means used in the fixation of the tibial fracture 1, both sides. Their number may vary depending on the type of fracture. Figure Ib schematically shows, for example, an external fixation means for use in the wrist area, in which the fixation spikes 4 penetrate the soft tissues 3 only at one end and are attached to one support structure 5.

: Kuvassa 2 on esitetty kaavamaisesti keksinnön mukai- i nen, pintakerroksen I muodostavalla, antimikrobiaa- 25 lista ainetta sisältävällä pinnoitteella 6 päällys-: : : tetty fiksaatiopiikki 4 (ydinkerros II), joka läpäi- see pehmytkudoksen 3 ja fiksoitavan luun 2 ja kiin-nittyy ulkoiseen tukirakennelmaan 5.Fig. 2 schematically shows a fixing spike 4 (core layer II) coated with an antimicrobial agent-containing coating 6 according to the invention, forming a surface layer I, which passes through the soft tissue 3 and the fixable bone 2 and the adhesive. linked to the external support structure 5.

30 Erään edullisen suoritusmuodon mukaan ulkoisen fik-saatiovälineen piikkiosan pintakerros I ja ydinkerros II (ytimen muodostava materiaali) ovat samaa ainetta ja myös ydinkerros II voi sisältää antimikrobiaalista ainetta. Tällaisiin polymeerisistä materiaaleista 4 83729 tai niiden komponenteista valmistettuihin implantaat-teihin voidaan lisätä antimikrobiaalisia aineita jo polymerointivaiheessa, polymeeriraaka-aineen prosessoinnissa puolivalmisteeksi tai tuotteeksi tai im-5 plantaatin valmistuksen jälkeen esim. imeyttämällä antimjkrobiaalinen aine materiaalin sisään. Kun tällainen implantaatti sijoitetaan elimistöön, liukenee sen pintakerroksesta ympäröivään kudokseen antimikro-biaalista ainetta, joka estää tehokkaasti infektioi-10 ta. Tällaisesta materiaalista tai materiaaliyhdistel- mästä valmistetut implantaatit voivat kudosolosuh-teissa luovuttaa antimikrobiaalista ainetta monien kuukausien ajan, kun antimikrobiaalisen aineen kon-sentraatio pintakerroksessa on riittävän suuri ja/tai 15 sen diffuusio pintakerroksesta ympäröiviin kudoksiin on riittävän hidasta ja/tai kun implantaatin pinnalta kudoksi in di ffundoituvan antimikrobiaalisen aineen tilalle diffundoituu jatkuvasta ydinmateriaalista uutta antimikrobiaalista ainetta. Kun tällaiset kek-20 sinnön mukaiset polymeeriset piikkiosat valmistetaan biodegradoituvasta polymeeristä, sekapolymeerista, polymeeriseoksesta tai komposiitista, niin ne tukevat fiksoitavia kudoksia tarvittavan ajan menettäen samalla vähitellen lujuutensa luukudoksen parantuessa. 25 Samanaikaisesti tällaiset ulkoisen fiksaatiovälineen piikkiosat luovuttavat niitä ympäröivään luukudokseen ja/tai pehmytkudokseen antimikrobiaalisia aineita, mikä estää tehokkaasti infektioita. Murtuman parannuttua biodegradoituvat piikkiosat eivät tarvitse 30 poistoleikkausta, koska elimistö käyttää biodegra doituvat piikkiosat ravinnokseen. Näinollen voidaan ulkoisen fiksaatiovälineen poiston yhteydessä jättää luun sisässä olevat fiksaatiopiikkiosat paikoilleen, koska elimistö käyttää ne soluravinteikseen myöhäi-35 semmässä vaiheessa.According to a preferred embodiment, the surface layer I and the core layer II (core-forming material) of the spike part of the external fixation means are the same substance, and the core layer II may also contain an antimicrobial agent. Antimicrobial agents can be added to such implants made of polymeric materials 4,83729 or their components already in the polymerization step, in the processing of the polymer raw material into a semi-finished product or product, or after the manufacture of the implant, e.g. by impregnating the antimicrobial agent inside the material. When such an implant is placed in the body, an antimicrobial agent dissolves in the surrounding tissue from its surface layer, which effectively prevents infection. Implants made from such a material or combination of materials can deliver an antimicrobial agent under tissue conditions for many months when the concentration of the antimicrobial agent in the surface layer is sufficiently high and / or its diffusion from the surface layer to the surrounding tissues is sufficiently slow and / or in place of the fusible antimicrobial agent, a new antimicrobial agent diffuses from the continuous core material. When such polymeric spike parts according to the invention are made of a biodegradable polymer, copolymer, polymer blend or composite, they support the tissues to be fixed for the required time while gradually losing their strength as the bone tissue heals. At the same time, such spike portions of the external fixation device deliver antimicrobial agents to the surrounding bone tissue and / or soft tissue, effectively preventing infections. Once the fracture has healed, the biodegradable spike parts do not need 30 removal surgeries because the body uses the biodegradable spike parts for food. Thus, upon removal of the external fixation means, the fixation spike portions within the bone can be left in place because the body uses them as its cellular nutrients at a later stage.

5 83729 Näin voidaan keksinnön mukaisia, ainakin osittain biodegradoituvia fiksaatiovälineitä käytettäessä eliminoida myös ne komplikaatiot, joita potilaalle voi aiheutua ulkoisen fiksaatiovälineen piikkiosan 5 poiston yhteydessä, sen mahdollisesti katketessa ja jäädessä osittain luukudoksen sisään.Thus, when using the at least partially biodegradable fixation devices according to the invention, the complications which may occur to the patient in connection with the removal of the spike part 5 of the external fixation device, possibly breaking it and remaining partially inside the bone tissue, can also be eliminated.

Erään edullisen suoritusmuodon mukaan keksinnön mukaiset piikkiosat voivat sisältää myös yhden tai 10 useampia onkalolta tai vastaavia, jotka on oleellisesti täytetty kudosolosuhteissa vapautuvalla anti-mikrobiaalisella aineella tai aineseoksella. Tällöin voidaan piikkiosien sisältämä antimikrobiaalisen aineen kokonaismäärä saada nostettua suureksi. Kun täl-15 löin piikkiosasta diffundoituu sen ulkopinnan kautta antimikrobiaalista ainetta ympäröiviin kudoksiin, diffuntoituu poistuvan aineen tilalle onkalosta/onka-loista uutta ainetta niin, että antimikrobiaalisen aineen konsentraatio piikkiosassa, sen pintakerrok-20 sessa I ja siten myös sitä ympäröivässä kudoksessa pysyy pitkään korkeana. Onkalon yhteys pintakerrokseen voidaan sulkea aineella, joka kudosolosuhteissa ainakin osittain biodegradoituu ja/tai liukenee nopeasti, jolloin yhteys pintakerrokseen avautuu.According to a preferred embodiment, the spike portions of the invention may also contain one or more cavities or the like substantially filled with an anti-microbial agent or mixture of agents released under tissue conditions. In this case, the total amount of antimicrobial agent contained in the spike parts can be increased. As the spike diffuses through its outer surface into the tissues surrounding the antimicrobial agent, new material diffuses from the cavity / cavities in place of the effluent so that the concentration of antimicrobial agent in the spike portion, its surface layer I and thus in the surrounding tissue remains. The contact of the cavity with the surface layer can be closed with a substance which, under tissue conditions, is at least partially biodegraded and / or rapidly dissolves, whereby the contact with the surface layer is opened.

2525

Keksintöä on havainnollistettu seuraavan esimerkin avulla.The invention is illustrated by the following example.

ESIMERKKIEXAMPLE

30 Käytettiin kuvassa Ib esityn tyyppistä, tutkimuskäyttöön rakennettua fiksaatiovälinettä, joka muodostui ulkoisesta tuki rakennelmasta ja siihen tuetuista, luuhun kiinnitettävistä fiksaatiopiikeistä 6 83729 (ns. "half-pins"), kaniinin distaalisen reisiluuos-teotomian ulkoiseen fiksaatioon seuraavasti.A research-type fixation device of the type shown in Figure Ib, consisting of an external support structure and supported bone fixation spikes 6,83729 (so-called "half-pins"), was used for external fixation of a rabbit distal femoral theotomy as follows.

Tutkimussarjan (20 kaniinia) fiksaatiovälineiden 5 teräspiikit (paksuus 1.6 mm) pinnoitettiin pehmyt kudokset läpäisevältä osaltaan ja 10 mm:n matkalta kudosten ulkopuoliselta osaltaan 0.3 mm paksulla kerroksella poly-DL-laktidia (Mw 100 000), joka sisälsi siihen liuotettuna seoksena 10 paino-% Kefalo-10 sporiinia.The steel spikes (1.6 mm thick) of the fixation devices 5 of the study set (20 rabbits) were coated with a 0.3 mm thick layer of poly-DL-lactide (Mw 100,000) containing 10 wt.% Of the soft tissue-permeable portion and 10 mm of the extracorporeal portion. % Kefalo-10 spores.

Kontrollisarjän (20 kaniinia) välineitä ei pinnoitettu.Instruments from the control set (20 rabbits) were not coated.

15 Kaikki fiksaatiovälineet steriloitiin etyleenioksi- dilla.All fixatives were sterilized with ethylene oxide.

Nukutetun kaniinin reiden distaalisen lateraalipuolen alueen karvat ajeltiin, iho pestiin Neo-Amisept 20 liuoksella ja reisiluun distaaliosa paljastettiin pitkittäisellä viillolla. Suunnitellun osteotomia-tason distaalipuolelle tehtiin polvinivelen yläpuolelle kaksi pientä ihoviiltoa, joihin painettiin fiksaatiopiikit luukontaktiin, jonka jälkeen kärki-25 osaltaan kierteitetyt piikit kierrettiin luun sisään niin, että ne lävistivät molemmat korteksit. Samoin tehtiin osteotomiatason proksimaalipuolelle käyttäen kolmea fiksaatiopiikkiä. Fiksaatiopiikit kiinnitettiin tukirakennelmaan. Reisiluuhun tehtiin osteotomia 30 timanttilaikalla n. 2 cm:n korkeudelle polvinivelen yläpuolelle hohkaluualueelle. Luupinnat saatettiin kompressiokontaktiin säätämällä tukirakennelmasta proksimaalisten ja distaalisten piikkiryhmien välistä etäisyyttä. Avaus suljettiin biodegradoituvalla om-35 peleella (fiksaatio esitetty kaavamaisesti kuvassa 5).anesthetized rabbit hair from the lateral aspect of the distal thigh area was shaved, the skin was washed with Neo-Amisept solution 20 and the distal portion of the femur was exposed with a longitudinal incision. On the distal side of the planned osteotomy level, two small skin incisions were made above the knee joint, on which the fixation spikes were pressed into the bone contact, after which the tips threaded by the tip-25 were screwed into the bone so that they pierced both cortexes. The same was done for the proximal side of the osteotomy plane using three fixation peaks. The fixation spikes were attached to the support structure. The femur was osteotomized with 30 diamond discs at a height of about 2 cm above the knee joint in the pumice area. The bone surfaces were brought into compression contact by adjusting the distance between the proximal and distal peak groups from the support structure. The opening was closed with a biodegradable om-35 game (fixation shown schematically in Figure 5).

7 837297 83729

Kontrollisarjassa, jonka fiksaatiopiikkejä ei oltu pinnoitettu, esiintyi paranemisen aikana neljä infektiota fiksaatiopiikkien alueella kudoksissa. Tutkimussarjassa, jossa käytettiin polylaktidi-anti-5 bioottiseoksella pinnoitettuja piikkejä, esiintyi paranemisen aikana vain yksi pinnallinen infektio piikin ihon lävistävällä alueella.In a control series with uncoated fixation peaks, four infections in the area of fixation peaks in the tissues occurred during healing. In a series of studies using spikes coated with a polylactide-anti-5 biotic mixture, only one superficial infection occurred in the area of the skin penetrating the spike during healing.

Claims (4)

8 83729 Patenttivaatimukset;8,83729 Claims; 1. Kirurginen implantaatti, erityisesti luunmurtuman fiksaatioon tarkoitettu implantaatti, joka käsittää ainakin ydinkerroksen (II), joka on valmistettu metallista, metalliseoksesta tai polymeerimateriaalista tai edellä mainittujen materiaalien yhdistelmämateriaa-10 lista eli komposiitista sekä ydinkerrosta (II) ainakin osittain peittävän, ainakin osittain kudosolosuhteissa absorboituvasta polymeeristä, sekapolymeerista tai polymeeriseoksesta muodostetun pintakerroksen (I) , tunnettu siitä, että mainittu pintakerros (I) on 15 sinänsä tunnetusti tarkoitettu toimimaan kudosolosuhteissa vapautuvan antimikrobiaalisen aineen tai aineyhdistelmän kantajana (matriisina) ja että mainitut pintakerros (I) ja ydinkerros (II) on konstruoitu ulkoisen fiksaatiovälineen piikkiosaksi ja läpäisemään 20 ihon siten, että ainakin osa implantaatista on kudosten ulkopuolella pintakerroksen (I) ollessa järjestettynä implantaattiin siten, että se sijoittuu implantaatin ollessa asennettuna ainakin pehmytkudoksen kohdalle.A surgical implant, in particular an implant for fixation of a fracture, comprising at least a core layer (II) made of metal, alloy or polymeric material or a composite material of said materials, i.e. a composite, and a tissue condition at least partially covering the core layer (II). a surface layer (I) formed of a polymer, copolymer or polymer blend, characterized in that said surface layer (I) is known per se to act as a carrier (matrix) of an antimicrobial agent or combination of substances released under tissue conditions and in that said surface layer (I) and core layer (II) external fixation means and penetrate the skin so that at least a portion of the implant is outside the tissues with the surface layer (I) arranged in the implant so that it is positioned when the implant is positioned at least at the soft tissue. 2. Patenttivaatimuksen 1 mukainen implantaatti, tunnettu siitä, että ainakin niiden pintakerros (I) sisältää avointa huokoisuutta.Implant according to Claim 1, characterized in that at least their surface layer (I) has an open porosity. 3. Patenttivaatimuksen 1 mukainen implantaatti, 30 tunnettu siitä, että pintakerros (I) muodostuu ainakin osittain huokoisesta tai kuitumaisesta materi-. .. aalista, jonka huokoset tai kuitumaisten rakenneyksik- köjen väliset tilat on ainakin osittain täytetty orgaanisella tai epäorgaanisella aineella, joka on . 35 tarkoitettu toimimaan ainakin kudosolosuhteissa vapautuvan antimikrobiaalisen tai muun kemoterapeut-tisen aineen kantajana (matriisina). 9 83729Implant according to Claim 1, characterized in that the surface layer (I) consists at least in part of a porous or fibrous material. .. an ore whose pores or spaces between fibrous structural units are at least partially filled with an organic or inorganic substance which is. 35 is intended to act as a carrier (matrix) for an antimicrobial or other chemotherapeutic agent released at least under tissue conditions. 9 83729 4. Patenttivaatimuksen 1 mukainen implantaatti, tunnettu siitä, että mainitut implantaatit sisältävät 5 ainakin yhden ydinkerroksessa olevan onkalon tai vastaavan, joka on tarkoitettu kudosolosuhteissa vapautuvaa antimikrobiaalista tai muuta kemoterapeut-tista ainetta tai aineyhdistelmää varten ja että mainittu ainakin yksi onkalo tai vastaava on ainakin 10 kudosolosuhteissa järjestetty yhteyteen pintakerroksen (I) kanssa. ίο 83 729 Patentkrav;An implant according to claim 1, characterized in that said implants comprise at least one cavity in the core layer or the like for a tissue-released antimicrobial or other chemotherapeutic agent or combination of agents and in that said at least one cavity or the like is at least 10 in tissue conditions. arranged in contact with the surface layer (I). ίο 83 729 Patentkrav;
FI875223A 1987-11-26 1987-11-26 SURGICAL IMPLANTS. FI83729C (en)

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Application Number Priority Date Filing Date Title
FI875223A FI83729C (en) 1987-11-26 1987-11-26 SURGICAL IMPLANTS.
JP50945188A JPH02502612A (en) 1987-11-26 1988-11-24 Tissue contact articles containing antimicrobial agents
AU27119/88A AU2711988A (en) 1987-11-26 1988-11-24 Articles for tissue contact containing an antimicrobial agent
PCT/FI1988/000191 WO1989004674A1 (en) 1987-11-26 1988-11-24 Articles for tissue contact containing an antimicrobial agent
EP19880910043 EP0351424A1 (en) 1987-11-26 1988-11-24 Articles for tissue contact containing an antimicrobial agent

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FI875223A FI83729C (en) 1987-11-26 1987-11-26 SURGICAL IMPLANTS.
FI875223 1987-11-26

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FI875223A FI875223A (en) 1989-05-27
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AU2711988A (en) 1989-06-14
FI83729C (en) 1991-08-26
JPH02502612A (en) 1990-08-23
FI875223A0 (en) 1987-11-26
FI875223A (en) 1989-05-27
WO1989004674A1 (en) 1989-06-01
EP0351424A1 (en) 1990-01-24

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