DK3021883T3 - Biomimetisk kollagen-hydroxyapatit kompositmateriale - Google Patents

Biomimetisk kollagen-hydroxyapatit kompositmateriale Download PDF

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DK3021883T3
DK3021883T3 DK14741205.0T DK14741205T DK3021883T3 DK 3021883 T3 DK3021883 T3 DK 3021883T3 DK 14741205 T DK14741205 T DK 14741205T DK 3021883 T3 DK3021883 T3 DK 3021883T3
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collagen
hydroxyapatite
bone
biomimetic
composite material
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DK14741205.0T
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English (en)
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Michael Bufler
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Geistlich Pharma Ag
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/30Inorganic materials
    • A61L27/32Phosphorus-containing materials, e.g. apatite
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/22Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/24Collagen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L27/46Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with phosphorus-containing inorganic fillers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58Materials at least partially resorbable by the body
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B82NANOTECHNOLOGY
    • B82BNANOSTRUCTURES FORMED BY MANIPULATION OF INDIVIDUAL ATOMS, MOLECULES, OR LIMITED COLLECTIONS OF ATOMS OR MOLECULES AS DISCRETE UNITS; MANUFACTURE OR TREATMENT THEREOF
    • B82B1/00Nanostructures formed by manipulation of individual atoms or molecules, or limited collections of atoms or molecules as discrete units
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/112Phosphorus-containing compounds, e.g. phosphates, phosphonates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412Tissue-regenerating or healing or proliferative agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/12Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/18Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00Materials or methods for coatings medical devices
    • A61L2420/02Methods for coating medical devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/02Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/06Materials or treatment for tissue regeneration for cartilage reconstruction, e.g. meniscus

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Dispersion Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Materials Engineering (AREA)
  • Nanotechnology (AREA)
  • Composite Materials (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Materials For Medical Uses (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)

Claims (15)

  1. BIOMIMETISK KOLLAGEN-HYDROXYAPATIT KOMPOSITMATERIALE Patentkrav
    1. Biomimetisk kollagen-hydroxyapatit kompositmateriale omfattende en mindst delvist fibrøs kollagenstruktur som inkluderer modne native kollagenfibre, som besidder tredobbelt helicitet som vist ved cirkulær dikroisme spektroskopi, hvor disse modne native kollagenfibre er mindst delvist dækket med epitaktisk dyrkede krystaller af nanokrystallinsk hydroxyapatit, hvorved de epitaktisk dyrkede nanokrystaller har den samme morfologi som menneskelig knoglemineral og den samme størrelse som menneskelig knoglemineral, nemlig en længde på 30 til 50 nm og en bredde på 14 til 25 nm og hvor de epitaktisk dyrkede krystaller af nanokrystallinsk hydroxyapatit danner et lag med en tykkelse på mindst 30 ± 15 nm, som bestemt ved røngtendiffraktions-analyse.
  2. 2. Biomimetisk kollagen-hydroxyapatit kompositmateriale ifølge krav 1, hvor den mindst delvist fibrøse kollagenstruktur omfatter på dens ydre overflade mindst 2 % af modne native kollagenfibre bestemt ved billedanalyse af SEM mikrografer og cirkulær dikroisme spektroskopi.
  3. 3. Biomimetisk kollagen-hydroxyapatit kompositmateriale ifølge krav 1, hvor den mindst delvist fibrøse kollagenstruktur omfatter på dens ydre overflade mindst 10 % af modne native kollagenfibre bestemt ved billedanalyse af SEM mikrografer og cirkulær dikroisme spektroskopi.
  4. 4. Biomimetisk kollagen-hydroxyapatit kompositmateriale ifølge et hvilket som helst af kravene 1 til 3, hvor vægt til vægt forholdet af den fibrøse kollagenstruktur til de epitaktisk dyrkede krystaller af nanokrystallinsk hydroxyapatit er mellem 5:95 og 95:5, fortrinvis mellem 10:90 og 90:10.
  5. 5. Biomimetisk kollagen-hydroxyapatit kompositmateriale ifølge et hvilket som helst af kravene 1 til 4 som er et formet legeme.
  6. 6. Formet legeme ifølge krav 5 som er et knogleerstatningsmateriale med en struktur der har profil som en ossøs legemsdel.
  7. 7. Formet legeme ifølge krav 5 eller 6 som har en drejningsmomentmodstand på mindst 30 Nem i tør tilstand.
  8. 8. Biomimetisk kollagen-hydroxyapatit kompositmateriale ifølge et hvilket som helst af kravene 1 til 5 som er membran-formet.
  9. 9. Fremgangsmåde til fremstilling af det biomimetiske kollagen-hydroxyapatit kompositmateriale ifølge et hvilket som helst af kravene 1 til 8 omfattende trinnene a) at nedsænke en mindst delvist fibrøs kollagenstruktur, som inkluderer modne native kollagenfibre der besidder tredobbelt helicitet som vist ved cirkulær dikroisme spektroskopi, i en mættet vandig opløsning af mættet Ca2+/ HxP04<3"x), som er en phosphatbuffer opløsning (PBS) omfattende fint dispergeret alpha-TCP, beta-TCP, TTCP, octacalcium phosphat pentahydrat, dicalcium phosphat eller dicalcium phosphat dihydrat, for at udføre en dannelsesproces af komposit-implantatmaterialet hvorved epitaktisk dyrkede hydroxyapatit-nanokrystaller dannes på disse modne native kollagenfibre, hvor disse epitaktisk dyrkede hyroxyapatit-nanokrystaller har samme morfologi og samme størrelse som menneskelig knoglemineral, b) at stoppe dannelsesprocessen af komposit-implantatmaterialet ved at adskille faststof materiale fra den vandige opløsning, rense med vand og tørre, og c) at eventuelt sterilisere det adskilte materiale fra trin b).
  10. 10. Fremgangsmåde ifølge krav 9 hvor i trin b) pH'en af den vandige opløsning forbliver inden for et område af 5,5 til 9,0.
  11. 11. Fremgangsmåde ifølge krav 9 hvor i trin b) pH'en af den vandige opløsning forbliver inden for et område af 6,5 til 8,0.
  12. 12. Fremgangsmåde ifølge krav 9 eller 10 hvor temperaturen i trin b) er mellem 25 og 45 °C.
  13. 13. Fremgangsmåde ifølge krav 9 eller 10 hvor temperaturen i trin b) er mellem 35°C og 42 °C.
  14. 14. Biomimetisk kollagen-hydroxyapatit kompositmateriale ifølge et hvilket som helst af kravene 1 til 7 til anvendelse som et implantat eller protese til knogledannelse, knogleregenerering, knoglereparation og/eller knogleerstatning i et defekt område hos et menneske eller et dyr.
  15. 15. Membran-formet biomimetisk kollagen-hydroxyapatit kompositmateriale ifølge krav 8 til anvendelse som et implantat til kombineret knogle og brusk regenerering.
DK14741205.0T 2013-07-19 2014-07-18 Biomimetisk kollagen-hydroxyapatit kompositmateriale DK3021883T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13003647.8A EP2826495A1 (en) 2013-07-19 2013-07-19 Biomimetic collagen-hydroxyapatite composite material
PCT/EP2014/001966 WO2015007393A1 (en) 2013-07-19 2014-07-18 Biomimetic collagen-hydroxyapatite composite material

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DK3021883T3 true DK3021883T3 (da) 2017-01-16

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US (1) US10029028B2 (da)
EP (2) EP2826495A1 (da)
JP (1) JP6478993B2 (da)
KR (1) KR101944163B1 (da)
CN (1) CN105358189B (da)
AU (1) AU2014292503B2 (da)
BR (1) BR112016001093B1 (da)
CA (1) CA2917997C (da)
DK (1) DK3021883T3 (da)
ES (1) ES2611202T3 (da)
HK (1) HK1218083A1 (da)
HU (1) HUE031178T2 (da)
PL (1) PL3021883T3 (da)
PT (1) PT3021883T (da)
RU (1) RU2662326C2 (da)
SG (1) SG11201600364VA (da)
WO (1) WO2015007393A1 (da)

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WO2015007393A1 (en) 2015-01-22
CA2917997A1 (en) 2015-01-22
CN105358189A (zh) 2016-02-24
PT3021883T (pt) 2016-12-23
EP3021883A1 (en) 2016-05-25
EP2826495A1 (en) 2015-01-21
BR112016001093B1 (pt) 2020-07-28
AU2014292503A1 (en) 2016-02-11
KR101944163B1 (ko) 2019-01-30
US10029028B2 (en) 2018-07-24
CA2917997C (en) 2019-08-20
SG11201600364VA (en) 2016-02-26
CN105358189B (zh) 2018-03-16
JP6478993B2 (ja) 2019-03-06
EP3021883B1 (en) 2016-11-09
RU2016105556A (ru) 2017-08-24
JP2016524964A (ja) 2016-08-22
RU2662326C2 (ru) 2018-07-25
KR20160032116A (ko) 2016-03-23
AU2014292503B2 (en) 2017-06-15
PL3021883T3 (pl) 2017-03-31
HK1218083A1 (zh) 2017-02-03
HUE031178T2 (en) 2017-06-28
US20160144071A1 (en) 2016-05-26
ES2611202T3 (es) 2017-05-05

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