JP4420816B2 - 関節置換インプラントのための開孔を有する金属コーティング、およびその製造方法 - Google Patents
関節置換インプラントのための開孔を有する金属コーティング、およびその製造方法 Download PDFInfo
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- JP4420816B2 JP4420816B2 JP2004516563A JP2004516563A JP4420816B2 JP 4420816 B2 JP4420816 B2 JP 4420816B2 JP 2004516563 A JP2004516563 A JP 2004516563A JP 2004516563 A JP2004516563 A JP 2004516563A JP 4420816 B2 JP4420816 B2 JP 4420816B2
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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
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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- A—HUMAN NECESSITIES
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- 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
- A61L27/28—Materials for coating prostheses
- A61L27/30—Inorganic materials
- A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
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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
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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
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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
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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
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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
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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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
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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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Inorganic Chemistry (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Dispersion Chemistry (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
- Paints Or Removers (AREA)
Description
骨が内部で成長できるが、サブマイクロメートル範囲では、骨芽細胞の接着に、またその結果として、従来技術よりも迅速且つ優れた方法での骨の内部成長に、何らの局所的刺激も与えないような、開孔を有するコーティングを形成すること;
より優れた骨芽細胞の接着のために、数マイクロメートルの表面粗さと、サブマイクロメートルの構造とを提供する表面処理方法を使用可能にするが、しかし、これらの表面は骨が内部に成長できる開孔を有する構造を有していないこと;
多孔性の度合いが制限された、数十マイクロメートルの範囲内の高度の表面粗さを有するコーティングを製造するが、この場合も、事実上サブマイクロメートル構造は有していないこと;
骨が内部に成長でき、また、その表面がサブマイクロメートルの表面粗さを有した開孔を有するようにコーティングを形成するが、しかし、このコーティングのマクロの表面粗さは十分高度なものではないため、結果的に骨に「接着する」ことができないという問題点が残るものであった。
インプラント表面を製造するために、少なくとも1層の生体適合性金属又はその合金を、前記インプラントの素地表面に付着する工程と、
前記インプラント表面のエッチング、及び/又は前記インプラント表面へ細かな生体適合粒子を付着することによって、前記インプラント表面上に表面マイクロ構造を形成する工程とを備える、開孔を有するように加工され、コーティングされたインプラント、特に関節置換インプラントを製造する方法によっても解決される。
Claims (24)
- インプラントの素地表面上に配置される、インプラント用の開孔を有する生体適合表面層を有するインプラントであって、
前記開孔を有する表面層の厚みが0.1mm〜2.5mmの範囲内であり;
前記開孔を有する表面層の多孔性が20%〜85%の範囲内であり;
前記開孔を有する表面層がサブマイクロメートルの範囲の表面粗さであることを特徴とするインプラント。 - 前記開孔を有する表面層がピットを有し、該ピットの直径が0.1μm〜2.5μmの範囲内であることを特徴とする請求項1に記載のインプラント。
- 二酸化チタン又はリン酸カルシウムの生体適合粒子を、前記インプラント表面上に付着することを特徴とする請求項1又は2に記載のインプラント。
- 前記生体適合粒子の粒子サイズが、0.01μm〜5μmの範囲内であることを特徴とする請求項3に記載のインプラント。
- 前記開孔を有する表面層が、実質的にチタン、ジルコニウム、ニオブ又はタンタルから成ることを特徴とする請求項1又は2に記載のインプラント。
- 前記開孔を有する表面層が焼結されることを特徴とする請求項1〜3の何れか1項に記載のインプラント。
- 開孔を有するようにコーティングされた請求項1のインプラントを製造する方法であって、
インプラントの表面を作成するために、少なくとも1層の生体適合性金属又はその合金を前記インプラントの素地表面に付加する工程と、
前記インプラント表面のエッチング、及び/又は前記インプラント表面への微細な生体適合粒子の付着によって、前記インプラント表面上に表面マイクロ構造を形成する工程とによって特徴付けられるインプラント製造方法。 - 前記生体適合性金属が、真空プラズマ・スプレー法によって付着されることを特徴とする請求項7に記載の方法。
- 前記生体適合性金属が、ブラッシング、スプレッディング、スプレー等の付加技術によって付着されることを特徴とする請求項7に記載の方法。
- 前記インプラントの素地表面に付加される前記少なくとも1層が焼結されることを特徴とする請求項7〜9の何れか1項に記載の方法。
- 結合剤及び/又は焼結補助剤が使用されることを特徴とする請求項10に記載の方法。
- 焼結補助剤として、焼結補助金属を前記生体適合性金属又はその合金と共に使用し、低融点共晶、特にシリコン又はコバルトを、好ましくは元素粉体形態に形成することを特徴とする請求項11に記載の方法。
- 焼結が真空内で実施されることを特徴とする請求項10〜12の何れか1項に記載の方法。
- 焼結が脱結合及び/又は脱水素段階を備えることを特徴とする請求項10〜13の何れか1項に記載の方法。
- 800℃〜1500℃の範囲内の焼結温度が使用されることを特徴とする請求項10〜14の何れか1項に記載の方法。
- 前記生体適合性金属を粉体形態において使用することを特徴とする請求項7〜15の何れか1項に記載の方法。
- 開孔を有する表面層の厚みが、0.1mm〜2.5mmの範囲内で形成されることを特徴とする請求項7〜16の何れか1項に記載の方法。
- 前記インプラントの素地表面に付加する前記生体適合性金属の粒子サイズが、50μm〜800μmの範囲内であることを特徴とする請求項7〜17の何れか1項に記載の方法。
- 前記生体適合性金属がチタン、ジルコニウム、ニオブ、タンタルであることを特徴とする請求項7〜18の何れか1項に記載の方法。
- 前記生体適合性金属が、金属水素化物粉体の形態において使用されることを特徴とする請求項9〜19の何れか1項に記載の方法。
- 前記インプラント表面のエッチングが、酸(溶液)エッチングによって、及び/又はプラズマ・エッチングによって実施されることを特徴とする請求項7〜20の何れか1項に記載の方法。
- 前記微細な生体適合粒子の粒子サイズが、0.01μm〜5μmの範囲内であることを特徴とする請求項7〜21の何れか1項に記載の方法。
- 前記微細な生体適合粒子が、結合剤を使用して、ゾル−ゲル法で付着されることを特徴とする請求項7〜22の何れか1項に記載の方法。
- 前記微細な生体適合粒子のための材料として、二酸化チタン、リン酸カルシウム、又はこれ以外の生体適合性材料を使用していることを特徴とする請求項7〜23の何れか1項に記載の方法。
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DE10228746 | 2002-06-27 | ||
DE10243101A DE10243101A1 (de) | 2002-06-27 | 2002-09-17 | Offenporöse Metallbeschichtung für Gelenkersatzimplantate sowie Verfahren zur Herstellung |
PCT/EP2003/005586 WO2004002544A1 (de) | 2002-06-27 | 2003-05-27 | Offenporöse metallbeschichtung für gelenkersatzimplantate sowie verfahren zur herstellung |
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US (1) | US20060100716A1 (ja) |
EP (1) | EP1515758B1 (ja) |
JP (1) | JP4420816B2 (ja) |
CN (1) | CN1318101C (ja) |
AT (1) | ATE424859T1 (ja) |
AU (1) | AU2003238418A1 (ja) |
DE (2) | DE10243101A1 (ja) |
DK (1) | DK1515758T3 (ja) |
ES (1) | ES2324404T3 (ja) |
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2002
- 2002-06-27 US US10/519,338 patent/US20060100716A1/en not_active Abandoned
- 2002-09-17 DE DE10243101A patent/DE10243101A1/de not_active Withdrawn
-
2003
- 2003-05-27 DE DE50311277T patent/DE50311277D1/de not_active Expired - Lifetime
- 2003-05-27 WO PCT/EP2003/005586 patent/WO2004002544A1/de active Application Filing
- 2003-05-27 DK DK03732486T patent/DK1515758T3/da active
- 2003-05-27 EP EP03732486A patent/EP1515758B1/de not_active Expired - Lifetime
- 2003-05-27 AU AU2003238418A patent/AU2003238418A1/en not_active Abandoned
- 2003-05-27 JP JP2004516563A patent/JP4420816B2/ja not_active Expired - Fee Related
- 2003-05-27 ES ES03732486T patent/ES2324404T3/es not_active Expired - Lifetime
- 2003-05-27 CN CNB038151049A patent/CN1318101C/zh not_active Expired - Fee Related
- 2003-05-27 AT AT03732486T patent/ATE424859T1/de active
- 2003-05-27 PT PT03732486T patent/PT1515758E/pt unknown
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WO2004002544A1 (de) | 2004-01-08 |
DE10243101A1 (de) | 2004-01-22 |
AU2003238418A1 (en) | 2004-01-19 |
CN1665551A (zh) | 2005-09-07 |
EP1515758B1 (de) | 2009-03-11 |
ATE424859T1 (de) | 2009-03-15 |
JP2005533542A (ja) | 2005-11-10 |
EP1515758A1 (de) | 2005-03-23 |
DE50311277D1 (de) | 2009-04-23 |
PT1515758E (pt) | 2009-06-18 |
CN1318101C (zh) | 2007-05-30 |
DK1515758T3 (da) | 2009-07-06 |
US20060100716A1 (en) | 2006-05-11 |
ES2324404T3 (es) | 2009-08-06 |
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