JP5042410B2 - 骨組織および/または結合組織の内成長および成長をもたらすためのボディ並びにこのようなボディを作る方法 - Google Patents
骨組織および/または結合組織の内成長および成長をもたらすためのボディ並びにこのようなボディを作る方法 Download PDFInfo
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- JP5042410B2 JP5042410B2 JP2000613493A JP2000613493A JP5042410B2 JP 5042410 B2 JP5042410 B2 JP 5042410B2 JP 2000613493 A JP2000613493 A JP 2000613493A JP 2000613493 A JP2000613493 A JP 2000613493A JP 5042410 B2 JP5042410 B2 JP 5042410B2
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- growth
- bone
- bone tissue
- tissue
- ingrowth
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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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
- A61F2310/00341—Coral, e.g. aragonite, porite
-
- 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
- A61F2310/00365—Proteins; Polypeptides; Degradation products thereof
-
- 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
- A61F2310/00365—Proteins; Polypeptides; Degradation products thereof
- A61F2310/00377—Fibrin
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/23—Sheet including cover or casing
- Y10T428/233—Foamed or expanded material encased
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/23—Sheet including cover or casing
- Y10T428/239—Complete cover or casing
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/24—Structurally defined web or sheet [e.g., overall dimension, etc.]
- Y10T428/24273—Structurally defined web or sheet [e.g., overall dimension, etc.] including aperture
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/249921—Web or sheet containing structurally defined element or component
- Y10T428/249953—Composite having voids in a component [e.g., porous, cellular, etc.]
- Y10T428/249954—With chemically effective material or specified gas other than air, N, or carbon dioxide in void-containing component
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/249921—Web or sheet containing structurally defined element or component
- Y10T428/249953—Composite having voids in a component [e.g., porous, cellular, etc.]
- Y10T428/249967—Inorganic matrix in void-containing component
- Y10T428/24997—Of metal-containing material
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/249921—Web or sheet containing structurally defined element or component
- Y10T428/249953—Composite having voids in a component [e.g., porous, cellular, etc.]
- Y10T428/249971—Preformed hollow element-containing
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/249921—Web or sheet containing structurally defined element or component
- Y10T428/249953—Composite having voids in a component [e.g., porous, cellular, etc.]
- Y10T428/249978—Voids specified as micro
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/249921—Web or sheet containing structurally defined element or component
- Y10T428/249953—Composite having voids in a component [e.g., porous, cellular, etc.]
- Y10T428/249978—Voids specified as micro
- Y10T428/249979—Specified thickness of void-containing component [absolute or relative] or numerical cell dimension
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- Inorganic Chemistry (AREA)
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- Heart & Thoracic Surgery (AREA)
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Description
SE‐B‐462,638は、空洞を有する生体組織へ大腿骨人工器官のステムのような細長い人工器官を固定するための手段について開示しており、1本の人工器官がその空洞の境界部へ隙間をあけて入れられる。本質的に、その隙間全体が、ゆったりしているがいっぱいに詰め込んだ生体適合性物質の粒体で満たされ、その粒体は相互につながれている。粒体質の例としてチタンが挙げられ、その粒体は不規則で、本質的に非弾性であり、好ましくは多孔質であると述べられており、後者の性質が骨性壁から成長した骨組織の増殖部分を結合していると言われている。多孔性は粒体物質の溶融物にガスを吹き込んで得られた。
【0002】
US‐A‐5,217,496は、生体骨組織で使用に適し、多孔質外表面を有するチタンの支持体と、粉砕された生体骨組織およびチタン粉末からなる混合物の付着層とから構成される、インプラントについて開示している。その混合物には栄養素が補充されるが、これは粉砕された骨組織を成長させて、粉砕された生体骨組織およびチタン粉末を互いにおよび支持体と結びつける組織を形成させる。
【0003】
US‐A‐5,676,700は骨組織の修復、強化および置換のための生体適合性構造材料について開示しており、その材料は骨組織空洞で骨接続性および骨誘導性マトリックスを形成するように適用される。その材料物質はチタンでもよく、材料は自然骨の内成長のために微孔質であることが有利と言われている。
【0004】
上記すべての文献では、生体適合性物質として、チタンに加えて、特にヒドロキシルアパタイト、バイオセラミックス、バイオガラスを挙げている。
上記文献では、生体適合性物質の多孔性が骨組織の結合にとり好ましいものを生じさせていると指摘している。
【0005】
本発明によると、生体適合性物質の多孔性の既定尺度が骨組織の成長速度に関する実際上の決定的要因であることが意外にもわかった。
‐生体適合性物質の粒体のようなボディが連続的な多孔質であり、
‐ボディの多孔性が最低限界値を有しているならば、
表面多孔性が確かに骨組織を結合させながら、骨組織の有意に高い成長速度および多量の骨、ひいては生体適合性物質で骨組織の有意に改善されたアンカーリング(anchoring)および強度が得られることがわかった。
本発明の追加利点は多孔質顆粒の強度により得られ、その強度は骨組織を内成長させた方が骨を内成長させない場合よりも大きい。骨の内成長のおかげで、強度が主に骨組織により得られるようになり、これはバイオメカニカルな観点からは好ましい。
【0006】
“連続的な多孔質”とは、生体適合性物質の粒体のような多孔質ボディ中に骨組織を成長させるような多孔性を意味している。本発明によると、このような多孔性は導管、通路で相互につながれた空洞をボディにもたらすため、そのボディの外表面の一部への骨組織の成長は、ボディ内を通って、ボディの外表面の他部分から外部へと成長を続けさせる。空洞とは、任意形状の切れ込み、くぼみ、ポケットを意味し、これらの空洞をつなげる導管、通路は任意形態を有して、空洞の一部を構成することができる。このような構造の例は、サンゴまたは鍾乳洞で自然にみられる。
【0007】
最低限界値とは、>約50μmの幅を有した切れ込み、くぼみ、ポケットおよび導管の開口部をここでは意味する。栄養素の供給が抑制されて、含有された材料で骨の正常な構造に発育させることが妨げられることから、それより小さな開口部寸法では骨組織の成長を制限または抑制してしまう。事実、ボディの多孔性に上限はない。上限はむしろボディの強度により決められる。
本発明によると、互いに隣同士に位置して開いた表面孔を有するボディで表面孔から空洞を形成させることができ、その結果あるボディの表面孔が他のボディの表面孔と一緒になって空洞または導管/通路を形成する。
【0008】
本発明によると、ヒドロキシルアパタイトのような脆い生体適合性物質は、このような物質が自然骨の修復、強化および置換に用いられたとき、本発明の目的にとり最適ではないこともわかった。このような物質は、必然的に生じる負荷に曝されたとき、例えば粒体のような生体適合性ボディが存在する人体または人体の一部が例えば四肢を動かしたときに負荷に曝されたとき、容易に分解してしまう。生体適合性物質のボディの分解部分は、骨の形成を妨げて骨吸収を多々もたらすという、好ましくない炎症反応を生じる。
【0009】
本発明によると、金属物質または非脆弱複合材が選択され、そこではヒドロキシルアパタイト、バイオセラミックスなどのような天然物質を多孔質ボディの物質中の成分として含有させてもよく、プラスチックのような他成分も可塑性を保証する。本発明によるボディ物質は事実上可塑性または非本質的に弾性にすべきである。過度な弾性は骨組織に圧力をかけて、後でそれを壊してしまう。
【0010】
チタン(二酸化チタン)が金属物質として有利に選択される。チタンボディの多孔性はチタンの溶融物にガスを吹き込んで有利に得られる。こうして、SE‐B‐462,638で記載されているように、チタン粒体を生産することができる。
しかしながら、上記のような多孔性に関する要件は、金属の溶融物にガスを吹き込むことだけで、自動的に満たされるわけではない。本発明によると、こうして得られたボディ/粒体の多孔性をチェックして、それが要件を満たすかどうかを確認する。チェックは、例えば、適切な波長での蛍光透視法、およびTV受像機、および上記要件を満たさない粒体の自動分離(例えば、コンベヤーベルトから)により行うことができる。
【0011】
>約50μmの上記限界値は骨組織に関する。結合組織の内成長が骨組織の代わりにまたはそれを犠牲にして望まれるならば、限界値は>約50〜10μmとなる。
本発明による粒体のような多孔質ボディは、インビボで骨組織の成長後に代替物として骨空洞、失われた足(リウマチ、骨粗鬆症)を満たすため、またはSE‐B‐462,638に従い人工器官を固定するために、人体のような生体ボディに埋め込むことができる。本発明による多孔質ボディは、インビトロで骨組織の前培養向けのベースとして機能することもあり、または後で生体組織へ埋め込むためにインビトロで特に成長因子を含有した栄養溶液で満たしてもよい。骨空洞を満たす場合には、ボディは粒状および不規則的で、<10mmの大きさを有していることが好ましく、こうすると複数/多数の粒体で骨空洞を最適に満たせる。
【0012】
多孔質ボディは、例えば、天然物質のいわゆるマトリックスの分解性物質で満たしてもよい。このような天然マトリックスの例は、コラーゲン、フィブリン、デンプンおよびヒアルロン酸のゲルである。本発明によると、このマトリックスは分解して内成長骨組織に置き換わる。骨組織の内成長は、成長刺激物質、特にTGFβ(トランスフォーミング成長因子β)またはBGF(骨成長因子)のような成長因子が分解性物質へ加えられたならば、更に刺激される。本発明によるボディの孔は、例えば吸引により、ゲル物質と共に動かしてから、その物質をゲル化してもよい。
【0013】
本発明による粒体で、小さなボディは、インプラントを生産するために、フレキシブルなまたは堅いケーシングに封入してもよい。例えば、本発明による粒体は、スリーブ(例えばUS‐A‐5,015,247のスリーブ参照)と一緒にして、背骨インプラントを形成するために、堅いスリーブに封入してもよい。ケーシングに封入する他の可能性はSE9803078‐6で開示されている。ケーシングは、生物細胞物質の内成長および成長を、その粒体へおよびそこからそのケーシングへと行わせるための開口部を有している。本発明による粒体は、分解した生物組織と混合してもよい。
【0014】
本発明の態様は電子顕微鏡画像である添付図面で説明されており、図1は本発明による多孔質構造を示し、図2はチタン粒体の外表面の本発明による別な多孔質構造を示している。図3は本発明による多孔性を有したチタン粒体の薄片の画像である。すべての画像は、SE‐B‐462,638で更に詳細に記載された振動技術を用いて埋め込んだ後に人体の大腿骨から除去された、不規則な粒体または顆粒から作成されている。
【0015】
図1は石の山の形態をした構造を示し、図2はサンゴ構造を示している。その構造は、チタンの溶融物にガスを吹き込み、上記の品質チェックを行うことにより得られた。双方の画像は骨組織の前段階として生体物質の淡灰色皮膜を示しており、それは粒体の外表面を覆って、チタン粒体の孔における空洞および隙間中へ浸透していた。図1は構造中の空洞/隙間を橋かけする骨細胞増殖も示している。
図3は、本発明による粒体と交わってそこに浸透した骨組織を示している。
【0016】
臨床分析では、図1〜3による粒体中の骨組織が95〜98%骨、2%骨髄および0〜3%結合組織の組成を有しており、その粒体外でそれらの近くに存在する骨の組成と本質的に一致することを証明した。
【図面の簡単な説明】
【図1】 本発明による多孔質構造を示す電子顕微鏡画像である。
【図2】 チタン粒体の外表面の本発明による別な多孔質構造を示している電子顕微鏡画像である。
【図3】 本発明による多孔性を有したチタン粒体の薄片の電子顕微鏡画像である。
Claims (1)
- 骨組織および/または結合組織の内成長および成長をもたらすための不規則形状の金属または金属合金粒体の製造方法であって、
該粒体は、該粒体の中を通して連続的である多数の孔を含んでなり、該多数の孔の開口部、および該多数の孔の少なくとも一部をつなげる導管または通路の開口部は50μmより大きい幅を有しており、
上記方法は、
金属または金属合金の溶融物にガスを吹き込んで多数の粒体を作り、多数の孔開口部を有する粒体を分離することを特徴とし、
ここで、上記の孔開口部は50μmより大きい幅を有し、該多数の孔の少なくとも一部をつなげる導管または通路は50μmより大きい幅を有している、方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE9901523-2 | 1999-04-28 | ||
SE9901523A SE515227C2 (sv) | 1999-04-28 | 1999-04-28 | Kropp för åstadkommande av in- och tillväxt av benvävnad och/ eller bindväv och sätt för framställning av kroppen |
PCT/SE2000/000802 WO2000064504A2 (en) | 1999-04-28 | 2000-04-28 | Body for providing ingrowth and growth of bone tissue and/or connective tissue and method of making such a body |
Publications (2)
Publication Number | Publication Date |
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JP2002541984A JP2002541984A (ja) | 2002-12-10 |
JP5042410B2 true JP5042410B2 (ja) | 2012-10-03 |
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JP2000613493A Expired - Fee Related JP5042410B2 (ja) | 1999-04-28 | 2000-04-28 | 骨組織および/または結合組織の内成長および成長をもたらすためのボディ並びにこのようなボディを作る方法 |
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US (2) | US7056577B1 (ja) |
EP (1) | EP1187641B1 (ja) |
JP (1) | JP5042410B2 (ja) |
KR (1) | KR100879424B1 (ja) |
CN (1) | CN1229147C (ja) |
AT (1) | ATE404229T1 (ja) |
AU (1) | AU763045B2 (ja) |
BR (1) | BR0010152B1 (ja) |
CA (1) | CA2370724C (ja) |
DE (1) | DE60039871D1 (ja) |
ES (1) | ES2308980T3 (ja) |
HK (1) | HK1047056B (ja) |
IL (2) | IL146089A0 (ja) |
MX (1) | MXPA01010958A (ja) |
NO (1) | NO323629B1 (ja) |
PL (1) | PL202374B1 (ja) |
RU (1) | RU2222290C2 (ja) |
SE (1) | SE515227C2 (ja) |
WO (1) | WO2000064504A2 (ja) |
ZA (1) | ZA200108483B (ja) |
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