JP2018525090A - プロテーゼ構成部品およびその製造方法 - Google Patents
プロテーゼ構成部品およびその製造方法 Download PDFInfo
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Images
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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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- A61F2/36—Femoral heads ; Femoral endoprostheses
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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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- 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
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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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- 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
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- Veterinary Medicine (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- Manufacturing & Machinery (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
Description
表面における今後の骨結合を促進するために適した設計および特殊加工表面仕上げを有するポリマ基材を形成すること、および物理蒸着(PVD)スパッタリングによって、上記ポリマ基材にチタンを備えるコーティングを堆積することのステージを備える。
・造骨細胞活動を刺激するために適した表面の微小粗さ、
・寛骨臼腔内におけるカップの圧入組立て、
・8mm以上の耐疲労性(サイクル荷重)を確実にするUHMWPE寛骨臼の厚さ。
・コーティングとポリマ基材との良好な接着性、
・骨結合を刺激する生体活性表面、
・造骨細胞活動を刺激するために適した粗さ。
・固着層13
このコーティングエリアの目的は、金属性のコーティングの下側エリアとポリマ性の構成部品基材表面との良好な接着および強力な固着を確実にすることである。コーティングのこの第1層は、10nm〜100nmの範囲の厚さ、および均一な組成の金属クロム(Cr)から成る。
・中間移行層14
コーティングのこの移行エリアは、UHMWPEポリマ基材の表面と直接接するコーティングの第1固着層のすぐ次に位置する。移行層は、基材の表面と直接接する固着層と、股関節の骨組織と直接接するコーティングの表面層との間に設けられる。
・コーティングにおける内部応力の発生に関するあらゆる問題を防止する、層の厚さに沿った機械的特性の段階的移行、
・コーティング内部の層間に境界がないことにより、コーティングの構造安定性および耐疲労性を大幅に高めること、
・単層構造内の様々なコーティング組成の相乗効果の利点を得ることが可能であり、生物学的および骨結合の観点において最適な表面層に加えて、コーティングの最適な接着および固定を確実にする組成を固着層に存在させることが可能であること。
・外表面層15
コーティングの外表面層は、中間移行層の上面に接して位置する。表面層は、移行層と、股関節の骨組織表面との間に位置する。
・コーティングの生体適合性を確実にすることにより、プロテーゼシステムの不具合を招く繊維被包形成を防止する、
・後述するコーティング表面の生体活性を確実にするとともにコーティングの骨結合を確実にする、後続の熱化学処理を実行することを可能にする、
・チタン層によって生成されるイオンの放出に対する障壁の効果とともにコーティングの優れた耐腐食性をもたらす。
・システムの構造安定性および生体活性を確実にすること、
・移植時に生体内条件下で有害になり得るいかなる種類の表面汚染も持ち込まれていないことを確実にすること、
・コーティングの表面に骨を固定させるために最も適切なレベルの粗さを確実にするために、処理の実行前に処理されるサンプルの初期状態の表面粗さレベルを維持すること。
Claims (20)
- ポリマ材料で作られた基材(11)およびコーティング(12)を備え、前記コーティング(12)はチタンを含むことを特徴とする、プロテーゼ構成部品(10)。
- 前記構成部品はクロムも含むことを特徴とする、請求項1に記載のプロテーゼ構成部品(10)。
- 前記コーティング(12)は、基材(11)と接する固着層(13)およびチタンを含む外表面層(15)を備えることを特徴とする、請求項1に記載のプロテーゼ構成部品(10)。
- 前記コーティング(12)の前記固着層(13)はクロムで作られることを特徴とする、請求項3に記載のプロテーゼ構成部品(10)。
- 前記コーティング(12)は、前記固着層(13)と前記外表面層(15)との間に配置された移行層(14)を更に備えることを特徴とする、請求項3に記載のプロテーゼ構成部品(10)。
- 前記移行層(14)はクロムおよびチタンの合金で作られることを特徴とする、請求項5に記載のプロテーゼ構成部品(10)。
- 前記固着層(13)は、10nm〜100nmの範囲の厚さを有することを特徴とする、請求項3に記載のプロテーゼ構成部品(10)。
- 前記外表面層(15)は、400nm〜1000nmの範囲の厚さを有することを特徴とする、請求項3に記載のプロテーゼ構成部品(10)。
- 前記移行層(14)は、10nm〜50nmの範囲の厚さを有することを特徴とする、請求項5に記載のプロテーゼ構成部品(10)。
- 前記コーティング(12)は、2〜6μmの範囲の外面粗さを有することを特徴とする、請求項1に記載のプロテーゼ構成部品(10)。
- 前記コーティング(12)は、物理蒸着(PVD)スパッタリングによって前記基材(11)に堆積されることを特徴とする、請求項1〜10のいずれか1項に記載のプロテーゼ構成部品(10)。
- 前記ポリマ基材(11)は、超高分子量ポリエチレン(UHMWPE)、高架橋ポリエチレン(HXLPE)、高密度ポリエチレン(HDP)、ポリエーテルエーテルケトン(PEEK)、ポリメチルメタクリレート(PMMA)および/またはポリエチレン(PE)、またはそれらの組み合わせを備えることを特徴とする、請求項1に記載のプロテーゼ構成部品(10)。
- 前記ポリマ基材(11)は、ビタミンEを更に含むことを特徴とする、請求項1に記載のプロテーゼ構成部品(10)。
- ポリマ基材(11)を形成するステージ、および
物理蒸着(PVD)スパッタリングによって、前記ポリマ基材(11)にチタンを備えるコーティング(12)を堆積するステージを備える、請求項1〜13のいずれか1項に記載のプロテーゼ構成部品(10)を製造する方法。 - 前記基材(11)の堆積後に表面生体活性化処理ステージを更に備えることを特徴とする、請求項14に記載のプロテーゼ構成部品(10)を製造する方法。
- 前記表面生体活性化処理ステージは、
前記コーティング(12)にチタン酸ナトリウムゲルの層を生成するための前記構成部品(10)の化学処理、
前記チタン酸ナトリウムゲル層の乾燥、および
前記寛骨臼構成部品(10)の熱処理を備えることを特徴とする、請求項15に記載のプロテーゼ構成部品(10)を製造する方法。 - 前記化学処理は、6時間〜72時間の範囲の期間にわたり40℃〜140℃の範囲の温度のNaOH溶液に前記構成部品(10)を浸漬することを備えることを特徴とする、請求項16に記載のプロテーゼ構成部品(10)を製造する方法。
- 前記化学処理は、前記NaOH溶液に前記寛骨臼構成部品を浸漬した後、超純水に前記部品(10)を浸漬することを更に備えることを特徴とする、請求項17に記載のプロテーゼ構成部品(10)を製造する方法。
- 前記乾燥は、6時間〜72時間の範囲の期間にわたり40℃〜140℃の範囲の温度で実行されることを特徴とする、請求項16に記載のプロテーゼ構成部品(10)を製造する方法。
- 前記化学処理は、40℃〜140℃の範囲の温度で60〜300分の範囲の期間にわたり実行されることを特徴とする、請求項16に記載の股関節プロテーゼの寛骨臼構成部品(10)を製造する方法。
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