JP7413554B2 - 骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼ及びその製造方法 - Google Patents
骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼ及びその製造方法 Download PDFInfo
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- JP7413554B2 JP7413554B2 JP2022549958A JP2022549958A JP7413554B2 JP 7413554 B2 JP7413554 B2 JP 7413554B2 JP 2022549958 A JP2022549958 A JP 2022549958A JP 2022549958 A JP2022549958 A JP 2022549958A JP 7413554 B2 JP7413554 B2 JP 7413554B2
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- zirconium
- tray
- trabecular
- niobium alloy
- intermediate product
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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
- A61F2/28—Bones
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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
- 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
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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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- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30884—Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
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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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- 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
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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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- A61F2/3094—Designing or manufacturing processes
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- 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
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00089—Zirconium or Zr-based alloys
-
- 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
- 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
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- A61F2310/00095—Niobium or Nb-based alloys
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- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
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- A61L2420/00—Materials or methods for coatings medical devices
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- B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
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- B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
- B22F3/24—After-treatment of workpieces or articles
- B22F2003/248—Thermal after-treatment
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
- B22F2998/00—Supplementary information concerning processes or compositions relating to powder metallurgy
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
- B22F2999/00—Aspects linked to processes or compositions used in powder metallurgy
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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
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- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
- Y02P10/00—Technologies related to metal processing
- Y02P10/25—Process efficiency
Description
2)第2の中間生成物をプログラム冷却ボックスに入れ、1℃/分の速度で温度を-80℃~-120℃に下げ、一定温度で5時間~10時間放置し、プログラム冷却ボックスから取り出し、液体窒素内に入れて16時間~36時間置き、温度を室温に調整して第3の中間生成物を得るステップ、
3)第3の中間生成物をプログラム冷却ボックスに入れ、1℃/分の速度で温度を-80℃~-120℃に下げ、一定温度で5時間~10時間放置し、プログラム冷却ボックスから取り出し、液体窒素内に入れて16時間~36時間置き、温度を室温に調整して第4の中間生成物を得るステップ、
4)第4の中間生成物を機械加工トリミング、光沢仕上げ、洗浄及び乾燥させ、トレイ上面の表面粗さRa≦0.050μmとなる第5の中間生成物を得るステップ、及び、
5)第5の中間生成物を管状炉に入れ、酸素含有量5質量%~15質量%の常圧不活性ガスを導入し、5℃/分~20℃/分で500℃~700℃に加熱し、0.4℃/分~0.9℃/分で温度を400℃~495℃に下げ、200℃以下に自然冷却してから取り出し、骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼを得るステップ、
を有する骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの製造方法であって、
骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの第1の中間生成物、第2の中間生成物、第3の中間生成物、第4の中間生成物、第5の中間生成物は、骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの構造と同じであり;
前記不活性ガスは、ヘリウムガス又はアルゴンガスであり;
前記骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼは、腎臓形トレイ1を備え、腎臓形トレイの内側に湾曲した箇所の上面にダブテール形凸部3が設けられ、ダブテール形凸部3の2つの斜めの枝部の外側面に後部凹溝5が設けられ、腎臓形トレイ1のダブテール形凸部3に対して外向き湾曲部の上面に円弧状凸部2が設けられ、円弧状凸部2の内側面に前部凹溝6が設けられ、腎臓形トレイの下面の中央にステム4が設けられ、腎臓形トレイの下面のステム4を連結する部分以外の他の部分に骨梁9が設けられ、骨梁9は、近位トレイ骨梁層21と遠位トレイ骨梁層20とから成り;前記近位トレイ骨梁層21の気孔径及び気孔率は、均一に設けられ、遠位トレイ骨梁層が3つの領域に分割して設けられ;対応する腎臓形トレイの横径10は、第1のマーカー11及び第2のマーカー12によって第1セクション25、第2セクション26及び第3セクション27に分割され、第1セクション、第2セクション及び第3セクションの長さが腎臓形トレイの横径の25%~38%:24%~50%:25%~38%の順であり、第1の領域分割線13は第1のマーカー11を通過し、第2の領域分割線14が第2のマーカー12を通過し;第1の領域分割線13及び第2の領域分割線14は、直線又は円弧線で、対応する腎臓形トレイの遠位トレイ骨梁層20を内側領域15、中間領域16及び外側領域17に分割し;内側領域15骨梁の気孔径及び気孔率は、外側領域17及び中間領域16の骨梁の気孔径及び気孔率より順次大きい。
骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの製造方法であって、以下の構成を有する。すなわち、
1)ジルコニウム・ニオブ合金粉末を原料として、3Dプリントで一体成形して骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの第1の中間生成物を得、第1の中間生成物を熱間静水圧加圧装置に入れ、ヘリウムガスの保護雰囲気下にて、温度を1250℃に上げ、180MPaにて一定温度で3時間放置しながら常圧まで下げ、200℃以下となるまで炉内で冷却して取り出し、第2の中間生成物を得るステップ、
2)第2の中間生成物をプログラム冷却ボックスに入れ、1℃/分の速度で温度を-80℃に下げ、一定温度で10時間放置し、プログラム冷却ボックスから取り出し、液体窒素内に入れて16時間置き、温度を室温に調整して第3の中間生成物を得るステップ、
3)第3の中間生成物をプログラム冷却ボックスに入れ、1℃/分の速度で温度を-80℃に下げ、一定温度で10時間放置し、プログラム冷却ボックスから取り出し、液体窒素内に入れて16時間置き、温度を室温に調整して第4の中間生成物を得るステップ、
ステップ2)、ステップ3)の温度調整の具体的なステップは、温度を-120℃に上げ、一定温度で5時間保持し、次に温度を-40℃に上げ、一定温度で5時間保持し、さらに温度を4℃に上げ、一定温度で3時間保持した後、温度を上げ、
4)第4の中間生成物を機械加工トリミング、光沢仕上げ、洗浄及び乾燥させ、トレイ上面の表面粗さRa=0.012μmとなる第5の中間生成物を得るステップ、
5)第5の中間生成物を管状炉に入れ、酸素含有量5質量%の常圧ヘリウムガスを導入し、5℃/分で500℃に加熱し、0.4℃/分で温度を400℃に下げ、200℃以下に自然冷却してから取り出し、骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼを得るステップ、
骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの第1の中間生成物、第2の中間生成物、第3の中間生成物、第4の中間生成物、及び第5の中間生成物の構造は、骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの構造と同じである。
近位トレイ骨梁層21骨梁の気孔径は、0.43mmで、気孔率が60%で、開気孔率が100%で、厚さが0.6mmである。
骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの製造方法であって、以下の構成を有する。すなわち、
1)ジルコニウム・ニオブ合金粉末を原料として、3Dプリントで一体成形して骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの第1の中間生成物を得、第1の中間生成物を熱間静水圧加圧装置に入れ、ヘリウムガスの保護雰囲気下にて、温度を1350℃に上げ、160MPaにて一定温度で2時間放置しながら常圧まで下げ、200℃以下となるまで炉内で冷却して取り出し、第2の中間生成物を得るステップ、
2)第2の中間生成物をプログラム冷却ボックスに入れ、1℃/分の速度で温度を-100℃に下げ、一定温度で7時間放置し、プログラム冷却ボックスから取り出し、液体窒素内に入れて24時間置き、温度を室温に調整して第3の中間生成物を得るステップ、
3)第3の中間生成物をプログラム冷却ボックスに入れ、1℃/分の速度で温度を-100℃に下げ、一定温度で7時間放置し、プログラム冷却ボックスから取り出し、液体窒素内に入れて24時間置き、温度を室温に調整して第4の中間生成物を得るステップ、
ステップ2)、ステップ3)の温度調整ステップは、温度を-100℃に上げ、一定温度で4時間保持し、次に温度を-30℃に上げ、一定温度で4時間保持し、さらに温度を6℃に上げ、一定温度で2時間保持した後、温度を上げ、
4)第4の中間生成物を機械加工トリミング、光沢仕上げ、洗浄及び乾燥させ、トレイ上面の表面粗さRa=0.035μmとなる第5の中間生成物を得るステップ、
5)第5の中間生成物を管状炉に入れ、酸素含有量10質量%の常圧ヘリウムガスを導入し、15℃/分で600℃に加熱し、0.7℃/分で温度を450℃に下げ、200℃以下に自然冷却してから取り出し、骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼを得るステップ、
骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの第1の中間生成物、第2の中間生成物、第3の中間生成物、第4の中間生成物、第5の中間生成物は、骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの構造と同じ、
前記ジルコニウム・ニオブ合金粉末の化学組成は、質量%で、Zr:93.4%、Nb:5.1%を含有し、残部が不可避不純物であり;ジルコニウム・ニオブ合金粉末の粒子径は、45~150μmであり、西安賽隆金属材料有限責任会社から購入した。
骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの製造方法であって、以下の構成を有する。すなわち、
1)ジルコニウム・ニオブ合金粉末を原料として、3Dプリントで一体成形して骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの第1の中間生成物を得、前記第1の中間生成物を熱間静水圧加圧装置に入れ、アルゴンガスの保護雰囲気下にて、温度を1400℃に上げ、140MPaにて一定温度で1時間放置しながら常圧まで下げ、200℃以下となるまで炉内で冷却して取り出し、第2の中間生成物を得るステップ、
2)第2の中間生成物をプログラム冷却ボックスに入れ、1℃/分の速度で温度を-120℃に下げ、一定温度で5時間放置し、プログラム冷却ボックスから取り出し、液体窒素内に入れて36時間置き、温度を室温に調整して第3の中間生成物を得るステップ、
3)第3の中間生成物をプログラム冷却ボックスに入れ、1℃/分の速度で温度を-120℃に下げ、一定温度で5時間放置し、プログラム冷却ボックスから取り出し、液体窒素内に入れて36時間置き、温度を室温に調整して第4の中間生成物を得るステップ、
ステップ2)、ステップ3)の温度調整の具体的なステップは、温度を-80℃に上げ、一定温度で3時間保持し、次に温度を-20℃に上げ、一定温度で3時間保持し、さらに温度を8℃に上げ、一定温度で1時間保持した後、温度を上げ、
4)第4の中間生成物を機械加工トリミング、光沢仕上げ、洗浄及び乾燥させ、トレイ上面の表面粗さRa=0.050μmとなる第5の中間生成物を得るステップ、
5)第5の中間生成物を管状炉に入れ、酸素含有量15質量%の常圧アルゴンガスを導入し、20℃/分で700℃に加熱し、0.9℃/分で温度を495℃に下げ、200℃以下に自然冷却してから取り出し、骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼを得るステップ、
骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの第1の中間生成物、第2の中間生成物、第3の中間生成物、第4の中間生成物、第5の中間生成物は、骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの構造と同じであり;
ジルコニウム・ニオブ合金粉末の化学組成は、質量%で、Zr:96.5%、Nb:1%を含有し、残部が不可避不純物であり;ジルコニウム・ニオブ合金粉末の粒子径は、45~150μmであり、西安賽隆金属材料有限責任会社から購入し;
骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼは、腎臓形トレイ1を備え、腎臓形トレイの内側に湾曲した箇所の上面にダブテール形凸部3が設けられ、ダブテール形凸部3の2つの斜めの枝部の外側面に後部凹溝5が設けられ、腎臓形トレイ1のダブテール形凸部3に対して外向き湾曲部の上面に円弧状凸部2が設けられ、円弧状凸部2の内側面に前部凹溝6が設けられ、腎臓形トレイの下面の中央にステム4が設けられ、腎臓形トレイの下面のステム4を連結する部分以外の他の部分に骨梁9が設けられ、骨梁9は、近位トレイ骨梁層21と遠位トレイ骨梁層20とから成り;前記近位トレイ骨梁層21の気孔径及び気孔率は、均一に設けられ、遠位トレイ骨梁層が3つの領域に分割して設けられ;対応する腎臓形トレイの横径10は、第1のマーカー11及び第2のマーカー12によって第1セクション25、第2セクション26及び第3セクション27に分割され、第1セクション、第2セクション及び第3セクションの長さが腎臓形トレイの横径の25%:50%:25%の順であり、第1の領域分割線13は第1のマーカー11を通過し、第2の領域分割線14が第2のマーカー12を通過し;第1の領域分割線13及び第2の領域分割線14は、円弧線(図4)で、対応する腎臓形トレイの遠位トレイ骨梁層20を内側領域15、中間領域16及び外側領域17に分割し;
近位トレイ骨梁層21骨梁の気孔径は、0.36mmで、気孔率が55%で、開気孔率が100%で、厚さが0.2mmである。
ジルコニウム・ニオブ合金粉末(実施例1と同じ)を原料として、3Dプリントによる一体成形及び機械加工トリミングを経て、実施例1と同じ構造の脛骨プラトープロテーゼを得た。
実施例1、2、3の有限要素モデルに対し有限要素解析を実施して得られた有限要素解析ひずみのクラウドマップは、1000~3000の範囲の微小ひずみ(影付き部分)のみを示している。脛骨プラトー骨組織全体の有限要素モデルにおける実施例1~実施例3の脛骨プラトー骨組織の有限要素モデル上の1000~3000の微小ひずみ領域の割合は、65.6%、64.4%及び68.1%(図10、図11、図12)で、本発明の骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼが骨組織大部分領域の微小ひずみが最小有効ひずみ閾値と超生理学的ひずみ閾値との間にあることを実現し、骨の内方成長に有利であることを示している。
Claims (6)
- 1)ジルコニウム・ニオブ合金粉末を原料として、3Dプリントで一体成形して骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの第1の中間生成物を得、前記第1の中間生成物を熱間静水圧加圧装置に入れ、不活性ガスの保護雰囲気下にて、温度を1250℃~1400℃に上げ、140MPa~180MPaにて一定温度で1時間~3時間放置しながら常圧まで下げ、200℃以下となるまで炉内で冷却して取り出し、第2の中間生成物を得るステップ、
2)前記第2の中間生成物をプログラム冷却ボックスに入れ、1℃/分の速度で温度を-80℃~-120℃に下げ、一定温度で5時間~10時間放置し、プログラム冷却ボックスから取り出し、液体窒素内に入れて16時間~36時間置き、温度を室温に調整して第3の中間生成物を得るステップ、
3)前記第3の中間生成物をプログラム冷却ボックスに入れ、1℃/分の速度で温度を-80℃~-120℃に下げ、一定温度で5時間~10時間放置し、プログラム冷却ボックスから取り出し、液体窒素内に入れて16時間~36時間置き、温度を室温に調整して第4の中間生成物を得るステップ、
4)前記第4の中間生成物を機械加工トリミング、光沢仕上げ、洗浄及び乾燥させ、トレイ上面の表面粗さRa≦0.050μmとなる第5の中間生成物を得るステップ、及び
5)前記第5の中間生成物を管状炉に入れ、酸素含有量5質量%~15質量%の常圧不活性ガスを導入し、5℃/分~20℃/分で500℃~700℃に加熱し、0.4℃/分~0.9℃/分で温度を400℃~495℃に下げ、200℃以下に自然冷却してから取り出し、骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼを得るステップ、
を有する骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの製造方法であって、
骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの前記第1の中間生成物、前記第2の中間生成物、前記第3の中間生成物、前記第4の中間生成物、前記第5の中間生成物は、前記骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼの構造と同じであり;
前記不活性ガスは、ヘリウムガス又はアルゴンガスであり;
前記骨梁付き酸化物層を含むジルコニウム・ニオブ合金の脛骨プラトープロテーゼは、腎臓形トレイ(1)を備え、前記腎臓形トレイの内側に湾曲した箇所の上面にダブテール形凸部(3)が設けられ、前記ダブテール形凸部(3)の2つの斜めの枝部の外側面に後部凹溝(5)が設けられ、前記腎臓形トレイ(1)の前記ダブテール形凸部(3)に対して外向き湾曲部の上面に円弧状凸部(2)が設けられ、前記円弧状凸部(2)の内側面に前部凹溝(6)が設けられ、前記腎臓形トレイの下面の中央にステム(4)が設けられ、前記腎臓形トレイの下面のステム(4)を連結する部分以外の他の部分に骨梁(9)が設けられ、前記骨梁(9)は、近位トレイ骨梁層(21)と遠位トレイ骨梁層(20)とから成り;前記近位トレイ骨梁層(21)の気孔径及び気孔率は、均一に設けられ、前記遠位トレイ骨梁層が3つの領域に分割して設けられ;対応する前記腎臓形トレイの横径(10)は、第1のマーカー(11)及び第2のマーカー(12)によって第1セクション(25)、第2セクション(26)及び第3セクション(27)に分割され、前記第1セクション、前記第2セクション及び前記第3セクションの長さが前記腎臓形トレイの横径の25%~38%:24%~50%:25%~38%の順であり、第1の領域分割線(13)は前記第1のマーカー(11)を通過し、第2の領域分割線(14)が前記第2のマーカー(12)を通過し;前記第1の領域分割線(13)及び前記第2の領域分割線(14)は、直線又は円弧線で、対応する前記腎臓形トレイの前記遠位トレイ骨梁層(20)を内側領域(15)、中間領域(16)及び外側領域(17)に分割し;前記内側領域(15)骨梁の気孔径及び気孔率は、前記外側領域(17)及び前記中間領域(16)の骨梁の気孔径及び気孔率より順次大きい
ことを特徴とする製造方法。 - 前記ジルコニウム・ニオブ合金粉末の化学組成は、質量%で、Zr:85.6%~96.5%、Nb:1.0%~12.5%を含有し、残部が不可避不純物であり;前記ジルコニウム・ニオブ合金粉末の粒子径は、45~150μmである
請求項1に記載の方法。 - 前記近位トレイ骨梁層(21)骨梁の気孔径は、0.36mm~0.50mmで、気孔率が55%~65%で、開気孔率が100%で、厚さが0.2mm~1mmである
請求項1に記載の方法。 - 前記遠位トレイ骨梁層(20)の前記第1の領域分割線(13)及び前記第2の領域分割線(14)が直線の場合、平行又は八字形に配置され;前記第1の領域分割線(13)と前記腎臓形トレイの横径(10)とのなす角度(18)は100°~60°の範囲で、前記第2の領域分割線(14)と腎臓形トレイの横径(10)とのなす角度19は80°~120°の範囲である
請求項1に記載の方法。 - 前記遠位トレイ骨梁層(20)の前記内側領域骨梁の気孔径は1.00mm~1.10mmで、気孔率が77.6%~85%で、開気孔率が100%であり;前記中間領域骨梁の気孔径は、0.74mm~0.85mmで、気孔率が70.0%~74.7%で、開気孔率が100%であり;前記外側領域骨梁の気孔径は、0.86mm~0.99mmで、気孔率が74.8%~77.5%で、開気孔率が100%で;前記遠位トレイ骨梁層20の厚さが0.5mm~3mmである
請求項1に記載の方法。 - 前記ステムは、支持板が連結され異径管、支持板が連結され、底部が閉鎖された異径管、十字形リブプレート、又は湾曲した十字形リブプレートである
請求項1に記載の方法。
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